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The Panel met at 8:00 a.m. in Salons A, B,
and C of the Hilton Washington, D.C.
North/Gaithersburg, 620 Perry Parkway, Gaithersburg,
Maryland, MICHAEL A. CHOTI, M.D., Chairman, presiding.
MICHAEL A. CHOTI, M.D., Chairman
GRACE T. BARTOO, Ph.D., RAC, Industry Representative
BRENT A. BLUMENSTEIN, Ph.D., Voting Member
LEIGH F. CALLAHAN, Ph.D., Temporary Voting Member
LEELEE DOYLE, Ph.D., Consumer Representative
CHERYL A. EWING, M.D., Voting Member
A. MARILYN LEITCH, M.D., Voting Member
STEPHEN LI, Ph.D., Temporary Voting Member
JOSEPH LoCICERO III, M.D., Voting Member
BARBARA R. MANNO, Ph.D., Temporary Voting Member
MICHAEL J. MILLER, M.D., Voting Member
AMY E. NEWBURGER, M.D., Voting Member
DAVID KRAUSE, Ph.D., Executive Secretary
Call to Order 3
Conflict of Interest and Opening Remarks 4
David Krause, Ph.D. Executive Secretary
Panel Introductions 6
Michael Choti, M.D., Chairman
Panel Update 13
CDR Stephen R. Rhoades, USPHS, Acting Deputy
Director, Division of General, Restorative,
and Neurological Devices, Office of Device
Welcoming Remarks 16
Miriam Provost, Ph.D., Acting Director,
Open Public Comment 26
(8:05 a.m.)
EXECUTIVE SECRETARY KRAUSE: Good morning everybody. If we could have everybody find a chair? We're trying to get the speakers. There are still some speakers outside. And it's the staff trying to get them in. So we may have to wait a little bit later, but I think we'll go ahead and get started now. And then if everybody's not quite ready, we'll just hold up a few minutes. But I think we'll get the meeting started so that we can at least try to keep close to schedule.
Good morning, everyone. We're ready to begin the 66th meeting of the General and Plastic Surgery Devices Panel. My name is David Krause. I'm the Executive Secretary of this panel. And I'm also a biologist and a reviewer in the Plastic and Reconstructive Surgery Devices Branch in the Division of General, Restorative, and Neurological Devices.
I'd like to remind everyone that you are requested to sign in on the attendants' sheets, which are available at the tables by the doors just outside. You may also pick up an agenda, a panel member roster, and information about today's meeting out there on the tables.
The information includes how to find out about future meeting dates through the advisory panel phone line and how to obtain meeting minutes or transcripts.
Before I turn the meeting over to Dr. Choti, I'm required to read a statement into the record regarding conflict of interest.
EXECUTIVE SECRETARY KRAUSE: "The following announcement addresses conflict of interest issues associated with this meeting and is made a part of the record to preclude the appearance of an impropriety.
"To determine if any conflict existed, the agency reviewed the submitted agenda for this meeting and all financial interests reported by the committee participants.
"Conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employers' financial interests. However, the agency has determined that participation of certain members and consultants, the need for whose services outweigh the potential conflict of interest involved, is in the best interest of the government.
"We would like to note for the record that the agency took into consideration certain matters regarding Dr. Miller. Dr. Miller reported his institution's past and current involvement with firms at issue.
"In the absence of personal financial interest, the agency has determined that he may participate fully in the panel's deliberations. In the event that the discussions involve any other products or firms not already on the agenda for which an FDA participant has a financial interest, a participant should excuse him or her self from such involvement. And the exclusion will be noted for the record.
"With respect to all other participants, we ask in the interest of fairness that all persons making statements or presentations disclose any current or previous financial involvement with any firm whose products they may wish to comment upon."
At this point I'd like to turn the meeting over to Dr. Choti, the chairman.
CHAIRMAN CHOTI: Thank you, Dr. Krause, and good morning.
My name is Dr. Michael Choti. I'm in the Division of Surgical Oncology at Johns Hopkins University. And I am the standing chair of this panel.
During this three‑day meeting, we, our panel, would like to make recommendations to the Food and Drug Administration on two pre‑market approval applications.
CHAIRMAN CHOTI: The next item of business is to introduce the panel members, who are giving their time to help the FDA in these matters and the FDA staff here at the table. I'm going to ask each person to introduce him or herself, starting with both the area of expertise, position title, institution, and his or her status on the panel, either voting member or industry. Let me start on the left side of the panel here with Dr. Bartoo.
MEMBER BARTOO: My name is Grace Bartoo. I'm the General Manager of Decus Biomedical. I have experience in biomedical engineering. That's what my training is in. But I also have a lot of experience in clinical trials and medical advice research.
I am the industry representative for the panel.
MEMBER DOYLE: My name is LeeLee Doyle. I have a Ph.D. in reproductive physiology. I am a Professor Emeritus of Obstetrics and Gynecology and currently the Assistant Dean for Faculty Development at the University of Arkansas for Medical Sciences College of Medicine.
I am the consumer representative, a nonvoting member.
MEMBER BLUMENSTEIN: My name is Brent Blumenstein. I am a biostatistician. I work independently from Seattle, Washington.
MEMBER EWING: My name is Cheryl Ewing. I am a faculty member at the University of California at San Francisco in the Department of Surgery in surgical oncology with a specialty in breast oncology.
MEMBER NEWBURGER: I'm Dr. Amy Newburger. I'm a dermatologist in private practice, Director of Dermatology Consultants of Westchester. I teach at St. Luke's‑Roosevelt Hospital Medical Consortium.
MEMBER LoCICERO: I'm Joseph LoCicero. I'm a thoracic surgeon specializing in foregut surgery. I'm Professor and Chair of Surgery at the University of South Alabama.
And I am a voting member.
MEMBER MANNO: I'm Dr. Barbara Manno. I am a toxicologist. I'm a professor with the Department of Psychiatry at the Louisiana State University Health Sciences Center in Shreveport, Louisiana and voting today.
MEMBER LI: My name is Steve Li. I am the President of Medical Device Testing and Innovations in Sarasota, Florida. My areas of expertise are biomechanics and biomaterials.
And I am a voting member today.
EXECUTIVE SECRETARY KRAUSE: My name is David Krause. I am the Executive Secretary.
MEMBER CALLAHAN: I'm Leigh Callahan. I'm a health outcomes researcher, an epidemiologist at the University of North Carolina in Chapel Hill. I'm in the Departments of Medicine and Orthopedics.
And I am a temporary voting member for this panel.
DR. MILLER: I'm Michael Miller. I am Professor and Deputy Chairman of Plastic Surgery at University of Texas, M. D. Anderson Cancer Center.
My clinical work involves cancer‑related reconstructive surgery. I also have appointments in biomedical engineering with the University of Texas Center for Biomedical Engineering and at Rice University.
MEMBER LEITCH: I'm Marilyn Leitch. I'm a surgical oncologist at the University of Texas Southwestern Medical Center in Dallas. I also am involved primarily in the treatment of breast cancer patients but do see patients with benign diseases as well. And I am a professor of surgery.
DR. PROVOST: I'm Miriam Provost. I am Acting Director for the Division of General, Restorative, and Neurological Devices in the Office of Device Evaluation at FDA.
EXECUTIVE SECRETARY KRAUSE: Let me just clarify for the record that Drs. Leitch, Miller, LoCicero, Newburger, Ewing, and Blumenstein are all voting members on this panel. Drs. Manno, Li, and Callahan are deputized voting members. And we will read the deputization memo tomorrow.
CHAIRMAN CHOTI: I would like to note for the record that the voting members present constitute a quorum, as required by 21 CFR Part 14.
Let me read a letter from Dr. Michael Olding, who was to be a member, a nonvoting member, on this panel. He elected not to be present and requested that the following letter be read, "Dear Dr. Choti, I would like to request the following statement to be read into the record at the time of the General and Plastic Surgery Panel meeting.
"On December 2004, I agreed to serve on this panel with great enthusiasm for its mission and with a full understanding of the commitment and the need for impartiality. Accordingly, I completed the required conflict of interest statement in January 2005, indicated that there are no conflicts.
"Subsequently, on March 21st, 2005, Medicus Pharmaceutical Corporation announced plans to merge with Inamed Corporation, a firm at issue. That merger is subject to approval by stockholders, regulatory approvals, and customary closing conditions according to the companies.
"Upon learning of the planned merger, I immediately notified the Executive Secretary of the proposed merger and that I owned a quantity of stock in Medicus.
"Initially, on April 1st, 2005, the Executive Secretary indicated that my service on the panel would not be affected by my stock holdings and the planned merger, but one business day before this meeting, on Friday, April 8th, I received a fax from Integrity Committee and Conference Management Branch informing me that due to the stock‑holding value, between 50,000 and 100,000, in a firm that is slated to merge with a firm at issue, I would be excluded from voting on the panel. It does appear that I would be allowed to 'review and discuss matters before the panel,' even though I am denied the right to vote.
"As the chronology demonstrates, the incipient conflict was created by the decision of the two companies to merge and not by any action on my part. Indeed, I made the FDA aware of the situation.
"I was fully prepared and committed to continuing my service on the panel impartially and a relatively small stock‑holding I have in the company, which until March 2005 had no interest in the outcome of our work, would have no bearing on my decision‑making process.
"I do not feel it is appropriate for me to continue my service on the panel as a partial member; that is, one without voting rights. Since the FDA has concluded that my voting may create an appearance of a conflict due to my stock holdings, I do not want my continued service as a nonvoting panel member to be suspect in any way.
"I regret having to make this decision as I possess important experience as a plastic surgeon for the panel to consider. And my departure will leave only one other professional with similar experience. But the handicap that the FDA has placed upon me because of the incipient conflict, not of my making, that arose since my appointment to the panel makes my decision necessary.
"Thank you for your consideration and understanding. And good luck to you and the panel in your important work. Sincerely, Michael Olding."
Now I would like to introduce Commander Stephen Rhoades, the Acting Deputy Director of the Division of General, Restorative, and Neurological Devices, who will update the panel since the last meeting.
Dr. Rhoades?
CDR RHOADES: Thank you, Dr. Choti.
CDR RHOADES: I am Stephen Rhoades. I am the Acting Deputy Director in the Division of General, Restorative, and Neurological Devices. Welcome, members of the panel, members of the public, and manufacturers, to this important three‑day meeting of the General and Plastic Surgery Devices Panel on two silicone gel‑filled breast implants.
Tomorrow you will make recommendations and vote on Inamed Corporation's pre‑market approval application. On Wednesday, you will make recommendations and vote on Mentor Corporation's pre‑market approval application.
Because of the high public interest in silicone gel‑filled breast implants, in addition to the regular public comment periods for any PMA discussion, we have scheduled a full day for a public comment on issues related to silicone gel‑filled breast implants.
This panel last met on March 25th of 2004, at which time you recommended approval of Dermik Laboratories pre‑market approval application for their Sculptra dermal filler for lipoatrophy in HIV‑positive patients. This device application was approved on August 3rd with a conditional post‑approval study to evaluate long‑term safety.
On April 22nd of 2004, FDA approved Genzyme Corporation's Hylaform dermal filler for moderate to severe facial wrinkles and folds.
This panel recommended approval of this device at the November 21st, 2003 panel meeting. The approval included a condition for a post‑approval study in patients with Fitzpatrick IV to VI skin types.
On August 9th, 2004, FDA issued a final rule classifying silicone sheeting for the management of closed hyperproliferative scars as Class I devices exempt from pre‑market notification. This panel recommended that these be Class I‑exempt at the July 24th, 2003 panel meeting.
The agency appreciates the commitment of the panel members. And we also appreciate the comments of the representatives of the 30 professional organizations and 145 members of the public who have requested time to address the panel today.
Thank you for your attention. I would now like to introduce Dr. Miriam Provost for a few words.
DR. PROVOST: Good morning. As Commander Rhoades said, I am Miriam Provost. I am the Acting Director for the Division of General, Restorative, and Neurological Devices.
I would like to just take a few minutes and give everyone a brief regulatory background followed by a discussion of why we have convened this meeting and what are we asking you, our distinguished advisory panel, to do.
First, some background on the regulatory status of silicone gel‑filled breast implants. Prior to 1991, silicone gel‑filled breast implants were sold on the market either as pre‑amendments devices, which means they were on the market prior to May 1976, or as a 510(k)‑cleared device.
In April 1991, FDA issued a regulation that required all manufacturers of silicone gel‑filled breast implants to submit safety and effectiveness data in PMAs in order for their products to remain on the market.
Several PMAs were submitted and presented to an advisory panel in November 1991 and then again in February 1992. In April 1992, FDA determined that the PMAs did not include adequate safety data to support approval. However, at the same time, FDA believed there was a public health need to have breast implants available for reconstruction in revision patients.
In 1992, because FDA believed it was important to provide continued availability of silicone gel‑filled breast implants for women seeking breast reconstruction or revision, we developed a new type of study design referred to by industry and the FDA as an adjunct study.
Inamed in 1998 and Mentor in 1992 are the only two companies that have received FDA approval for an adjunct study. Inamed's and Mentor's adjunct studies currently remain active. Both adjunct studies require five‑year follow‑up for each patient enrolled. And there is no limit on the enrollment of reconstruction or revision patients or on the number of investigational sties.
Adjunct studies are focused on the collection of safety data and do not include MRIs screening for silent rupture. The 1992 agreements between FDA and industry also described information to be collected in the study design to evaluate safety and effectiveness to support a PMA, the so‑called "core study."
The investigational device exemption, or IDE, studies are the mechanism by which the core study data, which you will hear referenced during this panel meeting, are collected.
Inamed submitted and received approval for their core study in 1998. Mentor submitted and received approval for their core study in 2000.
At the current time, FDA has not approved any PMAs for silicone gel‑filled breast implants. They remain investigational devices, which means that a patient must be enrolled in an adjunct study or an IDE study in order to receive one of these implants in the U.S.
I'd also like to note that in January 2004, FDA issued a draft update of our guidance document for manufacturers of breast implants. This document is a framework for breast implant manufacturers. And it includes recommendations on the kind of information that FDA recommends be provided in a PMA.
We have received numerous comments on the draft guidance. And at the present time, we are continuing to review the comments that we received. Once we have reviewed the comments and made revisions, as appropriate, the guidance document will be released in final.
It should be emphasized that our review of the information in a PMA is not affected by whether a guidance document for the product in question is in draft or final form. As is the case for all medical device applications, FDA will base our decisions on the scientific and clinical data in the PMAs as well as the panel's deliberations and recommendations regarding those data.
Now for the task at hand. Inamed's PMA, P020056, was presented previously at the October 2003 meeting of the General and Plastic Surgery Devices Advisory Panel. The panel recommended in a nine to six vote that the PMA was approvable with conditions.
In January of 2004, after considering the data in the PMA and the panel's deliberations of the data, we determined that the PMA was not approvable because the data did not provide a reasonable assurance of safety for the device.
Therefore, FDA's presentation at this panel meeting for the Inamed PMA will focus on the additional information submitted by Inamed to address the outstanding safety issues. The Inamed PMA will be the panel's focus on Tuesday.
Mentor's PMA, P030053, is being presented for the first time at a panel meeting. Therefore, FDA's presentation for this PMA will involve a summary of all relevant preclinical and clinical data. The Mentor PMA will be the panel's focus on Wednesday.
It should be noted that, although the core study is the primary source of clinical data for both PMAs, both sponsors use data and information from multiple sources to address the key safety issues.
Based on your own scientific and clinical knowledge, we are asking you, the panel, to discuss the data in each individual PMA and advise us as to whether there is sufficient information to provide a reasonable assurance of safety and effectiveness for each device.
After the panel meeting, FDA will continue to review the information contained in this PMA. We will carefully consider the deliberations and recommendations that you make during this meeting. Ultimately FDA will make a decision on the approvability of these two PMAs.
We will also hear a number of comments from the public today as well as on Tuesday and Wednesday. And I want to thank the members of the public for making the effort to come here today to present their views on these applications.
I want to assure everyone that the FDA will carefully listen to these comments. And, as previously stated, we will make our decision based on the scientific data in the PMAs and the panel's deliberations on the data.
I do want to remind everyone, however, that this meeting is not intended as a general referendum on silicone gel‑filled breast implants. This panel meeting focuses specifically on the safety and effectiveness of two individual breast implant PMAs. And the object of this meeting is to obtain input from you, the panel, on the data in these applications. The FDA is very appreciative of your giving of your time and expertise to accomplish this important task.
Thank you very much. And now I'm going to turn it back over to you, Dr. Choti.
CHAIRMAN CHOTI: Thank you, Dr. Provost.
We will now proceed with the open public hearing session of this meeting. All persons addressing the panel are asked to speak clearly into the microphone as the transcriptionist is depending on this as a means to accurate recording of the meeting.
I would like to have the attention of all of the individuals who are registered to speak to the panel today. You have been given a number of correspondence regarding the order of your appearance.
Please come to the podium area in advance so that we are not spending a great deal of time in transitions from speaker to speaker. And we have two podiums set up in order to alternate and for time sake. The FDA panel will direct you to the appropriate podium.
Please remain within your time constraints as a timer will be present to help you with this. We have many public speakers today. And so it is extremely important that we stay on time.
There is a yellow light that will flash 30 seconds before your time is up. And the red light flashes as soon as your time is up. If you're still speaking at that time, then I will promptly instruct you to summarize and cut off. If after ten seconds that is not done, then I have been told that the microphone will be cut off. So please try to stay to your allotted times.
Also, regarding your written comments, please only bring to the panel your written comments that have been submitted or your presentation slides. No additional material, please.
We would also like to address the issue of financial disclosure. Before the Food and Drug Administration and the public believe in transparent process for the information gathering and decision‑making, to ensure such transparency at the open public hearing session of the Advisory Committee meeting, the FDA believes it is important to understand the context of an individual's presentation.
For this reason, the FDA encourages you, the open public hearing speaker, at the beginning of your written or oral statement to advise the Committee of any financial relationship you may have with the sponsor; its product; and, if known, its direct competitors. For example, this financial information may include the sponsor's payment for your travel, lodging, or other expenses in connection with your attendance at the meeting. Likewise, the FDA encourages that you at the beginning of your statement advise the Committee if you do not have such financial relationships.
If you do not choose to address this issue of financial relationships at the beginning of your presentation, it will not preclude you from speaking.
Let's begin with the first speaker. These individuals are the ones who have notified the FDA of their intent to testify during the open public session.
The first speaker, please? Thank you. Good morning.
MS. JOHNSTON: Thank you.
MS. JOHNSTON: Good morning. My name is Kathy Keithley Johnston. I'm the Executive Director and founder of Toxic Discovery, a national not‑for‑profit consumer advocacy organization. I am also a registered nurse. And I myself used to have silicone gel breast implants. I have no conflicts of interest.
I am here today carrying the voices of thousands who have been directly affected by the failure of the FDA to require long‑term safety studies concerning breast implants.
We believe the FDA made the right decision in 2004 when they decided not to approve Inamed's silicone breast implants. The new guidance that the FDA issued at the same time was an important step forward, demonstrating the FDA's commitment to assure that breast implants are safe for long‑term health studies before they allow them to be widely sold.
I am here today counting on you to help the FDA to adhere to the guidance document. Silicone breast implants should not be approved until a company can prove the safety of devices for long‑term use. Since safety cannot be proven, we ask you to deny the manufacturer's application.
Implant lobbyists claim that there are over 100 studies of women with implants that show no evidence of harm. That is clearly and absolutely false. These groups conveniently ignore the following studies: a study by the FDA of women with silicone breast implants that at least found for six years that women had at least one failed breast implant, even though they did not know it. This is referred to as a "silent rupture."
That same study found that 21 percent had silicone leakage outside the scar capsule surrounding their implant. From there, silicone could harm breast tissue, could migrate into lymph nodes and, thereby, travel to lungs, liver, or other vital organs.
The FDA also found that women with leaking silicone breast implants were more likely to report fibromyalgia and other connective tissue diseases. Scientists at the National Cancer Institute found that women having breast implants for at least seven years were twice as likely to die of brain cancer, three times as likely to die of lung cancer, and four times as likely to commit suicide compared to other plastic surgery patients.
A Canadian study found that women with breast implants for augmentation were more likely to be hospitalized and had more physician visits than women of the same age living in the same communities.
These are just a few of the studies that were a serious concern about risk of silicone leakage. Research has not yet been done to determine exactly what chemicals leak into a woman's body and what long‑term health consequences then results from that leakage and migration of silicone. How can informed consent be obtained when information is not even known by the very physician implanting these risky devices?
Neither Inamed nor Mentor has conducted studies of the health impact of leaking silicone in a woman's body. Dow‑Corning has funded one such study. In a Danish study, Holmich claimed that leakage was not significantly related to connective tissue disease. However, there were only 23 women in this study with extracapsular leakage, a sample that is much too small to provide meaningful safety data. In fact, the study showed that women were four times as likely in that study to report a connective tissue disease compared to women whose implants were not ruptured. But these impressive differences were not statistically significant because the sample was too small.
You would certainly think after 40 years that implant manufacturers should find more than 23 women with extracapsular rupture. Without a doubt, there are more than 40 in this very room today. There are hundreds of thousands of women in this nation whose body would show you that leakage is present if testing was provided.
Our organization has serious concerns about the integrity of the studies conducted by Inamed and Mentor. Patients in these studies have informed us of their fears that they believed that their problems with implants were never reported by their physician or the manufacturer.
In closing, let me remind you of the duties of the FDA. First and foremost, the FDA is a public health agency charged with protecting American consumers. The FDA should be the consumer watchdog and not the advocate of the breast implant manufacturer.
It is your job to make sure that the FDA protects patient safety concerning breast implants. This can only be done by requiring long‑term health studies before approval and not after approval.
It is certainly not your job to protect the livelihood of plastic surgeons or implant makers. Both have failed in their promises to protect women, which will not make the situation better. It will only allow it to continue. And we ask you, please protect the women of this nation.
CHAIRMAN CHOTI: Thank you.
Next speaker?
MS. GROSS: Good morning, panel. I am Marcy Gross. I am a consultant who specializes in women's health issues. I am a member of the State of Maryland Women's Health Promotion Council and serve on the boards of various private health organizations.
Prior to becoming a consultant, I worked for the Department of Health, U.S. Department of Health and Human Services, where I was a Senior Policy Analyst for a number of years in the Office of the Assistant Secretary for Health. And in my last position, I was the Senior Adviser for Women's Health at the Agency for Healthcare Research and Quality, where I served while there on the secretarial ad hoc task force on silicone breast implants.
I give you this resume to establish my familiarity with the issues at hand. However, I am speaking as a private citizen. I have no financial links to any of the applicants.
A legacy from my six‑year tenure at AHRQ is an appreciation of the need for a strong evidence base to support medical decisions. One of my concerns today is that an adequate evidence base for the approval of silicone gel breast prosthesis still does not exist. Worse, a truly long‑term gold standard study that will produce independent, objective research findings seems not to be on the horizon.
We do have 40 years of experience with breast implants, including 25 years when the silicone implants were available to women, all women. They were pulled from the market for good reason. They were associated with major medical problems.
The basic facts on this issue have not changed in the 14 years subsequent. First, available studies on the health aspects of silicone gel implants are still short‑term and are often produced by companies that manufacture the devices or materials.
Second, the work that is available, some from FDA itself, indicates that the rate of complications of implantation, reinfections, reoperations, and other adverse events are sufficiently high to remain a major concern, despite advances in materials.
Third ‑‑ and this is a change from the past ‑‑ the Mentor applicant agrees that the devices will not last indefinitely and warned women that they should expect to have them replaced. So the issue becomes one of sequencing in looking at the data. Do we get the data first and approval after or the reverse?
Letting women be living testers I find highly objectionable since these are elective procedures and there are alternatives, especially since the data on improvements in the quality of life for patients undergoing implantation are weak by accepted research standards and most especially since it is expected the devices will fail and will have to be removed.
On this last point, the overall failure rate, it should be noted that Mentor acknowledges that their devices will have a finite in vivo life, which means, really, that all will fail and need to be surgically removed. We just don't know when.
I would assert that if this were an NIH‑funded research study, it's unlikely it would go forward.
CHAIRMAN CHOTI: Please sum up for us.
MS. GROSS: Yes, please. I just ask that you have the data in hand before you reintroduce the silicone breast implants. Thank you for your time.
CHAIRMAN CHOTI: Thank you.
Let me remind the audience that speakers have three minutes unless it's a national organization. And then it's five minutes.
Yes, next speaker?
MR. SCHULTZ: Good morning. My name is William Schultz. I am representing a group of women's organizations led by Command Trust. I appreciate being given five minutes. Thank you.
Thank you for the opportunity to address this Committee on the very important question of whether FDA should approve the applications for silicone gel breast implants. For the record, I have no financial ties to either of the applicants.
Congress enacted the medical device amendments in 1976 in the wake of several tragedies, including the Dalkon shield IUD, which killed 16 women and injured countless others. Congress sought to remedy the defect by a new law, the defect being that medical devices were being marketed without any demonstration of their safety or any adequate testing.
Congress was particularly concerned about the safety of implantable devices. The basic showing that it required manufacturers of these devices to make was that there was a reasonable assurance that the device was safe and effective. In the case of breast implants, efficacy is obviously not the issue. Instead, the issue is safety.
If you think about it, for a therapeutic product, such as a heart valve, the safety standard entails a weighing of risk versus benefits to health. And so FDA may approve a product with substantial risks if it finds the benefits are even greater.
But for a cosmetic product, which is what we have before us today, there are no therapeutic benefits. For these products, the law does not allow approval if the product is associated with significant risk or even if there is significant uncertainty about safety. And I think that is a very important principle to keep in mind as we go through the next three days.
It is also relevant that the manufacturer has the burden of proof. Where there are doubts or uncertainties, then the product may not be approved because the manufacturer has not carried its burden. The law does not contemplate that the patients or consumers should bear the risk of unanswered questions.
At the October 2003 Advisory Committee meeting, there was discussion of various approval conditions and post‑market studies. First, the Committee should understand that any approval conditions are not enforceable by FDA. Once the agency approves a product, then physicians are allowed to deviate from restrictions on the use of the product. And FDA has no authority to enforce those restrictions.
Second, while post‑market studies may be useful, they cannot substitute for the basic safety standard in the statute. The statute does not provide that the agency may approve a product now and allow the demonstration of safety at a later date.
At the last Advisor Committee meeting, there was also discussion about whether women should have the option or the choice of using breast implants as long as they were fully informed.
Although Congress has adopted the buyer beware approach for dietary supplements and in other areas, this was not the approach that it adopted for medical devices. Instead, for these products, it has declared in law that medical devices are not to be available until the manufacturer has demonstrated safety. It is this Committee's charge to do its best to apply that law.
Congress' approach has two important benefits. First, it means that patients and consumers can be confident of the safety of device products that they use. It also creates an important incentive to the manufacturers to design their products to meet the high standard that Congress established.
Significant questions have been raised about the safety of breast implants. I'm not going to address those. But it's important, of course. These products are going to be in the body for many years. Even though the manufacturers have known about the standards of the statute for more than 25 years, we don't really have long‑term data. And given the extremely high breakage rate of these products, lack of long‑term data raises serious problems.
In January 2004, FDA determined that the evidence was not adequate. And the question that this Committee must look at is whether the companies have produced additional data that is sufficient to justify approval.
In conclusion, approval of silicone gel breast implants without an adequate demonstration of safety would have two very unfortunate consequences. First, we would have lost the opportunity to require that these products be adequately tested.
And, perhaps even more important, such a decision would send a message to other product manufacturers that the door has been open for approval of medical devices that do not meet the safety requirements established by law and that patients will suffer.
Thank you very much. And good luck.
CHAIRMAN CHOTI: Thank you.
Next speaker?
DR. HELMAN: Hi. Good morning. I'm Susan Helman from Florida. I have paid my own way here because I feel that this panel needs to hear from women like me.
I had breast implants for 15 years and suffered greatly. My implants ruptured. And after numerous surgeries to remove silicone from my body, the last surgeon stated, "There is no way to remove it all, Susan. It's migrated to all your tissues, your organs. It's everywhere." Silicone as well as platinum was found in my cheek cells, bone marrow, and lymph nodes, also in my urine and in my blood.
My urine platinum levels when measured eight years after explantation were 25 parts per billion, which is within the range of patients receiving chemotherapy agent cisplatin. The urine platinum level in the general population is .04 parts per billion. So mine was more than 500 times greater.
The platinum ion in my urine and in my tissues I found was the exact match to my implants that they studied as well. My body is full of ionized platinum with no known way to remove it.
As you know, the CDC has identified platinum as a suspected toxin. Because of my ruptured implants and the resulting exposure to silicone and platinum, I have been diagnosed with MS and lupus and fibromyalgia and scleroderma among many other things.
And I'm sick. And I can't get health insurance. When I need it the most, I can't get it. I don't want anybody else to suffer this way. I get severe disabling headaches and nausea when I am exposed to exhaust fumes or unusual odors of any kind, and I never had this problem before ever.
I'm also concerned about young women of childbearing age and their children. I've heard that platinum can be transmitted in milk. And I have platinum in my urine. So, you know, I see no reason why it couldn't be in breast milk.
Any mother would be heartbroken to find out that during a cosmetic surgery, unbeknownst to her, it caused her breast milk to be adulterated and cause injury to her newborn child.
I just ask that before implants are considered safe, platinum testing be done on a random sample of women with silicone gel breast implants and on women with implants, the breast milk of women with implants.
And, in closing, please, please, please vote against the gel‑filled breast implants until you're sure that the benefits far outweigh the risks. The first oath a doctor learns is do no harm.
Thank you.
CHAIRMAN CHOTI: Thank you.
Next speaker?
DR. GLICKSMAN: Mr. Chairman and members of the panel, my name is Dr. Caroline Glicksman. And I am reading the testimony from my patient Valerie Hartwell, a 45‑year‑old mother of 3 who is unable to attend today because of work requirements.
"I would like to advise the Committee that I have no financial relationships with anyone connected at this meeting. I had silicone breast implants for two years. I had them put in because of a chest wall deformity I was born with that caused a considerable and noticeable depression along the sternum on my right side.
"The size of one of my breasts was considerably smaller than the other, causing me to be extremely self‑conscious my whole life. I would not wear bathing suits or shirts with a neckline lower than my collarbone because my deformity was so obvious.
"I am so thrilled that I had the silicone implant option available to me. It has made a dramatic difference in my self‑esteem. My self‑confidence has improved drastically.
"I have one anatomical implant on the defective side, which has helped with the depression along my sternum. The other implant is round, to create uniformity. I have had absolutely no side effects.
"My breasts remain soft and natural‑looking, which is very important to me. They feel natural as well. I am able to sleep comfortably in any position. I have had no problem with hardness and no dimpling.
"My husband and I were concerned that I would lose nipple sensitivity. That has not been the case at all. I am so pleased with the results. I am a grateful recipient of a wonderful product that has made a huge difference in my life.
"Thank you, Valerie Hartwell."
CHAIRMAN CHOTI: Thank you.
Next speaker, please? Good morning.
MR. BRENT: Good morning. My name is Ed Brent. And I am representing my wife, P. J. Brent, and our children.
My wife had silicone breast implants for ten years. She had no problems at first but became increasingly ill. On May 29th, 2000, my wife committed suicide. She left behind seven children. On behalf of my wife and my seven children, I urge this panel and the FDA not to approve silicone breast implants unless there is clear evidence that the implants being sold now are safe for long‑term use, meaning ten years or more.
Several studies have shown higher rates of suicide among breast implant patients. And a National Cancer Institute study found that women with implants were four times as likely to kill themselves as other plastic surgery patients.
The implant makers think the explanation is that women with breast implants had lower self‑esteem before they got their implants, but there is no reason to think that women who decide to get implants have lower self‑esteem than women who decide to get liposuction, nose jobs, or any other plastic surgery.
My wife was not a woman with low self‑esteem. She was a vibrant, loving wife and mother. P. J. loved the way she looked the first few years after her implants. Then she began to get sick, and her joints hurt, her fingers would swell. She had lupus‑like symptoms and was diagnosed with fibromyalgia.
P. J. breast‑fed two of our daughters after getting implants. Both are seriously ill. My daughter Catherine, who is with me now, was diagnosed with chronic inflammatory demyelinating polyneuropathy as well as esophageal motility disorder. She spent years in leg braces, and now the leg braces have been replaced with a wheelchair.
Our daughter Christine also has esophageal motility disorder and leg weakness as well. In contrast, our five children born before my wife got breast implants are perfectly healthy.
After P. J. committed suicide, an autopsy was performed. Large amounts of platinum were found in her body. And a doctor at the CDC after seeing the amount of platinum in P. J.'s body said she could not have been in her right mind.
Tissue samples from our daughters who had breast‑fed found that they, too, had elevated platinum levels. These findings were presented at a meeting of the American Chemical Society last year.
P. J. felt terrible guilt that her two daughters had been so seriously harmed by her decision to get breast implants. It was not her fault. She had no way of knowing what would happen. Most doctors did not know that there had not been any long‑term studies on the breast implants.
Just two months before my wife's death, she testified at a previously FDA meeting on breast implants. She felt the panel ignored testimony given by women with implants.
And I am here today to ask you to listen to these patients and their loved ones and do not endorse a product not proven safe for long‑term use. Women and their yet unborn children may be forever affected. This is a scientific issue and a moral issue.
Thank you.
CHAIRMAN CHOTI: Thank you.
Next? Good morning.
MS. HICKEY: Good morning. I am Lisa Hickey, and I am from Phoenix. I have no conflicts of interest.
I am here to tell you I experienced four surgeries in four years due to complications with implants. My experience involved three manufacturers and new and improved products. Two of the surgeries were back to back after a rupture occurred.
Concurrent with the implant exposures, I experienced serious systemic illness and visual and motor impairment, which improved considerably after the implants and capsules were removed.
After the rupture diagnosis, I was required to sign a Mentor informed consent document in order to receive replacements. That occurred after a moratorium had been placed on the implants that I knew nothing about.
During prep for the rupture removal, I was sedated and negotiated with for my rupture evidence. My baseline mammogram and evidence were taken away from me around the same time as that surgery.
If implants are so safe, why are there gag orders and sealed documents regarding silicone implants from an historical perspective? Now I understand that the Justice Department has entered a settlement agreement with manufacturers for recovery of enormous expenses paid out to Health and Human Services claims for breast implant complications.
Aren't Social Security and Medicare in enough trouble already? How is it that the Justice Department can recover its losses with the Daubert rule in place, not allowing important evidence from expensive medical testing, while at the same time there is a law in place requiring insurance to cover breast cancer reconstruction with implants?
And I have been told the Navy Department is conducting a large breast cancer study. I am a furloughed flight attendant for a struggling airline that is required to pay for products with high complication rates for reconstructions when the Justice Department is trying to recover U.S. losses incurred by enormous claims from complication.
Now, I do not have a fancy degree or knowledge about rocket science, but my grandparents were educators. And they taught me to read the road signs on the highway of life. I can read that things just don't add up to safety when it comes to silicone gel.
Many of my fellow flight attendant friends and acquaintances with implant exposures have been ill. And some have passed on in the prime of their lives.
Is silicone research taking place in the morgue? In your approval process, please consider what this research does not tell you. Breast implant exposures altered my health forever. Believe me, experiencing illness serious enough to have my implants cut out in hopes of feeling better did not improve my self‑esteem.
I implore you to help ensure that what happened to me and my friends with silicone exposures never happens to anyone else, especially young women in childbearing years, single mothers with limited financial resources, and vulnerable cancer patients.
Thank you.
CHAIRMAN CHOTI: Thank you.
Next? Good morning.
MS. P. DOWD: Good morning. Mr. Chairman, ladies and gentlemen of the panel, I thank you for this opportunity to come before my government and speak on the dangers of silicone gel breast implants. I come as a little David to approach the giants of the silicone industry.
My name is Pam Dowd of Boise, Idaho. I represent Implant Veterans of Toxic Exposure. I have driven almost 2,500 miles in a 1984 Southwind motor home at my own expense to be here. I felt it was that critical.
On May 21st, I will reach my 30th year of being free of breast cancer. In 2003, I told the panel about my experience as a breast cancer survivor and about the failed reconstruction that included three ruptured silicone breast implants. I told the panel about the excruciating pain of a spontaneous rupture that literally had me pulling at my hair, about the experience of having my chest scraped and cauterized following the explant, and that the Mentor implants of 1988 that caused me to cough constantly and choke on my own saliva for seven years, and about the pain in the long bones that at times has me screaming in pain.
Today I come to address the issue of the denial of health care insurance for women who have had breast implants. On page 5 of the Mentor Corporation 48‑page informed consent is this warning. Inamed does not provide this information online. "For patients who have undergone breast implantation, either as a cosmetic or a reconstructive procedure, health insurance premiums may increase, coverage may be dropped, and/or future coverage may be denied. Treatment of complications may not be covered as well. You should check with your insurance company regarding these coverage issues."
Ladies and gentlemen, there is no "may" about this critical health crisis with implanted women. The denial of health insurance to women who have had implants is increasing across the land. Until last year, I had no personal knowledge of being denied health insurance.
Last October, my late husband went on Medicare. And we lost his COBRA insurance. For 30 years, I had been covered under group policies. Blue Cross had paid for this devastation that's called breast reconstruction. Yet, in the end, I am denied health insurance based on the diagnosis of Sjogren's, Raynaud's, peripheral neuropathy, fibromyalgia, and a long list of other diagnoses I have received since getting breast implants.
Insurance companies such as Blue Cross/Blue Shield, Equitable Life Insurance, Aetna, AARP supplemental insurance, Prudential, Republic Bankers Life Insurance, Times Insurance Company are denying health care coverage to women who have had breast implants.
I found evidence on the evidentiary CDs from the MDL that this concern was first reported by doctors in 1989. Insurance application forms are now asking for implant history.
If, as the manufacturers and members of the ASPRS repeatedly claim, there is no connection between implants and health problems, then why the insurance denials? If there are no health risks, then why does Blue Cross/Blue Shield of Texas have declined if implants are explanted as their underwriting guidelines as far back as 1996? What is the toxic secret the insurance companies know but aren't sharing?
In 1998, I presented the results of a survey of implanted women to the Institute of Medicine. Of the respondents, 30 percent of the women were on disability and are drawing assistance for living needs from government and charity offices. Many of those who were disabled were disabled before the age of 50 and within 15 years of getting breast implants.
With Inamed's latest figures of 325,000 newly augmented women per year, this has the probability of creating another 100,000 women on disability a year within the next 15 years. This has the potential of being in excess of $100 million burden on the American taxpayer.
On pages 40 and 41 of Mentor's 48‑page informed consent are Mentor's support of the diabolical and barbaric flat surgeries that are disabling, creating permanent and sometimes total disability for the recipients.
The insurance companies are already saying they are not going to pay for the health care needs of even the reconstruction patients they have already covered.
Ladies and gentlemen, it will be seven and a half years ‑‑
CHAIRMAN CHOTI: Would you please sum up?
MS. P. DOWD: ‑‑ before I am eligible for Medicare. I am 57, uninsured, and uninsurable.
CHAIRMAN CHOTI: If you could please sum up for us?
MS. P. DOWD: Yes.
CHAIRMAN CHOTI: Your time is up.
MS. P. DOWD: Putting the burden of health care of thousands of women on my child's shoulder is a task I could not in good conscience do. Can you?
Again, thank you for this opportunity.
CHAIRMAN CHOTI: Thank you.
Next? Good morning.
MS. B. DOWD: Good morning. Mr. Chairman and members of the panel, I appreciate the opportunity to speak to you about the dangers of silicone breast implants.
My name is Brenna Dowd. I am from Boise, Idaho. I came with my mother in our old motor home. We used my father's life insurance money to get here.
Ever since I have been old enough to pay attention to my mother's health, she has been sick. My dad died in December. And now we are alone, and I have to take care of her.
I have never known a healthy mother. Mom will never tell people about all the times she has been unable to walk right, sometimes crawling, many times falling. She would never tell you about the times when she gets confused or when her legs hurt her so much she has to sit in a hot bath maybe three times a day or more just to ease the pain because of the silicone breast implants.
Mom will never tell you how she fell out of the motor home on the way here and I was afraid she wouldn't be able to finish the trip or when we got to Hagerstown Saturday night, she was too exhausted to even eat.
My mother liked to go camping in the mountains in Idaho with my father. She hasn't been able to do that for a long time. She gets too tired to do anything physical.
Mom has never been able to do many things other moms should be able to do with their children, such as shop all day in the mall or play real hard with me. Even simple walks exhaust her. She tries, but she is too sick.
In closing, I leave a message from my father. One of his greatest regrets in life was that he had not protected my mom from the implants and that she could not get health insurance. He blamed himself, but Dad was not to blame. These companies that sell implants to innocent women and make them sick are the ones who should be held accountable. They poisoned my mother and robbed me of a healthy mom and my father of a healthy wife.
I beg you to please ban silicone breast implants. Thank you.
CHAIRMAN CHOTI: Thank you.
DR. BERMAN: Good morning. I'm Dr. Alan Berman, Executive Director of the American Association of Suicidology located here in Washington, D.C. For 37 years, the AAS has had as its primary mission that of understanding suicide as a means of promoting human welfare.
I come here today at my own expense with no financial ties to either sponsor or any of their competitors. The majority of Americans report having thought about suicide at some time in their lives. Most everyone decides to live because they come to realize that their pain is temporary but death is not.
On the other hand, some people in the midst of a crisis perceive their problems as inescapable and feel utterly hopeless. Tragically, some 31,000 Americans take their lives annually.
The AAS believes it is essential to have sound empirical study of suicide. I am here to briefly discuss five studies that have shown an increased risk of suicide among women who have undergone breast augmentation.
Scientists from the NCI reported that breast augmentation patients were four times as likely to kill themselves as were other female plastic surgery patients matched for age, socioeconomic status, health status, and habits. It is important to note that all the women in this study had implants for at least seven years, much longer than in other implant studies. A weakness of the study was the confounding variables, such as depression or marital discord, were not controlled.
Three European studies, one each from Sweden, Finland, and Denmark, consistently found that women who had had breast implants for augmentation were three times more likely to complete suicide than women in the general population of those countries.
In the U.S., a recent study of mastectomy reconstruction patients also found a higher rate of suicide among implant patients compared with women who underwent mastectomies without reconstruction.
The American Society of Aesthetic Plastic Surgeons and Dow‑Corning funded articles concluding that the increased risk of suicide likely existed before surgery. They argue that women who get breast implants may be more likely to suffer from low self‑esteem and/or depression. In addition, based on their demographics, they may be at higher risk for suicide.
But the research data does not back this up. One study noted that eight percent of Danish augmentation patients had a psychiatric admission before surgery compared to six percent of women who had other cosmetic procedures. Danish women, however, had to get psychiatric referrals before they could get free augmentation from the public health system. Clearly, this could be the reason behind this insignificant difference.
Implant patients, like most plastic surgery patients, tend to be unhappy with the specific body part they want changed. But they are not less satisfied with the overall appearance or with themselves.
A Danish study found that women who had breast implants for augmentation were five to seven times more likely to be taking antidepressants than women who had breast reduction surgery or women in the general population. Women who had their implants removed and replaced at least one time were also more likely to be taking antidepressants than women who still had their original implants.
The relationship between multiple implant surgeries and the use of antidepressants may be, in part, because complications from implants contribute to depression, but it is not possible to know if these women had a prior history of depression.
Women with breast implants who testified before the FDA in October 2003 provide anecdotal evidence for the connection between pain following augmentation surgery and suicidal thoughts. Several women described feeling depressed and suicidal as a result of debilitating pain, fatigue, and mental confusion, years after getting silicone breast implants. They said when the implants were removed, their health improved. And they experienced less depression and less suicidal thinking.
Anecdotal case reports such as these are for qualitative data that informs hypothesis testing that simply has not occurred to date. We have here an ad hoc challenge/dechallenge test that has never been studied or rechallenged empirically.
It is possible that women who undergo augmentation have lower self‑esteem than other women, but studies have not supported this. Again, studies show that women who plan to undergo augmentation tend to feel less attractive regarding their breasts but do not have overall lower self‑esteem or self‑confidence.
There is no a priori reason to believe that women who decide to undergo breast augmentation have lower self‑esteem or are more depressed than women who undergo liposuction or other plastic surgery procedures.
Interestingly, while breast implant manufacturers attribute suicide excess to pre‑implant psychiatric disorders, they also maintain that implants improve a woman's self‑worth. There are no studies to support this assertion either.
The bottom line is that every published study on suicide and breast implants shows that there is an increased risk of suicide. The question is why.
No prospective study of depression before versus after augmentation has yet been reported. No study has yet examined post‑surgical outcomes among patients who later completed suicide. Well‑designed, case‑controlled psychological autopsy studies are needed to make differentiations and/or links between preoperative and postoperative risk variables.
Thank you.
CHAIRMAN CHOTI: Thank you.
Good morning. Next?
MS. HOUSER: Good morning. My name is Christie Houser. I have no conflicts of interest. I'm a 47‑year‑old mother of 2 boys and a full‑time first grade teacher's assistant. I got silicone implants for augmentation at age 25. I researched my particular implants and was told by every doctor that everything would be fine and that the implants would outlive me.
Everything was great for a while, but after five years, I started experiencing joint problems, flu‑like symptoms, rashes, and a cough that wouldn't go away. The doctors told me that the symptoms could not be related to the implants. And I believed them and trusted them.
The implant makers will present four years of studies tomorrow. If I had been included in these studies, most of my problems would not have been seen. We must have real long‑term studies to truly evaluate the safety of the product.
Silicone implants have been on the market for 40 years. Yet, the industry has never presented more than four years' worth of data. Why is that? What are they afraid of? I believe we need to ask the long, hard‑term questions.
Eventually my health got so bad that I had an MRI and an ultrasound. They found that there was something behind my left breast, but they couldn't really see exactly what it was. The implant was covering it. So they couldn't really tell.
When they removed my implants ten years after augmentation, the outer coverings of both of my implants were gone. There was a golf ball‑sized cyst behind my left breast, which they could not see with an MRI or ultrasound. And both implants were ruptured.
They removed the implants and as much silicone as they possibly could and sewed me up. After two months of the surgery, I noticed that my scars were not healing and they were tender. I went to the doctor, and he told me that it would take time to heal.
I went to another doctor. And he saw something that was trying to come out of the scar. In fact, it was silicone that was leaking out of my scars in places that were not healing.
I have two sons. They both have diseases that are unusual. My 16‑year‑old son has Hashimoto's thyroid disease, which is typically found in adult women over 30. My eight‑year‑old has something called urticaria pigmentosa, which is a cafe au lait spot that can blister and previously has put him in anaphylactic shock.
There is no evidence showing that my son's illnesses are through breast‑feeding, but it does beg the question. How did they end up with these strange diagnoses?
There are too many unanswered questions to approve this product. The American people look to you to guide their health and their children's health. I am not against implants, but if we do not demand the research to determine that silicone implants are safe for long‑term use, we have to answer a new generation of women and their children with serious, serious health problem.
Thank you so much for listening.
CHAIRMAN CHOTI: Thank you.
MS. VAN FOSSEN‑NYE: Good morning. My name is Kathleen Van Fossen‑Nye. I drove here from Sinking Spring, Pennsylvania to speak before the panel. And I have no conflict of interest. I spoke before the panel in October of 2003.
My history with silicone breast implants is almost as long as the products have been on the market. In 1968, when I was 22 years old, I was implanted with the original Cronin implant following a bilateral mastectomy for a precancerous condition.
A military doctor performed my first breast implant surgery because my husband was in the U.S. Navy. In the government lawsuit, manufacturers agreed to pay five government agencies, including the Department of Defense, the Department of Veterans Affairs, Medicaid, and Medicare, millions of dollars to reimburse them for the costs they incurred treating women made ill by silicone breast implants. This settlement demonstrates that the federal government is aware and has acknowledged that silicone breast implants cause health problems and disabilities.
However, how can the FDA even consider approving these PMAs when the Department of Health and Human Services has already made it clear that silicone breast implants pose a serious health risk to women, costing millions of dollars?
In the past, I have heard the panel members ask why so many women get breast implants and why they keep getting them, even after they fail? I have heard plastic surgeons on the panel say that the women don't mind the complications because they really like their implants. This was not true for me.
I started to suffer from fatigue and joint pain, and the implants were hard and painful. I went to a number of plastic surgeons, asking to have my implants removed. I found a plastic surgeon who was willing to remove the implants. He removed and replaced my implants with a new and improved implant. This started my journey through a silicone nightmare.
I have experienced the gamut of problems, including outright rejection. Eventually necrosis developed, and the implant actually came out through my skin and popped out on its own. Here is the photo of what happened.
Despite my mastectomy, I developed breast cancer in '86. I have had a total of 15 implants and expanders over the years. Why did I have 15 implants? I had so many because I believed my doctors when they told me they were new and improved. I wanted to believe my doctors when they told me they were new and improved.
For over 35 years, I have experienced new and improved implants. I have come to the conclusion there is no such thing as a new and improved silicone breast implant.
CHAIRMAN CHOTI: Thank you. Good morning.
DR. GLICKSMAN: Mr. Chairman and members of the panel, I am a plastic surgeon practicing in New Jersey for 15 years. I have not received any financial support from any implant manufacturer. And I traveled here at my own expense.
Before I get to my statement, I have a quick comment regarding Dr. Olding's letter to the panel. This development clearly demonstrates that the FDA's review process is flawed. They have no backup plan and no provisions for an alternate panelist. I now have serious questions about the FDA's ability to conduct fair hearing.
I am testifying again, as I did in 2003. And the question today should be what has changed since 1992. Now, clearly we have the evidence‑based science to demonstrate the safety and efficacy of these implants. Over 15 years of study show no link exists between silicone and systemic illness.
What has changed in the last 20 years are the devices, the surgical techniques, and the role of plastic surgeon as both physician and educator. And, most importantly, we now encourage the shared responsibility of the patient to maintain good breast health by follow‑up exams and replacement of their implants as necessary.
The devices used today have evolved dramatically from those of the '70s and '80s. I can tell you that the devices, surgical techniques, and our preoperative patient evaluation have changed so dramatically that my reoperation rate at five years is less than three percent.
But what about the patients? How do you get American women between 18 and 80 to choose a board‑certified plastic surgeon to understand the concept that a breast augmentation is not just a boob job and every pretty blonde does not have to be a D‑cup? Here's where a new generation of plastic surgeons under a new generation of leadership has made their greatest strides.
Manufacturers in the plastic surgery societies have in place courses that teach the techniques that reduce the reoperation rates. We have published algorithms that can help reduce the cycle of reoperations for implant complications. And we have created Web sites where American women can research their choices and become fully informed of their potential risks and benefits of implants, even before they step into a doctor's office.
Women demand and deserve a better level of health care. No medical device lasts a lifetime. And technology now exists, such as MRIs, that can evaluate the integrity of silicone implants as they age.
Even with these changes, we cannot force American women to choose a board‑certified plastic surgeon or return for follow‑up care, just as we can't force adults to quit smoking, lose weight, or wear their safety belts. But we should not limit the use of an implant that has been shown to be safe and effective in study after study because it is used for aesthetic reasons, purely for the enhancement of a woman's self‑esteem.
No different is it from drugs for erectile dysfunction. Their sole purpose is to improve a man's self‑esteem and quality of life and were approved by the FDA without controversy.
As a plastic surgeon, I have performed thousands of implant surgeries using both silicone and saline. I have found silicone to be safe and effective and far superior.
In 1876, William Welch, the founder of Johns Hopkins Medical School said, "In the end, our preconceived beliefs must change and adapt themselves." The facts of science will never change. I base my medical decisions on fact, and the FDA should do the same.
I urge the panel to make a determination on evidence‑based science, not politics and emotions, and leave the choices up to individual women and their physicians.
CHAIRMAN CHOTI: Thank you.
Next speaker?
BETH: My name is Beth, and I have no conflict of interest. To protect my family's privacy, I thought long and hard about whether I should come and testify today. I decided that because of my concern for children born to implanted mothers, I would come at my own expense to tell you how I became convinced that the platinum and other toxic chemicals found in breast implants have harmed my health and that of my two young daughters.
For privacy, I will refer to them as "Muffin." She's seven. "Stinkerbelle" is nine. Both of my girls have tested for lupus due to their extremely high platinum levels, especially Muffin. We have been told that her bones are deteriorating. Here is my story.
After ten years of implantation, a chronic cough caused my right implant to herniate outside the scar tissue. Due to numerous symptoms, including hair loss and swollen lymph nodes. My implants were removed in '92 without replacement.
Two years later I became pregnant with my third child, then my fourth. I was plagued with autoimmune symptoms during these pregnancies, swollen lymph nodes throughout my body, and weight loss. I was so ill in this last pregnancy with Muffin that my doctor informed me that she was living off my body fat.
Published research shows that platinum is stored in the fat of breast‑implanted women. I am convinced this is why Muffin has an even higher lupus score than I do. And even her platinum level is higher than mine, so high that I cannot say it out loud at this hearing.
I also understand that ionized platinum can cross the placenta. And significant levels of platinum are found in breast milk. I breast‑fed both of my daughters.
Since that time, my health has deteriorated. Some of my symptoms and diagnosis include asthma, photosensitivity, hives, throat swelling, and lupus, lung and bone pain.
My two children born before I had implants are very healthy, while Muffin and Stinkerbelle are constantly reacting as if they have multiple allergies when they have none. They endure bladder problems, photosensitivity, eczema, intense bone pain that wakes them up in the night screaming, lung pain, asthma, chronic pneumonia. Their lives and health have been forever altered.
As a mother who faces an unknown future for health consequences for herself and her young daughters, I ask you to vote no on this PMA application.
CHAIRMAN CHOTI: Thank you.
Good morning.
MS. SHEPPARD: Good morning. My name is Audrey Sheppard. I live locally and have no financial conflicts.
For four years, 1996 through '99, I directed the FDA Office of Women's Health. As a result of my professional involvement with silicone breast implants, I regard sharing my perspective an ongoing responsibility. I hold the agency and you in high regard and am optimistic about your making scientifically sound judgments.
My role at OWH, nearly a decade ago, requested by and partnering with the Center for Device Leaders, was to chapion and obtain full funding to conduct what became the critically important FDA rupture study. Its findings have resulted in a better understanding of the frequency of these devices rupturing over time.
You will be briefed ‑‑ and there has been reference to it already ‑‑ on the results. Suffice it to say that over time more than 65 percent of women in the study were found to have at least one ruptured implant and over 21 percent had silicone gel outside the capsule in one or both breasts. The latter finding is particularly concerning since the effect of silicone on the tissues and in development or progression of disease remains unknown.
After leaving the agency five years ago, I have advised and assisted women's health and other women's nonprofits and projects and from this vantage point will share three requests. One, follow the science.
Even the company's data, which you know will put on the best face, will not dispute a significant rupture rate nor other consequences of having these devices for years. These are not lifetime devices and, as such, without regular and too frequent resurgeries are not safe and effective, as intended.
Two, pay close attention to FDA's own documents and data. A number of documents on the CDRH Web site, including ‑‑ and I have the names, but you can find them. These themselves are damning information that is based on scientific research, decades of experience, tens of thousands of adverse event reports. And it also includes disconcerting photographs.
Please don't discount this body of material with the argument that the devices are much improved today. Make certain there is data to prove it.
And, number three, please believe your own eyes and ears when you see the dozens of sincere women whose health has been compromised standing before you. Of course, you will also hear from those who are highly satisfied. Their experience does not provide reason enough to open implants to wide use for augmentation, even by teenage girls.
To summarize, the health and well‑being of some of America's women and girls will be affected, even if they won't know it for years to come, by your decisions.
Thank you.
CHAIRMAN CHOTI: Thank you.
Good morning.
MS. GREEN: I'm Bettye Green. I'm the President of African American Women in Touch. And I am a breast cancer survivor. And I chose reconstruction after a mastectomy. However, I believe breast cancer patients deserve more information than they are getting.
Fortunately, there are many more options than there used to be for breast cancer patients. More than three out of four are eligible for lumpectomy. So relatively few women with breast cancer have a need to undergo a mastectomy in the last few years or in the coming years.
And, fortunately, women who undergo mastectomies have two other alternates to silicone breast implants. They can choose saline breast implants, which have a lower complication rate and are easier to remove when they break, or they can choose an autologous tissue transfer, a very popular procedure that moves tissue, in fact, from the abdomen or other areas to create a breast that is much more natural looking and feeling than a breast implant reconstruction.
Over the years, FDA panels have heard from some breast cancer survivors about the mental health benefits of silicone breast implants for mastectomy patients who want to reconstruct their breasts, but now that there are so many choices, do silicone breast implants offer benefits that are greater than other options, so great that they are more important than safety?
Research by Dr. Julia Roland of the National Cancer Institute and her colleagues found no difference in the quality of life of women who underwent lumpectomies, women who underwent mastectomies, and women who have had mastectomies with reconstruction.
Even more surprisingly, the women who had reconstruction felt their sex lives had been harmed more than mastectomy patients. If we look at the data presented by Inamed and Mentor, these findings make sense.
Most reconstruction patients require a lot of complications. They report more autoimmune symptoms two years after implants, such as joint pain and mental confusion, compared to before getting breast implants.
According to a study of women who had reconstruction five years earlier, most implant patients were no longer satisfied. In contrast, most of these autologous tissue transfer reconstruction patients remain satisfied. The implant makers remind us that their studies show that patients are satisfied.
But as a cancer survivor, a nurse, and a leader of a national group for breast cancer patients, I can tell you that most breast cancer patients don't tell their plastic surgeons that they are unhappy. They have been through cancer. Most don't like to complain about how they look now, especially in a study when being honest will not help them in any way and could potentially harm their relationship with their doctor.
I have another concern that nobody has mentioned and that is very important. There are very few African American women or Asian American women in the Inamed or in the Mentor study. For example, there are only six African American breast cancer patients in the Inamed core study and only five Asian American women.
This is a big problem because African American and Asian women are more likely to develop a cheloid scarring. This scarring tendency could potentially increase the risk of capsular contracture as well.
African Americans are also at an increased risk of autoimmune diseases. So it is essential that silicone gel breast implants not be approved until they are carefully studied on women of color.
In summary, research suggests that women who have had reconstruction after mastectomy do not have a higher quality of life than women who do not undergo mastectomy. Their sex lives seem to suffer more, not less.
Independent researchers found that the majority of implant reconstruction patients are not satisfied five years later. These findings are more credible than those funded by implant companies.
In one study, reconstruction patients were ten times as likely to commit suicide as mastectomy patients who do not undergo reconstruction. More African American and Asian American women need to be included in breast implant study, especially studies of breast cancer patients. Neither Inamed nor Mentor have studied enough women of color to determine if the risks are any different for them compared to white women.
Thank you so much for listening.
CHAIRMAN CHOTI: Thank you, Ms. Green.
Next? Yes?
MS. KUECK: Good morning. My name is Jana Kueck, and I'm a registered nurse from Branson, Missouri and a sister of an injured breast implant consumer. I've been a registered nurse for 21 years. My background includes labor and delivery, newborn nursery, and assisting new mothers as a former breast‑feeding educator. I have no financial relationship with the PMA sponsors, their products, and their competitors.
Numerous studies have found that breast‑feeding provides newborns with essential nutrition and improved resistance to infections. By impeding or preventing breast‑feeding, implants have become a public and pediatric health problem as they are essentially depriving newborns from these benefits.
According to the Institute of Medicine, any kind of breast surgery, including breast implant surgery, makes it three times more likely that women trying to breast‑feed will have inadequate milk supply or lactation insufficiency.
In a study conducted by Marianne Neifert and colleagues of the University of Colorado at Madison, women who had breast surgery were three times more likely to have lactation insufficiency than those that did not have surgery. The doctors compared the rate of weight gain of breast‑fed infants born to mothers who either did or did not have previous breast surgery. Mothers whose babies did not gain at least one ounce per day or required supplemental feedings with formula were deemed to have lactation insufficiency.
Interestingly, the women who had breast surgery through an incision in the nipple area or periareolar incision had a higher incidence of problems. Those women were more likely to suffer from insufficient milk supply.
I frequently have observed decreased milk production in mothers of breast‑implanted surgery. In addition, implanted mothers' infants also had difficulty latching onto the breast due to the firmness, usually caused by capsular contracture, even a mild contracture, from the implants.
We don't know how silicone breast implants affect what is in the mother's milk, but it is certainly worthy of more study. Recent research suggesting platinum in breast milk due to the platinum used as a catalyst in silicone breast implants concerns me a great deal.
Because of what is known and what is yet not known about the risk of implants on breast‑feeding, I am asking you to vote against the approval of Mentor's and Inamed's application. Voting against approval will support women's health and the health of precious newborns.
CHAIRMAN CHOTI: Thank you.
Next? Good morning.
DR. GOLDBERG: Good morning. Thank you for the opportunity to highlight a few scientific issues pertinent to the panel's review of gel implant safety.
I'm Eugene Goldberg. I direct the Biomaterials Center at the University of Florida. I have no financial interest in breast implants. I traveled here at my own expense.
My group has conducted research on the biocompatibility of silicone implants for more than ten years. In addition to my comments here, I have appended more information for you.
We published the only large cohort clinical evaluation of gel implants. This is a meta analysis of about 10,000 implants from 42 different papers. A high prevalence of rupture and additional surgeries was found. A plot of failure versus time showed 29 percent of rupture at 5 years and 70 percent of rupture at 17 and a half years. When the next slide comes up, you will see that.
One of every three women with implants required additional surgery within six years due to pain, hardness, disfigurement, or rupture. In an FDA‑NIH study using MRI plus explant surgery, Brown and coworkers confirmed our results. They found 69 percent rupture at 16 and a half years. And that falls directly on our implant rupture curve that is shown up there.
A Mentor consultant states that "Rupture is a critical safety parameter," but Inamed in a letter to the FDA says that rupture is "an unintended patient outcome." Frequent additional surgeries are truly also unintended, but both pose major safety risks.
Inamed now tells us that surgical damage is the leading cause of failure. If so, why aren't gel implants properly designed for normal surgical procedures? Inamed's 4‑year clinical results show still a high 10‑22 percent rupture, despite a presumably thicker shell with phenyl siloxane as a barrier. Short‑term rupture is actually not much lower than reported before.
Also note that crazing and cracking of phenyl siloxane coatings can occur after four to five years. And the barrier properties and strength may deteriorate as a result after five years. Four‑year clinical data are not adequate.
Finally, an increased risk for cancer of the lung, cervix, and brain is reported for gel implant recipients. It is simply not reasonable for Inamed to blame this on lifestyle with no scientific evidence. This is another potentially serious problem, and it must be resolved.
Thank you.
CHAIRMAN CHOTI: Thank you.
Good morning.
DR. WOOLEY: Good morning. I'm Paul Wooley. I'm Professor of Orthopedic Surgery, Immunology, and Biomedical Engineering at Wayne State University in Detroit. I have no financial ties with the sponsors or any of their competitors.
I would like to address the issue of latency and, in particular, the adjuvant effects of silicone. My group has been studying this for about a decade.
The hypothesis that we address is that silicone as a rather sticky substance, proteins, normal proteins of the body, can adhere to silicone. And minor conformational changes in the protein can result in the development of autoantibodies. And such autoantibodies may be significant in the pathology of connective tissue disease.
I have four publications in leading journals on the subject. And I would like to update the panel on the studies that we have conducted since they last met.
In our early studies, we demonstrated that silicone implantation in mice did result in autoantibodies, but those autoantibodies did not alter the disease process in either arthritis or lupus. However, our third study clearly demonstrated in a long‑term implantation in mice that disease was indeed exacerbated.
To take those studies to the human, we studied VP shunts in children and demonstrated adjuvant effects with the development of an autoantibody that was associated with an increased revision rate. However, the data that I have made available to you today is the first study that we have done in silicone breast implant material.
Paired samples of breast explant material, silicone explant material, and sera were made available to us from Dr. Fred Miller and Terry O'Hanlon at the NIH. These were provided in a blinded manner. We did not know which sera went with which breast implant, and we did not know the diagnosis or reason for the explantation.
Three of them it turned out the patients had either an autoimmune or a connective tissue disease. Three of them were clinically normal at the time of explanation.
We used a published and recognized method of removing the proteins from the silicone surface and we used the sera in a Western blot assay to assess whether the patient has a reaction against any of the adherent proteins.
Our findings were we believe quite significant. A novel 205‑kilodalton protein was removed from the surface of these explanted materials and was found to be immunologically active.
It turns out that this ‑‑
CHAIRMAN CHOTI: If you could sum up, please?
DR. WOOLEY: Yes.
‑‑ that this protein was associated with either MGUS or mixed connective tissue diseases. However, the antibody to that protein was also detected in patients who were clinically normal at the time of explanation. This antibody is not present in normal women.
Thank you.
CHAIRMAN CHOTI: Good morning.
MS. HEIDE: Good morning. My name is Terry Heide. And I'm reading a statement on behalf of a patient who couldn't be here today.
"My name is Nancy Reuben Greenfield, and I am sorry that medical issues have kept me away from delivering this speech personally. I want to thank the panel for giving me an opportunity present my support for silicone breast implants.
"First I need you to know that Inamed Corporation generously and compassionately sponsored my book, When Mommy Had a Mastectomy, which is designed to help parents and children through the trauma of breast cancer and the process of recovery.
"I am actually not one to talk about breasts in general, let alone in public. I have always been a tomboy. I got a sports bra because I had to. But along the way, I became a woman and a mother. And I will always consider nursing my children as one of the true highlights of my life.
"When I was 39, I got breast cancer and needed a double mastectomy. I wasn't sure what I would do after the mastectomies. I decided staying flat wouldn't suit me. And prosthetics are a great idea, but I have enough trouble finding my keys. So I decided on breast reconstruction, and I appreciated the fact that as a breast cancer survivor, I had the choice between silicone and saline implants.
"My plastic surgeon highly recommended silicone implants because his patients raved about their comfortability and he saw no differences in terms of their safety.
"When you have breast cancer and you have children, at some point you have to tell them. My children were five and seven at the time, and there was no book that could help me. So I decided to write one.
"Writing it was easier than getting it published. Even when I found a publisher, there were no funds available for the project. It was then that my publisher and I came up with the idea of asking the manufacturer of my implants if they would be interested.
"Based on my research, silicone has no worse or better effects on the body than saline. Based on my personal experience, my silicone implants are really comfortable.
"Frankly, I don't really understand the FDA research on silicone implants. They are already on the market for breast cancer patients. They have proved to be safe. And women are very satisfied with the results.
"Why should breast cancer be the determining factor on the use of silicone implants? It seems more like moral judgment on why people choose to have implants, rather than an issue of science and medicine.
"The choice to have silicone implants shouldn't be a consolation prize after breast cancer. Any woman who changes her breasts, for whatever reason, should have the option to use silicone implants.
"I ask you today to approve silicone implants for any woman who wants or needs them. Let all women be treated equally. Nancy Reuben Greenfield."
CHAIRMAN CHOTI: Good morning.
MR. GOOZNER: Good morning. My name is Merrill Goozner, and I am the Director of the Integrity in Science Project at the Center for Science in the Public Interest.
Integrity in Science seeks to focus public attention on the issue of how financial conflicts of interest are affecting the objectivity of the scientific process, especially through federal scientific advisory committees, such as this one.
While CSPI is largely self‑funded through its newsletter, the Integrity in Science Project I run receives additional funding from several foundations. None of these outside foundations have a particular interest in this issue or, I might add, in medical issues generally.
The Federal Advisory Committee Act prohibits people with conflicts of interest from serving on committees providing scientific advice. The logic behind this provision is that a person sitting in judgment of a body of evidence should not simultaneously be employed by an entity with a stake in the outcome.
The law allows for an agency to grant waivers if a scientist expertise is deemed necessary for the committee, which has happened in this case, a point I will return to in a second.
The law also requires that committees be balanced as to points of view, a recognition that even when there isn't a direct conflict of interest, a person's outside employment can influence their outlook on the questions at hand. The scientific literature is very clear on the impact of financial conflicts of interest on the outcome of science.
With this by way of background, allow me to address the makeup of this Committee. This Committee is smaller, yet similar, in makeup to the last committee evaluating the silicone gel breast implants. Its permanent roster includes Dr. Michael Miller.
According to your own statement this morning, Dr. Miller's institution has received $25,000 from Inamed, one of today's petitioners, for his role in producing an educational CD‑ROM about breast reconstruction surgery.
I have viewed video excerpts from that CD‑ROM. In it, Dr. Miller states, and I quote, "At this time, a number of good studies have been completed and there are others ongoing that show implants do not cause disorders, such as cancer or autoimmune diseases. Based on these studies, we are confident that breast implants are safe."
It would appear based on this evidence that Dr. Miller not only has a conflict of interest but has a point of view about the evidence he is about to hear regarding the safety and efficacy of these products.
The purpose of waivers is to allow scientists to serve when their expertise is deemed critical to the Committee's deliberations. In no way can Dr. Miller's expertise be considered unique. He is one of four plastic surgeons on this Committee, which brings me to the second issue of concern about this makeup.
The Federal Advisory Committee Act requires that committees be balanced. Eighteen months ago, after the last committee voted nine to six in favor of allowing the silicone gel breast implant on the market, with all four plastic surgeons on the committee voting in favor, the chairman of that committee, Dr. Thomas Whalen, wrote then FDA commissioner, Mark McClellan, decrying the committee's lack of balance. Specifically, he noted, "Even in academic settings, plastic surgeons may stand to increase their own income with the use of these devices."
Whether one agrees with that statement or not, the fact is that the number of plastic surgeons on this committee is double the number of physicians who treat the diseases that might arise from the use of these devices. Where is the balance?
The Center for Science in the Public Interest is extremely disappointed that the FDA chose to overlook the conflicts of interest and has created an unbalanced panel to evaluate the evidence on this issue. The FDA has again created a situation where the final vote will be clouded by the perception that some members had conflicts of interest that my have influenced the vote.
CHAIRMAN CHOTI: Thank you.
Good morning.
MR. COMPTON: Good morning. I'm Phil Compton, and I'm Community Organizer for our Florida Consumer Action Network, a grass roots consumer organization with more than 40,000 members statewide. I come here today with no financial ties to either sponsor or any of their competitors.
Following the October 2003 panel, the chairman of the advisory panel, Dr. Thomas Whalen, took the highly unusual step of writing a public letter to then FDA commissioner Mark McClellan. This is the first time that a chairman of an FDA advisory committee ‑‑ and there are literally hundreds of them spread over the 5 operating centers of FDA ‑‑ has written such a public letter in at least a decade. This letter was reported on the front pages of major newspapers across the country.
For the new members of the panel, here is what Dr. Whalen wrote, "Dear Dr. McClellan, on October 14 and 15 of this year, I chaired the General and Plastic Surgery Devices Advisory Panel in Gaithersburg, Maryland for consideration of a PMA by Inamed Corporation for silicone gel breast implants.
"As I am sure you are aware, the panel voted nine to six that this PMA was approvable, and the matter is now under consideration for action at the CDRH. I write to express as the panel chair my very strong reservations concerning this vote, having thoroughly reviewed the PMA, heard my scientific colleagues on the panel, as well as the presentations of Inamed and the FDA, and having intently listened to all of the over 100 individuals who gave public testimony.
"At its essence and as is mandated by federal code, the mission of an FDA panel and then the FDA itself acting upon the panel recommendation is really elegantly simple: To judge that the company bringing the PMA before them has demonstrated with reasonable assurance that the product under consideration is both safe and effective. Effectiveness was demonstrated and is almost self‑evident.
"Long‑term safety, the concern that prompted the removal from the market 11 years ago, was clearly not demonstrated. And to approve this device poses threats to women that are clearly unknown.
"In my opinion, there is at least one facet of long‑term danger that was established during the panel: Specifically the obscuration of surrounding normal breast tissue to mammographic detection of breast cancer. The reoperation rates and other local complications from silicone leaking outside the breast area have also been established by FDA scientists and are not minor considerations for a cosmetic device.
"Moreover, despite the sophistication of the Institute of Medicine's report, all of what was considered by them reflected low‑quality data in the age of evidence‑based medicine.
"It is incumbent upon the FDA to demand that the manufacturer establish in a rigorous prospective, controlled study that these devices, despite their established breakage and leakage rates, are safe in the long term. If that is deemed to not be feasible for the company, then they should abandon pursuit of approval. However, the company's track record suggests that they are capable of such research but have not been sufficiently motivated to complete it.
"The plethora of approval conditions that had my head spinning during panel deliberations is proof that even those who voted the PMA as approvable are deeply concerned about the lack of long‑term safety data on this product. What will motivate the company to follow these FDA requirements?
"Most upsetting was when an FDA official admitted, at my pressing, that there is little, if any, remedy for the FDA if demands to demonstrate long‑term safety are not carried out by the company.
"I need not point out to you in your position what the term 'FDA‑approved' represents to our citizenry. Once this horse is out of the barn, indeed for a second time, there will be no recourse.
"I have the utmost respect for my colleagues on the panel, one and all. This most assuredly includes the four well‑respected and knowledgeable plastic surgeons. Certainly, it was essential to include board‑certified plastic and reconstructive surgeons when considering a PMA on breast implants.
"On the other hand, it serves the reputation of the FDA in general and the standing of the panel process, in particular, exceedingly poorly to have had all of the plastic surgeons vote the PMA as approvable on such a close vote. Even in academic settings, plastic surgeons may stand to increase their own income with the use of these devices. To cite a worn aphorism, it just does not play well in Peoria.
"In closing, I must add that the issue of medical care of women who suffer complications from these implants is extraordinarily troubling. Costs for removal of these implants and for extra‑capsular silicone can be enormous and are very rarely covered by a health plan. This is a public health issue of no small import that must be addressed should the FDA second this misguided panel decision.
"I have been honored to be a part of the General and Plastic Surgery Devices Advisory Panel these past few years, and have been extremely impressed by the devotion and professionalism of those in your agency.
"I regret that the final chapter of my FDA experience was this one and implore you and Drs. Feigal and Witten to not approve this PMA. I would be delighted to provide any further information if you desire it.
"Sincerely yours, Thomas V. Whalen, M.D., Professor of Surgery and Pediatrics."
Now, there are two questions each of you should ask. What did the Center for Devices and Radiological Health do to find out what happened here and to correct it? If FDA did nothing, then how can the agency expect to have an impartial advisory committee meeting?
Thank you.
CHAIRMAN CHOTI: Good morning.
DR. PARISIAN: Good morning. I'm Dr. Suzanne Parisian. I am speaking on behalf of Pro‑Choice Alliance for Responsible Research. I formerly was a chief medical officer for Office of Device Evaluation, Center for Devices and Radiological Health at FDA. I'm a physician. I'm board‑certified in pathology. And I'm author of FDA Inside and Out.
Thank you for considering my testimony. I have no conflicts of interest with any of the applicants or their competitors.
When FDA denied Inamed's marketing application in 2003, it followed by releasing a guidance document requesting ten years prospective data for primary augmentation, reconstruction, and revision populations.
FDA provided methods for mechanical testing, requested rupture rates, and longer clinical studies, addressing areas which FDA indicated were critical to the assessment of safety.
FDA expressed concerns that implants were rupturing at unacceptably high rates, that longer‑term health risks were still unknown, and silicone's effect on the body was not yet fully studied.
Liquid silicone injection has not been found to be safe by FDA in other application reviews. However, industry routinely dismisses FDA's requests for long‑term data and continually ignores all the safety concerns.
On average, women begin to report problems with their breast implants at seven to ten years after implantation. Therefore, three to four‑year studies with clinical data are not adequate to assess safety. We still do not have the adequate long‑term safety data for silicone breast implants. The manufacturer's application should be denied.
FDA first requested this safety information for silicone breast implants in 1988 for products that had already been on the market 20 years. Instead of science, valid data, and a concern for women's health, FDA continues to be met with well‑financed and well‑organized resistance. If FDA cannot compel PMA sponsors to provide the adequate long‑term safety data for silicone breast implants before PMA approval, it will never be obtained.
Improved manufacturing practices, quality controls, and informed consents have been instituted through the efforts of CDRH's staff. I know that. And this is for both the saline‑filled and the silicone gel breast implants.
I know that sponsors tell FDA that the women are lost to follow‑up for long‑term data because they're too embarrassed to talk about their silicone breast implants with the companies. Yet, these same sponsors can find these women in order to finance their breast implants and make payments or they can suddenly locate data in Europe that they didn't have before.
Although there are many inadequacies in these PMA applications, time only permits me to make four brief and important points. First, neither Inamed nor Mentor have come up with reliable safe rupture rates. They have come up without good methods to detect rupture rates. And their data does not reasonably predict the safety profile for each device over its lifetime.
According to the FDA analysis of the industry data, three‑quarters of implanted women will have at least one ruptured implant within ten years of receiving the devices. Specifically, FDA has estimated that up to 93 percent of breast cancer reconstruction patients should receive at least one broken implant. They will have, will expect to have, not receive.
Second, FDA should have the PMA sponsors obtain information about the children. As we have been hearing, the children have been left out of the guidance document. And we need further information about what happens to the children born to women with silicone breast implants. No woman would want to have a cosmetic surgery and then hurt her children. And these products will be aggressively marketed to women, young women. Now implants are being put in women younger than 18 years of age.
Third, implants can obscure mammographic imaging by hiding the breast tissue. MRIs have been set as an alternative technology to screen these women, but they're not always accurate. MRI doesn't always detect rupture in these women. And there's conflict between rupture and explants.
Additionally, it has been very misleading to the public to imply that MRI facilities are trained, willing, or can be reimbursed for these types of studies. The average cost of an MRI is $1,890. So a recommendation that women receive MRI is not inconsiderate in terms of expenses. And also, young women do not routinely receive any kind of imaging.
Fourth, FDA's approval, as I know, is the gold standard for the American consumer. After the 2003 FDA panel meeting, FDA determined that silicone breast implants were unsafe. The long‑term effects still have not been adequately addressed by either sponsor as they continue to ignore FDA guidance. You still do not have that safety data that you thought was necessary 20 years ago. So please do not recommend approval.
Thank you very much.
CHAIRMAN CHOTI: Good morning.
MS. BAEKE: I am Suzanne Baeke. I am a registered nurse, patient educator specializing in plastic surgery. I have no financial ties with any of the breast implant manufacturers.
I chose to have breast implants seven years ago. Three years later, my life with silicone gel breast implants would be best described as the roller coaster ride from hell.
Each day brought with it new horrors: fevers up to 103, chills, memory loss. Concentrating on everything became a problem, hair loss, repeated bladder infections, zero sex drive, dry mouth, severe joint pain, painful feet, and crippling muscle spasms to the point where I had to have three deep tissue massages per week.
The mood swings were crippling, not just for me but my entire family. At times I wished I were not alive. I suffered the chronic fatigue, yet suffered from insomnia. I would at times have to pull into a parking lot and shut my eyes for what I thought would just be a minute but turned out to be 45.
I was evaluated by my rheumatologist at the Mayo Clinic for chronic fatigue syndrome. MS, fibromyalgia, ankylosing spondylitis were all considered. Members of the Committee, I would not have wished my life on anyone, but I refuse to give up. I refuse to live this way. And I was on a mission to find out what was wrong with me.
I bought every product on late‑night television that promised to fix me. Eventually I found an endocrinologist, Dr. Bernard Rice. He performed on me the most comprehensive evaluation I had ever witnessed. Eventually he took me by the hand, took my husband, and said, "Your wife needs hormone replacement. The fact that you are still married is incredible. Most men get out when things get this bad."
Dr. Rice is one of the pioneering investigators in the gradual but debilitating effects of hypo‑ovarian syndrome. Call it premenopause if you wish. All women begin to suffer the effects of low ovarian testosterone production early in life, progressing until full menopause. For me, the hysterectomy with an oophorectomy sped up this insidious process.
Distinguished panel, I am here to set the record straight. It is no coincidence the symptoms of which I suffered are identical to many of the women testifying today. I submit that silicone implants have been ridiculously maligned when more likely the culprit is the low testosterone levels in the pre‑menopause and menopause patient. With expert estrogen and testosterone replacement, all of my symptoms immediately reversed. And I still have my silicone gel implants.
To the National Organization of Women, I challenge you. If your motives are truly honorable, consider that you may be wrong. Read my lips. The real problem afflicting millions of women is not silicone gel implants. It's, rather, inadequate hormone replacement therapy.
Thank you.
CHAIRMAN CHOTI: Good morning.
DR. BAEKE: My name is Dr. John Baeke. I am a plastic surgeon with extensive knowledge regarding silicone gel breast implants. I have no conflict of interest.
Second slide. Please review my data carefully, paying close attention to my low complication, reoperation, and zero deflation rates. I provided full handouts out in the hallway for each one of the panel members. And I invite you to please pick up one.
After the 2003 hearings, I was disheartened by the dearth of testimony supporting the elective cosmetic surgery patients. I will not be shy in standing up for these women. Organizations like NOW too often portray women desiring breast enhancement as bimbos. Shame on you. The cosmetic patient is typically careered, in her 30s, seeks multiple opinions, is well‑versed on the subject, and on average requests only one and a half cup size increase.
Slide. Surgeons performing breast augmentation do so not out of financial motivation. Those guys can be found next door at the Botox hearings. If we were purely profit‑motivated, cheaper, wrinkle‑prone saline implants would suffice. As plastic surgeons, we are committed to providing women with the most beautiful breasts possible. And that requires silicone implants. If not for that simple fact, we'd all go home.
Slide. How extraordinarily hypocritical, if not insulting, to allow silicone implants for the cancer survivor but not for the cosmetic patient. To the mastectomy patient, the message is, "You're going to die of a disease anyway. So who cares?" To the cosmetic patient, the message is, "Your plight is not to be taken seriously." It is arrogant for anyone to believe a small‑chested woman is not experiencing real pain because of her developmental misfortune.
Slide. What a double standard for feminist groups to promote a woman's right to choose when it comes to issues of abortion but not to embrace that same freedom when it comes to silicone implants.
Slide. Why is mere dozen‑word warning appropriate for cigarettes; yet, for silicone implants, the bar is set higher?
Slide. Shame on the naysayers for the hypocrisy of condemning Inamed for presumed insufficient data. Remember, the core and adjunct studies that criticized were designed with the oversight of the FDA. At the same time, these individuals have become masters of the melodrama, presenting volumes of purely anecdotal, nonverifiable, oft exaggerated quips before this esteemed Committee without ever undergoing any type of similar scientific scrutiny.
Does it stand the test of logic that surgically removing implants would lead to sudden improvement in symptoms when this is supposed to be a disease caused by systemic‑wide dissemination of silicone?
Slide. One simple answer to this dilemma should satisfy all. Legislate a standardized, comprehensive informed consent. Require its usage by all. Then trust the sanctity of the patient‑physician relationship.
Slide. Since no one else will stand up and say it, I will. Companies like Inamed should be commended for the millions they have invested in research and development. The modern‑day silicone implant is safe to the satisfaction of medicine and science alike. Thank you, Inamed.
MS. CUMMINGS: Good morning. Ladies and gentlemen, my name is Arlene Nicole Cummings. I came here at my own expense today to tell you about how breast implants have affected me.
At the age of 12, I had a breast tumor removed from my right breast. This left me with an asymmetry problem that only got worse as I got older and had my children.
Fixing my breast was something I had thought about for years. After I was done having my children, I felt the time was right. I did a lot of research online and found a great deal of information but nothing personal. This is what prompted me to start implantinfo.com back in 1998, after my own surgery.
Implantinfo is now the largest community Web site for breast augmentation patients where women can research the good and the bad about breast implants and go through photos and stories of thousands of other women.
I am here today primarily because I am a satisfied breast augmentation patient. However, I never had the option of choosing silicone back in 1998. After years of talking to women and doing my own research, I now believe silicone is a superior product in many ways. If I had the option today, I would choose silicone over saline.
On my Web site, I have corresponded with countless women who, for many reasons, probably should have had the silicone option but did not. They were denied silicone implants, had an unsatisfactory result with saline, and then had to have a second surgery to replace their saline implants with silicone. So they actually had to have two surgeries to get the result they wanted the first time.
I am also aware of the frustration surgeons feel because they cannot give a patient what they know in some cases will produce a better result for them.
The risk of a second surgery in my opinion is far greater than any silicone implant would have posed. Ironically, breast cancer patients already have compromised immune systems but for the most part can receive silicone implants.
Are they at less of a risk of the supposed risks of silicone breast implants? I believe silicone implants provide a far better result for reconstruction. If these patients get better results with silicone implants, shouldn't they be available to all of us? Women along with their surgeons should be allowed to choose silicone or saline. We are neither ignorant nor shallow, and we are not seeking breast augmentation without informed consent.
We have researched the procedure for years. The average age of a woman on my Web site is 34. Most of us are married with children and just want to get back what we lost after pregnancy and nursing.
I believe in informed consent. And women should know all of the risks. But in the end, after we review that information, let us decide along with our surgeons silicone or saline.
I've received dozens of e‑mails from women who wanted to be here today in person but could not for many reasons. There are thousands of women like me on implantinfo.com. And I encourage you to come to the Web site to read more about us and to give us both the choice of silicone and saline.
Thank you for your time.
CHAIRMAN CHOTI: Thank you.
MS. COLOMBO: Good morning. My name is Michele Colombo. I am 36 years old, married, and I have one child. And I come here at my own expense.
For many years, I was dissatisfied with the size and appearance of my breasts. I am a very self‑confident and educated person, but I have always seriously considered improving my appearance by undergoing breast augmentation.
I researched breast augmentation for approximately five years, including reading the FDA Web site as well as other resources on the internet. In doing so, I satisfied myself that silicone implants are a safe alternative for my breast augmentation.
Due to a vocal minority in the early 1990s, silicone breast implants were banned for sale to most ordinary people, like me, in the United States. If I lived in Europe, I could get silicone breast implants without any question. If I traveled to Europe, I could get silicone breast implants and I could come back to the U.S. and live here with them, even though they're unavailable here. If I had breast cancer, I could get silicone breast implants, perhaps because those with breast cancer are less prone to the purported risks of silicone breast implants.
What's more, if I were a man, I could get silicone testicular implants. And if I required shunts for medical reasons, it would also be made of silicone.
Fortunately for me, in an ironic way, when I was seeking breast augmentation options, I was able to qualify for silicone implants because I have a congenital deformity. What does not make sense to me is that silicone breast implants have been shown in numerous studies to have no more long‑term health risks than saline breast implants and other silicone devices.
Despite the fact that the FDA up until now has allowed some people to get silicone and not others, I don't understand why someone else can decide that they are safe for me or for a cancer patient but not safe for someone else. In other words, a woman can make a decision about safety of breast implants if they have cancer but not if they simply want to improve their physical appearance.
I am here to tell you that the benefits to women, regardless of whether they have cancer or some other arbitrary qualifying factor, are equal. My life has improved dramatically since I had my surgery last year. My sense of self has improved. And it has affected aspects of my life too numerous to mention. I had a child after my breast augmentation with silicone breast implants and breast‑fed him successfully.
I think it is time to reevaluate the true motivation for the ban on silicone breast implants. The fact that breast cancer patients may obtain them and cosmetic patients cannot exposes the true reason for the ban. What is at stake is a moral judgment, rather than a medical one.
If my breasts are completely deflated from breast‑feeding, weight loss, or age, improving my appearance with breast implants is deemed unacceptable because it would be for vanity. If I had a mastectomy, it would be acceptable because it could be justified as medically necessary, although many women choose not to get implants after mastectomy.
The difference is a moral one, not a medical one. I don't believe the FDA is the right organization, if any, to determine what is morally appropriate to do to our bodies. If the FDA is going to ban silicone implants based on unacceptable risk, I think it is time to ban all medicines which have side effects.
Why is my psychological desire to improve my appearance less important than the desire of others to curb their appetites through approved weight loss drugs, reduce heartburn, stop hair loss, et cetera? The truth is it's just as important.
I urge you to remove the ban on silicone breast implants and let women make informed decisions about their bodies the way millions of people do every day with countless other devices and medicines approved by the FDA.
Thank you for your time.
CHAIRMAN CHOTI: Thank you very much.
And at this point, we'll take a break of about 15 or 20 minutes. Let's resume promptly at 10:30. Thank you.
(Whereupon, the foregoing matter went off the record at 10:10 a.m. and went back on the record at 10:39 a.m.)
EXECUTIVE SECRETARY KRAUSE: I think we are about ready to start. AnnMarie is here. Okay. I am going to turn the meeting back over to Dr. Choti.
CHAIRMAN CHOTI: Good morning. May we have our next public speaker, please? Remember, you have three minutes. And, just to remind you again, the yellow light comes on with a 30‑second warning. And you need to stop by the time the red light is on.
MS. CORBETT: Actually, I'm representing an organization.
CHAIRMAN CHOTI: Okay. So five minutes.
EXECUTIVE SECRETARY KRAUSE: Are you Christianne Corbett?
MS. CORBETT: Yes, I am.
EXECUTIVE SECRETARY KRAUSE: Okay.
MS. CORBETT: Yes. Good morning. My name is Christianne Corbett. I am the Program Coordinator at the National Council of Women's Organizations, NCWO. NCWO is am umbrella group for 200 women's groups. And I am speaking on behalf of the over ten million women nationwide that NCWO represents.
NCWO is very concerned about the safety of medical products used by women. The key question for this FDA advisory panel is whether silicone gel breast implants are safe, whether the benefits outweigh the risks.
In my testimony, I will focus on what we know and don't know about long‑term safety. We know from hearing testimony of the women at the 2003 panel meeting and again today that many of these women were very happy with their implants for the first few years. But after seven or more years, especially after their implants broke and started to leak, many women reported serious problems.
Local complications are the best established problems. These complications can be short‑lived, like most infections, or can be devastating. Chronic pain is very difficult to live with.
Having breasts that are hard as rocks is not a goal for most women. And if things go wrong and implants have to be removed, then what happens?
I have some photographs that I want to share with you. The photograph up right now is a photograph of a 29‑year‑old woman who had her implants removed after 7 years. She had capsular contracture that was so painful that she decided to have her implants removed. This photograph is from the FDA website.
Here is another woman ‑‑ you can go to the next slide ‑‑ who wasn't so lucky. This woman's ruptured implant had leaked into her healthy breasts. And when the silicone was removed, that is all that was left of her breasts.
Now let's look at some long‑term studies of diseases. The National Cancer Institute looked at thousands of women who had implants for at least eight years. They found women with implants were twice as likely to die from brain cancer, three times as likely to die from lung cancer, and four times as likely to commit suicide compared to other plastic surgery patients.
FDA's scientists did the best study of the health of women with ruptured silicone implants. All the women in their study had breast implants for at least six or seven years. So some had implants that had been leaking for several years. They found that women with implants that leaked outside the scar capsule were significantly more likely to report fibromyalgia and several other painful connective tissue diseases.
Dow‑Corning paid for another study on ruptured implants, referred to as the Danish study in the FDA review that was provided to you. Unfortunately, the Danish study included only 23 women with implants that leaked outside the scar capsule. They found that those women had more pain and other problems than women whose implants were not leaking, but because of the small sample size, those differences were not statistically significant. The study is not conclusive because the number of women with extracapsular leakage is much too small.
Implant makers often say that there are more than 100 studies of women with implants and that these studies prove that implants are safe. When they say this, they tend to ignore the studies that don't agree with them, which tend to be the studies of women who had implants the longest, such as the FDA and the NCI studies.
Most of the studies that the implant makers quote as proving safety were funded by Dow‑Corning. Almost all of the studies in the often‑quoted Institute of Medicine report, including the Mayo Clinic study and the Harvard study, were funded by Dow‑Corning. And, like the Danish study I mentioned, they tend to have rather small samples. And most studied women who had implants for a short period of time. For example, the Mayo Clinic study included only 749 women with breast implants, and only 375 of them had had implants for more than 7 years.
Autoimmune diseases take years to develop and be diagnosed. And the sample would have to be larger to adequately study diseases that are so rare in young women. You don't have to take my word for it. The authors point that out themselves.
Listen to the testimony you will hear from the women today. It took years for them to develop diseases after getting their silicone implants. First, they had symptoms that they didn't take very seriously. When they were tired or their joints hurt or they had trouble concentrating, they thought that perhaps they just weren't getting enough sleep or they were working too hard.
Those are the same symptoms reported by Inamed in their patients who had implants for only two years. They aren't sick or diagnosed with diseases like rheumatoid arthritis, but it will take at least a few more years to find out if they will be.
One more thing is that almost all of the women in the core studies are white. Women of every racial group got breast cancer, but only six African American women and five Asian American women are in the Inamed reconstruction study. Race is an important issue because African American women are more likely to get autoimmune diseases than white women.
In conclusion, not enough research has been done on large diverse samples of women that proves that silicone breast implants are safe in the long term. Because of this, on behalf of the National Council of Women's Organization and the ten million women NCWO represents, I urge you to vote against the approval of silicone breast implants.
Thank you.
CHAIRMAN CHOTI: Good morning.
MS. SILVERMAN: Good morning. My name is Virginia Silverman. This is my daughter Eve. She is six years old. I am from Laguna Niguel, California. Inamed paid for my flight here today. I am here today to talk about choice, a woman's inherent right to choose what is right for her body.
In September 2001, just days after September 11th, I was diagnosed with early‑stage DCIS breast cancer. After educating myself about the aggressive nature of my cancer, my treatment options, recurrent statistics, and my potential for complete cure, I chose to have a bilateral mastectomy. As a result of my aggressive treatment choice, I was cured of the disease with no need for chemotherapy, radiation, or tamoxifen.
To expedite my recovery, I chose to initiate my breast reconstruction during the initial cancer surgery. When I awoke from the operation, the cancer had been excised and saline tissue expanders had been inserted.
During the 12 weeks following my mastectomy, saline was injected into my expanders each week. As more and more saline was injected, the saline implants proved to be extremely uncomfortable. The water was hard inside its containers. And I experienced my breasts as inflexible, immovable objects on my chest. With every movement of my body, I was acutely aware of the foreign objects residing beneath my chin.
Finally, my tissue extension phase was over. And I received my permanent silicone implants. I chose the Inamed silicone gel implants because I was confident, then and now, after exhaustive research of their safety.
It has been three and a half years since I chose to cure myself of breast cancer and place silicone gel implants inside my body. Compared to the rigidity and discomfort of the saline implants, my silicone implants are comfortable and pain‑free.
While the saline implants were annoyingly inflexible and hard, my silicone implants are pliable and comfortable, contouring to both my body and my clothing. They even move when I dance and exercise.
As the Vice President of Marketing for Lindora, America's leading medical weight management company, it is my responsibility to be an active advocate on behalf of women's health issues.
I stay abreast of the most current medical advancements leading to healthier, happier lives for women everywhere. After over a decade of diligent research showing virtually no health issues with the product, I believe silicone gel implants should be available to all women, whether they are breast cancer survivors or not.
In conclusion, on behalf of myself, my six‑year‑old daughter Eve, who is with me today, and all women who are choosing to enhance their lives through breast reconstruction or enhancement, I urge you to approve the use of silicone gel implants for wide consumer use.
We have a right to decide what is right for our own bodies. I chose to live by electing my double mastectomy. I chose to live well by selecting silicone gel implants. I choose to be here today to encourage you to give women here in America the opportunity to choose for themselves which implant is right for their bodies.
Thank you very much for your consideration and your time today.
CHAIRMAN CHOTI: Thank you.
Yes? Next? Good morning.
DR. MAHARAJ: Good morning. I'm Dr. Susan Maharaj, and I am a professor of chemistry. I have no conflict of interest. Today I am presenting the results of Maharaj 2004, Maharaj and Lykissa 2004, and Lykissa and Maharaj 2005.
Next slide, please. Maharaj 2004. The results show that high levels of platinum are present in silicone breast implant gel, shells, and in the corresponding capsular tissue of women exposed to silicone breast implants. The gel and shell platinum values in this study are much higher than reported by manufacturers. Platinum tissue concentrations in women exposed to silicone breast implants are higher than in tissue samples of women not exposed to these devices. And, in fact, the values do not overlap.
Next slide, please. Maharaj and Lykissa 2004 and Lykissa and Maharaj 2005. Mean platinum concentration in whole blood and urine samples of women exposed to silicone breast implants was higher than in control subjects.
Mean platinum concentration in whole blood and urine samples of children conceived after their mothers were implanted was higher than in children conceived before their mothers were implanted.
Next slide, please. Mean platinum concentration in hair, nails, and sweat samples of women exposed to silicone breast implants and in children conceived after their mothers were implanted were higher than that of the general population and higher than in children conceived before their mothers were implanted.
Mean platinum concentration in breast milk samples of women exposed to silicone breast implants was much higher, about 100 times higher, than samples from women not exposed to these devices.
Next slide, please. Mean platinum oxidation states in explanted silicone breast implants occur mainly in the +2, +4, and +6 valence states. This is a very important point. Manufacturers are claiming and FDA believes that platinum is in the zero valence state. Mean platinum oxidation state in whole blood samples of controlled subjects was mainly in the zero oxidation state.
Next slide, please. Mean platinum oxidation states in whole blood and urine samples of exposed women were mainly in the +2, +4, and +6 oxidation states. Mean platinum oxidation state in whole blood samples of children conceived by mothers after implantation and in a brain tissue sample of an exposed individual were in the zero, +2, and +4 oxidation states.
Next slide, please. In conclusion, my main three points are as follows. Number one, the platinum concentration in gel and shell material of silicone breast implants is actually much higher than reported by manufacturers.
Number two, the platinum concentration in many different types of samples is consistently higher in women exposed to silicone breast implants than in non‑exposed individuals and is higher in children conceived after implantation than in children conceived prior to implantation.
And, number three, silicone breast implants contain highly reactive forms of platinum.
Thank you very much.
CHAIRMAN CHOTI: Thank you.
MS. WOLF: Good morning. My name is Carolyn Wolf. I live in Virginia, and I came here at my own expense. I have no conflicts of interest.
In 1972, after subcutaneous mastectomies, I had reconstruction with the newest, best construction, silicone implants, that were safe and would last my lifetime.
There were no problems in the beginning. By the seventh year, burning, blister‑like growths started on my neck and boil‑like growths on my forehead. Sixteen years after, three days were spent in ICU because of severe burning chest pains.
By the 21st year, my family had noticed a change in personality. And I had noticed cognitive changes. By the 25th year, though a non‑smoker, I was coughing up hard, greasy, gold‑colored plugs. X‑rays showed chronic obstructive pulmonary disease.
A military plastic surgeon checked me every year. I never connected my problems with the implants until my left breast capsule collapsed 28 years after implantation. MRI showed both implants extensively ruptured. Shortly thereafter, a glob of silicone moved from my breast into my armpit, leaving an elongated swelling in its path. There was excruciating pain.
In April 2000, vision was lost in my left eye for 45 minutes. Pain continued in that eye until a long, stringy glob came out of it several weeks later. Two similar strings were exuded from my left ear in the 30th year.
Explantation performed in 2000 showed the left implant measuring only four centimeters. The scar capsules surrounding the implants contained chronic inflammation and foam cells containing silicone. Few women had implants as long as I.
I have been diagnosed with silicosis, rheumatoid arthritis, connective tissue disease, Raynaud's, and silicone‑induced MS‑like syndrome with neuropathy of the extremities.
My brain MRI shows more than 20 lesions. My silicone level is .11, more than double what is normal. My platinum level is 20 times normal. Silicone continued to be exuded from my nipples until simple mastectomies to remove painful calcified tissue was performed six months ago.
National Cancer Institute has conducted the only study of women implanted for more than eight years. That found women are much more likely to die of brain and lung cancers and suicide. If implants are so safe, make sure that manufacturers prove that it is safe.
The studies you will hear about tomorrow do not prove that. The women studied were not implanted for more than ten years. You have no control over the advice given or not given by plastic surgeons. What happened to me will eventually happen to thousands of women with silicone implants. And please do not inflict this on another generation.
CHAIRMAN CHOTI: Thanks.
MS. KEELING: My name is Marlene Keeling. I am President and founding Director of Chemically Associated Neurological Disorders, or CANDO. I have paid my own way here because of my concern over toxic and hypersensitizing chemicals that I am convinced are leaking or bleeding from implants into not only the bodies of women but, even more worrisome, their children born after implantation.
I was implanted with McGhan double lumen breast implants in 1978. I had my ruptured implants removed in 1994, after I became convinced that my implants were causing my swollen lymph nodes, hair loss, memory loss, overwhelming fatigue, peripheral and demyelinating neuropathy. I was perfectly healthy before I got implants, got sick, had my implants and scar capsule removed in block and not replaced, got better.
When tested for platinum six years after explantation, my urine was found to contain 36 parts per billion per liter of urine. Platinum was found to leak from my implants. And platinum was also found in my hair, nails, sweat, and blood.
The ionization or speciation of my platinum was +2 and +4. Dr. Joseph Bubinak, a board‑certified hematologist and medical oncologist, testified before a breast implant advisory board in 2002 regarding his experience with the chemotherapy agent cisplatin.
Dr. Bubinak reported that he was astounded to learn that the catalyst used to manufacture the silicone for breast implants was platinum chloride, a highly reactive molecule and precursor to the chemotherapy agent cisplatin. He stated that some breast‑implanted patients have the same systemic complaints and side effects as cisplatin‑treated patients, including fatigue; hair loss; loss of short‑term memory; rash; and other allergic reactions; respiratory system problems; and peripheral neuropathy, which is sometimes disabling.
Dr. Bubinak stated that the migration of reactive platinum alone could explain capsule formation and tells the world that the chemicals in breast implants are not inert.
Can you go to C? Dr. Maharaj has presented data from CANDO's research project number 1 here today. Based on this research, it was determined that urine was the least invasive, best method to test for platinum levels in the body.
CANDO's research project number 2 has now tested the urine of over 50 breast‑implanted women and their children born prior to and after implantation. I have copies of this raw data, which I can give to the panel today.
Previously in a written submission, I gave the panel a copy of the CDC's platinum urine study in the general U.S. population of over 1,000 people. And not one of them had over the level of detection of 0.04 parts per billion.
To quickly recap, the results of the raw data presented today, one child born after implantation tested over 300 parts per billion. One woman tested over 200 parts per billion 11 years after explantation. And nine women and one child tested over 100 parts per billion.
The panel was also given a copy of Dow‑Corning's 1996 letter notifying the EPA of substantial risk to their platinum catalyst used in breast implants. Ionized platinum is on the list as being a suspected neurotoxicant and immunotoxicant.
Mentor's most recent FDA‑approved product insert makes the following statement, "Toxicity studies are currently in progress by various research facilities, universities, government agencies, the medical community, and the medical device industry. Some of these studies are conducted in animal models to determine potential immunotoxicity and autoimmune issues related to silicone materials. There is the potential that in the animal models being studied, immunotoxicity may result."
I submit it is not safe enough for the FDA to simply say it is not known if a small amount of silicone may pass from the silicone shell of an implant into breast milk. If this occurs, it is not known what effect it may have on the nursing infant. We must protect our future generation, who cannot make a choice.
Thank you.
CHAIRMAN CHOTI: Yes? Good morning.
DR. MAO: Good morning. My name is Jeremy Mao. I am Associate Professor of Bioengineering and Cell Biology at University of Illinois. I come here today with no financial ties to either the sponsor or any of their competitors. My testimony today will be related to mechanical testing of silicone breast implants.
I have reviewed the scientific and regulatory literature extensively on mechanical testing of silicone breast implants. After review, it seems that there is a shortage of data, mechanical testing of implants in simulated in vivo environment.
The in vivo environment surrounding silicone breast implants is complex and consists of fibrous capsules, many cytokines, protolytic enzymes. The local chemical and physical environment, such as pH and temperature, may also affect the outcome of mechanical testing.
There is experimental evidence that the in vivo environment weakens silicone gel breast implant shells over time. Several articles published in Plastic and Reconstructive Surgery and other journals have demonstrated the need for performing mechanical testing in simulated in vivo environment.
Silicone breast implants rupture for a variety of reasons. The complexity of tissue‑borne mechanical stresses on implants is a result of tension, compression, and shear stresses. In most previous mechanical testing studies, only uniaxial mechanical forces are applied. This represents only one of the multiple dimensions of mechanical stresses in vivo.
Multidimensional forces may be used to simulate mechanical testing of breast implants to adequately simulate the conditions in vivo in the patient's body.
ASTM International has several guidelines for testing silicone breast implants, such as tensile strength, ultimate elongation, and fatigue life. However, in 1989, Plastic Surgery Subcommittee members stated that the tensile and tear strength measurements are not particularly relevant to the clinical circumstances under which implants rupture.
In addition, there is a need to examine whether there is a correlation between MRI findings of rupture or potential rupture with mechanical testing data. A recent article in the European Journal of Radiology reports correlation between MRI findings of silicone breast implant rupture and clinical examination at the time of implant removal. However, it is known in the literature if there is a correlation between MRI findings and implant rupture and mechanical testing of the implant prior to and after implantation.
Mechanical testing prior to implantation could be useful reviewing what type of implants are more susceptible to MRI‑detectable ruptures.
Thank you.
CHAIRMAN CHOTI: Yes? Good morning.
DR. MELMED: Good morning. I'm Edward Melmed. I have no conflict of interest. I am a plastic surgeon who has done breast implants since the day they were introduced. I did my first year of residency in 1963, when Cronin first introduced silicone implants. So I have seen the evolution through the Cronin implant; the Jenny (phonetic) inflatable, which was a balloon through to the silicone pads; the Dacron patches; Meme implants, et cetera.
I wrote extensively about this in the Plastic and Reconstructive Journal in the '90s. But from 1992, I had a complete change‑around. I started seeing the devastation and complications from breast implants. And since 1992, I have explanted over 800 women with breast implants. I wrote about this in Plastic and Reconstructive Surgery in 1998.
My statistics that I wrote in 1998 showed a rupture rate at 10 years of approximately 50 percent, a rupture rate at 15 years of 70 percent, and a rupture rate at 20 years of 94 percent. My current figures show no deviation from this. It's a time‑dose‑related phenomenon. Research that shows two, three, or four years' duration, my statistics show the same. It shows a four percent rupture rate.
The problems become manifest the longer the implants are in. The implants will rupture and just disintegrate. And sometimes no wall of the implant can be found.
I have brought some short clips that I'd like to just show in the background of what implants really look like when you get into the 10‑15‑year rate of removal. The silicone will simply well out with no visible evidence of any wall.
Now, if we take the statistics that are currently available, approximately 330,000 women received breast implants in ‑‑ at least 2004. If we extrapolate that figure ‑‑ sorry. Let me backtrack and say that if we accept that no medical device is safe ‑‑ and I think we must say that ‑‑ then just assuming there's one percent failure rate, at 10 years, you're going to have 33,000 women with problems, which if it becomes 3 percent is 100,000 women.
Now, no batch can be identified of what implants disintegrate. So we're left with this uncertainty of the future of these women. So a girl of 16 who you are going to allow this device in is very different from the 70‑year‑old who has a hip prosthesis that might fail, a woman who is going to be left with an inevitability of having four or five operations in their lifetime.
Lastly, how do you recall implants? If I buy a new Ford and it has a brake problem, the National Highway Traffic Safety will report it if there was more than one percent failure rate. Here we've got 17 percent failure rate. How do we recall them?
Thank you very much.
CHAIRMAN CHOTI: Sir, we have a question here. Yes?
MEMBER LI: This is Steve Li, Dr. Melmed. Just one quick question. Your rupture rates, was that your own personal experience of your own patients?
DR. MELMED: That's our own personal experience in practice.
MEMBER LI: And roughly how many patients was that?
DR. MELMED: That was over 500 patients.
MEMBER LI: And just over what calendar period?
DR. MELMED: From 1992 until 2004.
MEMBER LI: Thank you.
CHAIRMAN CHOTI: Yes? Good morning.
DR. ZONES: Good morning. I'm Dr. Jane Zones, a medical sociologist here representing Breast Cancer Action as a member of its board of directors.
Breast Cancer Action is a national grassroots membership‑based education and advocacy organization that works to make the changes necessary to end the breast cancer epidemic. BCA has a corporate donations policy that forbids us from accepting donations from any entity that might present a conflict of interest. This includes not only all health industries but organizations whose products or manufacturing processes may contribute to cancer incidents generally.
We have no financial interest in the outcomes of these hearings.
Breast Cancer Action's major concern is the continued lack of data to assure long‑term safety and the need for specific guidance for women seeking reconstruction after mastectomy that would allow making an informed decision about the silicone breast implants. In particular, we are disturbed by the data supplied by the applicants on short‑term complications and resurgeries that are particularly prevalent in women undergoing reconstruction after mastectomy.
We are grateful for the care which the FDA staff analyzed the data submitted by the applicants and agree with FDA's analysis that the assumptions employed in industry's projections improperly minimize the risk of rupture in the future.
We have many breast cancer‑related concerns with silicone breast implants. Today, however, I would like to address a topic not specific to breast cancer, which is post‑marketing surveillance.
At the October 2003 meeting of this committee, Inamed struck a deal that promised ongoing follow‑up of women in their studies in return for a conditional approval by the panel. This appeared to have been negotiated with at least some on the panel behind closed doors during the night before the vote. By early in the morning on the last day of that meeting, dozens of copies of the proposed agreement had been duplicated and were handed out to meeting participants.
Since the FDA Modernization Act authorized FDA to conduct post‑marketing surveillance of drugs in 1997, hundreds of new drug reviews have required Phase IV post‑marketing clinical studies as conditions of their approval.
In their most recent report to Congress, the FDA indicates that over two‑thirds of new drug approvals with open post‑marketing commitments had not yet initiated required Phase IV studies.
The situation for medical devices is even less developed. In June 2002, FDA announced plans to require manufacturers of some devices to conduct post‑marketing surveillance for up to three years. Breast implants are covered by this rule because the category includes medical devices implanted for more than a year.
However, there is no reason to expect device manufacturers to be any more compliant than pharmaceutical companies in their pursuit of post‑market approval data. In fact, an article in the Wall Street Journal less than two weeks ago quoted an internal report by FDA scientists, saying that the CDRH had only limited procedures for monitoring manufacturers' progress and results.
Of 45 devices conditionally approved between '98 and 2000, nearly two‑thirds included no information about post‑marketing studies in manufacturers' annual reports to the FDA. Final results on over half of studies that were known to be due had not been submitted.
FDA has little recourse where manufacturers either fail to meet post‑marketing commitments or find evidence of greater risk except to pull the product from the market. This has never happened with devices nor, as far as I know, with drugs.
The dramatic removals we have witnessed in recent years have usually involved whistle‑blowers, leaked documents, journalistic exposes, or unexpected findings from post‑market studies designed to broaden indications for use of the product.
Inamed and Mentor have proposed up to ten years of total follow‑up of the women in their studies, but the medical device regulation has an upper limit of three years, which, if effected, would preclude prospective analysis of the effects of aging of the implants, which are thought to rupture at increasing rates.
We urge the panel to act on the data that is now before you and not on that which may be promised in the years ahead. The manufacturers know that it is unlikely that you would ever be called to review post‑market surveillance data in the future and that the consequences for less than quality follow‑up or for findings of greater risk are minimal.
Women who are at risk for breast cancer or who currently are living with the disease are depending upon you to hold these devices to a high standard.
CHAIRMAN CHOTI: Thank you.
Next speaker, please.
MS. PAM DOWD: Hello. My name is Pam Dowd, and I have been asked to speak on behalf of Cristy Warschaw, founder of Women in Health, one of the largest support groups in southern California for silicone breast implant women. Neither she nor I have any affiliation with Inamed or Mentor. Neither of us have received monies from either company for this testimony.
"I, Cristy Warschaw, have had both Inamed and Mentor post‑1990 silicone breast implants. I am unable to attend this hearing because of my continued health problems associated with these implants.
"My history is very simple. No health problems until November 1989, when at age 28 I underwent a mastectomy with reconstruction with silicone breast implants.
"I had a family history of breast cancer and calcified fibrocystic disease. I became ill as soon as the implants were placed. I had to stop working as a medical administrator and stop my Master's degree program at UCLA.
"I have been on disability for most of the last 16 years. I have had seven surgeries, all associated with the implants. As of today, at the age of 43, I have undergone total mastectomy with no further reconstruction because I am not a candidate for TRAM flap or any other reconstructive surgery.
"It has been discovered that I am one of a few people allergic to silicone. If I even ingest milk, I can have an anaphylactic reaction as silicone is used as a defoaming agent in processing. I cannot place any silicous, silicones, dimethicones, or any cones on my body because I will break out in a rash.
"IV needles are coated with silicone, and I have not been able to keep one in me for more than one day because of the silicone reacting and inflaming the IV site.
"Having been a support group leader for 12 years and having had both manufacturers' implants, I have done a lot of investigation on both companies. My number one concern is the FDA 483 inspections. Inamed is manufacturing its SBIs in Costa Rica. By what means is the FDA inspecting this manufacturing plant?
"Mentor's manufacturing facilities in Texas have failed viscosity, dipping, and humidity control over and over again. Also, medical device reporting has also proven to be a problem as well.
"If the FDA is taking Inamed's chemistry and mechanical testing from only Inamed's say, then this is a complete failure on behalf of the FDA. It is also jeopardizing every woman receiving an SBI.
"Neither company has ever been able to assure shell thickness during the dipping process due to inability to control humidity. So they cannot predict clinical outcomes, as requested by the FDA, because each lot will produce a different result.
"As a health care professional who has kept clinical data for FDA experimentation and clinical trials, I have great anxiety in allowing silicone breast implants to be placed back on the market.
"Also, having been a support group leader and seeing women affected by SBIs, I know how people fall out of the studies. Women will not see a reason to follow up in‑house with a plastic surgeon at the recommended intervals.
"There is no way a physician can detect a silent rupture. MRIs cost thousands of dollars. The study is already set up to fail. Women move. Women with SBIs are being treated for cancer. Therefore, there is a higher mortality rate for these women.
"No guards are set in place to retrieve post‑mortem implants for study. There is a strong possibility these women can lose health insurance and will not return for follow‑up appointments.
"Women will have a problem and not return to the same surgeon. They may very well go to a surgeon who is not part of the study. What happens to those implants?
"Women do not relate their fatigue to implants and are seen by their personal M.D.s for this and may not relate these to silicone breast implants.
"I have had four different surgeons and to this day and am in possession of four of my five implants. The silent contained rupture was not noticed on MRI two days before I had surgery. Four years after this rupture, I had 15 granulomas relieved from my chest wall by yet another surgeon.
"There has never been an FDA PRP report filed on me or MDR report on my rupture or fungus‑infected implants. I fell through all the loops. And as a support group leader knowing about breast implants, how many of these women will fall through the loops as well? Women with breast cancer are too busy worrying about their lives to think about SBIs. They just want to be whole again.
"I could go on and criticize each part of the draft guidance for industry and FDA staff saline, silicone gel, and alternative breast implants, but that would take up more time than I have. It is my opinion that neither company has met the FDA guidelines to demonstrate a reasonable assurance of the safety and effectiveness of SBIs. Therefore, they should deny approval.
"After ten years of trying" ‑‑
CHAIRMAN CHOTI: If you could sum up, please?
MS. PAM DOWD: Yes. I've just got this one sentence.
"After ten years of trying, yet just not making it, SBIs should be removed from the market altogether."
MS. SMITH‑MILES: Good morning. My name is Rebecca Smith‑Miles, or Becky. I am from northern Michigan. I am a registered nurse. My husband is a radiologist. I have no conflicts of interest.
I had silicone implants put in over 15 years ago. Within two years, I developed capsular contracture and experienced intense pain. My plan to be more beautiful was ironic in that I was uglier by the day. I had larger breasts, but they were hard, painful, and ugly. I was ashamed for even my husband to see them.
Within seven years of getting the implants, I was diagnosed with an atypical neurological disease. Eight years after being implanted, I had my implants and scar capsules removed. They had ruptured. And the plastic surgeon attempted to retrieve all of the leaked silicone, but he was unsuccessful.
If I had been included in the three‑year and four‑year studies at that time, only capsular contracture and pain would have been picked up, not the rupture and not the systemic problems.
I have gone from being a very athletic and active person to being physically inactive and at times bedridden. I worked daily prior to getting implants. Now I'm on disability. And sometimes I'm even unable to perform my daily household tasks, simple tasks.
I have severe overwhelming fatigue, joint and muscle aches, pain, dry, scratchy eyes, skin rashes, numbness in my calves and toes, hair loss, night sweats, and daily headaches. I am easily confused and have a constant fog in my head.
My skin develops rashes and reacts to previously normal substances. I have blister‑like eruptions in my fingers that are intensely painful. And along with the pain comes burning and itching and total intolerance to any pressure. I can't use that finger. I scratched it and scratched it until the top came off. And then I felt with my tongue a tiny sliver of crystal. When I got that crystal out, it healed immediately.
I fear that I have silicone crystals running throughout my body, and I wonder what kind of damage it has done to my internal organs. I had silicone leakage in my chest, axillary lymph nodes down my arms.
My last surgery a year ago removed silicone after an ultrasound located it in my chest and breasts. I had a lemon‑sized portion of my right breast tissue removed as a result of the leaking silicone from the rupture over ten years ago. The surgery has made that right breast noticeably smaller, but it's worth it.
My life since getting implants has changed completely. My social and family lives have suffered. I can no longer be a normal wife, mother, or grandmother. Even so, I'm lucky because my husband is a physician, and we are not financially devastated by my disability.
I beg you, as you make this very important decision, think not only of my experience but also of the lives of other women, your friends, your relatives, who may end up like me. Silicone breasts are not worth the known risks, let alone the unknown long‑term risks.
Thank you. Any questions?
CHAIRMAN CHOTI: Thank you very much. Good morning.
MS. DALY: Good morning, ladies and gentlemen. My name is Anna Daly, and I'm from Nashville, Tennessee. I was asked to come and speak to you today by my plastic surgeon, Dr. Melinda Haws, of the Plastic Surgery Center of Nashville, and the Inamed Corporation, who provided my transportation and lodging.
On December 30th of 2003, I had my very first mammogram. On January 26th of 2004, I was diagnosed with ductal carcinoma, breast cancer, on my left side. Though the cancer was still fairly small and had not yet spread, it was labeled as high‑grade and aggressive. And I was not yet 40 years old, with a 2‑year‑old and a 4‑year‑old at home.
After speaking with my family and the doctors involved, we decided the best option would be to undergo a bilateral mastectomy with immediate reconstruction using tissue expanders, which I did on February 13th. The choice was made because of the nature of the cancer, the probability of it recurring on the opposite side, and the symmetry that would be provided by doing both sides at once.
During the next five months, we discussed and researched my implant options: saline versus silicone, smooth, textured, and size. The tissue expanders that I received were saline‑filled. And my experience with them was not a pleasant one. I did not like the fact that I could hear the liquid sloshing in my chest, nor feel the saline moving from side to side as I walked, caused several cases of severe motion sickness that I did not want to repeat.
Appearance was also considered. I didn't like the way the saline‑filled implants have a tendency to ripple. And the profile of the implants did not appeal to me. So I made my decision.
After signing a waiver regarding the possible side effects and enrolling in a research study to be conducted over the next five years, I had my tissue expanders removed. And I chose to have silicone‑filled implants on July 1st of last year.
I like the projection of my breasts that the silicone‑filled implants provide because it is very natural. The feel is also very natural to the touch. And they are as close to the feel of my own breasts that I could have imagined.
After going through the invasive nature, trauma, and emotional upheaval of a mastectomy, appearing and feeling normal become very important to you. Important also is the fact that I have a choice in the type of implants that is to be placed in my body.
So many choices are already made for you when you are faced with a cancer diagnosis. Knowing that I could help choose the way I would look coming out of this was very empowering and very uplifting.
My request of you is to clear the way for silicone implants to be a choice for all women, reconstruction or augmentation, research study or not. We all deserve to feel beautiful and, if not beautiful, at least normal.
CHAIRMAN CHOTI: Good morning.
MS. ANTOLICK: Good morning, ladies and gentlemen. My name is Karen Antolick. And I live in Columbus, Mississippi. I have no conflicts of interest.
My desire for implants began at the age of 15. And then at the age of 22, I took my savings along with a small loan and had silicone breast implants placed.
I was told by my plastic surgeon that sometimes implants could hard and have to be replaced but that if I massaged my breasts as instructed, that this was most likely not going to happen. I was told that breast implants were a lifetime investment and safe. I also did not receive any literature outlining the potential risk.
I thought that my life could only improve with implants. And after my surgery, I felt implants were the best thing that had ever happened to me.
Within the first year, however, I began having serious medical problems. Over the years, I was in and out of doctors' offices with various symptoms: chronic fatigue; memory loss; migraines; chronic pain; hearing loss; burning in my chest; and numbness in my lips, hands, and feet. I did not know, nor did the doctors, that most of these symptoms are autoimmune symptoms and common with breast implant patients.
The pain and burning in my chest along with nipple discharge became so severe that I went to a plastic surgeon to have the implants removed. Once removed, my doctor told me that both implants were ruptured, capsulated, and had been leaking for many years.
During the surgery, she removed lymph nodes because they had become contaminated with silicone. This was very surprising to me because each year my mammogram showed that my implants were intact.
I am not unusual. I now know that FDA study found that most augmentation patients had at least one broken silicone implant within ten years. And silicone migrates outside of the breast capsule for 21 percent of women with implants.
I was young and naive when I received implants. I didn't have the foresight to see that my health is much more important than my breast size. Instead of providing me with self‑esteem, like I thought, they provided me with a life of pain and dependency.
Now, 23 years later, I can no longer work as I used to. I had to move closer to my parents so that they could help care for my children. Probably the most difficult change I have had to come to terms with is not being able to care for and enjoy my children the way that a mother should.
Please make sure that young girls who are considering implants will not have to sacrifice their health for a certain body type like I did. Thank you for your time and consideration.
DR. TEBBETTS: Good morning. Dr. Choti, members of the panel, I am Dr. John Tebbetts. I am a board‑certified plastic surgeon. And my testimony this morning is based on 26 years of clinical experience performing breast augmentation; 17 years of experience designing breast implants; and my peer‑reviewed publications, which I have provided members of the panel.
I have a conflict of interest but not with the devices here today. I have designed devices for Inamed Corporation, received compensation as a consultant. None of my devices are under consideration. And I am here today to speak to you about an issue that really applies more to all devices but has concerned me for some time.
For the past 15 years, through 3 PMAs for totally different devices, surgeons, plastic surgery organizations, and manufacturers have not improved the 15 to 20 percent 3‑year reoperation rates for primary breast augmentation. I believe that one of the main reasons for that is that our educational methods are not sound.
Although we have provided information and previous panels have made recommendations about specific information to be provided, we are not teaching patients and surgeons how to make decisions. We are not testing to ensure that the information has been delivered. And we are not providing incentives to assure implementation of best practices that we know by peer‑reviewed results have been proven.
The bias characteristics affect outcomes in only a percentage of cases while patient and surgeon decisions impact outcomes in every case, regardless of the device and often far more than the device itself.
As we listen to saga after saga of compromised outcomes, we should be asking ourselves, was it the device or was it the decision‑making process of the patient and the surgeon. Could the saga have been avoided or at least terminated early by simply applying endpoints, removing and not replacing the implants?
The best indicators of quality of surgery are the patient experience and reoperation rates. Today, over 80 percent of augmentation patients can be out to dinner the evening of surgery without bandages, drains, pain pumps, or narcotic pain medications.
And 96 percent of those patients can return to full normal activity the next day with a 3 percent 7‑year reoperation rate. Most patients have no idea that this level of outcome is routinely possible and even being delivered by surgeons less than ten years in practices.
The processes and practices that generate these peer‑reviewed results can directly impact outcomes and reoperation rates but only if they are transferred through optimal education.
Improving patient outcomes requires accountability from those who make decisions and from those who provide education and who want to provide certification.
I hope that, as you consider these devices and other devices, you will make strong recommendations in that regard. There are good solutions. Time does not allow me to go into them today.
Thank you for your time and the opportunity to address the panel.
CHAIRMAN CHOTI: Thank you.
Good morning.
DR. FRAGEN: Good morning. I approached Inamed and Mentor and volunteered to come here today to speak to the panel. I am a member of their institutional review boards. And Inamed did provide for my transportation. I am kind of a gray‑haired doc. And I thought it would be interesting to give you my perspective.
My name is Ronald Fragen. I am a physician and surgeon who has been performing breast implant surgery for 30 years. I practice in Palm Springs, California. I have traveled across the country because I believe women are able to evaluate the risks of breast implant surgery and make their own decisions without restriction. To my knowledge, no other country restricts the use of silicone gel implants and 60 countries have approved their use.
I was licensed to practice medicine in 1964 and began practicing medicine in California in 1971. I have performed breast augmentation surgery for 30 years.
Just so you know me, I was an Assistant Professor at the University of California Medical School at Irvine for 20 years. I am the past President of American Society of Cosmetic Breast Surgery, past President of American Society of Liposuction Surgery, past President of California Academy of Cosmetic Surgery, and a member of the board of directors of both the American Academy of Cosmetic Surgery and the American Board of Cosmetic Surgery. I have practiced exclusively cosmetic surgery for 20 years.
I have seen nearly every breast implant ever used. The current silicone breast implants have been used in my practice since the mid 1980s, when they were first introduced. I have patients who have had these implants in for 20 years.
With the old implants, 20 to 25 percent of our breast surgeries every year were revised problems, usually capsule contracture or rupture. In the last 20 years, I cannot find 15 patients who have needed revision surgery using the new gel implants.
I have done thousands of breast implants. The new implants have a thicker shell and a coherent gel that doesn't run. The old implants had a thin shell, more fragile, a gel that flowed like sticky molasses. Since using the new implants, I have seen only one shell split. And that gel did not leak. It behaved like cut Jell‑O. There was no leakage.
Do not mix the results from old implants and the new thick‑shelled implants with coherent gel. These new implants are safe. By comparison, aspirin is not safe. Skateboards, skiing, motorcycles, alcohol, tobacco, and exhaust from automobiles I think are far more hazardous.
Women have many breast deformities: congenital; small; malformed breasts; breasts that change after cancer surgery; and the largest group, those whose breasts have become deflated skin sacs after pregnancy.
Most of these patients I see fall in the latter category. They cannot wear clothes they desire and often lose self‑esteem. They desire to regain their shape. We allow women who have congenitally deformed breasts and women who are cancer survivors to regain their shape using silicone gel implants. These women and their surgeons pick the best implant to fit their anatomy without restriction from the FDA.
Implants are safe for these people. Why do we trivialize post‑pregnancy breast deformity and not allow these women and their surgeons free access to the best implant for their particular anatomy? We should.
These implants are safe. Saline implants are stiffer. They ripple. And they more often give a balloon‑like shape. However, they are easier to implant. It's an easier operation for the surgeon than a silicone gel implant is. A silicone gel implant is a better choice for the patient in many instances, however.
CHAIRMAN CHOTI: If you could wind up, please?
DR. FRAGEN: Yes. These implants are a new and better machine and should not be compared to the old implants. This is really a woman's issue. The surgeons have no secondary gain to use silicone implants.
I just want to tell you that one of my reasons for going into medicine was an aunt who started practicing medicine right after World War I before the Nineteenth Amendment to the Constitution was enacted. That's the women's right to vote. I'm sure she would not have ‑‑
CHAIRMAN CHOTI: Sorry.
Next speaker? Good morning.
DR. KASPER: Good morning. My name is Anne Kasper. I have worked in women's health for 30 years. I have been a breast cancer counselor for four years in Bethesda, Maryland. I am also the Breast Cancer Counselor for Mobile Medical Care, which serves the uninsured, low‑income, and homeless of Montgomery County, Maryland. I am the Senior Editor of Breast Cancer: Society Shapes and Epidemic, a book published in 2000.
The women I counsel who have faced breast cancer have one primary concern. They want to survive this disease and live out their lives for as long and as healthy as possible. Women want to be able to trust that the treatments and recommendations given them by health professionals, science, researchers, and drug and device manufacturers will halt the progress of the disease and promote their health and well‑being. Few women want to take any unnecessary risks with their health once they have faced a diagnosis of breast cancer and endured its treatment.
For many women who have undergone the loss of a breast looking and feeling normal and comfortable without further health risks involves no more than a good mastectomy bra and well‑fitted prosthesis.
Many women who are offered breast reconstruction refuse it because they don't want to undergo further surgery, anesthesia, risk of infection, and recovery. They are also concerned that a breast implant will obscure finding a breast cancer recurrence or that the implant will rupture and further surgery will be needed.
There are also many more options than there used to be for breast cancer patients who want to keep their breasts. More than three out of four of the women who are newly diagnosed with breast cancer are eligible for lumpectomy and, therefore, won't need reconstruction.
The number of women who need a mastectomy, instead of a lumpectomy, is much smaller than it used to be. In addition, women who undergo mastectomies have other alternatives to silicone breast implants. Saline breast implants have a lower complication rate and do not cause, as far as we know, the serious problems if they leak as to silicone implants.
Many women tell me that they don't want silicone breast implants because they have never been proven safe specifically for women with breast cancer. Having endured cancer in their bodies, women tell me that the last thing they want to do is willingly introduce a foreign substance that has not been proven safe over the long term, will rupture in time, will leak silicone into the body, will interfere with mammography, and may cause additional health problems as well as repeated surgeries.
Implant makers tell us that women need silicone gel implants for their emotional well‑being. Today you're hearing from patients who say they want implants to help them feel better about themselves and that it improves their quality of life. However, we know that there are no studies to support that claim.
A study by Dr. Julia Roland and Dr. Patricia Ganz and colleagues compared the quality of life of women who underwent lumpectomy, women who underwent mastectomy, and women who had mastectomy with reconstruction. They found no difference, no difference, in quality of life between the three groups of women.
There were some differences in certain aspects of their lives, however, but the reconstruction patients were not necessarily the happiest ones. As I consider the needs of the cancer patients I work with, the lack of long‑term safety data and the lack of evidence that breast implants improve women's quality of life, I don't see a reason to approve silicone gel breast implants.
I urge the FDA to once again deny approval to silicone breast implants. If the companies finally develop a safer implant in the future, the FDA can then reconsider.
Thank you.
CHAIRMAN CHOTI: Thank you.
Good morning.
MS. BEAGLE: Good morning. My name is Kitty Beagle. And I am here today speaking on behalf of Anna Carpenter, who was, unfortunately, unable to attend the meetings.
"My name is Anna Carpenter. And I am a member of the Younger Women's Task Force. The task force is a project of the National Council of Women's Organization, which represents over 200 women's groups across the nation. As a young woman in the age of cosmetic surgery, reality shows, like 'The Swan,' 'Extreme Makeover,' and 'I Want a Famous Face,' I'm here to talk about what kind of risk these devices pose to women in my generation.
"Our parent organization is the sponsor" ‑‑
CHAIRMAN CHOTI: Excuse me. One moment. I wonder if the group who is walking back there, if you could just hold off on that so we can hear the discussion. Okay? The point is for the speaker to speak at the podium if that would be all right. Thank you.
I'm sorry. Continue.
MS. BEAGLE: Thank you.
"Our parent organization is the sponsor of the Extreme Measures Tour, a body image campaign which is traveling the campuses across the nation featuring young women telling their peers about their personal experiences with failed breast implants. The response has been astounding.
"On one Texas college campus, the school's volleyball coach asked that the speakers would visit with the local girls' high school team because all of the players were insistent that they would receive breast implants on their 16th birthday.
"At a New Jersey campus, audience members told story after story of young women receiving complication‑laden breast implants before rushing sororities.
"The extreme measures campaign Web site has received e‑mails from women on campuses across the country asking that the tour visit their school. Why is this happening? Why are women on college campuses so eager to hear about their peers' experiences with breast implants?
"Look at the numbers. The American Society of Plastic Surgeons recently reported that this past year, 3,962 augmentation procedures were performed on women 18 years and younger, a shocking increase from the roughly 400 procedures done on the same age group in 1994. Three thousand, nine hundred, sixty‑two means approximately ten teenagers receive breast implants every day.
"According to manufacturers' own data, 21 percent of these teens will require reoperation within 3 years. That means that every day, 2 of those teens going under the knife will be back on the operating table within 36 months. That is not including the staggering numbers of young women who will experience what is termed 'local complications.'
"Surgery is surgery. And it carries inherent risks, no matter how minor the procedure is billed to be. Manufacturers state that breast implants will need to be replaced every ten years.
"A young woman who receives breast implants on her 18th birthday and lives to be 88 will need at least 7 sets of implants in her lifetime, each time paying out of pocket for the removal of the old sets and implantation of the new sets, because health insurance rarely covers the cost of problems related to breast implants.
"Even more troubling, many insurance companies will not enroll a woman with implants. Few teens can grasp the significance of what having health insurance means, let alone how not having it could create extreme financial hardships in the future.
"As a young woman, it is also hard to understand the importance of early detection and mammography. Mammography misses 55 percent of the cancers in women who have implants. Will young women take this into account when considering implants?
"Although some cosmetic surgeon groups may not endorse silicone implants for use in teens, I will remind you that the FDA does not have a mechanism to police the sale of implants once restrictions are lifted. I will remind you that Dr." ‑‑
CHAIRMAN CHOTI: If you could wind up, please?
MS. BEAGLE: Thank you.
CHAIRMAN CHOTI: Sorry. Thank you. I apologize, but we really need to try to stay on time. Thank you.
Next? Good morning.
MS. HEIDE: Thank you. Good morning. And thank you for the opportunity to speak here today.
My name is Terry Heide. I am 51 years old, married with no children. And I work as the congressional liaison for the Department of the Army's contracts for the reconstruction of Iraq.
I was diagnosed with breast cancer in January '03. I had bilateral mastectomies in July '03 and reconstruction with tissue expanders. I received my permanent silicone implants in October '03 and have had no health problems since.
I also have no financial interest in Inamed, Mentor, or any other medical company. And neither Inamed nor Mentor nor anyone else is paying any expenses associated with my appearance here today. Those are the facts about me, but it is not who I am.
Who I am is an intelligent, educated, and compassionate woman who knows her own mind. Who I am is a woman who has always made decisions, tough decisions, using the best information available. Who I am is no different than any other woman who has faced challenges and triumphs, loss and recovery.
Like many other women, unfortunately, I had breast cancer. But, unlike thousands of other women who are diagnosed every year, I did not require chemo or radiation. I had my first surgical biopsy when I was 19 years old. So I have been closely monitored my whole adult life.
I was lucky my cancer was caught early and was easily treated. I was also lucky to have my choice of implants. And never once did I consider any other option other than silicone.
I am well‑read regarding the science on silicone implants. And, again, being in the business that I am, I am also well‑aware of the politics of breast implants. This here today is about politics, not science.
Silicone is a common material in a wide variety of implantable medical devices. And there are even acceptable medical uses of liquid silicone. And none of these other products or uses have been restricted or banned. It is only breast implants.
There are also many implantable medical devices that fail at a rate equal to or greater than the rate at which silicone implants might fail. And none of those other products have been restricted or banned. It is only breast implants.
The reason I believe is because silicone breast implants are a woman's health issue. And there is an assumption at work here that women are incapable of making sound and rational decisions about their health or their bodies, that somehow we need to be protected from ourselves simply because we are women.
Silicone is the closest to real breasts. It looks the closest to real breasts and feels the closest to real breasts. But it is not right for everyone. The decision to have a mastectomy or reconstruction or augmentation or saline or silicone implants is an individual decision and one that can only be made in consultation with a woman's doctor. But this here is not about science.
Yes, implants fail and planes crash and people get cancer. There is no guarantee that life will be as we wish it to be. We all make decisions every day about how we live our lives that involves risks. There are hundreds of products out there made to make people feel more whole, such as hip replacements and titanium rods that go into people's back. And all of these things ‑‑
CHAIRMAN CHOTI: If you could sum up, please, for us? Thank you.
MS. HEIDE: Thank you.
CHAIRMAN CHOTI: Just sum up for us, if you would, please?
MS. HEIDE: Oh, yes. My concern is that I wish there was no breast cancer. I wish we weren't here today. I wish that everybody had the body and the breasts and the health that they wish for. But, unfortunately, that isn't how life works.
And I am extremely concerned that the FDA would make women come here and talk about this most private of things.
CHAIRMAN CHOTI: Thank you. I'm sorry.
Next speaker? Good morning.
MR. MILLER: My name is Steve Miller. I have no conflict of interest. My wife is here today. And she will be sharing her story about how silicone implants she received for correction of a congenital defect have harmed her.
I am reading this testimony on behalf of another man whose wife has also suffered greatly due to silicone implants. I am here to read the testimony of T. Wade Clegg of Panama City, Florida who could not be here with us today. He has no conflict of interest.
"My family life has been severely affected by my wife's disastrous experience with silicone gel breast implants. That is why I wish to share my thoughts with the Advisory Panel.
"I believe that silicone gel is one of the most insidious and invasive products ever allowed in the public marketplace. Silicone can migrate to distant places within the body, such as the liver, thyroid, under the arms, into the arms, and across the chest. Such was my wife's experience.
"For years, her neck would swell and diminish, blocking her breathing. Her thyroid was removed, and the pathology report said it was Sjogren's disease. She is now on permanent medication and must wear a 24‑hour opium patch.
"Sjogren's disease, by the way, can take years to diagnose. Only long‑term studies will be able to show whether implants cause this disease.
"My wife was not informed about the dangers of silicone breast implants. She is serving a life sentence of pain. Normal for my wife has become a loss of physicality, loss of sleep, and diminished health, which has led to massive medical bills, bankruptcy, the loss of our farm, and a downward spiral resulted from silicone gel breast implants.
"Most women do not know that silicone gel can calcify and mix into breast tissue. The pain can be extreme, as in my wife's case. Once this takes place, the surgeon has to literally scrape the silicone off the chest cavity until there is nothing left. This was my wife's experience.
"My wife no longer has breasts. For women of childbearing age, this is particularly devastating and can mean the inability to breast‑feed.
"The FDA had questions about the safety of implants last year and didn't approve the application for implants back then. The real question is, have the manufacturers really answered all of these questions in the space of one year? Since only four years worth of data is being presented, I doubt it.
"Please ask yourself, if the same question exists, then why are we here? I plead with this FDA Advisory Committee to continue to restrict silicone gel implants while research continues. Do not improve implants which have not been proven safe for long‑term use. This is not about aesthetics. It's about women's health.
"Thank you."
MS. STANSELL: I was supposed to have five minutes.
CHAIRMAN CHOTI: Please go ahead. Yes.
MS. STANSELL: Okay. Thank you.
My name is Anne Stansell, and I have no conflicts of interest. I represent a support group of about 45 women, all with experiences similar to mine. One, Ann Palmer, a cancer survivor, was in the Mentor study. When her silicone implants ruptured at about two years, she was dropped from the study. And her record at Mentor and, thus, presented to you tomorrow shows no adverse effects. Ann Palmer died of breast implant complications in 2001.
I was diagnosed with breast cancer when I was 39. I underwent a mastectomy, radiation therapy, and breast reconstruction with silicone implants. Four doctors recommended that I get silicone implants. At the time there was no research on silicone breast implants in cancer survivors. But none of the doctors told me that. Not one of them told me about the risks, the fact that they can rupture and leak silicone and other chemicals into my body.
Because of these chemicals in my body, I now get severe headaches when I am exposed to any common household products with phenolic disinfectant, such as Lysol.
After six years, I started to get sick with joint pain, muscle pain, skin problems, dry mouth, and dry eyes. My eyes are so dry that it has caused a retina to tear. These are all autoimmune symptoms.
I was also diagnosed with an autoimmune symptoms called Grave's disease. After fighting cancer, the new illnesses caused by my implants, I then had to fight with my insurance company to have the implants removed. You see, the law states that they must provide implants for mastectomy patients. There is no law that says insurance companies must replace them in case of rupture or remove them in case of adverse effects.
When my implants were removed, half of one of them was gone. This is not surprising given that Inamed's own data shows that 20 percent of reconstruction patients experience ruptured implants within just three years. Studies have shown that silicone can leak into the scar capsule and the lymph nodes, even when the implants haven't yet ruptured.
After I had the implants removed, I started to slowly get better. This is also typical. I have read a study by National Cancer Institute researcher Dr. Noreen Aziz which shows that most women with implants who have rheumatological symptoms get better when their implants are removed and not replaced. If their implants were replaced, most got worse.
I am not fully recovered, unfortunately. In addition to continued fatigue, the many surgeries to put in and remove my implants had left me with such chest tenderness that I cannot have anything more than a soft t‑shirt on my chest. Now prosthetics even are out of the question.
This controversy has been going on for 15 years. The whole new generation is now being seduced into believing these products are safe when they are not.
No significant improvements have been made in silicone breast implants in the last 15 years. This is the same product with new advertising and new hype. Just because these manufacturers have created a market for their products with advertising and TV makeover shows does not mean the product is safe.
If you want to help breast cancer patients, please insist on long‑term safety data before approving this product. You owe it to us older women who have suffered for years and years and to the young women who will suffer for many years if you approve this product.
CHAIRMAN CHOTI: Thank you.
Yes? Good morning.
DR. TAYLOR: My name is Dr. Joy Taylor. I was a hospice physician. I have no financial ties to the manufacturers or their competitors.
I had breast implants for 18 years before I became ill. A CT scan showed bilateral ruptured implants, and I was diagnosed with pleurisy and pulmonary fibrosis. I then began collecting autoimmune disorders.
I was diagnosed with Hashimoto's thyroiditis, Sjogren's syndrome, autoimmune diseases that attack the thyroid, the salivary, and the tear glands. I also developed polymyositis, a coagulopathy, Alzheimer's‑like symptoms, severe fatigue, MS symptoms, constant tinnitus, and Crohn's disease.
My colon was perforated in several places and had to be removed. I was in ICU for over six weeks and on life support and had every complication possible.
The ICU doctor told my family that in 30 years, he had never seen anyone in my condition survive. He told my family to make arrangements for my funeral. I lived through that crisis, but there were more to come because my body was producing antibodies that attacked me.
In addition to all of this, I suffer the debilitating disease porphyria. There are only two ways to get porphyria: exposure to heavy metals, like platinum; or heredity. I have no family history of porphyria. Platinum exposure causes malfunction of the immune system.
Since my implants ruptured, I have had ten surgeries. My family has planned my funeral twice. And I am unable to practice medicine. I regret my decision to get implants. And I am alive today because of the skillful, caring doctors and many prayers. The ICU doctor says I am a miracle, and he is right.
Please don't approve silicone implants until they are adequately tested long‑term and proven safe. Women, after all, have the right to have accurate information on which they may make an intelligent decision. Women's health and lives depend on it.
CHAIRMAN CHOTI: Excuse me. Were you representing an organization for that session?
DR. TAYLOR: Yes, Platinum Awareness.
CHAIRMAN CHOTI: Thank you very much.
Yes? Next speaker, please. Good morning.
MS. MARSHALL: Good morning. Good afternoon. Hello. My name is Cindy Marshall. Here's my story, which is, sadly, just one of literally hundreds of thousands of similar stories.
Silicone gel implants have destroyed my precious, priceless health, drastically changing forever the quality of my life. Women like me are proof of the truth.
I still remember the words that board‑certified plastic surgeon spoke to me, "These implants are safe to last a lifetime." What a wonderful 21st birthday gift, "You'll forever love how you'll look and feel." If only his words were true.
I first experienced flu‑like symptoms, hair loss, bone pain, fatigue, which resulted in countless doctor appointments. I had three mammograms, beginning in 1997, then in 2000, last in 2003.
The last mammogram indicated that my silicone gel breast implants were leaking and ruptured. I had to get explanted quickly and was in May 2004. By this time, it was too late. The damage was already done. My silicone gel breast implants had leaked and ruptured, leaving me with currently irreversible damage, silicone poisoning, and silicone‑associated disease.
Here are just some of the numerous symptoms, conditions, and diseases: swollen lymph nodes; hair loss; chronic bone muscle; skin tissue and organ pain; connective tissue disease; arthritis; scalp, face, body rashes; vision problems; blood in stools; blood leakage from breasts; chronic weakness, fatigue; Raynaud's syndrome; irreversible brain damage, demyelinating disease; MS‑like.
I used to have a business in home health care. Now I am the patient. I experience scary, unpredictable episodes and attacks during these times in which I have slurred speech, severe termor, difficulty walking or fall down, and even episodes of paralysis.
I must depend on others for my daily needs because of my difficulty performing. I have difficulty performing even the simplest of tasks: using the bathroom, showering, dressing, and feeding myself. One of my doctors now thinks I have lupus.
If I had been informed of the truth that silicone gel implants were never proven safe, that they leak, rupture, and bleed toxic substances into the immune system, contain close to 40 known toxic chemicals, mind you, not meant for human consumption, never ever would I have consented or allowed them to be put into my body.
I'm only 37, a single mom of 3 beautiful girls. I just want to be here for Brooke, Erica, and Danielle. My children who need their mommy fear for their mommy, who fears for every young girl and woman everywhere.
FDA, please support public health safety and not the industry poisoning the public. Thank you.
CHAIRMAN CHOTI: Thank you.
Next speaker?
DR. MILLER: My name is Dr. Claudia Miller. I have no financial interests in this hearing, and I'm here at my own expense. I'm actually a professor at UT Health Science Center in San Antonio. I'm an allergist/immunologist. And my research is focused on people who report chronic disabling symptoms following some environmental exposure, the symptoms you have heard about today.
I have served as a consultant to the Department of Veterans Affairs on Gulf War veterans, the EPA on sick buildings, the National Institute of Dental and Craniofacial Research on temporomandibular joint implants, where, by the way, you see similar kinds of complaints.
What unites ill Gulf War veterans, sick building occupants, and patient with implants who are having problems is the fact that following a well‑defined exposure event, a subset, not every one, a subset of them, go on to lose their prior natural tolerance for a wide variety of substances that are structurally unrelated.
Thereafter, common foods, medications, alcoholic beverages, caffeine, chemical inhalants, like diesel exhaust, and fragrances you have heard about today, exposures that never bothered people before suddenly trigger symptoms in them. And these can be disabling.
This two‑step disease process ‑‑ you can go to the next slide ‑‑ has come to be known as toxicant‑induced loss of tolerance, or TILT. It does not appear to matter whether the exposure that initiated this, which is at the bottom of the right‑hand slide, was endogenous or exogenous. The body's response is remarkably similar.
Next slide. We have reported on 87 individuals with surgical implants, three‑quarters of them with breast implants. Sixty‑nine percent reported rupture. Seventy‑eight percent had one or more implants removed. Of those who had undergone explanation, less than ten percent reported their health status as greatly improved.
Next slide. Using a validated questionnaire, we found that the symptom severity scores of implant recipients rivaled those of the environmental exposed groups we were studying. And there were four of those.
Next. Compared to controls, implant recipients reported much more severe adverse responses to everyday chemical exposures as well as having problems with various foods, medications, alcoholic beverages, and caffeine.
We are a couple of slides behind. Go ahead. Next slide and then the next one. Thank you. And then the next one. Toxicant‑induced loss of tolerance is a new paradigm for environmentally induced disease that differs from classical toxicity and allergy.
Affected individuals may be completely unaware of the intolerances resulting from this because of a phenomenon we call masking. If a person is reacting to many different things and having symptoms as a result of those, then the symptoms may overlap in time. And, consequently, they feel sick all of the time, often reporting chronic fatigue or flu‑like illness that won't go away.
Recent Canadian studies show that genetic polymorphisms may determine who is more vulnerable to developing this illness. And in September ‑‑ next slide ‑‑ I will be chairing a meeting on the toxicant‑induced loss of tolerance sponsored by two NIH institutes where we'll be discussing various aspects, clinical models, animal models, and so on, in order to understand this problem better in providing you with a questionnaire that I showed a moment ago to help physicians and researchers better understand this problem.
And I will be happy to provide you with any references. Thank you.
CHAIRMAN CHOTI: Thank you. And I would like to thank all of the speakers this morning for their time. We are going to take a lunch break now. We are going to resume promptly at 1:15. Thank you.
(Whereupon, at 12:05 p.m., the foregoing matter was recessed for lunch, to reconvene at 1:15 p.m. the same day.)
(1:21 p.m.)
EXECUTIVE SECRETARY KRAUSE: We are going to start the afternoon session off. Dr. Choti is going to go over the instructions for the speakers one more time. And then we'll get started. Thank you.
CHAIRMAN CHOTI: Good afternoon. So this is the start of the open session for the afternoon. Just to remind again, the speakers, either five minutes or three minutes depending. We're going to really try to stick to the time.
Just so I don't have to be the heavy here, watch the monitor. At 30 seconds before, the yellow light will go on. When your time is up, the red light will go on. If you're not finished, I will instruct you to summarize quickly. If not, the microphone will be cut off.
Again a reminder for those of you since it's important to maintain a transparency, you're encouraged to let us know whether you have any financial relationship with any organizations that may be related to this, including mentioning whether your travel, lodging, or other expenses were covered. You don't have to do it. You're still entitled to speak, but you're encouraged to do so.
Why don't we go ahead and start with our first speaker? Thank you.
MS. GLENN: Thank you, Doctor.
My name is Linda MacDonald Glenn. And I am testifying today on behalf of the Women's Bioethics Project, a nonprofit, nonpartisan public policy institute dedicated to ensuring that women's voices, health, and life experiences are brought to bear on ethical issues in health care and technology.
I am a biomedical ethicist, attorney, educator, and long‑time patient advocate. I spent 20 years as an attorney, a prosector, government adviser, and general practitioner. During that time, I was called to the field of biomedical ethics, both personally and professionally. I went back to school to switch my career to biomedical ethics.
Upon graduating in 2002, I went to the American Medical Association, where I was a senior fellow at the Institute of Ethics. I hold a faculty appointment at the University of Vermont. And I was recently given the honor of being named a Woman's Bioethics Project scholar. I have no financial conflict of interest.
"Tell me what you don't like about yourself." This catch phrase is the opening line to the controversial TV drama "Nip/Tuck" that sums up a plastic surgeon's attitude towards his patient. The implication is that plastic surgeon can fix what you don't like about yourself.
And while we're not here today to talk about plastic surgery, we are here to talk about the new silicone breast implants, which manufacturers have promoted as a woman's choice; in other words, "Let us help you feel better about yourself." But, as I will follow up and explain, the FDA's summary of the manufacturer's own reports indicate that this is a hollow promise.
There are some key ethical issues involved in your decision today. Issues of long‑term safety and truly informed consent are the primary concerns.
In biomedical ethics, there are four principles that are weighed and balanced against each other to arrive at an ethically sound decision. Those are the principles of autonomy, the right of control over your own body; benefit, the good that is accomplished from the treatment and the application of technology; no harm, the risks and burdens of the treatment; and justice, a question of fair and equitable access.
The public relations firm hired by the breast implant companies came up with a slogan, "Women have the right to choose breast implants, which chooses to emphasize autonomy. However, if autonomy were the only principle to be considered, there would be no need for the FDA. And there would be no protection against the claims of charlatans and those peddling magic elixirs.
The slogan "The right to choose" implies a benefit that a woman will feel better about herself and her appearance, but, in fact, the data submitted by Mentor Corporation does not bear out that benefit.
Mentor's own data and the data that Inamed provided in 2003 both showed that on most measures, women feel the same about themselves and their lives two years after getting breast implants compared to before getting breast implants. That is consistent with other research as well, as shown in the FDA summary of Mentor's reports on pages 66 to 73, indicating there is no measurable benefit for women who have received breast implants.
To quote, in summary, the literature does not provide strong scientific support that breast implants have a measurable psychological and psychosocial benefit for women seeking breast augmentation. Each study had serious flaws, including the apparent exclusion of participants with adverse outcomes. This was true for augmentation and reconstructive patients.
The summary on page 73 explains that Mentor did not provide adequate literature that evaluates the short‑term or long‑term psychological or psychosocial benefits of breast implants as a reconstructive procedure.
The burdens and potential risks are substantial, not only the risks of invasive major surgery but also serious questions about long‑term safety issues regarding silicone leakage, silicone migration, and resulting autoimmune disorders.
Research of women with implants for at least six years found that one in five women had silicone leaking outside the scar capsule and didn't even know it. Clearly, more studies on long‑term safety need to be done.
In terms of ethically sound decision‑making, this is what I would call a slam dunk for the Committee. Autonomy, the right to choose, is not a factor when the benefits are not measurable and the burdens and risks are significant. The path this Committee ought to take is clear. These implants should not be approved until clear benefits and long‑term safety are established.
Thank you for your thoughtful consideration in listening today.
CHAIRMAN CHOTI: Thank you.
Next speaker? Good afternoon.
DR. OPPENHEIMER: Hi. My name is Marcy Oppenheimer. I am a recent medical school graduate, and I work in health policy. I reviewed the publicly available Inamed and Mentor data. And I have no conflicts of interest.
I would like to focus your attention on one aspect of the manufacturer's applications dealing with the benefits or the effectiveness of implants. And, actually, my comments follow on those of previous witnesses.
Any benefits of this product are emotional. However, they can be studied, like any other medical question. Just as data are necessary to evaluate the risks of implants, data are necessary to evaluate the benefits. Anecdotes are not sufficient.
The anecdotes about implant problems that you have heard today do not prove the product is unsafe. They simply raise questions about the adequacy of the safety data. Likewise, there has been a lot of anecdotal evidence that implants have benefit for quality of life. But in the case of the benefits of implants, the data clearly show otherwise.
FDA and other experts have pointed out significant gaps in the research about implant safety. No one has raised similar questions about the validity of the research on emotional and psychological benefits. In fact, these data do appear to be adequate to answer the question of whether implants provide a measurable benefit. And the answer they point to is no.
To show effectiveness, manufacturers presented patient satisfaction data, which consisted of asking patients two years after they had had their surgery whether they would have the surgery again. By this measure, almost all patients were satisfied.
These data are of limited scientific merit, however, because of the patients' initial bias towards the surgery as well as their bias towards justifying their decision to undergo surgery.
However, both Mentor and Inamed also used standardized, validated questionnaires that assessed issues such as self‑worth and emotional well‑being. These questionnaires were answered before implant surgery and then two years afterward.
As you can see from the Mentor data on the screen, using multiple types of analyses of emotional benefit, the results do not support the conclusion that there is such a benefit attributable to implants.
The Inamed data are similar to Mentor's. The published literature, like the manufacturer's data, also contains no compelling scientific support for a measurable benefit of implants according to the FDA reviewers in the summary statement of Mentor's data.
So what evidence is there in support of the benefit of implants? Anecdotal evidence and patient satisfaction data of questionable scientific merit.
In the age of evidence‑based medicine, is this evidence enough to balance the proven risks as well as the potential but unproven risks of this purely cosmetic product? This is your question.
Thank you.
CHAIRMAN CHOTI: Thank you.
MS. VOLPE: Thank you for allowing me to present this statement. I am Margaret Volpe, a breast cancer survivor with a silicone breast implant. I have no financial ties to manufacturers or health care providers and am not being reimbursed for my appearance here.
I am a volunteer representing Y‑ME National Breast Cancer Organization. Y‑ME has no financial ties with either of these manufacturers. Y‑ME is committed to providing support and accurate information to empower individuals touched by breast cancer so they can select the most appropriate options in conjunction with their health care provider.
Y‑ME's comments concern silicone implants for breast reconstruction or other medical need. We have no opinion on silicone implants for cosmetic purposes. We are not endorsing a product or manufacturer but feel strongly that silicone breast implants should be more widely available as an option for patients requiring reconstruction.
Options for reconstruction are limited. TRAM flap reconstruction is major abdominal surgery with a painful recovery period, leaving patients without their abdominal muscles. Many patients do not have this option or do not want the surgery.
The latissimus dorsi reconstruction usually requires an implant. Other reconstructive procedures using autologous tissue often prove unsuitable for many patients.
Saline implants are available, but for many, they are unsatisfactory. A silicone implant gives a more natural look and feel. Y‑ME emphasizes the need for a range of treatment options so that each patient can choose what best fulfills their needs. And patients who have had mastectomies do not have mammograms.
Please adhere to the science when evaluating silicone breast implants. In 1999, the Institute of Medicine's exhaustive and definitive review of existing research found no evidence that silicone breast implants caused cancer or disease and no convincing evidence that silicone produces an immunologic response. The report stated such diseases or conditions are no more common in women with breast implants than in women without them.
The U.S. Court's National Science Panel and several European government scientific panels issued similar findings. NCI's large analysis, recently published in the New England Journal of Medicine, concluded there is no evidence of an association of silicone gel‑filled breast implants with connective tissue diseases or other autoimmune or rheumatic conditions.
Another NCI study found no evidence linking implants with breast or other cancers. Several long‑term epidemiological studies in Scandinavia and Australia also found no association between silicone breast implants and connective tissue or autoimmune diseases.
Another study found the use of implants in post‑mastectomy patients with early‑stage breast cancer did not adversely impact survival in women under the age of 65. These women were followed for a median of over 12 years. Over 4,000 patients participated in the study.
Other studies have demonstrated improved quality of life for patients wanting implants for reconstruction. Our hotline receives calls from elderly patients who want reconstruction as well as from younger patients.
Y‑ME urged its patients to fully understand the risks and benefits of any medical or surgical choice. No medical device lasts forever. Shunts, pacemakers, artificial knees and joints have an expected life span and possible complications, including capsular contracture.
Patients must be aware of such side effects as capsular contracture, potential rupture, and the need for replacement. Doctors must provide accurate information about the risks and benefits of silicone implants. There must be long‑term follow‑up and data collected.
Privacy‑protected patient registries and physician training are vital along with timely communication of significant findings to consumers, patients, and providers.
Until the cause of breast cancer is found and the disease is eradicated, making implants no longer necessary, breast cancer survivors or those needing prophylactic mastectomy must be assured the right to select appropriate and effective medical therapies or devices.
Y‑ME urges you to act based on the science alone. Thank you.
CHAIRMAN CHOTI: Yes?
MS. MORRIS: My name is Andrea Morris. I am 46 years old. I want to thank the FDA for ensuring the safety of silicone implants and for their concern about women's health issues.
I would like to state for the record that I have had breast reconstruction and that I have been part of the Mentor Corp. research trial since August 2002.
Mentor has not asked me to testify, nor have they provided me with any financial incentive. I am here to testify solely as a two‑time breast cancer survivor and as an advocate for other women affected by breast cancer.
I serve on the board of Living Beyond Breast Cancer, a nonprofit national organization whose mission is to empower all women affected by breast cancer to live as long as possible with the best quality of life.
I was first diagnosed with breast cancer 9 years ago, at the age of 37, and again 3 years ago, at the age of 43. When I was diagnosed, I was devastated. I had numerous conversations with my team of physicians to discuss and evaluate my treatment options.
I decided to have a bilateral mastectomy. However, this meant I would no longer have my breasts, the ones that had been part of my body for 43 years.
My plastic surgeon discussed the various reconstruction options. He explained the risks of using silicone implants and the benefits. We reviewed the issues involved in years of product liability litigation, including the risk of ruptures. He believed silicone implants were safe. He also felt they made the breasts look and feel more natural. Clearly concerned about the risks of one option over another, I also believe it is very important to look better so that you can feel better.
The breast reconstruction, which I elected, involved bilateral submuscular tissue expanders. This procedure involved being expanded numerous times with saline. At the end of the expansion process, silicone implants were inserted. The expansion process was not fun. In fact, at times I was in excruciating pain. However, the end result was worth the pain.
Having breast cancer has had a profound impact on my life. It has forced me to make many life‑altering decisions. It has made me realize that the quality of life is paramount. What is the point of undergoing major surgery in which your body is cut and mutilated if one's quality of life is compromised?
I will continue to live with the potential risks of having silicone implants, but every day I wake up and have the benefit of feeling confident about myself and am a complete woman.
I have great admiration for myself and other breast cancer survivors who have the courage to speak out publicly about their illness and ordeals. We are teachers, role models, and a source of inspiration for other women diagnosed with breast cancer today, tomorrow, and in the years to come until this awful disease is eradicated.
I recommend availability of silicone implants for breast cancer reconstruction along with continued study into the long‑term health‑related concerns. I believe other women should have the same opportunity to make their own decision on the use of silicone implants for breast cancer reconstruction.
Thank you for your time.
CHAIRMAN CHOTI: Thank you.
DR. BERG: Dr. Choti, members of the panel, I am Dr. Wendie Berg, a radiologist specializing in breast imaging. And I have served on the Radiologic Devices Panel of the FDA previously.
I wanted to just review the literature on screening for breast cancer in women with implants. If I could actually go two slides forward, please? My credentials are in the paperwork.
Mammography is the only screening test to date which has been shown to reduce deaths due to breast cancer. And across numerous randomized controlled trials, there has been overall a 40 percent reduction in breast cancer mortality among women who are actually screened.
Next. Importantly, screen‑detected cancers have a much better prognosis than those that are clinically found with 50 percent of screen‑detected cancers found with good prognosis, translating to 95 percent 20‑year survival compared to only 19 percent of those that are clinically found having good prognosis and nearly half having a poor prognosis with 40 percent 20‑year survival.
Next. Also, the lymph node status of the breast cancer correlates with survival. And in the trials where there was a benefit to screening mammography, you can closely correlate that, the reduction in mortality with the reduction in node‑positive cancers.
Next. Importantly, mammography and implants, there are issues of limitations. All implants, including both saline and silicone implants, hide some of the breast tissue, requiring both routine and displaced views to be obtained, resulting in twice the radiation dose to the patient for every mammogram performed.
Implants cause mass effect on the remaining breast tissue and reduce the compression that we can achieve, which results in poorer quality mammograms as well as increased radiation. And the patients, of course, often experience pain and contracture, which limits the ability to position and compress the breast.
It's worse if the implants are in subglandular location. It's better for mammography if they're in subpectoral, behind the muscle, position. And in some women, there is so little breast tissue to start with that the mammography is just not possible after implant.
There is patient concern about rupture and discomfort, resulting in non‑participation in mammographic screening. Here is an example of a patient who did have a mammogram that was successful in depicting her small focus of cancer that was manifest as calcifications. This was DCIS.
The next slide, however, shows another patient who with the implant we were unable to obtain any visualization of the breast tissue. And, in fact, you can see on the right her cancer adjacent to the implant on ultrasound only. This was a lump that she felt and was, therefore, clinically detected.
Even after removal of the implants, we can have severe limitations to mammography, as in this patient, who on the left‑hand side, had extensive silicone granulomas in her breasts that mimic suspicious masses, required further evaluation, and on the right‑hand side had seroma.
Over several studies, there has been a reduction in the mammographic sensitivity to the level of 45 to 57 percent. That's rather severe, 33 to 40 percent reduction overall. Cancers were more likely palpable. And in one study, there were fewer in situ cancers. There's a trend toward larger size and more node‑positive cancers.
This is the last issue here. These studies have not distinguished with patients who have smaller breasts, dense breasts, contracture, or subglandular implants. So there is a need for more studies.
Thank you.
CHAIRMAN CHOTI: Dr. Berg, can I ask you a question?
DR. BERG: Yes.
CHAIRMAN CHOTI: You mentioned that women with implants may not be as compliant for screening.
DR. BERG: That's correct.
CHAIRMAN CHOTI: Do you have data on that?
DR. BERG: I don't think there's been any systematic study on that issue, to my knowledge, but on a frequent basis, at least weekly, I get phone calls from women demanding to have an MRI, instead of a mammogram. It's not the standard of care. It's a $1,000 to $3,000 test, instead of a $70 test. It's not practical for screening. Ultrasound can be done, but it does not find DCIS. And so this is another issue.
Many of the women who do do mammography have severe pain and contracture. They're not thrilled to come back for their mammograms next year.
CHAIRMAN CHOTI: But you're not familiar in the radiology literature that the compliance, the percent of women that follow breast cancer screening is diminished in women who have implants?
DR. BERG: I don't know that it's been systematically studied. I think that's one of the problems.
CHAIRMAN CHOTI: Thank you.
MS. SCHECHTER: Hello. My name is Debbie Schechter. And I have no conflicts of interest. I'm here today as an attorney and a former policy analyst and as the friend of a woman who had breast implants and who killed herself.
Did she kill herself because of her breast implants? Research may help us answer that question. Studies conducted in Finland, Sweden, and Denmark each found that women who had breast augmentation were three times as likely to commit suicide as other women their age in those countries. Those findings seem eerily similar, making it hard to dismiss.
The groups were matched in race and age, but women who have breast augmentation may differ from other women in important ways that make them more vulnerable to suicide.
National Cancer Institute scientists conducted a study of women who had breast implants or other plastic surgery at least seven years earlier. The breast augmentation patients were more than four times as likely to kill themselves as other female plastic surgery patients.
Unlike the European studies, the NCI study was using a comparison group with very similar health habits, socioeconomic status, and concern about their appearance.
A fifth study of women in Denmark found that women with breast augmentation were five to seven times more likely to take antidepressants, compared to breast reduction patients and another comparison sample.
One of the interesting aspects of these studies is that the four European studies were all funded by Dow‑Corning, the silicone manufacturer. They accurately reported the findings but would not concede that implants might possibly cause suicide.
The funded a review article by Joseph McLaughlin that questioned the findings, speculating that depression and other possible causes of suicide probably were more common among the augmentation patients, even before they had breast implants.
An article by Tom Joiner funded by the American Society of Aesthetic Plastic Surgeons went even further, claiming that the suicide rate would probably have been even higher had the women not been so fulfilled because of their breast implants.
Knowing P. J. Brent, I have a different theory. P. J. was very ill. And she felt very badly because she believed she was responsible for making her daughters ill from breast‑feeding with implants.
P. J. did not have low self‑esteem. In fact, to the contrary, P. J. was vibrant, articulate, peppy, loving, warm, helpful. I lived in her community. And I can tell you that when news about her suicide spread as quickly as you can imagine to the thousands who came to her funeral, the one thing everybody said is that she is the last person in the world that we would expect to commit suicide.
I spoke to her the week before she committed suicide. And she was loving, concerned, peppy on the phone. She was an incredible human being. I respected her and loved her. But her illness and the frustration of lack of effective medical care for her conditions got to her.
If you look at the data from Mentor Corporation, you will see that breast implants do not make women feel better about themselves. Two years later, implanted women feel worse or the same about their lives and themselves. Inamed found the same result in the studies they provided to the FDA in 2003.
Finally, do breast implants cause suicide? They might. In light of the company's own data showing a decrease in quality of life after silicone implants, shouldn't that question be answered more conclusively before implants are approved by the FDA?
Thank you.
CHAIRMAN CHOTI: Yes?
MS. MILLER: I am Dawn Miller. I am from Massachusetts. I have no conflicts of interest.
I had silicone breast implants in 1990 at the age of 20 as a part of a correction for congenital deformity of my rib cage. It was recommended by my surgeons that I have implants at age 16. I waited until age 20 because I felt I really needed to explore the safety of the devices prior to surgery.
When I finally decided on reconstruction, an 80 cc silicone implant was implanted on my left side and a 200 cc silicone implant was implanted on my right side, filling in the cavity of my chest wall and creating a normal‑appearing breast.
I consulted with four plastic surgeons prior to my surgery. And they informed me that silicone was essentially synthetic sand, a building block of life and completely inert in the human body. I was told that it would take a severe physical trauma to rupture an implant.
In August of 2002, I experienced permanent hearing loss in my left ear and problems with my equilibrium. In January of 2004, I began to have heart arrhythmias. I never associated either of these conditions with my silicone implants.
Two years later, in August 2004, my sister heard a news report that scientists found high levels of platinum in some women who had silicone implants. Women with these platinum levels were experiencing neurological problems that included hearing loss.
At this time I contacted the manufacturer of my implants, Inamed Corporation, and inquired about my implants. I was told, and I quote, that "The same materials, silicone elastomers for the shell and silicone gel, are used in the fabrication of the Style 40 devices today."
Very concerned, I sent a sample of my urine to the scientists who performed the platinum testing on breast‑implanted women. My urine tested positive for high levels of platinum.
My implants were removed last November. My surgeon told me that my left implant was ruptured and leaking and my right implant appeared to be intact. Free silicone was found in the skeletal muscle and connective tissue taken from both my right and left sides. Platinum is a well‑known neurotoxin, as reported in the literature. The hearing loss, equilibrium problems, and heart arrhythmias I experience very closely resemble that experienced by those exposed to platinum through chemotherapy.
I had silicone implants for 14 years. At no time did I suspect a rupture. This is consistent with the FDA's study that showed that most women with implants will have at least one ruptured implant within ten years. And, just like me, the women in that study never knew they had a ruptured implant.
The fear, the outrage, and the sadness are with me still. These same feelings are shared by my family and friends, who support me through this. It has been devastating to learn that the same implants that have caused me harm are being considered for reintroduction to the open market.
The industry's four‑year studies are completely inadequate because they do not provide any information about the long‑term safety of these products. I urge you to recommend that the FDA not approve these PMAs.
Thank you.
CHAIRMAN CHOTI: Yes?
MS. MASON: Hello. My name is Jill Mason. I want to thank the panel for hearing my testimony today regarding my experience with silicone breast implants.
I am a 59‑year‑old, married, and work as a surgical tech in my local hospital's OR. My travel expenses have been paid for by the American Society for Plastic Surgeons. I do not have any financial interest in Inamed, Mentor, or their competitors.
I received my first silicone implants in 1989, only months before the controversy started regarding silicone implants. I had small breasts for a woman of my physical size and knew that one day I would get implants.
I chose silicone implants after talking with my plastic surgeon about the benefits and risks of both saline and silicone implants. I chose silicone implants because of their more natural look and feel. As a surgical tech, I had seen saline implants. And they were hard and unnatural looking.
Certainly I was concerned when the silicone implants were taken off the market, but I didn't panic. I talked at length with my plastic surgeon and my personal physician. With what information was provided to me about the implants, my concerns were put to rest.
I continued to hear horror stories about silicone implants and saw women on television who said these implants had ruined their lives. I personally felt great and looked even better.
I think the issue has been greatly overstated. A few years ago, one of my implants ruptured. The rupture was discovered during a routine mammogram. After consulting with my plastic surgeon, I decided to wait a few years, mainly because of financial consideration, and then have both implants replaced, which I did on January 7th of this year.
Even after the rupture, I had absolutely none of the symptoms that I have heard other women, whose implants had ruptured, complain about. Like many other women here today, I believe women should be able to make their own choice about what type of implants they want, but I am also here because I believe the public has largely heard one side of the story.
I understand that women with horror stories about their implants make better reading and better viewing, but their story is not the only story. And, from what I understand, their story is not supported by science. My story and the story of thousands of other women, whose voices have gone unheard, is one of complete satisfaction with our silicone implants.
I hope that you take our side of the story to heart, but, more important, I hope that the panel will let science, not emotion, put an end to this debate.
I appreciate this opportunity to share my thoughts. Thank you.
DR. WELLS: Good afternoon. My name is James Wells. I am a board‑certified plastic surgeon practicing in Long Beach, California. I'm a past President of the American Society of Plastic Surgeons. I am not a consultant for either company. The society has paid my travel. I use products from both companies.
I represented ASPS before the October 2003 panel hearing on silicone implants. My concern then, as it is today, is our patient safety, but this time around I have an additional concern: the potential subversion of the review process.
I fear that the current climate of questioning the credibility and trustworthiness of physicians who serve on government panels may ultimately undermine the process. When a physician is singled out because of a perceived conflict when, in reality, this individual may be best qualified to evaluate safety, we are doing a tremendous disservice.
FDA panels are particularly designed to represent expertise and judgment relevant to the product under review. We cannot let special interest and private agendas overshadow what we are here to evaluate. We must allow the panel to base its decision on scientific evidence, not on special interest, emotions, or anecdotes. That is what our patients expect and deserve.
After the FDA issued its 2004 draft guidance document, ASPS has sought ways to identify ways in which we can help answer some of the questions regarding the safety, efficacy, and utilization of this device. I will provide a brief overview of our activities.
First is the ongoing refinement of our educational programs relating to breast augmentation with silicone gel‑filled implants. Our primary educational objective is to provide knowledge that physicians need to achieve optimal levels of safety, post‑surgical outcomes, and patient satisfaction. There is a focus on physician responsibility for patient outcomes and efforts to improve overall rupture rates.
The second critical area is the informed consent resources and the breastimplantsafety.org Web site that has been developed to educate and inform our patients about the risks and benefits of breast augmentation and reconstructive surgery. The Web site is under continuous evolution. And new material is added as indicated.
Preoperative education regarding risk, alternatives, consequences, and benefits is integral to successful outcomes and patient satisfaction. Informed consents with algorithmic approaches are available to assist in the physician‑patient decision options, including implant choices, surgical options, complications, financial responsibilities, and reoperation choices.
The third key area of activity is the development of a practice parameter guideline of treatment principles for patients with silicone implants. The practice parameter is based on the most recent scientific literature and expert opinion. It describes principles of practice that meet the needs of patients with silicone gel‑filled breast implants.
The fourth area of activity is post‑market monitoring. The 2004 guidance documents suggest post‑market monitoring as a possible approval requirement. ASPS and ASAPS have recently achieved an agreement with the two manufacturers on a set of principles for voluntary post‑market surveillance of patients with silicone breast implants. This would involve a third party administrator and participation from organizations representing radiology, rheumatology, and others, to name a few.
Plastic surgeons and manufacturers recognize that post‑market surveillance is an important policy consideration for all device approvals.
Finally, the fifth area of focus has been a review of the scientific literature relating to breast implants. We have updated the bibliography that was submitted to this panel in October of 2003. The literature to date supports the use of silicone gel‑filled implants as a choice for women desiring cosmetic breast augmentation.
Plastic surgery has worked diligently to respond to the FDA concerns of 2003. We are committed to educating our physicians while taking a leadership role in the development of appropriate follow‑up mechanisms.
Today we have heard and will hear from numerous individuals and groups opposed to all women being allowed the choice of the silicone gel implant. Much of the opposition testimony is grounded in junk science. What we have not heard is scientific support regarding this systemic health problem.
The ongoing adjuvant studies since 1992 have now enrolled over 150,000 women combined. And the 13‑year experience from those patients with the devices you are reviewing this week, not the previous devices, has not produced a dramatic rise in either ruptured devices or women with the tragic stories you will hear over the course of this panel.
This device has been reviewed, re‑reviewed and in the opinion of many is expected to be the perfect device, free of failure, free of adverse surgical outcomes, and perfect for all. That is an impossible goal to obtain. An ethical decision does not require a perfect device but an informed choice in discussion.
Virtually every surgical specialty uses some type of silicone device. An ophthalmologist injects silicone oil for retinal detachment. Men have unrestricted access to a silicone device for penile insertion or testicular replacement. Neurosurgeons and orthopedic surgeons use silicone devices. Dermatologists are injecting liquid silicone subcutaneously in an off‑label use. Yet, in the United States, we only allow women with cancer or anatomical deformities or failed saline devices to access a silicone gel device.
If the device is satisfactory for some, why not for all? This is a question you must resolve. It is a question I cannot answer for my patients because in my mind, there is no rationale.
Patient safety and satisfaction are primary goals of plastic surgeons. We believe that implants are an informed choice, offer health‑related quality of life benefits for numerous women. Respectfully, I ask the panel to recommend approval so that our patients can have that choice.
Thank you.
CHAIRMAN CHOTI: Thank you.
Dr. Newburger? She has a question, sir.
MEMBER NEWBURGER: Dr. Wells, I have downloaded the Web site that ASPS and ASAPS ‑‑
DR. WELLS: Right.
MEMBER NEWBURGER: ‑‑ have made to provide information to potential patients. The Web site has a section on risks, but the only risks that you mention in it are surgical risks. But instead of providing statistics on capsular contracture, rupture, or other surgical complications, you tell patients to ask their doctors.
Now, my thought is that as the professional society, you all should be providing that information in the Web site. And if you don't, then can we really count on physicians to do that?
And I have a second question, which is, do you offer any help to patients who can't afford to remove their ruptured implants as a society?
DR. WELLS: Well, in regard to your first question about data and statistics, yes, we will eventually add all of that material. The implant site is a relatively new site and will be upgraded continually. And the kinds of suggestions that you are making are welcome. And we would take any input from the FDA to amplify the Web site. Your Web site contains a lot of that information, and patients can also go to that information.
As regards offering help to patients, it has been under discussion. No policy decisions have been made, but we would enter into discussion with the FDA advisory panel and discuss it further. It is not a closed option.
CHAIRMAN CHOTI: Thank you.
DR. GUY: Good afternoon. My name is Dr. Roxanne Guy. I am a practicing plastic surgeon in Melbourne, Florida. And I am also Vive President of the American Society of Plastic Surgeons. The society is covering my travel expenses for this presentation.
I have used silicone gel breast implants for over 22 years and have been using the third generation gel implants under the study protocols of both manufacturers. I received no compensation from either manufacturer.
In March of this year, in order to get a sense of the experience of practicing plastic surgeons throughout the country, the ASPS faxed an 11‑question survey regarding the implants being reviewed today to its membership. This slide summarizes the methodology.
The membership was not given any of the manufacturers' study data on these implants. The responses are based on their experience and expertise.
Nine hundred six questionnaires were returned. A survey summary was distributed to the panel, which I will synopsize briefly. Approximately 80 percent of the responding plastic surgeons have personally used these third generation implants since 1992. Fifty‑nine percent of the surgeons experienced this generation of gel implants as less prone to capsular contracture. Thirty‑five percent were unsure. And only six percent felt that they were not necessarily less prone to contracture.
On the issue of rupture, 93 percent responded that they rarely or never experienced significant local problems. Please note the second slide. Regarding follow‑up care, 75 percent felt that patients with these implants should be advised to be seen by a plastic surgeon every one to two years. Please see the third slide. The average suggested follow‑up time was every 1.9 years.
There was consensus on the question of monitoring for implant rupture, with 85 percent agreeing that this should be accomplished by physical exam followed by appropriate radiological tests as determined by the examining surgeon.
That testing could, of course, include MRI scanning. Respondents were divided, though, on the issue of routine MRI screening for silent rupture with half suggesting that routine screening was not necessary. Responses from the other half ranged from one to ten years, with a mean of seven years. Please see the fourth slide.
There was broad agreement; that is, 92 percent, that the availability of these implants is important to provide patients with the highest quality of care. Fully 98 percent agreed that patients should be able to participate with their surgeons in their choice of medical care, and 97 percent felt that patients should have access to these implants. This last slide illustrates these three points.
The survey results represent a cross‑section of the experience of practicing plastic surgeons with these third generation gel implants. What are these surgeons telling us? They're telling us that this generation of implants is vastly improved from previous generation implants, that they're safe and appropriate for use for their patients, that they have a keen interest in follow‑up patient monitoring, and that they feel these implants should be added to their options for patients in order to provide them with the best care.
Most importantly, they're telling us that their patients are fully capable of making an informed decision and that selection of these devices remains a personal decision made between an informed patient and her surgeon.
I wish to thank the panel for their attention.
CHAIRMAN CHOTI: Thank you.
DR. BASH: My name is Dr. Deborah Bash. I am the head of cosmetic surgery at the Mayo Clinic in Scottsdale, Arizona and an assistant professor at Mayo Clinic College of Medicine. I am a full‑time practicing plastic surgeon. I am here representing myself. And I have no financial interest in the sponsors. ASPS is reimbursing me for my travel expenses.
I have been in practice since 1992. And a very large part of my practice is breast surgery. I have been a participant in the FHA silicone gel breast implant adjunct study since 1992.
I bring a very unique perspective to this hearing in that I am a plastic surgeon, an educator, a scientist, and a woman who has had breast augmentation with silicone gel breast implants.
I had a breast augmentation for cosmetic reasons with silicone gel implants 20 years ago, when I was a third year medical student, with implants that are not under discussion today. At that time, silicone gel implants were the most common device used for the procedure.
After more than ten years of no problems, I electively chose to have them replaced in 1999 with the next generation of silicone gel implants, which are the implants you are addressing today. Most of the tragic stories you are hearing are related to the implants that precede devices you are now considering.
Since my second breast augmentation in 1999, I have done well, with no complications. I have never attempted suicide. I do not have fibromyalgia, lupus, scleroderma, rheumatoid arthritis, brain cancer or lung cancer, esophageal motility problems, neurologic problems. My teeth aren't green. My hair isn't falling out. And I can fully function as a highly trained and competent surgeon at a very respected medical institution.
I have yearly mammograms, as recommended by the American Cancer Society. And I was well‑aware in 1985 that my implants would not last forever. And I will have my implants replaced again with silicone as they age.
My experience as a surgeon and as a patient puts me at a uniquely credible position to discuss breast augmentation with my patients. I rely on science and factual data and speak to my patients openly and honestly. I always tell them that I have silicone breast implants and that I chose to have my implants replaced with silicone. In other words, I put my money where my mouth is.
While my experience allows me to relate to my patients at a different level, I am frustrated that they do not have access to the same options that I had. All of my patients wishing implants are shown both silicone and saline. And for those who qualify for silicone, almost all choose the silicone because of their more natural feel.
As a plastic surgeon, I am obligated to inform my patients about the risks of any surgical procedure or device. Likewise, patients must be an integral part of the decision‑making process. However, I have a difficult time explaining to my patients why some women are allowed silicone and some are not because of the FDA concerns about safety of the device.
I strongly believe that women should have the option to choose the type of implant surgery or device that works for them when adequately informed of the risk and benefits. I am fortunate. I had that option in 1999. That is my choice. Make it an option for all women.
Thank you.
CHAIRMAN CHOTI: Dr. Bash, may I ask you a quick question. Do you recommend to your patients that they be routinely changed every ten years or whatever interval you ‑‑
DR. BASH: I do. I recommend ten years. I say that they won't last forever and the recommended time is ten years.
CHAIRMAN CHOTI: Even without any evidence of a leak, you would recommend to your patients to change them out at ten years?
DR. BASH: I do.
CHAIRMAN CHOTI: Okay. Thank you.
Yes? Good afternoon.
DR. JEWELL: Good afternoon. My name is Dr. Mark Jewell. I'm President‑Elect of the American Society for Aesthetic Plastic Surgery. I'm here today speaking as their official representative. The society will reimburse my expenses for travel from Eugene, Oregon.
I have no financial ties to industry or medical associations. I am a clinical investigator for both Inamed and Mentor implant studies and have received funding for staff administrative support for these studies.
The American Society for Aesthetic Plastic Surgery also shares the concerns that you have heard earlier today by Dr. James Wells, who spoke just before me. It would be a disservice to patients that afterwards it was determined that this was a flawed process due to agency bias, misrepresentation of evidence, and absence of plastic surgeons on the panel.
Today I will address the topic of patient choice and informed consent. I am the lead author for the last ten years of the patient consultation resource book used by plastic surgeons for informed consent. Given the complexities of decisions involving breast implant surgery and the wide range of surgical techniques used, discussions regarding informed consent have become extremely important in addressing exactly what are the dimensions of risk and patient accountability with the clinical decisions made involving breast implant surgery.
Traditionally this has been a process of defining surgical procedures, its alternatives, and risks. The patient would then sign a consent indicating that the procedure was being performed with their consent.
It is known that even a patient may sign a consent form. It does not necessarily mean that they will in the future remember being informed about potential complications, need for reoperation, and who is responsible financially for future treatment.
Validation of informed consent and management of patient expectations all come down to placing the patient at the center of the decision‑making process that involves breast implants.
There are newer dimensions of informed consent that are extremely pertinent when it comes to implanted medical devices, patient expectations, and reoperative surgery. The placement of breast implants absolutely ensures that there will be at least one operation in the future to take care of potential problems or replacement.
The five dimensions of informed consent that are expanded are what are the pertinent undesirable outcomes. These can relate to surgery or a medical device, additional advisory information regarding future need for reoperation is needed.
Second, how permanent is the potential undesirable outcome? The possible severity, remedy, and permanence all are factors that affect a patient's decision. In some situations, the best choice involving reoperative breast surgery may be implant removal.
Third, when might the unwanted outcome occur? Negative outcomes may occur in the perioperative period or later Patients often think of future risks and immediate risks differently.
Fourth, what is the probability of an adverse event occurring? Now, we can predict the frequency of adverse events that were involving silicone breast implants.
And, fifth, how significant is the unwanted outcome to the patient? Patients will inevitably rate subjective badness differently. However, some patients may underestimate or overestimate the significance of a particular risk. It is important in this situation for the patient to facilitate an accurate perception of objective data.
In the case of breast implants, the following issues need to be emphasized. Like other medical devices, breast implants do not last a lifetime and failure can occur. Additionally, there are other known problems that can occur, such as capsular contracture, that may influence reoperation.
The vast majority of implant‑related issues are local in nature and treatable. They are, nevertheless, important considerations for any woman contemplating breast implant surgery. Patients must be informed that surgeons cannot control dynamics between implants and soft tissues and biological healing related to implants.
Patients need to understand the difference between inherent risks of medical devices and potential complications associated with surgical procedures. Patients are also entitled to know the clinical consensus of the scientific community regarding safety, efficacy, and reoperation of breast implants when making informed choice.
This must be a balanced process hearing both the risk and reward of a procedure. Patients should be aware that women undergoing breast augmentation and breast reconstruction often experienced self‑esteem and greater self‑confidence.
I would offer the panel informed consent documents from the 2005 edition of the ASPS patient consultation resource book that relates to breast implant surgery. These cover informed consent documents for primary gel augmentation, a codicil for patients seeking larger than recommended implant size, mastopexy, capsulotomy, capsulectomy, and implant removal. I have also included a flow chart, which details the process of informed consent.
Thank you.
CHAIRMAN CHOTI: Yes, question, Dr. Newburger?
MEMBER NEWBURGER: Thank you.
Dr. Jewell, I was very pleased to see the ASPS' Web site with statistics. It was certainly very helpful to me. I was intrigued by the fact that your Web site reports over 4,200 young women under the age of 18 having had breast implants. And there is a classification of the reasons for the surgery under age 18, including tubular breast deformity and Poland syndrome, in addition to 40 percent having it just for cosmetic reasons alone.
Is there an algorithm that your society uses to do this classification, degree of asymmetry or something like that?
DR. JEWELL: Well, first let me correct the matter with regards to those statistics. Our statistics are for women 18 years of age and younger. So I can't tell you exactly how many women under the age of 18 had breast augmentation ‑‑
MEMBER NEWBURGER: Okay.
DR. JEWELL: ‑‑ surgery versus reconstructive things. So this would technically be a patient one day before she is 19 and younger. So I can't really give you those numbers, nor do we have algorithms with regards to tubular breast, Poland syndrome, or asymmetry.
Thank you.
CHAIRMAN CHOTI: Yes? Thank you. Please?
DR. COLLINS: Members of the panel, good afternoon. My name is Dr. Dale Collins. I am a board‑certified plastic surgeon, Associate Professor of Surgery, and Director of Breast Oncology Services at Dartmouth Medical School.
I have no personal financial relationship with any implant manufacturer. I participate in two clinical trials of silicone breast implants: the Mentor adjunct and CPG implant studies.
ASPS paid for my travel. And I am here to discuss the findings from the published research that currently exist on silicone gel‑filled implants.
Like my colleagues, I fully support the FDA's ongoing regulatory process. Through monitoring the scientific literature on breast implants, our specialty supports sound science and is able to guide directed research projects in areas of identified concern. Plastic surgeons have actively supported scientific research on the safety and efficacy of breast implants as well as the psychological impact of breast augmentation and reconstruction.
A document summarizing the current literature has been submitted for the panel's information. The body of knowledge that currently exists supports the use of silicone gel implants as a choice for women desiring breast surgery.
As you are aware, the Institute of Medicine report in 2000 found no evidence of an association between silicone implants and systemic disease, echoing dozens of peer‑reviewed investigations.
Specifically, the report concluded that silicone implants do not cause major health problems, such as lupus or rheumatoid arthritis. Other significant findings conclude that silicone implants do not pose a threat in breast‑feeding or to unborn babies.
The report represents a comprehensive and unbiased review of the breast implant safety by top experts in a variety of medical fields. Three years later, the NIH issued a report to Congress on the status of its research on the long‑term health effects of silicone breast implants. They did not find sufficient evidence to support a relationship between breast implants and connective tissue disorders.
The report found that women with silicone breast implants are no more likely than the rest of the population to develop cancer, immunologic diseases, or neurological problems. It also cited a National Cancer Institute finding that women with breast implants show a slight decrease in risk for breast cancer.
As a woman and as a physician, I am aware that breast implants, both saline and silicone, may cause localized problems for some patients. And in some cases, this may require additional surgery or other intervention.
However, despite these facts, scientific studies over the years support the safety and effectiveness of these devices for augmentation and reconstruction. Moreover, patient satisfaction with the surgical outcomes remains high.
Like other implantable medical devices, breast implants may not last a lifetime, but women who understand this fact may choose to undergo breast implant surgery.
In closing, let me add that I have been an attending surgeon for ten years with a practice limited to breast reconstruction for the past five. My primary goal in appearing here today is to implore the panel to make silicone breast implants accessible to those women who make an informed choice to use them, either in reconstruction or in breast augmentation.
Thank you for the opportunity to speak here today.
DR. YOUNG: Good afternoon. My name is Leroy Young. I am testifying today for the Aesthetic Surgery Education and Research Foundation, or ASERF. I am a board‑certified plastic surgeon in private practice in St. Louis, Missouri and serve as a committee chair in various capacities for both the American Society of Plastic Surgeons and the American Society for Aesthetic Plastic Surgeons.
I currently have no financial ties with any implant manufacturer. In the past, I have received research funding from several implant manufacturers, including McGhan, and have served as a consultant to breast implant manufacturers.
I use implants in my medical practice. I chair the North American Breast Implant Registry and co‑chair the International Breast Implant Registry, which I will be discussing in some detail today. My travel expenses were paid by ASERF.
Our specialty has demonstrated a long‑term commitment to data collection and patient follow‑up. The National Breast Implant Registry, or NABIR, was created in 2000 for data collection on all implant types and procedures, specifically patterns of use and indications for procedure, implant or explant.
A later presentation by my colleague Richard D'Amico will outline a post‑market surveillance concept plan that would meet a panel‑recommended condition and build on the experience and commitment of NABIR.
NABIR has evolved since its inception to a dynamic Web‑based tool with participation from more than 316 surgical facilities and over 21,000 women. The registry is now linked to an innovative outcomes data collection program called TOOPS, Tracking Operations and Outcomes for Plastic Surgeons, a shared initiative of the American Society of Plastic Surgeons and the American Board of Plastic Surgery.
The internet data collections mechanism provides valid clinical and practice information to plastic surgeons and allows the individual surgeon to compare his or her outcome against national benchmarks.
NABIR has played a leadership role in international collaboration on breast implant data collection. The European Union has mandated that its member countries have breast implant registries. And plastic surgery societies in several countries have endorsed NABIR as the model of choice.
As a result, the International Breast Implant Registry was formed to allow collaborative data collection and analysis between U.S., European, South American, and Australian organized plastic surgery. We believe that NABIR is quickly becoming a world standard for an electronic breast implant registry.
NABIR has a number of key features that will likely be integral to a post‑market surveillance tool. It is secure, internet‑based, and HIPAA‑compliant. It is administered by a neutral third party. The registry is voluntary, and data submitted is anonymous, protecting the patient's and the surgeon's privacy and confidentiality.
A variety of data elements are tracked, including physician of implant, incision location, and well as indications for implant or explant, such as rupture, change in size, and migration. Collected data also encompasses method of tumor indication as well as level of staging as applicable. In the future, there may be an added value in integrating patient satisfaction and quality of life data collection.
Having had personal involvement in a large‑scale online survey funded by ASERF, we were able to collect a wealth of previously unavailable data on women undergoing or considering this surgery, particularly as relates to patient satisfaction with their choice.
The opportunities in a registry like NABIR are very exciting as a post‑market surveillance tool. As there is no legislative mandate in the United States for compulsory implant registries, we promote voluntary reporting by plastic surgeons to NABIR as an important tool for ongoing research and data collection.
We support the FDA's review process and believe a strong post‑market surveillance process similar to our National Breast Implant Registry can play a significant role. Preliminary meetings with the FDA and industry have been supportive of collaboration on the registry. We welcome the opportunity to build on the success of the National Breast Implant Registry.
Thank you.
DR. CASAS: I am Dr. Laurie Casas, Communication Commissioner for the American Society for Aesthetic Plastic Surgery, also called ASAPS. My travel expenses to this hearing were paid by ASAPS.
I am a full‑time Associate Professor of Surgery at Northwestern University Feinberg School of Medicine in Chicago. I have published extensively on breast surgery topics. I have participated in a soon‑to‑be‑published multi‑site prospective outcome study on patient satisfaction following cosmetic procedures.
I am a board‑certified plastic surgeon in clinical practice for more than 15 years. Therefore, a portion of my income is derived from breast implant surgery. I have no financial ties to any implant manufacturer.
To correct the record, I would like to state there are not four plastic surgeons on this panel, only one. The second plastic surgeon panelists felt forced to resign after concerns regarding possible conflict of interest.
I am here today on behalf of the many thousands of patients who tell me that breast implants have made a positive difference in their lives. Given the proven level of safety and efficacy of breast implants, I am in full support of the FDA's approval of these devices along with the FDA's continued oversight.
I feel that patient education, safety, and satisfaction are of primary importance. I believe strongly that a woman's right to choose breast implants is paralleled by her right to be fully informed about the risks and the benefits.
There is a growing body of knowledge and evidence that suggests that cosmetic surgery, such as breast augmentation, leads to an improvement in at least three areas of psychological functioning: body image, quality of life, and depressive symptoms.
The results of 2 surveys of more than 5,000 women with or considering breast implants were published in the Aesthetic Surgery Journal, the ASAPS' peer‑reviewed clinical publication.
Results of both surveys show that women's expectations were met by this procedure. Ninety‑two percent said they are happy about their decision to get breast implants and report positive effects on their overall appearance. Eighty‑nine percent said that augmentation completely or mostly met their expectations. Ninety‑four percent said they would recommend breast augmentation to friends or family members. The survey showed that 82 percent reported an improvement in their self‑confidence.
An increasing number of women today are choosing breast augmentation to restore and enhance their appearance, over a million in the last decade alone. It is important to note that over 95 percent of the women seeking breast augmentation come to me for 2 principal reasons. The first is a woman who finds that her once normal breasts have lost considerable volume after pregnancy and lactation and are not in proportion to the rest of her body. The second reason is a woman who comes to us for breast augmentation because she has grown into adulthood with no breast development at all. She feels her breasts are out of proportion to her body.
What I hope this panel will come to understand is that this experience parallels mine. The research has shown that the vast majority of women who have had breast augmentation would make the same choice again. The high satisfaction rate and the determination of so many women to undergo a surgery with the knowledge that it is not a perfect operation suggests just how strongly they feel.
I'd like to sum up by just saying silicone breast implants clearly provide women with options for self‑fulfillment. And breast augmentation produces a high level of patient satisfaction. I fully support the FDA's ongoing review of implant safety and efficacy and rely upon the agency's evaluation of the current science regarding breast implant products.
MS. BRANSON: Hi. My name is Kerri Branson. I traveled from North Aurora, Illinois. I've come here on my own expense, and I have no financial relationships with the PMA sponsors. I am a married 35‑year‑old stay‑at‑home mother with 4 children under the age of 7. My husband is a teacher.
In 1990, at the age of 20, I underwent bilateral breast augmentation. I received silicone gel implants over the muscle. Over the next year, both my breasts developed severe capsular contractions. I was never in any pain, and my breasts had no obvious deformities.
The only uncomfortable situations were lying on my stomach and hugging another person for the fear they could fear my contractions. To me, it felt like they were two oranges between myself and the person that I was hugging.
I lived with this for 14 years and I breast‑fed all 4 of my children with no worries because I had all of the facts. In June of 2004, I decided I was done having children. I wanted to firm up what childbirth had done to my body. So I decided for a second time to seek breast augmentation.
After doing extensive research and consulting with my new doctor, we decided to utilize silicone gel implants once again, but with this time a new approach I wasn't familiar with from a previous experience.
I underwent my bilateral capsulectomy with an implant exchange but this time underneath the muscle. Both old implants were removed completely and intact. I was given all the information about silicone, and my doctor taught me how to care for my implants. This included strict inactivity for several weeks of my upper extremities, massage therapy, dietary supplements, and an excellent follow‑up care with mandatory frequent physician visits. My doctor worked closely with me and still does to make sure that my recovery goes smoothly.
I am completely comfortable about my decision. One year later, after my surgery and following the strict regimen of my new phone doctor, I am doing wonderfully with no contractures in sight.
I attribute my previous scar tissue buildup to my own ignorance and also to my first doctor, who did not teach me how to take care of my implants to prevent contractures, because I had little or no follow‑up care.
I am ecstatic with my new results. I am in excellent health. And I have never ever regretted my choice. I feel fortunate I am one of the small groups of women who get a choice between silicone or saline.
My wish is that every other woman seeking breast augmentation will have access to this information so that she can be assured that she is given the right care and education about how to take care of her implants. She will feel great and have the excellent results that I achieved this past year.
I hope my testimony will prove that with education being the key, this informed decision of silicone versus saline should be a choice between women and her doctor, just as many other important decisions about a woman's own body have been in our country for years.
Thank you for your time and for listening to my story.
DR. D'AMICO: Mr. Chairman, Dr. Choti, members of the panel, my name is Richard D'Amico. I am a plastic surgeon. And I represent the American Society of Plastic Surgeons, the ASPS. I have no financial ties to either corporation. My travel has been paid by ASPS. My topic is post‑market surveillance with a new breast implant registry. My remarks will amplify the remarks of Dr. Wells and Dr. Young.
We believe there is sufficient data to support women's right to choose silicone gel‑filled implants. However, we also believe post‑market surveillance of this device will be essential to reassure the public regarding its long‑term safety and effectiveness.
To better understand a successful device registry, we studied the experience of other similar programs, including the Uterine Artery Embolization Fibroid Registry and the National Adult Cardiac Surgery Database.
We also built on the experience of the North American Breast Implant Registry, which was established by our Plastic Surgery Educational Foundation five years ago and which was just described by Dr. Young.
On March 14th of this year, we met with executives from Mentor and Inamed Corporations and agreed upon six principles for post‑market monitoring. Number one, industry will provide financial support to an ASPS‑ASAPS‑sponsored third party breast implant registry.
Number two, the registry will seek to collect information on each device implanted. Patients will also be encouraged to participate in longitudinal studies in key areas, including rupture, silent rupture, gel migration, capsular contracture, reoperation, and quality of life. Emphasis will be placed on creation of a valid database.
Three, the registry would be housed and managed by a reputable third party clinical research organization, such as the Duke Clinical Research Institute, with whom we have recently had preliminary discussions on this topic.
Number four, an oversight committee will be representative of the scientific and medical community, the FDA, the public, and industry. Medical specialties, such as radiology and rheumatology, with specific interest in implants will be invited to assist in design and implementation. The registry's multi‑disciplinary scientific panel will establish scientific and reporting guidelines and meet annually to review the data.
Five, public accountability and access are essential. Routine reports would be submitted to FDA. Summaries and published studies could be posted on a publicly accessible Web site, such as www.breastimplantsafety.org. And, six, the highest priority will be placed on confidentiality and data security.
We look forward to FDA comments. And I thank you for this opportunity to address the panel.
CHAIRMAN CHOTI: Yes. Thank you.
DR. HAECK: I am Dr. Phil Haeck. Thank you for allowing me to speak. I am a plastic surgeon in private practice in Seattle, Washington. I am the Editor of Plastic Surgery News. I am a member of the Board of Directors of ASPS. And I am also Chair of the Health Policy and Practice Committee of ASPS. I have no financial interest in Inamed or Mentor. And ASPS paid my travel expenses.
I am here to give you a brief overview of our new practice parameter: treatment principles of silicone breast implants. You have a copy of that. I would like to review in principle the following aspects of this treatment parameter.
Infrequent sequelae unique to silicone breast implant surgery have been challenging to diagnose and treat for plastic surgeons for over 40 years. These unique conditions can lead to patient dissatisfaction; possible implant removal, with or without replacement; and increased costs associated with reoperation.
The practice parameter focuses on the diagnosis, treatment, and management of several unique long‑term effects of silicone breast implants that may occur months or even years after insertion of the implant. These conditions include breast pain, late infections, rupture, and capsular contracture.
Breast pain is a symptom that can be associated with other conditions or a condition itself after breast augmentation and should not be dismissed. Breast pain after augmentation can be attributed to a variety of causes, including rupture, infection, calcification around the implant, and capsular contracture.
Patients experiencing breast pain should undergo serial examination and a workup of the symptoms. Mammography, ultrasound, or MRI examination may be necessary to determine the status of the implant and the source of the pain.
If the cause of the pain cannot be determined, symptomatic treatment should be ordered and reexamination taken at intervals to reassure the patient and surgeon that rupture has not occurred.
The signs and symptoms of late infection are often vague and can lead to delay in diagnosis and treatment. In the past, the treatment for late infection typically involved removing the breast implant, treating the infection, and replacing the implant at a later date.
Currently treatment recommendations are based on the severity of the infection and range from empiric antibiotics for erythema and fever to culture‑specific IV antibiotics and hospitalization for signs of sepsis.
In addition to IV antibiotics, the management of severe infection usually involves removal of the implant, along with surgical drainage. If patients choose to replace the implants, new implants may be inserted once the breast and pocket have been sterilized.
Another condition, unexplained or spontaneous implant rupture, can occur, even in patients without rupture risk factors. Our practice parameter reviews the steps needed to be taken when signs of rupture occur, such as mammography and MRI.
Though there is no consensus or scientific literature to support the routine screening for patients with silicone implants that have no indication of rupture, we are now recommending routine reexamination of all women with implants every three to five years and routine radiographic studies at ten years, followed subsequently as needed or at five‑year intervals.
Infection, hematoma, silicone bleed, and individual tendency to hypertrophic scarring are thought to be predisposing factors for capsular contracture. Plastic surgeons are in consensus that using the well‑known Baker's Scale of creating implants on a I to IV basis, grade III and IV contractures are rare but need to be treated.
However, there are large variations in the timing and methods of treatment, which must be tailored to the individual patients' needs and range from no treatment to removal with or without replacement. These varied events tend to be unique to each patient, both in terms of onset and treatment response, leading to difficult decisions that must be made by both the patient and physician.
CHAIRMAN CHOTI: If you could sum up, please, for us?
DR. HAECK: There are treatment options available which foster the safety, efficacy, and patient satisfaction of silicone breast implants.
Thank you.
DR. TAFRA: Good afternoon. Members of the General and Plastic Surgery Devices Panel, my name is Lorraine Tafra. I am a breast surgeon practicing in Annapolis, Maryland and the Director of the Anne Arundel Medical Center Breast Center in Annapolis as well as the immediate past President of the American Society of Breast Surgeons.
I am proud to represent the 66,000 fellows of the American College of Surgeons and wanted to thank you for this opportunity to offer breast surgeons' perspective on the issue of silicone gel‑filled breast protheses for patients who are considering breast reconstruction or augmentation procedures.
I am a board‑certified general surgeon and would like to state at this time I have no financial relationship with silicone or implant medical device manufacturers.
Today I would like to focus my comments on breast reconstruction and augmentation as procedures that improve quality of life for many patients. New medical techniques and devices have made it possible for surgeons to create a breast that can come close in form and appearance to matching a natural breast.
Frequently reconstruction is possible immediately following breast removal or mastectomy so the patient wakes up with a breast already in place, having been spared the experience of seeing herself with no breast at all.
The availability of breast reconstruction gives the woman an option over which she has some control during a very challenging time of her life.
As a surgeon, I spend a good portion of my time surgically removing breasts. I can tell you the psychological impact of losing that organ that is so visible to oneself and to others and that is so closely linked to gender identify is universally negative, no matter what the age.
The medical and cosmetic issues of removing this organ are inextricably linked. And returning that organ to a normal‑appearing state can be crucial.
But no two patients are the same. My patients are old. They're young. They're large‑breasted. They're small‑breasted. After mastectomy, some have thick flaps. I'm referring to the thickness of the skin that we leave behind. Some have thin flaps.
Most patients are asymmetrical. Sometimes the cancer side is the smaller side. Sometimes it's the larger side. One patient may have as her highest priority the new breast's appearance. Another may only be concerned that it feels like a normal breast. There is no universal reconstruction that works for everyone. And the more options we have, the better we can tailor our procedures.
Both breast reconstruction and augmentation provide enormous benefits to women, including improved self‑image and sense of normalcy. But, as is true with any operations, patients must think carefully about their expectations and discuss those with the surgeon.
The American College of Surgeons has had a longstanding commitment to improving the quality of surgical patient care and to enhancing patient safety. Consequently, we look forward to hearing more about the data collected by the manufacturer on the safety of silicone gel‑filled breast implants. And we welcome FDA's review of these new safety data.
If these devices prove to be unsafe, we certainly would not support their use in patients. Patient safety is and always will be the primary concern of the college. But we also feel strongly that decisions that effectively limit patient options must be made on the basis of solid scientific evidence.
We are concerned that procedures with benefits that are life‑enhancing, rather than life‑saving, are occasionally viewed by many as somewhat less important. Breast implants should be regarded as any other medical device that is considered by this panel.
Further distinctions should not be made between their use for reconstruction or for augmentation purposes. Why is this device deemed safe for reconstruction patients but not for those seeking augmentation? What message does this send to our breast cancer patients?
And, following more than ten years of clinical studies and trials, if conclusive data are not found showing that these devices pose a significant risk to our patients, we believe the choice to use them should be made available to consenting patients.
The college also agrees that it is vital for any woman considering a breast implant procedure to be well‑informed of all possible risks associated with the procedure as well as with the device being used.
Women must be informed, for example, that breast implants do not last forever, that complications can occur, and that additional operations may be necessary. Consequently, we support this panel's continued efforts to ensure that breast implant patients have access to comprehensive and comprehensible material that can be used in making truly informed decisions about these procedures.
To conclude, let me say again that all surgeons are obliged to be and the vast majority are scrupulous in providing their patients with the information they need to truly informed consent for any operation.
We are truly hopeful that the information collected by the manufacturer of these devices will contribute significantly to these efforts and help to resolve the continuing uncertainty about their safety.
Thank you again for the opportunity to appear here today. And I can take any questions.
CHAIRMAN CHOTI: Thank you, Dr. Tafra. That's all. Thank you.
MS. WILLSON: Good afternoon. My name is Shirley Willson. I want to thank the panel for hearing my testimony today regarding my experience with breast augmentation.
I am 53 years old, and I am a mother and a wife. I am also an office manager. I am here representing myself. ASPS has paid my travel expenses. I do not have any financial interest in Inamed, Mentor, or their competitors.
I have always been small in stature, and I have always had very small breasts. For many years, I have been under the false impression that breast augmentation was beyond my reach and only special and fortunate women could achieve such wonderful results. I found that not to be the case.
My opportunity presented itself while working in a plastic surgeon's office. I experienced firsthand women having breast augmentation procedures. I would see the fantastic results these women would obtain from their surgery. They would leave the office after surgery feeling better about their bodies and about themselves.
So after several years of contemplation, I decided that breast augmentation was the right decision for me. About six years ago, I spoke to my plastic surgeon and decided to go ahead with the procedure that I had been thinking about for years. I did a great deal of research on the procedure and what options I would have.
I did not expect my life to change dramatically because I was going to have larger breasts. I knew going in there that there are no guarantees with any kind of surgery, but I wanted to look better. I wanted to fill out a bathing suit or a tank top for once in my life. And I knew that this goal was within my reach. I had seen countless other women do it.
I had the surgery, and it was a success. I love my new body and am more confident because of it. I wish I had the courage to do it years earlier. My only regret is that when I decided to have the surgery, the only option available to me was saline implants. While I am very happy with my implants, I would have liked to have been given the chance to choose between saline and silicone for myself.
Looking back, I think that if silicone had been offered to me, I probably would have chosen it, not that saline was a bad option. I have had my implants for six years, and I am still quite pleased with them. The only problem I have is they are beginning to wrinkle. But I think the choice of what type of implant to put in my body should have been left up to me.
I know that I will probably have to replace my implants one of these days. And when I do, I hope that I will have the choice between silicone and saline. If I have that choice, I will once again do my research. I will have to discuss the pros and cons with my doctor and my husband, but I wanted to have that choice available.
I sincerely appreciate your time and the opportunity to share my experience with you. Thank you.
DR. GLASBERG: Good afternoon, Mr. Chair, panel members. And thank you for allowing me to address the panel today. My name is Scot Glasberg, and I am a board‑certified cosmetic and reconstructive plastic surgeon from New York City.
I am here testifying today as an individual but must note in the interest of full disclosure that I have served as a consultant for the Mentor Corporation.
As a physician, I not only see my role in this discussion as a disciple of the research and science surrounding breast implants but also as a patient advocate. I believe patients have the right to the most current, accurate, and scientifically sound information.
Therefore, I am here today to share my scientific opinion and serve as the voice for my patients who cannot attend this hearing and speak for themselves.
The time has come for the FDA to accept the overwhelming data and science collected during the last 13 years that show the safety and efficacy of silicone breast implants.
The multiple randomized prospective studies that have been performed, including the 1999 IOM report and last year's report from the National Cancer Institute, show no demonstrable link between silicone gel breast implants and health or safety concerns for women.
The proven safety record of silicone breast implants should be heard and contemplated. Historically the consideration of silicone gel‑filled breast implants has been an emotionally charged and controversial discussion. Now it is time to get past the rhetoric and focus on the reality, the science, and the data.
Patients, understandably, have a tremendous respect for the FDA and these processes. They rely on the FDA to evaluate the data on their behalf. And approval by the FDA would go a long way to lifting existing barriers and make patients feel more secure about these medical devices.
I have been placing silicone breast implants in patients as part of the adjunct study. And the medical outcomes have been excellent. It is impossible to ignore the clear superiority of silicone breast implants in comparison to saline implants. They are softer, more life‑like, and much more accurately mimic the soft tissue of a woman's breast.
Perhaps most importantly, my professional experience has been both that the capsular contracture rates and the rates of rupture are actually significantly less than even those of saline implants. In fact, many patients gain access to silicone implants because of their problems with saline breast implants.
I must also take into account the overwhelming satisfaction my patients experience with these medical devices. While silicone breast implants are available through small, limited studies, a vast subset of patients still cannot meet the criteria for inclusion.
Despite the increased amount of time involved with additional paperwork, I continue to place these patients into these studies because as a physician, I must do what is best for my patients. I truly believe based on the medical evidence and my particular experience in the superiority and safety of these medical devices.
From my practice experience, I feel that the FDA approval will also serve a subset of patients who have not had the ability or opportunity to gain access to these vital medical devices. In my practice alone, I have many women who are waiting for approval of silicone breast implants.
The mission of the FDA is "to protect the public health by assuring the safety and efficacy of medical devices, to advance the public health, and to help the public get the accurate science‑based information they need to improve their health."
I put forth to you today that the FDA has the opportunity to fulfill its mission statement. By simply focusing on the data and the science and approving silicone breast implants for general use, we have the opportunity to advance the health and well‑being of millions of women today.
Thank you for your time and consideration.
MEMBER BLUMENSTEIN: I'd like ‑‑
CHAIRMAN CHOTI: Yes? A question.
MEMBER BLUMENSTEIN: This is Brent Blumenstein. You mentioned multiple randomized studies. Could you please describe those to me?
DR. GLASBERG: If one looks at the general literature, including the IOM report, there is good evidence there in randomized fashion that shows that these are safe and effective devices.
MEMBER BLUMENSTEIN: I was unaware of randomized studies. That's what I'm focusing on.
DR. GLASBERG: I apologize. I should have said prospective studies.
CHAIRMAN CHOTI: Yes?
DR. ROTH: Members of the General and Plastic Surgery Devices Panel, I am Dr. Malcolm Roth. I am a board‑certified plastic surgeon practicing in Brooklyn, New York. I have no financial relationship with any implant manufacturer. ASPS has paid my travel expenses.
I have been in practice since 1988. During my plastic surgery residency, I had extensive experience with saline and silicone gel implants for reconstruction as well as cosmetic breast augmentation.
When I completed my training and entered practice, I offered both types of implants to my patients. In each case, I discussed the options in great detail with each of my patients. I provided literature to each woman, particularly the concerns about the safety of silicone.
When the moratorium went into effect in 1992, I reached out to every patient whom I had performed breast implant surgery on. I offered to speak with them on the phone or in person at no charge and with no time limit. Nobody called to ask questions, and nobody came in to discuss the concerns in person.
When ASPS had a live teleconference at that time during the moratorium on silicone breast implants to inform patients and answer questions and I personally called each woman to inform them of the time and place and that I would be there, only one patient came.
Afterwards that patient told me that the teleconference was a waste of time. She told me what all of my patients were telling me. She said that I had informed her extensively of the possibility of health risks and local problems and that she had made a choice to have silicone gel breast implants. She made her decision based on the science available at that time and having been fully informed before her surgery. The junk science which was being promulgated at that time did not change her views or otherwise affect her decision.
Now, 13 years later, the scientific studies have failed to demonstrate that women with these devices have greater health risks than women without implants. For many women who choose to have breast implants, silicone gel is more likely than saline to result in the natural appearance and feel of the reconstructed or enhanced breast.
I believe that if patients are educated about the risks and benefits of breast implant surgery and they receive preoperative materials and consent forms, women in this country should have the right to choose for themselves.
Post‑market monitoring of the device should be continued in order to assure patients of the long‑term safety of the device. A breast implant registry can and should play a significant role in post‑market monitoring.
I have two daughters. And while they have not indicated a specific interest in breast enhancement surgery, if they were so inclined, I would advise them to get silicone gel implants.
But since neither of them is likely to fit the criteria currently in place, they would have to have the surgery outside of the United States. It is remarkable to me that the U.S. is the only country where they would not be able to make this choice for themselves. It is time to let women in this country choose for themselves.
Thank you.
MS. GANDY: Good afternoon. My name is Kim Gandy, and I am President of the National Organization for Women. NOW is the oldest and largest women's rights activist organization in the United States, advocating for women's equal rights, economic and social well‑being, and for women's health.
The National Organization for Women and myself represent only our own 501(c)(4) nonprofit organization. And my appearance today is underwritten by our 550,000 members and contributing supporters.
To be blunt, it's disappointing that we find ourselves here today. Just last year, the Food and Drug Administration made it clear that there was insufficient long‑term safety data on silicone gel breast implants. And here you are again, and here we are again reviewing another petition for market approval, a little more than a year later, still without long‑term safety data.
What sort of message is the Food and Drug Administration sending to the public and to industry petitioners when it backs down so quickly on its demands for patient safety? Inamed's less than four years of data is not sufficient to demonstrate long‑term safety.
FDA reviewers agree that little can be learned about rupture and other aspects from studies of such short duration. And, indeed, the company's data that has been reviewed by the agency shows substantial evidence that these devices are not safe for women.
The agency reviewers estimate that between 74 percent and 93 percent of the implants under study will rupture within 10 years. Those projects and the absence of sufficient clinical data are solid reasons to recommend against allowing these implants to be marketed generally.
Aside from the prospect of frequent implant rupture, there is the equally serious problem of slow leakage. Silicone particles and chemicals from the implants can and do seep into the body. Inamed's own data submitted for the 2003 panel reported significant problems with silent rupture, local complications, connective tissue disorder signs and symptoms, and reoperations. There are too few properly designed studies that have been conducted to determine exactly what effect silicone gel has on human physiology.
Especially troublesome to us is the lack of knowledge about the effect of the chemical constituents of silicone gel in pregnant women on the developing fetus and lack of information about the transmission of potentially harmful substances to breast‑feeding infants through breast milk, all of which are items that we recommended last year for inclusion in guidance to the industry for further study. Such studies should also include following children born to women with silicone gel implants to evaluate health or developmental problems resulting from exposure in utero or exposure through breast milk.
Another area of concern relates to the difficulties that these implants pose for accurate mammogram readings. According to a five‑year evaluation of seven mammography centers involving thousands of mammograms, breast implants obscure and greatly reduce the accuracy of mammogram readings.
As reported in the Journal of the American Medical Association, 55 percent of breast cancers in this study went undetected in women with breast implants. That's 67 percent greater than the number that went undetected in women without implants.
Our national commitment to reduce the incidence of breast cancer could be undermined by the implant industry's media campaign to sell more implants. And the dramatically higher rate of implant rupture and complications experienced by post‑mastectomy as compared to augmentation patients seems a cruel consequence for women who have survived a life‑threatening battle with breast cancer.
This panel has already heard and will continue to hear the heartbreaking stories of women who became seriously debilitated after receiving breast implants. Many of these women can no longer work or take care of their families due to grave health problems.
Stories exactly like this from NOW members is what started our inquiry into this issue three years ago. I urge the panel members to consider how the availability of well‑based long‑term clinical data and an effective regulatory process could have changed these women's lives.
These women are asking the FDA to take responsibility for regulating an industry that cannot or will not regulate itself. In this specific instance, reneging on the reasonable requirements required last year in approving these implants could result in devastating health consequences. Such a public health catastrophe is preventable, and women are counting on you to prevent it.
Thank you.
MEMBER MILLER: Dr. Choti?
CHAIRMAN CHOTI: A question. Dr. Miller?
MEMBER MILLER: May I ask a question, Ms. Gandy? I appreciate hearing from you today. I'm curious. You know, your organization is funded by gifts, I believe, charitable types of gifts. Do you have any idea what percent of the gifts that you receive are related to this issue on your annual giving? I assume women are ‑‑
MS. GANDY: A fraction.
MEMBER MILLER: There are many people in the country who ‑‑
MS. GANDY: I think a fraction of a percent. We have a women's health project that occasionally gets dedicated gifts. I think the largest grant our women's health project has received in many years was about $300,000 for the work that we did on tobacco, tobacco use in women.
MEMBER MILLER: So do you have any way to determine the specific concerns of those who decide to support your organization in terms of whether they're concerned about one issue or this issue? Is there any way to determine that in how you organize yourself?
MS. GANDY: No. I mean, not in terms of our individual contributions. We are about a $5 million organization, and over 99 percent of our income comes from gifts from individual members, $5,000 and under.
They are average gift organizationally. If you add it all up and divide it by the total number of gifts, our average gift is about $42.
MEMBER MILLER: Okay. All right. Thank you.
CHAIRMAN CHOTI: Yes?
MS. COPPOLA: Hi. My name is Kyle Coppola. And I am an ordinary woman who people say accomplished an extraordinary thing. Before I talk about that, first I would like to say that it is a privilege to be here today. And, second, ASPS has paid my travel expenses here. I do not have any financial interest in Inamed, Mentor, or their competitors.
So what is it that I, a 46‑year‑old, middle class, working wife and mother, have achieved? It is that I used to weigh 434 pounds. I repeat: 434 pounds. I lost 300 pounds on my own through diet and exercise, and I am currently in the 5th year of maintaining that weight loss.
When I reached my goal, I felt very deformed. The years of yo‑yo dieting and excess weight had virtually destroyed my skin's elasticity. With all of the loose skin, I looked like a Sharpei puppy. The breasts I had were almost nonexistent. And you could see my chest wall right through my skin. No amount of diet or exercise was going to fix this. I wanted and I needed plastic surgery.
So over the past four years, I have undergone a series of operations, starting with my arms, then my abdomen and breasts, and then my lower body.
I am here today to speak to you about the breast surgery I had. I could have opted just for a breast lift, but because of the lack of breast tissue, I opted to include an augmentation.
As a result of this, I had a choice to make: silicone or saline. My knowledge about implants pre‑surgery was very limited. And I knew I needed to become informed. My career is in research and science. So I know how to review data, and I did.
I looked at all of the pros, and I looked at all of the cons. I also turned to my physician for guidance. She answered my questions. She brought up topics I had not thought of. She showed me implants. And she gave me written materials. I also spoke with women who have had implants. My physician took the time to make sure that I was fully informed. And I truly believe that I was given factual, unbiased, and complete information.
In the end, saline implants did not appeal to me because I felt the result would be undesirable. More importantly, after my thorough research, I did not feel that there was compelling evidence for me to reject silicone implants.
So my final decision was in silicone. And in 2001, I underwent breast mastopexy and augmentation. Because of a shift in implant position, I had a revision four months later. This would have happened with any device.
Other than the revision, I have had no problems with my implants, none whatsoever. There is no wrinkling. And in my opinion, my breasts look and feel natural.
Through the restorative nature of this surgery, I now like my figure. And I love the shape my implants provide. I am healthy. I repeat: I am healthy. I feel confident. And, best of all, I no longer feel as if I am pretending to be thin.
I believe strongly in research and in choice. In an effort to aid in research, I am a participant in a Mentor study for silicone implants.
CHAIRMAN CHOTI: Sorry. If you could try to wrap it up a little bit?
MS. COPPOLA: Okay. I am hopeful that my positive experience will help to offset some of the horror stories and to provide some balance.
I am not saying that silicone implants are right for everyone. What I am saying is that I believe a person should have the opportunity to make a choice. I believe that choice and education are the keys.
Thank you.
CHAIRMAN CHOTI: Yes. Good afternoon.
DR. JOHNSON: Hi. My name is Dr. Nancy Johnson. I'm a 50‑year‑old board‑certified anesthesiologist from Shreveport, Louisiana. I am testifying today as an individual with a strong opinion concerning silicone breast implants. My travel expenses were paid for by ASPS. I am not receiving compensation from any breast implant manufacturer, nor do I have a financial interest in such companies.
After completion of my residency at Baylor College of Medicine in Houston, Texas, I began private practice in 1983. I was one of those women who said I would never have breast augmentation. I was happy with my nice B‑cup breasts.
I've provided anesthetic care for many, many women undergoing breast augmentation, in addition to those whose implants have ruptured and required replacement. After observing pre and post‑operative results, I was more than happy to add my name to the surgery schedule. I was fully informed of the risk involved.
I don't think many people realize how strong breast implants are. One afternoon, there was a plastic surgeon and I that went to school together. We took one of each brand of implants and ran over them with his car. I was amazed that not a single one of them ruptured. What a startling example of a controlled scientific study but a true story, nonetheless.
I decided to have breast augmentation in 1985. And I can truly say that I have never had a single day of regret. I had surgery on Thursday, returned to work on Monday without difficulty. I've never experienced any discomfort secondary to my implants. I am completely unaware of them. And my health is excellent.
When my second child was born, my breasts did not return to their pre‑pregnancy shape. I began to develop a capsular contracture around my right breast. And in August of 2004, I had my implants removed and replaced with new silicone breast implants. Both implants had ruptured and encapsulated around the silicone.
As a physician, I do not believe that silicone floats around the body. One only has to observe the way the body walls off the rupture, just as it does in response to any foreign body.
I know a number of women, both friends and patients, who have had silicone breast implants removed and replaced with saline. Not a single one of them was pleased with the exchange. The saline implants are hard, cold, heavy, and do not feel natural.
My next door neighbor had her silicone implants replaced with saline after she was not given the option of silicone. After she observed my results, she scheduled her surgery for the next week.
I have many stories about friends preferring silicone. But the bottom line is in my opinion, as a physician, my patients are not pleased with saline once they see and feel the difference of the silicone breast implants.
I could not be more pleased with my new implants. My husband, who is an ob/gyn, is also thrilled. My breasts appear now the same as they did in 1985.
I have a 16‑year‑old daughter who is flat‑chested and greatly desires augmentation when she is old enough. But she was mortified when she knew I was going to say this. Until she has the option of silicone breast implants available, I will not allow her to have the procedure. She should have the right to choose after informed consent, as should each and everyone who considers this procedure.
Thank you for allowing me the opportunity to express my opinion.
CHAIRMAN CHOTI: Thank you.
Next speaker, please.
MS. FISHER: My name is Coni Fisher. I am 61 years old. I am a business development manager for VISX, the company that manufacturers the Excimer laser for laser eye surgery in California. I have worked in health care for over 30 years. I am very familiar with surgical complications, the informed consent process, and the FDA approval process. I have no financial interest in breast implant manufacturers. And my travel expenses have not been reimbursed by any related entitles.
I am here because I hope my testimony will change the current choices for primary breast augmentation material. I feel compelled to speak, as I know many individuals that are very unhappy with the feel, appearance, and less than natural result of saline implants and wish they could have had the same opportunity I had in 1985.
I had silicone breast implants 20 years ago. I have never regretted the decision. I have never understood why they were taken off the market with no statistical hard medical information to support the withdrawal.
I was appalled at legal advertisements for class action lawsuits in ridiculous settlement amounts. The negative media coverage had my own family urging me to have my implants removed, which I never considered. And should I need them to be removed and replaced, I would again choose silicone.
I recall my absolute relief to learn that when silicone was no longer a choice for primary implants, that should I require surgical removal for leakage, I could again have silicone.
My decision was cosmetic to restore ample appearance after breast‑feeding my daughter from the decade before. I chose silicone because they felt more natural. I can remember actually inspecting all of the implants. I still remember during my decision‑making process my mother‑in‑law, who had had a mastectomy and wore a prosthesis ‑‑ and it was not made of saline ‑‑ how much more natural silicone was. And I'm glad I had that choice.
My plastic surgeon fully explained every risk, benefit, potential possible complication, including the fact that future removal might be necessary. I would gladly have signed an addendum to my informed consent that I would not sue for future complications because I feel this is an elective procedure that I did by choice.
One of my best friends, Nancy Johnson, who just testified before me, we scheduled our surgeries on the same day. I developed a hematoma from continued bleeding. I had to go back to the operating room. Minor complication. After that, I have had no problems whatsoever.
I regret that women today don't have the same empowerment of choice and can only receive saline, which I felt was an inferior product 20 years ago. I believe American women deserve the same choices as those around the world and that I had.
I did not send my friends and family to Canada for Lasik surgery before the FDA approval process, a process that works and that is based on statistical medical outcomes.
I regret that negative medical outcomes received more attention, and I hope that the panel hears the silent testimony of the thousands of women like myself with silicone implants living busy, healthy, and happy lives.
Thank you so much for allowing me to testify.
MR. SAMP: My name is Richard Samp. I am chief counsel of the Washington Legal Foundation, a public interest law firm that devotes a significant portion of its resources to issues affecting health care delivery in this country.
Among WLF's members are doctors and medical patients who seek access to innovative drugs and medical devices shown to be reasonably safe and effective for their intended uses. WLF regularly litigates in support of the public's right of access to such products.
Neither I nor WLF has any financial arrangement with either Mentor or Inamed or anyone else in connection with my testimony. I paid my own transportation costs in coming here today.
My expertise is as a lawyer who specializes in administrative law issues. I do not have medical expertise and, therefore, have no basis for telling you whether silicone gel‑filled breast implants are safe and effective.
What I can tell you is that basic tenets of administrative law prohibit FDA from conditioning approval of the pending PMAs on provision of the vast amount of clinical data contemplated by FDA's January 2004 draft guidance. In particular, federal law does not permit FDA to deny PMAs to the two applicants based on an alleged need to provide on a preapproval basis the additional long‑term clinical data outlined in the draft guidance. Rather, any such long‑term clinical data may be required at the post‑approval stage only.
WLF reaches that conclusion because any effort to impose greater than three years of follow‑up clinical data would be inconsistent with the manner that FDA has treated all similar PMAs. It is an elemental principle of administrative law that the reason decision‑making mandated by the Administrative Procedures Act requires federal agencies not to depart from precedence in a sudden and unexplained way any decision to impose vastly increased follow‑up clinical data requirements on silicone breast implants on a preapproval basis would constitute just such an unwarranted departure from precedence.
WLF has submitted written comments that provide a more complete explanation of our legal analysis. The PMAs submitted by Mentor and Inamed included follow‑up data for at least three years post‑implantation. The study protocols required Inamed and Mentor to continue to collect follow‑up data for many years to come.
Both PMAs were complete when FDA issued their draft guidance in January 2004. That document focused considerable attention on long‑term clinical follow‑up for implant recipients. In particular, FDA sought clinical information regarding: one, how and when a breast implant will suffer complications over the course of time; and, two, the health consequences of complications over time, particularly with respect to failure.
The evidence suggests that complete data to answer queries raised by the draft guidance are not now available and will not be available for at least another five years.
The health consequences of medical device failures is, of course, a legitimate safety concern. Nonetheless, such concerns much be examined in the context of concerns inherent in FDA approval of any PMA.
All implantable products and prostheses eventually fail, whether by rupture, breakage, or other forms of malfunction. Such failure, whether it occurs soon after implantation or many years later, in many cases will entail significant health risks.
However, WLF is unaware of any instance in which FDA has required preapproval clinical testing of an implantable or prosthesis specifically designed to demonstrate when the product is likely to fail due to wear and tear and to measure the health consequences of such failure. Nor is WLF aware of any instances in which FDA has required preapproval long‑term clinical follow‑up testing of a duration that even approaches the number of years it would require here.
In the vast majority of cases of which WLF is aware, FDA required preapproval clinical data of no more than two years. Those cases included products with risk‑benefit profiles similar to that for breast implants, such as inflatable penile prostheses and testicular prostheses.
An agency is not free to permit two sets of similar products to run down two separate tracks, one more treacherous than the other, for no apparent reason. The APA's reasoned decision‑making requirement mandates that FDA not impose clinical data requirements for breast implants that it has not imposed for similar products.
Moreover, Congress has prescribed the approval standard for medical devices. A product need not meet an absolute safety requirement. It only need be reasonably safe.
Thank you very much.
DR. KINNEY: Good afternoon. I am Brian Kinney, M.D., from Los Angeles, California, a Clinical Assistant Professor of Plastic Surgery at UCLA and USC Schools of Medicine, a board member of the American Society of Plastic Surgeons and President‑Elect of the Plastic Surgery Educational Foundation. I have no consulting or financial ties to any companies' breast implant efforts. And the Plastic Surgery Educational Foundation has paid for my expenses to appear.
Since the panel last met, we have heard from you that surgeons should decrease reoperation rates and improve physician and patient education. I would like to present to you what we have done in our first four courses and what we plan to do in the upcoming year.
From 2001 to 2003, our educational activities have included instructional panels, lectures on the latest in breast surgery for reconstruction and augmentation, incorporating the use of silicone gel implants. The objectives for these various programs are in appendix A.
The overall content of these educational activities has included current regulatory status of gel implants, the advantages of gel versus saline, patient selection and consent, preoperative planning, interoperative technique, management of complications, and comprehensive patient care issues. The objective has been to provide the knowledge for patients to reduce the rate of reoperation and operative damage to the implant, achieve optimal levels of safety, improve post‑surgical outcomes and patient satisfaction, and support the effective tracking of patients after surgery.
An initial four‑hour comprehensive course specifically focused on silicone gel was held in Vancouver in April of 2004. In August 2004, the Sante Fe Breast Symposium contained programming related to gel implants, including the regulatory status of silicone, evolution of devices, and matching patients with appropriate devices. After these courses, the need for educational balance related to manufacture of data was obtained.
As part of an ongoing review, the Vancouver, of course, resulted in recommendations for adding components to ensure that surgeons obtained the necessary information for the use of gel implants if and when they return to the mass market.
From our discussions with the FDA, we implemented eight safety and educational checkpoints: one, addition of reconstruction to the overview of proper surgical technique; two, addition of FDA terminology in the agenda to match overall education objectives; three, addition of more patient‑monitoring information inclusion in the educational objectives; four, addition of clinical recognition of ruptures and solutions, including MRI surgical removal, et cetera, and inclusion in educational objective descriptions; five, increased informed consent information; six, addition of recommendations for long‑term patient follow‑up; seven, addition of cancer and tissue disease content; and, eight, addition of management of complications.
The second course focused on breast surgery was held in Philadelphia in October 2004 at our annual meeting. This symposium contained limited programming on gel implants.
A third four‑hour comprehensive course on silicone gel was held during the annual meeting in October, matching the outline of the comprehensive Vancouver course, enhanced with updates based on our discussions with the FDA and a personal visit by a number of us as well.
A fourth focused course will be provided to plastic surgeons in May 2005 in New Orleans. A comprehensive course is planned for August 2005 in Santa Fe. And a one‑hour panel and a separate four‑hour course are planned for our annual meeting in September 2005 in Chicago. Derivative materials from the August and/or September courses, including an educational DVD, and online learning modules are planned.
In anticipation of possible FDA approval, advance discussions have been held with industry on joint training. These could consist of additional programs containing balance procedural related education information from physician speakers followed by satellite symposium presentations from manufacturers on techniques related to specific devices and their use.
We would collaborate on training materials, to include test questions that could complement training programs for the purposes of certification. The objective for this collaborative effort would be to reflect complete and consistent training information throughout educational activities, implant packaging, and patient education, media, and materials.
The overall goal of all educational initiatives for us is to meet the global needs for uses of any device that would be approved on the market and to ensure efficacy and patient safety.
We are focused on supporting plastic surgeons by providing the most current educational guidance available related to technology, peer‑reviewed materials, physician‑to‑physician communications and research, course objectives, including training on development, better consultation techniques, and assisting the patient with topics such as distilling the package inserts, body changes, breast‑feeding, and returning to activities of daily living. Life educational programs, as well as distance learning opportunities, provide physicians with the most current credible scientific information available.
Thank you very much for speaking to you.
CHAIRMAN CHOTI: Thank you.
Next speaker?
DR. McGUIRE: Good afternoon. I'm Dr. Michael McGuire. I represent the American Association for the Accreditation of Ambulatory Surgery Facilities, or AAAASF. I am the immediate past president of AAAASF. They are paying my expenses for attending today's session. I have no financial interest in Inamed, Mentor, or their competitors.
AAAASF is the largest organization accrediting office space surgery facilities in the United States. We currently have 1,000 facilities accredited across the country. We are also recognized as a deeming agency for federal and Medicare certification. And we have over 30 such facilities as well.
In our facilities, approximately 1,500 plastic surgeons operate under all forms of anesthesia. Our standards require that all surgeons using our facilities must be board‑certified by a board recognized by the American Board of Medical Specialties. They must perform only those procedures recognized by their board as part of their training. And they must hold equivalent hospital privileges for all surgery done in the facility.
We also require a 100 percent compliance with all of our standards for accreditation and for our annual reaccreditation. One of our standards requires semiannual reporting of all complications and mortality in each facility to our central office.
An internet‑based system has been in use for the past six years of this mandatory reporting. This allows us to accumulate a wealth of data about the safety of surgery performed in our facilities. These data were the basis of a major report that was published in plastic and reconstructive surgery in May 2004, which documented an incidence of mortality and complications comparable to that in hospitals for similar procedures. There was only one death in every 58,810 procedures, or .0017 percent.
Using this data source, we have recently extracted the relative incidence of mortality and complications related to breast implant surgery. A review of over 913,000 procedures performed in our facilities during the period 2001 to 2004 revealed that more than 246,000 of these included breast implant surgery, in some cases performed with other procedures.
Analyzing these procedures, we found no operative deaths. There were two deaths in the postoperative period. Neither was related to the breast implant surgery. One occurred ten hours after surgery relating to an acute asthmatic attack. And a second occurred five days after a combined surgery that included abdominoplasty, or tummy tuck, and lipoplasty. This mortality was secondary to pulmonary embolism, blood clots to the lung, which is a known possible complication of abdominoplasty and lipoplasty, and was not related to the breast implant surgery.
There were 1,730 unanticipated problems in this group, for an incidence of one per 143 procedures, or 0.7 percent, less than 1 percent. The majority of these problems were hematomas, blood collections, in 1,059 of the cases. And other complications included wound infections, healing problems, and 37 cases of pneumothorax, or partial lung collapse.
Treatment of these 1,730 problems required hospitalization in only 142 cases. And all recovered without any long‑term effects.
This analysis demonstrates the great safety of breast implant surgery done in accredited office‑based ambulatory surgery facilities. There were no operative deaths and none in the postoperative period that were related to the breast implant surgery.
More than 244,000 patients, greater than 99 percent, had no postoperative problems. And none of the problems that were encountered in the less than one percent of the group that did have a problem resulted in any long‑term consequences.
Thank you for allowing me to make this presentation.
CHAIRMAN CHOTI: Thank you. We'll now take a 15‑minute break. And let's promptly be back here at 20 minutes 'til. Thank you.
(Whereupon, the foregoing matter went off the record at 3:23 p.m. and went back on the record at 3:45 p.m.)
EXECUTIVE SECRETARY KRAUSE: We are going to go on now. Okay. Dr. Choti?
CHAIRMAN CHOTI: If everyone is ready, let's resume with our next speaker. Good afternoon.
DR. SCHNEIDER‑REDDEN: Good afternoon. My name is Dr. Petra Schneider‑Redden. I'm a board‑certified plastic surgeon practicing in Hattiesburg, Mississippi. I'm a member of the Board of Directors of the American Society of Plastic Surgeons. I have no financial ties with any of the implant manufacturers. I do use implants in my practice. ASPS has paid my travel.
I am here today to discuss an issue that is so important to many women who choose breast implant surgery: patient quality of life. For plastic surgeons, patient safety and satisfaction are primary goals. We believe that making an informed choice for breast implants offers health‑related quality of life benefits for numerous women.
Breast implant surgery can have significant psychological benefit when it cosmetically improves appearance, corrects a loss in breast size following pregnancy or nursing, or rebuilds breast shape after breast cancer.
The choice is very personal for women. Each woman must decide if the benefits of the implants will meet her goals following careful consideration of the risks and potential complications.
Studies show that overwhelmingly women are happy with their breast implants for augmentation and reconstruction, even if they have some of the side effects related to the surgery.
In talking with my patients, many choose silicone implants for an improved result or a more natural look or feel similar to natural breast tissue. While this device is primarily available to my reconstructive patients, there are many other women who would happily choose silicone if it were available to them.
Simply speaking, I would not recommend this device to my patients if I did not have full confidence in its safety. One of my disappointments as a physician has been to tell my patients that the device is not available to them, especially when I feel it would be the best choice.
Research supports that while patients choose to undergo this surgery for many reasons, it has a positive effect on quality of life with particular regard to sex life, body image, and mood.
Credible studies continue to demonstrate positive results regarding concerns about appearance, stress relative to body image, and interpersonal relations. Plastic surgeons strongly support the importance of patients receiving accurate information about the risks and benefits of this device.
Generally, breast implants, as with any other medical devices, do not last a lifetime. And many patients will face the possibility of reoperation. Accurate and thorough information can help my patients deal with this and the other realities associated with breast implants, which can, in turn, lead to greater patient satisfaction.
Our specialty has shown a commitment to ongoing research that will optimize surgical outcomes as well as maximize patients' long‑term well‑being. The Plastic Surgery Educational Foundation is funding research that includes formally developing and validating patient satisfaction questionnaires for cosmetic and reconstructive breast surgery patients. These tools will not only help make better patient satisfaction measures but also provide our specialty with important measurement tools to support clinical audits and ongoing practice improvement. This and other studies are detailed in the literature review submitted by ASPS.
Finally, with many women obtaining significant quality of life benefits, the availability of silicone implants is an important choice. The panel's decision will impact whether my patients have this choice in their breast surgery options.
Thank you.
CHAIRMAN CHOTI: Thank you.
Next speaker?
DR. NAHABEDIAN: Good afternoon. My name is Maurice Nahabedian. I am an Associate Professor of Plastic Surgery and am the current Director of the Center of Aesthetic and Reconstructive Surgery of the Breast at the Johns Hopkins Medical Institutions. I have no financial affiliation with either company, and no company or organization is paying for my travel expenses.
The purpose for my being here today is to advocate on behalf of my patients that have or are interested in silicone gel breast implants. This is based upon a significant body of scientific evidence and upon my personal experience that silicone gel breast implants are safe and effective devices that pose no adverse health risks to women who have them.
Silicone gel breast implants have been extensively studied over the past 15 years and are now the most thoroughly investigated medical device in medical history.
Over the past ten years, we have followed a path of reproducibility that has clearly demonstrated that silicone gel breast implants are safe, effective, and pose no adverse health risk. There is no reason to suspect that future studies will not arrive at the same conclusions.
Therefore, when determining the fate of silicone gel breast implants, it is important to rely on the science, which clearly supports the fact that they are safe and not harmful.
The experience at the Johns Hopkins Hospital is the foundation for my opinion. In my personal experience that dates back to 1997, 230 women have had breast reconstruction using either a saline or a silicone gel implant. Of these, 21 percent have had silicone implants, and 79 percent have had saline implants.
In both groups, 90 percent of women have retained the original implant with no adverse health effects. In no woman that had a silicone gel implant was removal due to rupture. And in no woman with a silicone gel implant was there a postoperative concern for any connective tissue disorder.
I would, finally, like to convey that silicone gel implants provide real benefits and that women should have the right to choose an implant that will best suit their emotional, psychological, and physical requirements.
One advantage of silicone gel when compared to saline is that the breast will maintain a softer and more natural feel because silicone gel more closely mimics the texture of the natural breast. Another advantage of the silicone gel implant is there is much less palpable or visible rippling and wrinkling when compared to the saline. It has been my observation that silicone gel implants have improved the quality of life for women who have received them.
To conclude, I would like to state that the scientific evidence is clear and reproducible, demonstrating that silicone gel breast implants are safe and effective devices that pose no adverse health risks for women who have them. It is my hope that following these deliberations, women will be allowed to make an informed decision regarding which implant to choose.
Thank you.
CHAIRMAN CHOTI: Thank you.
Next speaker? Good afternoon.
MS. BROWN: Good afternoon. I'm Zora Brown, founder and Chair of the Breast Cancer Resource Committee. I founded BCRC after my own personal battle with breast cancer to be an educational advocacy outreach and support resource for African American women's organizations as well as for women facing a breast cancer challenge. I have no financial interest or gain associated with any of the PMA sponsors today, their products, or their competitors.
My experience with breast cancer has its roots in family history and began several generations before I was born. Three generations ago, when my great grandmother was diagnosed with breast cancer, little was known of this dreaded disease.
In my great‑grandmother's generation, breast cancer research was both limited and lacking in its capacity to identify causes. Mammography had not yet been discovered. Genetic factors had not been identified. And the psychological consequences of breast cancer were barely understood. Women who submitted to surgery were uncertain as to whether or not they would awaken with or without a breast. Radical mastectomy was virtually the only treatment option. And the survival rates were negligible.
When it came my grandmother's turn to suffer the same affliction, she, too, lacked the knowledge and the benefits of subsequent medical advancements to sustain her.
It would be yet another generation when my mother, also challenged with breast cancer, would face some of the same limitations but who utilized knowledge of family history and emerging medical advancements to successfully treat the disease, knowledge that she passed along to her offspring, knowledge that proved to be invaluable as each of her four daughters were eventually diagnosed with cancer.
My sister Margaret had bilateral breast cancer at age 27. My sister Velva when only in her mid 30s was diagnosed with breast cancer. Both Margaret and Velva subsequently died from the disease. Neither had breast implants or reconstruction.
My eldest sister Joyce was also diagnosed with breast and ovarian cancer. She has had silicone gel breast implants for over 20 years. And at age 68, she cares for my mother, who is now 90 years old.
I was diagnosed with breast cancer over 25 years ago, at age 31. Three of my 18 adult nieces have also been diagnosed with breast cancer. One has succumbed to this disease. One of my nieces underwent prophylactic breast surgery 16 years ago and was reconstructed with implants.
My own story is replicated in the lives of high‑risk families across the globe, families who every single day quietly and patiently confront the ravages of breast cancer with far more courage and fortitude than I could ever muster and with far fewer resources than I have at my own disposal.
Women face so many challenges when confronting breast cancer. There is a tremendous sense of loss, loss of confidence, dignity, and in the case of mastectomy part of one's physical essence.
Through both my personal and professional experience, I realize the importance of trying to preserve those things lost to breast cancer: energy, control, hair, and breasts. Unfortunately, many breast cancer patients aren't able to preserve all of these elements. Thus, in the absence of preserving any of these items, a key concern of breast cancer patients becomes preserving one's quality of life.
Part of our role at the Breast Cancer Resource Committee is educating African American breast cancer survivors about the myriad treatment options available to help mitigate the impact of these challenges.
It is important that the women be educated about the options available to enable and inform participation in their treatment decisions. Given that no treatment option is without risk, silicone breast implants shouldn't be treated any differently than other treatment options available to breast cancer patients. They should be informed about the inherent risk just as they would any other options but not be denied the opportunity to enjoy the quality of life benefits associated with breast reconstruction.
Not only do breast implants have the function of benefitting those stricken by breast cancer, but their availability can also benefit women from high‑risk families and those who test positive for the breast cancer gene who ought to pursue prophylactic mastectomy to reduce their risk of getting breast cancer.
While one would hope that women would have better options than voluntarily choosing mastectomy to avoid getting breast cancer, in the absence of a true method of prevention, these women should have access to all of the tools available given medical evidence that they pose no greater threat to health than existing treatment options, such as statistics indicating adverse events for implants exceeding those for radiation and chemotherapy.
BCRC supports making breast implants available to patients given evidence supporting their safety and recommends that patients be fully apprised of any risk associated with their use. It is our opinion that women should be armed with knowledge and empowered to make their own decisions concerning how best to preserve their quality of life after the devastation of breast cancer.
Thank you.
CHAIRMAN CHOTI: Thank you.
Next speaker?
DR. GOLDWYN: Mr. Chairman and members of the Committee, my name is Robert Goldwyn. I served as Editor of the Journal of Plastic and Reconstructive Surgery for about 25 years, precisely 25 years, from January 1st, 1980 to January 1st, 2005. I am Clinical Professor of Surgery at Harvard Medical School. I do not have a financial relationship with any company, including those involved in these hearings. My travel expenses, however, were paid by the American Society of Plastic Surgeons.
Plastic and Reconstructive Surgery is the official peer‑reviewed journal of the American Society of Plastic Surgeons. It has the goal and the responsibility of informing readers about all important developments in every discipline of plastic surgery, including breast, craniofacial, hand, reconstructive, and cosmetic surgery. Significant papers covering both clinical and laboratory research are invited for publication. PRS is the most subscribed scientific publication in plastic surgery with a circulation of slightly more than 10,000.
It is indexed by the National Library of Medicine, maintains the highest citation or reference index in plastic surgery. It is published 14 times a year. In 2004, we published 643 articles in 4,241 pages.
A literature review that was provided to you by Dr. Dale Collins entitled "Reviews of Selected Articles on Silicone and Saline Implants" summarizes, among others, more than 50 articles on breast implants which have been published in the journal since 1961.
These articles cover a wide range of topics from surgical technique to implant durability and other aspects of implants to management of patients and their quality of life. Every submitted article is evaluated almost always more than once by at least two, usually three to five, reviewers and, when indicated, ‑‑ and that is almost always ‑‑ by a biostatistician.
Relevance and excellence solely and not the nature of the findings determine acceptance or rejection. I emphasize this point because the journal holds scientific integrity as its highest and most important value.
We exist to give clinicians and researchers data to improve patient care and policy‑makers information to help direct public policy. The duties of the editor and the editor of the board of Plastic and Reconstructive Surgery have always extended beyond our obligations to merely authors and readers but ultimately to patients and their well‑being, to which all of us in every area of medicine must be unswervingly committed.
Thank you for this opportunity to address you.
CHAIRMAN CHOTI: Thank you.
DR. NORSIGIAN: Good afternoon. My name is Judy Norsigian. I am the Executive Director of Our Bodies, Ourselves, also known as the Boston Women's Health Book Collective, a nonprofit public interest, women's health, education, and advocacy organization. For 35 years, we have advocated for women's health from an evidence‑based and consumer perspective, most notably through our major publication, Our Bodies, Ourselves. We have no financial ties to either of the manufacturers or their competitors.
Our organization's interest in breast implants goes back to the mid 1980s, when the late Esther Rome, my coworker, began to work with hundreds of women, both locally and nationally, who believed that breast implants caused some serious problems. Many of these women were initially happy with their implants but later developed debilitating conditions after five or ten years or more. Even today, many women continue to have problems with more recent models. And we still do not have adequate data that would allow women to make informed choices about using these devices.
As we and others have said before, we do want choices, but we want safe choices. Since the October 2003 panel that addressed the safety of silicone gel implants, studies in mammography and platinum suggest new challenges for women with silicone gel implants.
A study published in the January 2004 JAMA issue found that breast implants interfere with mammography, missing 55 percent of breast cancers in women with breast implants, compared to 33 percent in women without implants. This fact alone provides a compelling reason for the FDA to weigh carefully the risk‑benefit issues regarding these products.
Silicone breast implants have also been found to contain platinum. A study published in the July 2004 issue of Analytical and Bioanalytical Chemistry found very high levels of platinum in silicone gel as well as the encasing materials, implant elastomer, double lumen, and foam, materials that are in direct contact with the chest wall of patients.
Much media coverage has suggested that there are many studies showing that breast implants are safe, but the largest, best designed studies do show increased risks. Even the Breiting, et al., study of Danish women noted substantial problems that call for further research. When read carefully, this study is anything but a stamp of approval for silicone breast implants.
Scientists at the FDA and NIH are among those who have called for more research to answer many of the key questions that have been raised repeatedly at FDA hearings. You should be joining them.
All assertions to the contrary, we simply do not have adequate data on such conditions as fibromyalgia. Our recent experiences with premature drug and device approval underscore how critical it is to take a cautious approach.
Although saline implants are less ideal for many women, they do provide a reasonable alternative while we await the findings of further research. And such research must include women with implants for a minimum of ten years, not an average of ten years.
Women's health and lives depend upon a careful assessment of these devices. We urge the panel to require adequate safety data to be collected before any decision to approve their use, especially in light of industry's current marketing strategy of targeting younger women, whose long‑term health status may depend upon your recommendation.
Thank you very much.
MS. HOWE: You've got two Massachusetts people together here. Thank you for this opportunity to testify. My name is Genevieve Howe, and I am a member of the board of Massachusetts Breast Cancer Coalition.
The coalition defines breast cancer as a political issue and challenges all obstacles to eradication of the disease. All board members are volunteers for the coalition, and it does not accept financial or any kind of support from pharmaceutical companies or any sources that profit from cancer or contribute to environmental pollution. I have no financial conflict of interest in this issue.
Although reconstruction after mastectomy represents only about 20 percent of breast implant surgeries, the devices play a significant role in the lives of the 215,000 women diagnosed with breast cancer each year.
I would like to address three concerns about silicone gel‑filled breast implants: one, health risks due to lower sensitivity of screening mammography; two, the very high rate of resurgeries and other complications, especially in reconstruction patients; and, three, the reluctance of organized plastic surgery and breast implant manufacturers to accurately inform women about the nature and magnitude of the risks involved in reconstruction with silicone implants.
Researchers generally agree that augmentation implants significantly reduce the ability of radiologists to analyze breast tissue in mammography, even when using special techniques.
Two sound studies, Miglioretti, et al.; and Brinton, et al., found that women with implants who were later diagnosed with breast tumors did not present with higher stage cancers. However, as Brinton accurately points out, there are major differences between women who undergo breast augmentation and those who don't.
Women who choose augmentation tend to be younger, to have a smaller breast size, and less glandular tissue mass, and to have their first child at a younger age than the adult female population as a whole. Each of these factors associated with lower breast cancer risk, particularly younger age.
In my written testimony, I have included a statement on conflicts of interest by researchers making the improbable claim that silicone breast implants can lower women's risk of developing breast cancer.
In their own data, both Inamed and Mentor find very high rates of moderate, severe, or very severe complications within three years. These complications are much more frequent in reconstruction patients than augmentation patients.
Inamed reports one or more resurgeries in 21 percent of augmentation patients and 39 percent of post‑mastectomy patients. That seems very high to me. Four out of ten have one or more repeat surgeries within three years.
Mentor's application shows resurgeries within 3 years on 15 percent of augmentation patients and on 26 percent of post‑mastectomy patients. Other local complications are also frequent. And many patients have more than one type of complication. Inamed lists 21 types of moderate, severe, or very severe complications, 6 of which were each experienced by 20 percent or more of reconstruction patients.
In both of the pending applications, the manufacturers tend to minimize the risks in patient information. For example, Inamed projects rupture risk as linear without acknowledging deterioration in device materials over time. And the company underestimates the decline in MRI sensitivity and specificity. Mentor's glowing measures of satisfaction include fewer than half of their original 251 reconstruction patients.
Organized plastic surgery has opened up a new dot‑org Web site, breastcancersafety.org, claiming we place patient safety above all else. The site's overview page links to a letter sent to this panel by 12 breast cancer advocacy groups, at least several of which have received contributions from plastic surgery organizations and/or breast implant manufacturers.
Given the plethora of biased information and research and the lack of long‑term prospective studies, it is difficult to imagine women being able to make truly informed decisions on silicone implants.
Judith Brady is a 67‑year‑old cancer activist in San Francisco. Both of her breasts were reconstructed with silicone implants following a double mastectomy nearly 25 years ago. She has been living with these implants ever since and considers them to be "a ticking time bomb," to quote her, in her body.
When I asked her what advice she would offer to women considering silicone implants, she said that, as far as reconstruction goes, "choose a plastic surgeon with great care."
As for women considering breast augmentation, she said, "That I think should be clearly avoided. In fact, I think doctors who do this surgery should be strung up." That is not a response we advocate, but my point is that our male‑dominated culture too often pressures women to risk pain, suffering, and great expense simply to fit in.
We urge the FDA to deny the pending applications for widespread use of silicone implants. We fear that a lack of caution by FDA in this matter could lead to further unnecessary pain and suffering on the part of women and additional years of costly litigation.
Thank you very much.
CHAIRMAN CHOTI: Thank you.
Next speaker?
DR. SATEL: Hi. My name is Sally Satel. I am a former research psychiatrist, and now I am a scholar at the American Enterprise Institute at a staff psychiatrist at a local clinic, both in Washington, D.C. I have no conflict of interest regarding silicone breast implants.
I am speaking here today to contribute to the effort to keep the facts separate from the hype and the emotion that distort this issue. The facts, as I will cite very briefly, strongly suggest there is adequate safety and that well‑informed consumers should be given the opportunity to decide for themselves about this cosmetic option.
Before moving to data, which, of course, will summarize very briefly, one has to wonder where the statements from the AMA, the American College of Rheumatology, the American Cancer Society ‑‑ if silicone implants were dangerous, I would think they would be speaking out and presumably they would be present to dissuade approval if objective aggregate data did not tell a different, less alarmist story than the ones presented by individuals, who are focused today, understandably, on their own poor health.
One of the major issues that you are considering now I understand is whether leaked silicone is harmful. Clearly, no device lasts forever. That is true. And early versions of the implants, the ones that have been around since the '70s, did rupture regularly at rates of between 50 and perhaps 80 percent after 15 years. But even then, generally the silicone did not migrate past the fibrous capsule that normally forms around the implant.
There are two key studies that have appeared over the last two years that I think inform this issue in a profound way. The first appeared last July in the Journal of Plastic and Reconstructive Surgery. I'm sure you're familiar with it. It was the first and only, to my knowledge, published study to track over time women, individual women, whose implants had ruptured, as detected by MRI.
These women had had their implants for a minimum of 12 years on average. And the idea, of course, was to assess potential damage two years later. This was a study in Danish women. After monitoring the 64 women who had at least one ruptured implant, authors found no change in immunological markers, indicators, of course, of connective tissue disease.
But most striking, in three‑quarters of the implants in those 64 women, the rupture was contained within the fibrous capsule, and most of the women did not even know the device had torn. In only four percent of ruptured implants did a small amount of silicone leak.
The second important study was from 2003 in the Archives of Surgery. This was the only study, again to my knowledge, that looked over time at rupture incidence rates, as opposed to being a cross‑sectional study. And the indication was that perhaps 20 percent of modern implants ‑‑ that's third and fourth generation devices ‑‑ ruptured within 10 years of cosmetic augmentation. The FDA calculation of 93 percent rupture that was discussed in the New York Times last week was based on a modeling equation, but why is modeling when there is empirical evidence?
As you know, several respected entities have concluded no greater incidence of connective tissue disease in women with ruptured implants than those without implants, referring to the IOM report, the U.K. review panel on silicone implants ‑‑
CHAIRMAN CHOTI: If you could sum up for us, please?
DR. SATEL: Okay. Basically if 50 percent of second generation implants rupture ‑‑ and clearly many of those women were included in those studies that I had just mentioned ‑‑ with some level of silicone escaping into the tissues, we would expect a disproportionate prevalence of CTD.
In summary, I believe the data about rupture rate and well‑replicated inability to find a link ‑‑
CHAIRMAN CHOTI: I'm sorry?
DR. SATEL: ‑‑ suggests an acceptable risk for informed consumers.
Thank you.
CHAIRMAN CHOTI: Thank you. Sorry. Please, speakers, if you could try to keep to your time, that way we won't cut you off. I apologize.
Next speaker? Yes?
MS. BRADSHAW: Thank you. Good afternoon, ladies and gentlemen. My name is Gina Bradshaw. And I would like to thank the panel in advance for this opportunity to speak with you today of my experience with silicone breast implants.
I am a 31‑year‑old woman who currently has silicone‑filled breast implants. I would like to note that I am receiving no compensation from any individual or group, monetarily or otherwise, in exchange for my testimony today. ASPS has covered my travel expenses. I do not have any financial interest in Inamed, Mentor, or their competitors.
A few years ago I felt the need to become healthier as I had become tired of being overweight and ashamed of my body. Through a combination of diet and exercise, I was able to achieve losing over 65 pounds.
After having lost that considerable amount of weight, I looked and felt much better about myself and more comfortable in my own body. I could wear clothes that I could never wear before when I was overweight. My children were proud to show me off when I dropped them off at school functions. And my husband appreciated my new figure.
However, the one part of my body that did not look better after the weight loss was my breasts. The weight loss had also entailed losing a lot of my breast tissue. And I was left with two empty sacs. Even with my new slender figure, I was unable to wear some of the clothes I wanted to because my sagging breasts did not look good in them. Despite all efforts at improving my body image, I was left with feeling as though I should do something about my breasts.
About three years ago, I began researching the available options to me. After having compiled all of the information, I discussed the choices with both the plastic surgeon and my husband and decided to undergo plastic surgery for a breast lift with augmentation.
I was able to qualify for silicone implants because I was also having a lift, breast lift, in addition to the augmentation. We decided that the silicone implants had a softer, more natural feel and look than saline implants.
I have had my implants for over three years, and I have experienced no problems with them. And I am in very good health. They look and they feel great. Although my husband and I have been together for many years prior to my surgery, he even sometimes has a hard time remembering that I have implants and that my breasts aren't natural.
I am proud of my body, and I have worked hard to make it look its best. I eat right. I work out regularly. And I have had a breast lift and implants so my breasts would look and feel as good as the rest of my body did. I feel very strongly that women in America should be able to make the same choice I did.
Women should be trusted to make informed decisions about their own bodies. They should be able to meet with their doctors and obtain all of the information about the risks and benefits of the procedures. And then they should be able to make the decision that is right for their body and their lifestyle.
Some years ago when I made the choice to live a healthier life, to get into shape, and to eat well so that I could play with my kids and take an active role in their lives, I also made a choice when I decided to get these silicone breast implants. I decided that I wanted to be proud of my entire body.
I know this was the right decision for me and my family. Whenever somebody asks me about my experience, I let him or her know how happy I am with my new breasts. I just hope that women in circumstances similar to mine will have the same opportunity that I did to make a personal decision based on all of the current available scientific information as to which is right for them.
I sincerely appreciate your time and your opportunity to share my experience with you today. Thank you.
CHAIRMAN CHOTI: Thank you.
MS. JAMES: Good afternoon. My name is Diane James. And I am here today on behalf of the Jacobs Institute of Women's Health. We are not supported by anyone with a financial interest in this matter.
The Jacobs mission is to promote excellence in women's health by studying the interaction of medical and social systems, facilitating informed dialogue and awareness among consumer and health providers and promoting problem resolution and information dissemination of key issues. It is from this perspective that the questions surrounding availability of silicone breast implants are important to the institute.
The regulation history of breast implants is long and complex. Following decisions made in the 1990s, use of silicone gel implants has only been permitted among women who have been part of adjunct studies. The limitation on use of these implants has been the result of numerous unanswered questions; in particular, questions regarding long‑term safety. These questions mandate carefully executed studies to acquire the data needed for approval.
Now in 2005, this distinguished panel has been assembled to determine once again whether questions related to the safety and effectiveness of silicone gel implants from Inamed and Mentor have been adequately investigated and if the accumulated data answer the safety questions sufficiently.
The panel must determine whether the current data available for review are sufficient to provide practicing physicians with the information they need in order to recommend these breast implants and have confidence that their use will not cause harm to their patients.
Physicians and other health care providers must know that the benefits far outweigh the risks for an elective procedure requested by women who often are young and in good physical health. The data must also be sufficient to provide women contemplating breast implants with the information they need in order to make a truly informed decision.
What are the key questions for which a physician must have answers? These have been outlined in the guidance document issued by FDA on January 13th, 2004. But clearly of prime importance is the question regarding complication rates. Has the longstanding issue of implant rupture during the lifetime of these devices been adequately addressed in the core study?
Preliminary estimates from reviewers released to the public late last week suggest that the rate of rupture of silicone implants within 10 years for women having reconstructive surgery may be as high as 93 percent. Among women undergoing breast implant surgery for other cosmetic reasons, the rate may be as high as 74 percent.
This ten‑year estimate obviously includes women whose implants will rupture long before ten years and raises questions about appropriate ongoing surveillance and diagnostic testing that will be required at regular intervals.
It also raises questions about who will pay for this surveillance. What percentage of women will be able to afford appropriate diagnostic tests and even further surgeries should health care coverage be unavailable for what is generally categorized as an elective cosmetic procedure.
Imbedded in this critical safety issue is the persistent question of what happens to the silicone when the silicone implants from Inamed and Mentor rupture. Are there adverse health effects from the ruptures, either local or systemic?
While an IOM committee in 1999 determined that there was little evidence that silicone implants caused connective tissue disease, we must keep in mind that this conclusion was based largely on retrospective data from the nurses' health study and from a case‑controlled database from the Mayo Clinic.
Because of the study limitations related to the size and types of studies used, the true risk of these conditions cannot be precisely estimated. There may still be a small but significant increased risk of some forms of connective tissue disease associated with the silicone implants under review.
From the patient's perspective, it will be vital for physicians to have these answers in order to openly and honestly discuss the risks and benefits of this procedure.
Women must be informed regarding the expected incidence of rupture and what rupture may mean in terms of the need for repeat surgeries. They need to know about the process for removing gel‑filled implants following rupture, discomfort they may experience, and the potential long‑term health consequences should silicone gel leak. Women must also have this information presented to them in a clear and concise fashion that is part of the informed consent process itself.
The Jacobs Institute is concerned about the existing process and urges the Committee to consider this in their deliberations. These concerns arise from examining current saline breast implant patient brochures provided by industry.
Subjected to a Fry analysis used by reading experts and those committed to following clear health communication principles, as advocated by the Surgeon General and the DHHS, this written information cannot be easily understood by the majority of audiences in the United States.
According to the Fry analysis, the 42‑page brochure reviewed is clearly written for college‑level individuals. This means women who are not able to read health information at the college level will not be able to fully comprehend the information provided.
We urge the Committee and the FDA to be certain that educational materials describing risks and benefits are written at a level that most women will understand.
In closing, we urge you, the Committee, to consider carefully the safety and effectiveness requirement that Congress has mandated to the FDA in determining whether devices should be permitted on the market.
Thank you for this opportunity.
MS. McDONOUGH: Good afternoon. My name is Mary McDonough. I am an actress, a mom, and a founder of In the Know, a supportive and caring community created by women in the entertainment industry to share information about health, body image, and plastic surgery. I have no conflicts.
Several of the plastic surgeons here today testifying have attempted to differentiate between the older generation and the new third generation of breast implants. It's important to point out to you that the new, "new," generation implants start in 1981. In October of 2003, Inamed stated that there had been no changes in this product since 1991. Mentor stated in their PMA that they have not changed their product since 1987. So we're talking about a product that has virtually gone unchanged for 25 years.
I was only 23 when I got my silicone gel breast implants. Because after my years of playing Erin on "The Waltons," I really wanted to continue my acting career, it was suggested to me that if I had larger breasts, that might do the trick.
Within 24 hours of my implant surgery, I broke out in a rash. Then for the first couple of years, my implants seemed like they were okay. Then by year seven, I got more and more symptoms that have led to a diagnosis of lupus.
Over the course of those ten years, I became more ill. And I felt like I was dying. When I asked my doctor about removing the implants, he told me that I would probably become too depressed. He also said that there was no link between the implants and everything that I had.
Another plastic surgeon told me, "Well, your breasts look and feel great. You know, I wouldn't touch them, at least not with a knife."
I had a mammogram at 31 to see if my implants were ruptured, but the mammogram came out clear. And then I had a breast MRI because it was supposed to be more conclusive. And, according to the MRI, the implants had not ruptured.
Inamed has said that if its PMA is approved, they will recommend an MRI every one or two years to monitor the rupture, but no one tells you what the physical experience of that MRI is like. It's long, and it's uncomfortable. Basically you lie face down in a dark enclosed tube with your breasts in these holes. And if you're in pain, like I was, it's even worse.
The other thing that Inamed doesn't mention is that MRIs are very expensive; on an average, $1,890 according to Blue Cross. That's $1,890 of your own money because they are not covered by insurance. Most women can't afford one MRI, let alone one every year or two.
Now, while Inamed has recommended the MRI, I don't see a plan that is set up or fund to pay for these MRIs. Also, not all MRIs or facilities are equipped to conduct the necessary procedures.
In clinical trials, the industry has been using very specific centers with experienced radiologists. And even those centers don't always detect rupture. And many women don't even find out they have a rupture until their implants are removed.
The industry's own data shows a high false positive rate for rupture detection through MRI. In the past, we have heard a 95 percent accuracy rate with MRI. Yet, according to Inamed's core study, more than a third of MRIs, 36 percent, falsely detect rupture. And such high rupture rates and false positives of those high rates create unnecessary anxiety for women and potentially unnecessary surgery.
In my experience, despite the fact that my MRI did not detect that my implants had ruptured, I still decided to have them out. But when they were removed, both of my implants were ruptured. And the outer shell had completely disintegrated. And now, while I still suffer from lupus, the farther I get away from my implant surgery, the better I feel.
I am not the only one with this experience. Other members of In the Know have had similar MRI experiences where a rupture was present but not detected.
MRIs are unreliable, expensive, and unpleasant. Inamed's recommendation for yearly MRIs is both unrealistic and disingenuous for the women who actually have to go through them.
Thank you very much for listening and for your time tonight. Thank you.
MS. NOONAN‑SARACENI: Hello. My name is Pamela Noonan‑Saraceni. I have no conflicts of interest.
On July 5th of this year, I will be celebrating my 27th year as a breast cancer survivor. However, I continue to live with the ramifications of silicone gel implants.
In 1978, when I was only 25 years old, I was diagnosed with breast cancer and had a modified radical mastectomy. I waited five years before I decided to have silicone implant reconstructive surgery. I led an active lifestyle, and I played tennis, jogged, and I taught aerobics. And I had grown tired of the inconvenience and embarrassment caused by my external prosthesis shifting and falling out of my bra.
I am a well‑educated woman. And I thought I had done my homework on breast implants prior to my reconstructive surgery, but I was never advised of any health risks associated with silicone breast implants or the fact that there was a chance for additional surgeries. In fact, I was told they would last a lifetime and complications were few, if ever.
Within three months of my initial reconstructive surgery, I was back on the operating table. My body has formed a capsule around my implant, and it had moved up to my collarbone.
The searing pain at the time caused my shoulder to freeze and become immobile. The surgery seemed to help, but symptoms of physical illness began to develop after that. At first, I attributed the fatigue, muscle aches, and pain to just getting older. However, I was only 36 years old at that time.
Before I had the implant permanently removed in 1994, ten years after my initial reconstruction, I had to again wear a partial prosthesis. Capsular contracture had again become a problem. And my breasts had become lopsided and misshapen. The explanation was the fifth surgery at my breast site.
I know that almost half of breast cancer patients with implants will need one additional surgery due to serious problems that occur within three years. And that is from Mentor's own data.
To date, my out‑of‑pocket medical expenses are approaching $50,000. My husband and I are self‑insured. And the insurance policy that we took out carries an exclusion that I would not be covered for any illness or disability related to my reconstructive surgery. The insurance company understands that there are health risks associated with the breast implants, and they are not willing to bear the financial cost.
Apparently the government also knows this. Last year the Department of Health and Human Services settled with silicone breast implant companies to recuperate the cost of caring for women made ill by silicone breast implants. How can the FDA even consider approving these devices while at the same time a sister agency sought financial compensation for harm that they caused hundred of thousands of women?
Please do not recommend approval of this product until the companies provide the long‑term data needed to prove their safety. Women across America are counting on you, the FDA, to protect them.
Thank you.
CHAIRMAN CHOTI: Thank you.
Next speaker?
MS. RAMSPOTT: My name is Kathy Ramspott. Thank you for giving me the opportunity to speak before this Committee. I would like to publicly state that Inamed has provided the transportation and accommodations for me so that I may address you today.
I would like to share my personal experience with the McGhan silicone‑filled breast implant. I am a two and a half‑year breast cancer survivor. When originally diagnosed, I sought the advice of a general surgeon and asked him to recommend a plastic surgeon.
It was the plastic surgeon's recommendation to do reconstruction at the time of the mastectomy. That was agreed upon. And after receiving my five months of chemotherapy, the expander, which was inserted at the time of the mastectomy, was removed and a saline implant inserted, my first mistake.
I did not do my homework and just assumed that saline was my only choice. Shame on me. I soon learned that the patient has to be their own advocate and must do their research. Yet, when given a diagnosis of cancer, your mind is not functioning in a normal manner.
Several months passed. I was acutely aware that the saline implant was not what I was hoping it would be, extremely unnatural and unmovable. I discussed this with my plastic surgeon and was asked to give this a full year before making any decisions. I was told that sometimes it takes that long for things to settle in.
I agreed to do this, even though I was not happy and not comfortable. I also asked why I had not been told that I could have had a silicone implant, and that should have been my choice. I was told that the saline was the safest.
Due to other misunderstandings, I sought the consultation of two other plastic surgeons: one at the same facility as the original plastic surgeon and another at a completely different campus.
After meeting with Dr. Patricia McGuire of Parkcrest Plastic Surgery in St. Louis, I realized I should have seen her initially. She explained in great depth to my husband and me that she felt I was a good candidate for the McGhan implant. She showed the actual implant to me and told me to give it consideration. She also gave me the alternative implant information.
I read the literature and decided that the McGhan implant was the direction I wanted to follow. Last September, Dr. McGuire began my reconstruction, and I have not regretted a moment since.
I realize this is not a subject that is discussed casually at a dinner party, but when you are the unsuspecting patient facing this dilemma, it is uppermost in your mind, not only your mind but your impaired body.
I have come to the conclusion that the most important aspect of this conflict is that a woman has to be given all of the information that is available so that she can make a choice. My first and foremost interest regarding this hearing is that a woman has to be given her right to a choice. This particular implant needs specific training for the surgeons who will use it in their patients.
Yes, as a cancer patient, it is uppermost in my mind. This implant should be available to the survivors. But there are other women out there that need this implant for various other reasons.
If you were to look at photos of women that have breast imperfections due to genetics, cancer, et cetera, you would understand.
CHAIRMAN CHOTI: If you could wrap up, please? Thank you.
MS. RAMSPOTT: Okay. In this age of body image, we continue to look at a woman and question what is her bra size. As I stated above, this is about choice.
I hope that sharing this information with the members of the Committee, it will be of some help to you and other women faced with this dilemma.
Thank you again for letting me express my point of view.
DR. TAYLOR: Hello. My name is Anne Taylor. And I am here to provide the panel my unique perspective on silicone gel breast implants.
I speak to you as a plastic surgeon who has placed more than 100 of these devices, but my experience is not only as a surgeon. I am also a patient. I have had both the saline and silicone gel devices. The ASPS has paid my travel expenses today.
I first had saline implants placed about five years ago after the birth of my first child, to address a loss in breast volume and ptosis. I experienced the usual range of irritating problems with the saline implants, including palpability, rippling, and thinning of tissue. These were not medical issues. I was simply not happy with the way the saline implants behaved. My patients have also complained about these problems with heaviness, rippling, and unnatural feel of the saline implants.
Two years ago, in '03, I opted to have my saline implants replaced with silicone gel implants. And the difference is night and day.
I often use the analogy of cars to explain the difference between these two types of implants. Both a Ford Taurus and a Mercedes will get you from point A to point B, but we all understand the difference between these two rides.
The gel implants are the Mercedes of the implants. They work better in almost every way. There's no problem with rippling. There's no problem with unnatural feel. They're softer, lighter, and more life‑like. The breasts feel and move naturally. You can even lay on your stomach with them. It's hard to describe the difference to someone who has not experienced both, but I can tell you it's night and day.
In my practice, since 2002, I have participated in both the major manufacturers' studies, though I focus mainly on the Inamed device. I have used them after mastectomy for reconstruction and for those with congenital anomalies and also in patients, like myself, who have had difficulties with their saline devices.
The patients are unanimous in their description of the gels. They're softer, comfortable, and better. Because of the well‑publicized history of the gel devices, most patients have some worries related to their use, but when presented with the literature, including the NIH study, they opt for the silicone gel implant. And my own personal history certainly gives them peace of mind in this regard.
I have studied the science thoroughly. And it says these devices are safe. Science should rule stronger than emotions. I am convinced of this so strongly that I not only recommend them to my patients but I have them in my own body.
There are issues with silicone implants, as with saline. I explain this to my patients, that they can rupture and when they do, they have to be replaced. Unlike saline implants, you might not know when the rupture occurs. So I encourage them to have regular mammograms.
I have not noticed any difference in frequency of complications between the devices. What I have noticed is the silicone gel implants accomplish the goal of the device better. The science says they are safe. And my experience is they are the superior device in every way.
Thank you.
CHAIRMAN CHOTI: Thank you.
Next speaker?
MS. HARRISON: Hi. My name is Jan Harrison, and I have no connections with Mentor or Inamed at all.
I support bringing the silicone implants back on the market so that women can have that option. To not have silicone implants on the market is discriminatory to women who want them. I feel that silicone implants feel and look more natural.
I chose to have breast augmentation in 1979. I had silicone put in on top of the muscle. I never once had any regrets or problems with my augmentation. I like the look and the feel of the silicone implants.
In 1991, I was involved in a water skiing accident, injuring my ribs and my chest muscles. I had a mammogram done in 1993 that showed a possible leakage. I was followed up six months later. Again it was confirmed that the implant was ruptured. I never once had any signs of disease or any medical conditions. The appearance of my breasts never changed, and I continue to have my mammograms.
In December of 1995, approximately four years later, I decided to have my implants exchanged with the advice of my physicians, Dr. Robert F. Jackson. Dr. Jackson did my original augmentation.
In removing my implant, it was found that the right implant was ruptured and I had some capsule formation. At that time, they were replaced with saline because the silicones were not available.
With the saline implants, I developed severe wrinkling on both sides. It was nothing you could see, but you could definitely feel the wrinkling, and so could my husband. It was very bothersome to me. I did not like the feel nor the appearance of the saline.
In 2004, I noticed that one side was considerably smaller than the other. Dr. Jackson confirmed that the saline implant had ruptured. This was nine years later.
On March 28th of 2004, I underwent replacement of my saline implants. At that time, I requested that the silicone implants be put back in. I feel that silicone implants look and feel more natural than the saline. I feel silicone implants are more durable and more appealing to the eye.
It has been proven in literature as well as my own experience that silicone implants cause no medical or health problems. I went several years with my ruptured implants and had no ill effects. Not once did I lose the size or shape of my breasts with silicone. I, however, did have wrinkling and loss of size with my ruptured implant.
I also work for a surgeon who placed many silicone implants prior to 1990. None of those patients have had any health problems, to our knowledge.
As a private citizen and a woman, I feel not to allow us to make our own decisions and choices with our physician is discriminatory. The self‑esteem achieved in the desire to better our appearance should be our decision. I feel silicone is preferable and safe.
Thank you.
CHAIRMAN CHOTI: Thank you.
Please, next speaker, step up to the podium. Yes? Good afternoon.
MS. SCOTT: Good afternoon. My name is Shannon Scott. I have no conflict of interest.
In 2002, I received silicone gel implants through Mentor's adjunct study. To be in the study, a patient must have a deformity, have had a mastectomy, or a problem with implants that need to be replaced. The goal of the study is to evaluate short‑term complications. I wanted implants for augmentation. Dr. Dennis Gaukin of San Diego stated that I was eligible for reconstructive surgery in the adjunct study, even though my only deformity was a nearly invisible blemish on my left breast.
I was in perfect health prior to augmentation. Three months after I began developing pain within my breasts, the implants started to harden. A plastic surgeon performed a procedure in which he squeezed them to break up the scar tissue.
In January of 2005, I was told by Mentor's patient service representative that closed capsulotomies are not to be performed. This procedure can cause the implants to rupture.
Dr. Gaukin is still a part of the adjunct study. He has refused to provide me with any future medical care. I was told that I would receive monitoring and medical treatment as needed through the adjunct study for the next five years. This has not happened.
Since the implants, I have had muscle, joint aches, severe chest pain, limited range of muscle motion, migraines, rashes, swollen lymph nodes, fatigue, sensitivity to light, and considerable memory loss.
I am now bedridden approximately 95 percent of the time. And due to the pain, I need assistance in even the most minor aspects of my life, such as brushing my hair or even getting dressed. I cannot afford the thousands of dollars it will take to have my implants removed.
This study is supposed to be monitored by the FDA. I did not receive informed consent. The doctor did a forbidden procedure that could have ruptured my implants, and now I can't afford to get them taken out.
I question how the FDA can allow this to happen to women. Dr. Gaukin's medical records in my case are incomplete and inaccurate. If Mentor is not provided data, such as in my case, you can assume that the clinical trial study data is also incomplete and inaccurate.
How many cases like mine occur? How many people are too ill or have been misdiagnosed or ended up committing suicide? Is the statistical data in these studies?
It is my hope to prevent other young women, young healthy women, from experiencing this nightmare. Thank you for your time.
CHAIRMAN CHOTI: Thank you.
Please, next speaker?
MS. JOHNSON: Good afternoon. My name is Marie Johnson. I am here on my own behalf, and I have no conflict of interest.
After having and nursing two children, I was dissatisfied with the size and appearance of my breasts. I am a very self‑confident, educated, and successful person. And I want to look the best I can possibly look. And so I decided on undergoing breast augmentation.
I discussed my options with my doctor and agreed that the most natural‑looking and feeling implants would be silicone. And that's why I agreed to be a part of the study. I believe it's a ten‑year study.
I'm extremely satisfied with the outcome and have not had a single problem in the over four years that I have had them. In addition, by participating in the study, I am given the opportunity to have an annual MRI on my breasts that are at no cost to me. I continue to also have my mammograms, as suggested by my ob/gyn, and have had not any problems with this test as a result of my implants.
I do not fully understand why silicone implants are still not permitted for use without restrictions. Like many medical and/or elective procedures, the risks are known and can be communicated to and understood by potential patients.
Furthermore, to me it seems inconsistent that it's legal to smoke cigarettes and consume alcohol, despite the known risks and devastating consequences. However, Americans are given the choice knowing the risks. It is unclear to me why the same choices are not available to patients seeking this procedure.
I think it is time to put politics and hidden motives aside and reevaluate the validity behind the ban on silicone breast implants. I urge you to remove the ban on silicone breast implants and let women make informed decisions about their bodies the same way millions of people do every day with countless other devices, medicines, and legal substances that are approved.
Thank you for your time.
CHAIRMAN CHOTI: Thank you.
Next speaker? Good afternoon.
DR. HYANS: Good afternoon. Mr. Chairman, members of the Committee, I am Dr. Peter Hyans. I have been in practice as a board‑certified reconstructive breast surgeon for the past 12 years. I do not have a financial relationship with any company involved in these hearings. My travel expenses were paid by ASPS.
Previous speakers have already presented their data and statistics. However, I would like to talk about the women affected by your decisions.
Lisa is a 32‑year‑old woman, mother of 2 children, recently diagnosed with breast cancer. Mary is a 60‑year‑old woman, married for 40 years, facing mastectomy. Karen is a 20‑year‑old woman born with a genital deformity that left her with only one developed breast.
Although their histories may be different, all these women have in common the difficult decisions facing them regarding their treatment. Thoughts about surgery, chemotherapy, and possible radiation are weighing on their minds.
Advancements in breast reconstruction have allowed these women and the millions like them to feel good about themselves and their feminine appearance following body‑altering surgery.
Fortunately, today there are many options available to women in their situation. However, if a woman chooses to have reconstruction with a permanent prosthesis that is not considered investigational, they have been restricted to saline implants.
The most common comment that I hear from patients reconstructed with saline implants is, "These implants look and feel like implants, not my own breasts." Often these implants are hard and firm. Often wrinkling increases are visible. Many of my patients claim they are uncomfortable and it limits them in terms of their physical activity.
Silicone implants, on the other hand, look and feel more natural. There is no question in my mind or the mind of my patients that silicone is a superior product compared to saline. My patients who have been reconstructed with silicone implants appear more confident in their appearance and the way their new breasts feel.
Having a more natural reconstructed breast allows women to more quickly resume a normal life without dealing on a loss and feelings of inadequate appearance.
At the time of their consultation, I counsel my patients on the risks and benefits of silicone and saline implants. The present available data regarding the safety record of these devices is discussed. Patients are shown examples of both devices along with written literature and pertinent Web addresses for more information.
Once most women have reviewed the available information and held both devices in their hands, their choice is usually silicone. Despite the fact that silicone implants have received negative press in the past and are still considered investigational, this is the preferred choice of most women in my practice.
As a reconstructive breast surgeon, I counsel about 70 to 80 new breast cancer patients a year. Over the past four years, I have participated in the National Breast Implant Registry, or NABIR. I have enrolled about 80 women in the silicone implant study and implanted approximately 140 silicone breast implants.
I have seen very few complications. I have not had a single deflation or rupture of a silicone implant while involved in NABIR. I have had to remove only two implants due to infection and one implant because of capsular contracture.
During the same period of time, I have implanted approximately 120 saline implants in 55 women for reconstructive purposes. However, I've had to exchange about ten percent of these implants to silicone because of patient dissatisfaction with wrinkling or firmness of their saline implants.
I have also seen a much higher deflation rate with the same saline devices.
CHAIRMAN CHOTI: If you can wrap up for us, please?
DR. HYANS: Please don't let sensationalism and hype created by the media affect your decision regarding these valuable devices. I believe the data speaks for itself. Let women as long as they are informed, like Mary, Lisa, Karen, and the millions like them who feel comfortable about their bodies, go forward with their lives without feeling self‑conscious.
MS. DOWD: Good evening. My name is Pam Dowd, and I am reading on behalf of Hilary Abigail Morrissey from Macon, Missouri. She does not have any conflicts of interest. Here is Hilary's story.
"I am just a 14‑year‑old. And I wanted my words to be heard. My mom, Cindy Morrissey, had many sets of silicone gel breast implants starting when she was a teenager. My grandparents gave the implants to my mom as a birthday present because she had a congenital deformity of her chest.
"Later I was born, and my mother breast‑fed me. I have had health problems ever since. I have scleroderma. And I had my first skin biopsy when I was six years old. This is not good when you are a kid because as I get older, my scleroderma, skin, and bones are getting worse. This is all very painful, and I do not like what is happening to my body.
"I also have a very bad bone problem called an acral bone dysplasia. My hands and my feet are the size of a 12‑month‑old baby's, and I have had many fractures.
"I want the breast implant companies to know that I do not like what they did to me with their bad breast implants. Breast‑feeding with implants makes kids sick, no matter what manufacturers want people to believe. I am living this.
"I asked my mom why I'm like this. She explained to me that my grandparents and her were not told the truth about implants when she was a teenager and over the many years she had them in. She said the companies did not do studies on the children and never will. She said it had been the big cover‑up in medicine because breast implants are all about money.
"I also think that TV shows like 'The Swan' and 'Extreme Makeover' make people and teenagers really hate themselves even more because when you look in the mirror after watching shows like this, you begin to think that a plastic surgeon can fix everything and make life better. But they can't.
"I wish a plastic surgeon could fix my hands and feet or take my scleroderma, my swallowing problems, and the insulin‑resistant problems away. But they can't.
"It sure does not make me feel good every time I see a plastic surgeon put a breast implant into one of these people on these types of shows. They are shows to promote breast implants and make more money for plastic surgeons and the companies.
"I want the breast implant companies to know I forgive you for doing what you have done to me and to others with your implants that have not been studied. I hope and pray that the FDA and the panel will not approve silicone gel breast implants. I will pray that God may open your eyes to the truth that breast implants also harm children.
"Thank you for listening to my voice."
CHAIRMAN CHOTI: Thank you.
Good afternoon, next speaker.
MS. LEVIN: Good afternoon. My name is Madeleine Levin. I am reading testimony for Diane King, who could not be here today. We have no conflicts of interest.
"My name is Diane King. I am from Concord, California. I was a very healthy 36‑year‑old woman when a plastic surgeon talked me into silicone breast implants, instead of a reduction, because he felt I would hate the scars.
I weighed 110 pounds, wore a size 36DDD, and he said breast implants would easily solve the sagging and neck aches. I considered it reconstruction, but he wrote "augmentation" on my surgical report, even though I reduced my breast size.
I began to experience problems 13 years after my implantation. My energy level dropped. I developed rashes, numbness in my arms and hands, burning sensations in my chest, night sweats, dry mouth, and weight gain.
Meanwhile, my physician said she was baffled and tried several medications to fix me, including antidepressants. I got myself off all medication after I met a woman who was dying from her silicone implants and educated me.
I had 26 symptoms out of 52 on the list of silicone‑related illnesses. When I took this information to my physician, she said there was no official medical evidence to back it up. So she never suggested my problems could be related to my implants.
By 1996, I could not lay flat. So my husband put adjustable beds in the family room, where I slept for a year. I was only able to get out of bed for a few hours each day. My skin tone became gray and yellow.
My HMO sent me to a rheumatologist, who diagnosed me with symptoms classic to ruptured implants and fibromyalgia. My sonogram failed to reveal the severe ruptures. And my HMO would not cover an MRI.
My removal and reduction in April of 1998 took almost six hours because I was so severely ruptured that the silicone had to be ripped from my chest muscles and peeled from my chest wall.
My health began to improve immediately. My cognitive problems cleared. The gray puffy skin, rashes, and most of the pains disappeared. It has been seven years since removal. And I am now realizing that I may never return to the high energetic top relator I was before the rupture. And I may have residual problems forever. But I am happy to be alive and sleeping in my own bed.
I was not warned of anything other than standard complications from surgery and anesthesia. There are more disclosures required to purchase property than to have this surgery, which can destroy a person's quality of life and ability to earn a living.
I feel the FDA has failed the women of this country by not requiring proper disclosures prior to surgery and by not requiring long‑term studies to disclose all of the possible risks associated with silicone breast implants.
My implants cost my family a substantial amount of money, hopes for a comfortable retirement. And, more importantly, we all suffered through my illness and lost over ten years of quality life that we cannot get back.
I implore you, do not allow more women to waste precious years of life and significant amounts of money on a product that is not safe.
Thank you.
DR. TEITELBAUM: Chairman and distinguished members of the panel, my name is Steven Teitelbaum. I am a board‑certified plastic surgeon from Santa Monica, California. I do not have any financial relationship with any implant manufacturer. And I paid for my own travel.
You have all been charged with a quite daunting task. Daunting? You've only had to decide whether the risks of silicone implants and the benefits weigh out favorably. That sounds easy enough. In fact, the FDA has approved implants and devices far more hazardous than anyone has ever thought that silicone breast implants could possibly be.
Something here is clearly different. Why is there so much testimony? Why is this room so full? This is it. It's that the risks and benefits of this device are described in very different languages. And because the languages are different, we cannot make a direct comparison. The risks are described in quantifiable scientific terms, but the benefits are described in vague sociological terms.
How can you, how can anyone offset the risk of an infection against improved self‑esteem? You can't. You can't for anybody except for yourself. Studies show silicone implants improve self‑esteem, but they cannot tell you how much weight to give to self‑esteem. Some would argue improving self‑esteem by surgery is of no value.
Others would say that self‑image is important to an individual's sense of well‑being, as any truly medical issue. Putting a value on self‑esteem requires a moral judgment, which I believe is inconsistent with your task here because you should be scientific and apolitical. An objective conclusion about this device, therefore, is impractical.
Since this surgery is elective, some suggest that you need to demand more for this device than you might for a medically necessary device. I see it the other way. With a medically necessary device, someone finds themselves sick or in pain, and they have no way to evaluate the device and due diligence it. They need you to do that for them.
But breast augmentation patients, they seek out these implants. They think about it over many years, absorbing sources of data from many places. They can due diligence this for themselves.
And this leads to the solution. Since a quarter of a million women choose breast augmentation, I believe you should accept as axiomatic that this is important, very important, and of value to some people.
Do we know the risks well enough to adequately inform women? The answer is an unequivocal yes. Questions remain. There are unknowns. We never know everything about anything. Just demand that the patients are told where the data ends and where the unknown is. As long as patients know what they know and what they don't know, they can make an informed choice.
Arguing that the data is insufficient to allow a thoughtful choice requires assumptions that the benefits do not outweigh those unknown risks. You have, therefore, used your own value system, your own value system, to unconsciously assign a low value to the benefits.
For some women, the benefits will not outweigh the unknown risks, but for others, it will. That is their decision. Female plastic surgeons prefer them predominantly when looking for themselves or loved ones. This proves that the severity and rate of complications is so low and so subtle that it does not rise to the level where the panel needs to protect Americans from this option.
It is often implied that the testimony of a plastic surgeon is biased by financial considerations. Actually, it is of no consequence at all to me whether I use saline or silicone, but it is a consequence to my patients. And that is why I am here.
I was moved by today's testimonies. But if you spend an hour in the lobby of any medical office building, you would hear similar stories from women who do not have implants.
CHAIRMAN CHOTI: If you could wrap it up, please?
DR. TEITELBAUM: I do not doubt the sincerity of these women. They are looking and think they have found an explanation for why they have developed the disease. But their belief is based upon faith. And this panel should render a decision only based upon science.
Thank you.
MS. GOLDRICH: Good evening. My name is Sybil Goldrich, and I am the Director of Command Trust Network.
First, I want to thank you all for sitting here for such a long time. I know how difficult it must be to hear everybody's opinion. So I'm especially thankful to you.
We were established in 1988 to make sure that the most up‑to‑date information was distributed about breast implants, both to women and to decision‑makers in Washington. And I come here with no financial ties to either the sponsor or to any of the sponsor's competitors.
In September of 2004, just seven months ago, these former silicone breast implant manufacturers agreed to pay the federal government $11.3 million to reimburse the government's cost for caring for women injured by silicone breast implants. This U.S. Justice Department lawsuit made it clear that silicone breast implants have cost the United States government millions in medical expenses and have cost women even more in terms of their health.
Also in 2004, the government received approximately $10 million from the Dow‑Corning bankruptcy estate in settlement of its claims for reimbursement for medical costs by Dow‑Corning implants.
The government agencies that sought reimbursement included the United States Department of Defense, the Department of Veterans Affairs, the Indian Health Service, the Centers for Medicaid and Medicare Services, and the Department of Health and Human Services, the very agency that oversees the FDA. Even Inamed settled with the government to reimburse Medicare. Inamed paid for the problems that they caused women.
Through all of these lawsuits, Department of Health and Human Services certainly recognized the safety problems with silicone breast implants. It sought compensation for the costs incurred from treating women with complications caused by implants.
Women with silicone implants whose health care is paid through these government agencies suffered serious complications from their implants. And this caused the United States taxpayers millions of dollars.
But there are thousands and thousands of women who do not have health care through these agencies and who have had problems with their silicone breast implants. Too often their health insurance does not cover the cost of MRIs to determine if implants have ruptured.
The cost of treating complications or of removing implants, even broken, ruptured, or leaking implants, isn't covered. If you recommend that the FDA remove the restrictions on these products, who is going to take care of all of the women who experience complications and health problems in these harmful products? What will the cost do to our already overburdened health care system?
It is incongruous that less than a year after the Justice Department has received over $20 million from companies which formerly manufactured implants, that the FDA would be here today considering Inamed's and Mentor's requests to put these same very harmful products back on the market without restriction.
How can the FDA even consider loosening restrictions on the sale of a product that the Department of Justice has successfully sued due to safety problems? Fortunately, the Department of Justice recognized that silicone breast implants caused serious health problems and held the industry accountable. I only hope that the FDA will follow their lead and make sure that the women's health is not further jeopardized by these devices.
Thank you.
CHAIRMAN CHOTI: Thank you.
DR. HESTER: Mr. Chairman, members of the Committee, I am Dr. T. Roderick Hester, Jr. I am a plastic surgeon and Chief of the Division of Plastic and Reconstructive Surgery of the Emory University School of Medicine in Atlanta, Georgia.
I have been actively engaged in the practice of academic and clinical plastic surgeon for 25 years, have no financial interest with any company involved in these hearings.
I have been and continue to be an investigator in FDA‑approved investigational device studies for both companies. I receive no personal remuneration as an investigator. I traveled here at my own expense. My overnight lodging was paid for by the American Society for Plastic Surgery.
Over my years, I have utilized silicone gel and saline implants in more than 3,000 patients for reconstructive and aesthetic purposes. There is absolutely no question that in the reconstructive setting, gel‑filled devices are far superior to saline. And this fact has, of course, been recognized by the FDA in previous decisions, allowing women facing reconstruction after mastectomy the choice of a gel‑filled implant.
In fact, even in more complex aesthetic situations, such as severe breast asymmetry, mammary ptosis, capsular contracture, gel‑filled implants, those considered an investigational device can be chosen.
As members of the panel may know, the number of women seeking aesthetic breast enhancement has increased significantly since the early 1990s to well over 300,000 in 2004. The vast majority of these women have not had the choice of using a gel‑filled implant. I believe this should change, and I will tell you why.
As I have previously stated, I have had the good fortune to be an investigator in studies in which women could choose the so‑called third generation devices for primary augmentation and would like to share my personal experience.
Over four years ago, I began using third generation devices in IDE studies. And at present, over 100 patients have had implantation. These patients are closely followed with over 95 percent returning for follow‑up.
A few facts. When given a choice after long consultation for the comprehensive informed consent, 95 percent of patients choose the gel‑filled device. Results with gel‑filled devices have been excellent. Unlike saline implants, problems with implant palpability and wrinkling have been almost nonexistent.
I have not seen a documented implant failure in this group. The incidence of capsular contracture and overall revision rate have been well under ten percent. Unlike saline implants, a gel‑filled device can be used even in the thinnest of patients with excellent results.
In my practice, most patients who cannot be enrolled in a study are choosing to wait, rather than to proceed with saline‑filled devices. I can also report since third generation devices became available, I have seen only one failure. And that was a surgically induced failure. In my experience, patients with saline implants are significantly more likely to require reoperation for implant patients, implant failure, and poor results.
A final thought. Many patients in my practice who cannot at this time choose a gel‑filled implants ask me a question, which is phrased something like "If there is any health risk for me to use silicone implants, why will the FDA allow them to use it in patients who have had cancer and whose health may not be as good as mine?" Quite honestly, I have trouble answering that question.
I believe the data has confirmed the safety of gel‑filled devices. And my patients and all American women should have the right to choose a gel‑filled device, whether for reconstructive or aesthetic purposes.
I thank you for your time.
CHAIRMAN CHOTI: Thank you.
Next speaker?
MS. LITWALK: My name is Katie Litwalk. I am reading testimony for Gloria Borland, who is unable to be here today. She has no conflicts of interest, and neither do I.
"My name is Gloria Borland, and I live in Alpine, Texas. Everyone wants to look their best. When I was younger, that was what motivated me to get silicone breast implants.
"I went to a plastic surgeon, who assured me that silicone breast implants were safe and that they would make me look my best. I was told that the silicone breast implants being used would last for the rest of my life.
"My doctor made it sound as if I was going to the beauty shop and choosing a different hairstyle, but hairstyles are easy to grow out or change. And I later found that the effects and symptoms of silicone breast implants are not.
"What I have experienced is a lifetime of additional surgeries and pain, not at all the picture painted for me by my plastic surgeon. The studies presented by the manufacturers show only the short‑term results of silicone breast implants.
"The women presenting today, including myself, are the long‑term studies that failed to be conducted scientifically. As you listen to us, you will note that most of the problems and complications we have experienced began five to seven years after implantation.
"Four years of data is not enough. The problems increase as the time goes by and last long after what is left after the implants are removed. We have experienced this.
"We are the long‑term studies. When my silicone breast implants were removed after 16 years, I already had neurological damage that was irreversible. I experience chronic pain and am unable to work as a result.
"The implants that were removed from my body were badly ruptured. Clearly they did not last my lifetime. I am, however, unable to live my life. Perhaps that is what my plastic surgeon meant when he said that they would last me a lifetime.
"Plastic surgeons offer breast implants on the installment plan. Many women will not be able to afford MRIs. They will still be paying off the initial surgery. If their implants are ruptured, many can't afford to have them removed.
"How can the FDA possibly approve silicone implants with those kinds of risks? Please think of the young women who trust the FDA to make decisions for them about both the short‑term and long‑term safety of products and do not recommend approval.
"Thank you."
CHAIRMAN CHOTI: Thank you.
DR. MILLER: My name is Claudia Miller. I'm a physician, and I'm actually testifying on behalf of a patient who is unable to be here. Her name is Marlene Miller. I'll be reading her testimony.
"My name is Marlene Miller. I had breast reconstruction with silicone gel implants after a double mastectomy. I have no conflicts of interest.
"Within six weeks of McGhan, experiencing extreme pain in my breast area from an infection, and four months later the implants had to be removed. After the explantation, I had to keep the incision site open and clean by pulling the nipple up to open the hole and with the other hand push the loose skin around to make the pus come out. I could see through the hole and look at my chest wall.
"Two years later I had new breast implants put in. Later that year, I felt something snag in my bra. I found a stiff blue thread sticking out through my skin under my left nipple. I pulled on it, and out came a string that had three knots in it with a liquid that stretched like rubber cement clinging to it. It stretched for about six inches before breaking loose.
"A surgeon took a sample of this gel and told me it was silicone. The implant was immediately removed. And the surgeon found a flap‑like tear through which the gel had extruded. He put in a new implant.
"Five years later my implants were hard as rocks. Another surgeon told me about a new silicone implant. He promised that they would never break and were specifically made for reconstruction. So I gave them a try.
"Soon afterward the headaches started, along with constant pain between my shoulder blades. My hair started falling out. I developed allergies to everything. I was tired all the time. I started coughing and vomiting up mucus.
"After seeing another plastic surgeon, who told me I had silicone poisoning, I argued, saying that I had implants that could not rupture. I had been promised.
"He removed my implants. And the left implant had an enlarged L‑shape rip in it. Silicone had spread throughout my chest cavity and had adhered to the chest walls.
"The surgeon said it was quite tedious just to remove what he could. He put in new silicone gel implants. This time the cosmetic problems were immediate. Within months, I was in so much pain and I was so deformed I wanted to die. I had the implants removed, and this time they were not replaced.
"Inamed's and Mentor's own research shows high complication rates, especially for mastectomy patients. The statistics don't really convey how terrible these complications can be. Plastic surgeons might look at my medical records and point out that even with all the problems, I kept replacing my implants.
"It's not because I was desperate to have breasts. It's because I was promised they would be safe. I ask the plastic surgeons on this panel, have you made promises to your patients like that?
"I have had a long and ugly history with implants. I ask you to simply adhere to the FDA's own guidelines when they rejected Inamed's application in 2004. Do not approve these products without long‑term safety data. No one should have to go through what I have gone through."
Now, Marlene Miller also answered a questionnaire that I showed you early in the day. And she said to me that she's had multi‑system symptoms, musculoskeletal, airway, gastrointestinal difficulties, and mood changes.
She's ill if she's exposed to pesticides, cleaning agents, and various fragrances. She is new intolerances for various foods, caffeine adverse reactions to many medications. And these new intolerances, as I told you earlier, are the hallmark symptoms of this toxicant‑induced loss of tolerance. And clearly they have impacted her in every facet of her life.
Thank you.
CHAIRMAN CHOTI: Thank you.
MS. WILLIAMS: She has another one she is going to read. Can she just do that?
CHAIRMAN CHOTI: Sure.
DR. MILLER: Again, I'm reading for a patient who cannot be here. She is too sick to be here today. She said she couldn't travel because of her chemical intolerances.
"My name is Beverly Ezra. Twenty years ago, I got silicone gel breast implants. Within a year of implantation, I developed arthritis, short‑term memory loss, and headaches. Several years ago, I lost my sense of smell and some of my sense of taste.
"My left implant ruptured in 1993 and was replaced with saline implants. Four months later, a bilateral open capsulotomy was performed and inflammatory fluid collections found in both breasts.
"A lung X‑ray at this time identified soft tissue density with significant scarring and calcification on the right lung. During this time, I started to develop multiple chemical intolerances and was diagnosed with spastic bowel.
"My urine has been tested for platinum and found to contain 158 parts per billion per liter of urine. My hair, nails, sweat, and so on, blood have been tested as well and have been found to be positive also for platinum.
"Ten years after having implants, I was diagnosed with connective tissue disease, organic brain syndrome with cognitive impairment, atypical neurological disease, and a multiple sclerosis‑like syndrome.
"My allergy tests indicate I am allergic to everything and I now react to small amounts of everyday chemicals. My 1999 brain scan, SPECT scan, came back as abnormal. And I was told that I have toxic encephalopathy, dry eye syndrome, immune dysfunction, and autoimmune disorder, multiple chemical intolerances, and elevated thyroid antibodies.
"The Western blot blood test in 2000 showed I have markers for sclerosis, lupus, and Sicca syndrome. I was also diagnosed with thyroid disease of Hashimoto's nature.
"I am now on total disability. And Social Security retrograded my disability back to 1993, listing my impairment to be severe from silicone toxicity.
"There is no known way to get ionized platinum and silicone out of the body. The platinum can cause systemic disease in humans as a result of toxic and/or hypersensitivity reactions. Soluble salts of platinum are the very potent chemical sensitizers.
"I'm currently considered high‑risk due to my chemical intolerances and am denied the surgeries I now need. The medical community does not know how to treat me. I react to most prescription medications or chemicals. Some of these reactions are life‑threatening because my throat constricts and I experience chest pains. Sometimes I cannot walk or talk for up to almost a day at a time.
"In conclusion, I ask that this panel vote no on approving gel‑filled breast implants made with a platinum catalyst. I hope that no one has to suffer the systemic disease symptoms that I have endured."
And as a further comment, she, again, answered some questions about her intolerances because when I hear this, I say, "Well, what things bother you?" And she gave a whole list of exposures that trigger symptoms in her, including having severe responses to pesticides, cleaning agents, fragrances that sound almost anaphylactoid; monosodium glutamate, making her hands and feet swell; alcoholic beverages, even a tiny amount, making her stuporous and sleepy; and adverse reactions to any medications. What type would be of interest to the FDA.
I think the important thing ‑‑
CHAIRMAN CHOTI: If you could sum up? Thank you.
DR. MILLER: ‑‑ is that this is a subset of patients we are dealing with, but the ones that are affected are affected very badly. And even though they report multiple diagnoses, these things are very real for them.
Thank you.
MS. HANSON: My name is Sarah Hanson. I am reading testimony for Linda Dintino, who could not be here today. She has no conflicts of interest either.
"My name is Linda Dintino. I was implanted with silicone breast implants due to a prophylactic mastectomy because of fibrocystic disease. At that time, I was told that I was at high risk for breast cancer. Silicone breast implants were in my body for 13 years, until they were removed. Before my implants, I was a very healthy woman.
"Within two months of being implanted, I developed migraine headaches. Even after that, I was athletic. I was an active mother of two boys, a Cub Scout leader, and a secretary of the PTA.
"Seven years after getting implants, I was too ill to continue these activities, sadly. I could not lift my arms above my head. The pain was too great. I literally had to sleep with pillows tucked between my breasts while sleeping on my side because of the burning hot pain.
"When the implants were removed from my body, I learned that my right implant had ruptured and my left implant was leaking. I was left with a big gaping hole in my right chest wall. My body would not heal properly.
"I walked around with this hole in my chest four months. My scars were open on both sides and would not close. Even the drainage holes where the drain tubes were took longer than they should have to heal.
"I dressed these holes in my body twice daily for four months while green, oozing slime dripped from them. I can barely walk. I can no longer do things like a normal person because of the excruciating pain in my body.
"The sad part is that the manufacturers and plastic surgeons don't seem to care. I had hope in 2004, when the FDA refused to put silicone implants back on the market and demanded long‑term safety data. I was hopeful that the FDA was listening to us and acting on its responsibility to protect the public from harm. But here we are again with no long‑term research.
"These manufacturers are not studying women, like me, who had implants for a long time. I am one woman in a sea of thousands, all experiencing the same problems. And the common denominator between us is the fact that we all had silicone breast implants.
"We need real research. We need answers. We need for this panel to take a stand and demand that thorough research be done. If you approve silicone breast implants, the FDA can't require the implant makers to do additional studies. The implant makers will have only an incentive to do research if required by the FDA."
MS. CAPLAN: Hello. I am representing Susan Scherr, who was unable to attend today's meeting. I am Elyce Caplan, Education Director of Living Beyond Breast Cancer. And I have no conflicts of interest.
"My name is Susan L. Scherr. I want to thank the panel for the opportunity to present my views. I have no conflicts of interest and have not received any support from either of the sponsors.
"I am speaking to you today as a 28‑year breast cancer survivor. I received silicone gel breast implants in 1978 and 1988 as part of my reconstructive surgery. I am also the former Director of Community and Strategic Relations for the National Coalition for Cancer Survivorship and continue to be active in the cancer community.
"My comments today are on my own behalf and are limited to the approval of silicone implants for reconstruction patients, specifically women with breast cancer, breast disease, and other medical needs and use only by qualified clinicians. I have no position on the use of these products for augmentation.
"I testified in favor of silicone gel breast implants for reconstruction before FDA in the early 1990s and before the Institute of Medicine in 1998 on behalf of NCCS. I testified again on behalf of NCCS and 12 other organizations before this panel in October 2003.
"Despite the documented long‑term safety of silicone gel breast implants and the continued publication of numerous studies, reviews, and reports, all concluding that there is no link between connective tissue disease and silicone, these products are still not available to the vast majority of American women.
"An NCI study of over 7,000 women published in October 2004 again reaffirmed these scientific conclusions. This panel has undoubtedly reviewed all of these studies, reviews, and reports. And in the face of such overwhelming evidence regarding the safety of silicone implants, it is a mystery why these products remain unavailable as an option for American women.