@Ilena: "<url>
The implant dilemma
Mon 13 Feb 2006 01:04 PM CST
WASHINGTON DC (myDNA News) 
Jean Winters was barely a teenager when she first thought of trying to
fix her breast "tubular deformities." 
At 30, after the birth of her first daughter, Winters went under the
knife. At first, everything was fine. But then, several years ago, she
developed itchy rashes, severe carpal tunnel syndrome and bouts of
fatigue and exhaustion. She assumed these symptoms were all unrelated
- perhaps a normal by-product of middle age or overworking.
"Every week, it seemed something worse was happening," said Winters.
In February 2003, she "developed hives and went into anaphylactic
shock for no apparent reason. I was sure I was going to die," she
said.
But then, later that fall, Winters got a magnetic resonance imaging
(MRI) test that showed a rupture in an implant. Her internist
confirmed that abnormal cells surrounding what was left of the implant
were the cause of her illness. And in April 2004, she underwent
surgery to have her implants removed.
Her experience is not unusual. 
One out of every 10 women in the U.S. has joint aches, muscle pains,
memory issues and chronic fatigue syndrome associated with receiving
breast implants, according to Ed Melmed, M.D., a specialist plastic
surgeon from the Medical City Hospital in Dallas, Tex.
"There is no difference - racial or ethnic - among women between 20
and 75 years of age," he said. And while things might seem fine
initially, nearly half of all implants will go bust in 10 year's time
- resulting in the creation of surrounding scar tissue. "It's like a
fly trapped into a spider's web," Melmed said.
Melmed is worried that "while the manufacturers say their devices are
100-percent safe, women come up with this 'missing-something-in-life'
syndrome." This leads many, like Winters, to pursue explant surgeries.
Afterward, 70 percent of individuals report a disappearance of
symptoms. 
A new report by the Washington, D.C.-based National Research Center
for Women and Families says that breast reconstruction patients
experience two to three times as many complications and additional
surgeries as augmentation patients. 
The most frequent problems are capsular contracture (a hardening of
scar tissue surrounding the implant), which causes the breast to feel
hard, and later the rupture of the implant, which can lead to
infections, bruising and blood collection at the wound site. 
The author of the report, Diana Zuckerman, Ph.D., said that "women are
very sensitive to silicone implants." "In our experience, it seems
that saline implants - given the chemical components in their shells -
can set off a reaction even more quickly than silicone gel breast
implants," she said.
Common reactions, she said, included rashes and hair loss. Joint pain,
chronic fatigue and memory problems are also issues. "Women in their
20s should not be experiencing those symptoms," she added. 
Zuckerman also chided the makers of breast implants, including Inamed
and Mentor, in the report: "After selling silicone breast implants to
tens of thousands of mastectomy patients in the last five years, under
the conditions that they participate in clinical trials, implant
manufacturer Inamed included only 80 such patients in their
longitudinal safety study submitted to the FDA (U.S. Food and Drug
Administration), and Mentor Corporation has not come up with any
useful information about rupture or silicone leakage for
reconstruction patients who have had their implants for more than two
years."
"There was a significant increase in autoimmune reactions when
researchers compared women before getting implants to the same women
two years after getting implants. It was shocking that the changes
were statistically significant after such a short time," she added.
Ilena Rosenthal, director of the San Diego-based Humantics Foundation
for Women, the largest breast implant support group in the world,
agreed. 
"The so-called 'studies' that the silicone manufacturers and plastic
surgeons rely on are too small, too short and include eliminating the
data from the women who removed their implants for any reason. This is
madness, such as removing anyone from a lung cancer study who coughed
or showed any other symptoms," she said.
The findings of the NRC research come on the heels of another report,
in January, when the 13-member Expert Advisory Panel on Breast
Implants recommended to the Canadian government agency, Health Canada,
that "a comprehensive breast implant registry would enhance our
understanding of the safety and efficacy of these devices, improve our
understanding of experiences with these devices, increase our ability
for conducting research on a large representative sample of women and
increase our knowledge of the health care utilization implications."
The panel recommended that implant manufacturers demonstrate that
leaked silicone provided an acceptable risk of hypersensitivity and
autoimmunity. At the same time, they also said "there is no current
scientific evidence to reliably support repeated - every one to two
years - breast MRIs for patients with breast implants." 
The assessment of silicone-filled breast implants, the panel said,
"should be at the discretion of the plastic surgeon, in consultation
with the patient, and preferably be based on new breast symptoms or
signs."
"MRIs are not always accurate, but their accuracy is higher if the
proper breast coil MRI equipment is used and the person reading the
MRI is experienced in what to look for," Zuckerman said. 
Melmed advises getting an MRI once every seven to 10 years to check
for implant ruptures.
When it comes to prevention of problems, the report suggested that
patients who suffer from depression or eating disorders be fully
treated prior to surgery. 
"It is obvious that women who seek any kind of plastic surgery should
be screened to make sure that their real problem isn't depression or
low self-esteem. Plastic surgeons say that they do this, but in fact,
they are not trained to screen for depression or mental problems,
don't know how to screen for mental problems, don't really want to
spend the time doing it, and there is not much incentive. After all,
they want these customers," Zuckerman said.
Rosenthal agreed. "This is a multi-billion dollar industry. Plastic
surgeons can make millions annually by performing only a handful of
breast augmentations a week. Removal is even more expensive and
profitable for them. The 'guarantees' by the manufacturers cover
replacement only - and not removal - and disinformation abounds
because the manufacturers have pooled their public relations dollars
with those of the oil, food, chemical and pharmaceutical industries to
turn 'science' upside down," she said.
"I remind women that there was no shortage of 'turn-on' of men for
women prior to breast implants! That healthy is 'sexy' ... energetic
is 'sexy' ... intelligence is 'sexy.' I tell them to fill their hearts
with love and appreciation of their health instead of a foreign object
which too frequently will cause them needless pain, expense and loss
of the breast tissue they have naturally," Rosenthal added.
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The implant dilemma
Mon 13 Feb 2006 01:04 PM CST
WASHINGTON DC (myDNA News) 
Jean Winters was barely a teenager when she first thought of trying to
fix her breast "tubular deformities." 
At 30, after the birth of her first daughter, Winters went under the
knife. At first, everything was fine. But then, several years ago, she
developed itchy rashes, severe carpal tunnel syndrome and bouts of
fatigue and exhaustion. She assumed these symptoms were all unrelated
- perhaps a normal by-product of middle age or overworking.
"Every week, it seemed something worse was happening," said Winters.
In February 2003, she "developed hives and went into anaphylactic
shock for no apparent reason. I was sure I was going to die," she
said.
But then, later that fall, Winters got a magnetic resonance imaging
(MRI) test that showed a rupture in an implant. Her internist
confirmed that abnormal cells surrounding what was left of the implant
were the cause of her illness. And in April 2004, she underwent
surgery to have her implants removed.
Her experience is not unusual. 
One out of every 10 women in the U.S. has joint aches, muscle pains,
memory issues and chronic fatigue syndrome associated with receiving
breast implants, according to Ed Melmed, M.D., a specialist plastic
surgeon from the Medical City Hospital in Dallas, Tex.
"There is no difference - racial or ethnic - among women between 20
and 75 years of age," he said. And while things might seem fine
initially, nearly half of all implants will go bust in 10 year's time
- resulting in the creation of surrounding scar tissue. "It's like a
fly trapped into a spider's web," Melmed said.
Melmed is worried that "while the manufacturers say their devices are
100-percent safe, women come up with this 'missing-something-in-life'
syndrome." This leads many, like Winters, to pursue explant surgeries.
Afterward, 70 percent of individuals report a disappearance of
symptoms. 
A new report by the Washington, D.C.-based National Research Center
for Women and Families says that breast reconstruction patients
experience two to three times as many complications and additional
surgeries as augmentation patients. 
The most frequent problems are capsular contracture (a hardening of
scar tissue surrounding the implant), which causes the breast to feel
hard, and later the rupture of the implant, which can lead to
infections, bruising and blood collection at the wound site. 
The author of the report, Diana Zuckerman, Ph.D., said that "women are
very sensitive to silicone implants." "In our experience, it seems
that saline implants - given the chemical components in their shells -
can set off a reaction even more quickly than silicone gel breast
implants," she said.
Common reactions, she said, included rashes and hair loss. Joint pain,
chronic fatigue and memory problems are also issues. "Women in their
20s should not be experiencing those symptoms," she added. 
Zuckerman also chided the makers of breast implants, including Inamed
and Mentor, in the report: "After selling silicone breast implants to
tens of thousands of mastectomy patients in the last five years, under
the conditions that they participate in clinical trials, implant
manufacturer Inamed included only 80 such patients in their
longitudinal safety study submitted to the FDA (U.S. Food and Drug
Administration), and Mentor Corporation has not come up with any
useful information about rupture or silicone leakage for
reconstruction patients who have had their implants for more than two
years."
"There was a significant increase in autoimmune reactions when
researchers compared women before getting implants to the same women
two years after getting implants. It was shocking that the changes
were statistically significant after such a short time," she added.
Ilena Rosenthal, director of the San Diego-based Humantics Foundation
for Women, the largest breast implant support group in the world,
agreed. 
"The so-called 'studies' that the silicone manufacturers and plastic
surgeons rely on are too small, too short and include eliminating the
data from the women who removed their implants for any reason. This is
madness, such as removing anyone from a lung cancer study who coughed
or showed any other symptoms," she said.
The findings of the NRC research come on the heels of another report,
in January, when the 13-member Expert Advisory Panel on Breast
Implants recommended to the Canadian government agency, Health Canada,
that "a comprehensive breast implant registry would enhance our
understanding of the safety and efficacy of these devices, improve our
understanding of experiences with these devices, increase our ability
for conducting research on a large representative sample of women and
increase our knowledge of the health care utilization implications."
The panel recommended that implant manufacturers demonstrate that
leaked silicone provided an acceptable risk of hypersensitivity and
autoimmunity. At the same time, they also said "there is no current
scientific evidence to reliably support repeated - every one to two
years - breast MRIs for patients with breast implants." 
The assessment of silicone-filled breast implants, the panel said,
"should be at the discretion of the plastic surgeon, in consultation
with the patient, and preferably be based on new breast symptoms or
signs."
"MRIs are not always accurate, but their accuracy is higher if the
proper breast coil MRI equipment is used and the person reading the
MRI is experienced in what to look for," Zuckerman said. 
Melmed advises getting an MRI once every seven to 10 years to check
for implant ruptures.
When it comes to prevention of problems, the report suggested that
patients who suffer from depression or eating disorders be fully
treated prior to surgery. 
"It is obvious that women who seek any kind of plastic surgery should
be screened to make sure that their real problem isn't depression or
low self-esteem. Plastic surgeons say that they do this, but in fact,
they are not trained to screen for depression or mental problems,
don't know how to screen for mental problems, don't really want to
spend the time doing it, and there is not much incentive. After all,
they want these customers," Zuckerman said.
Rosenthal agreed. "This is a multi-billion dollar industry. Plastic
surgeons can make millions annually by performing only a handful of
breast augmentations a week. Removal is even more expensive and
profitable for them. The 'guarantees' by the manufacturers cover
replacement only - and not removal - and disinformation abounds
because the manufacturers have pooled their public relations dollars
with those of the oil, food, chemical and pharmaceutical industries to
turn 'science' upside down," she said.
"I remind women that there was no shortage of 'turn-on' of men for
women prior to breast implants! That healthy is 'sexy' ... energetic
is 'sexy' ... intelligence is 'sexy.' I tell them to fill their hearts
with love and appreciation of their health instead of a foreign object
which too frequently will cause them needless pain, expense and loss
of the breast tissue they have naturally," Rosenthal added.
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