Specifically,  the device manufacturer through a 510(k) submission must notify FDA at  least 90 days before it intends to market a new device and establish that  such device is substantially equivalent to a predicate device. To be  substantially equivalent, a device must (1) have the same intended use  as the predicate device; and (2) have the same technological  characteristics as the predicate device, or have different technological  characteristics but submitted information demonstrates the device is as  safe and effective as the predicate device, and does not raise different  questions of safety or effectiveness. FDA Cleared 25 Power Morcellators; Most Devices Had the Same Intended Use and Technological Characteristics, and Could Be Used for Gynecological Surgeries

FDA documentation shows the agency cleared 25 510(k) submissions for  power morcellators to be marketed in the United States between 1991  and 2014. FDA Understood the Risk of an Unsuspected Uterine Cancer That Could Be Spread When Using a Power Morcellator to be Low; Has Taken Actions in Response to Adverse Event Reports

FDA was aware of the potential for spreading tissue when using a power  morcellator prior to receiving the first adverse event reports; however, the  general understanding was that the risk of an unsuspected cancer that  could be spread when using the device was low. In response to adverse  event reports, FDA has taken several actions, including estimating cancer  risk, warning against certain uses of power morcellators, and  recommending new labeling. Prior to Adverse Event Reports, FDA Was Aware of the Potential for Power Morcellators to Spread Tissue, but Understood the Risk of Unsuspected Cancer that Could Be Spread to be Low

FDA officials were aware of the potential for spreading tissue during  procedures that involved the use of power morcellators before receiving  the first adverse event reports describing the spread of cancerous tissue  after the use of a power morcellator to treat uterine fibroids. Specifically,  according to FDA officials, the potential for spreading tissue—cancerous  or noncancerous—following the use of a power morcellator has been  known since the agency cleared the first device in 1991. FDA’s Response to First Adverse Event Reports Included Estimating Cancer Risk, Warning Against the Use of Power Morcellators, and Recommending New Labeling

FDA took several actions after receiving the first adverse event reports in  December 2013 describing the spread of cancerous tissue after using a  power morcellator to treat uterine fibroids. 3.) Based on  this review, FDA estimated that about 1 in 350 women undergoing the  surgical procedures of hysterectomy or myomectomy to treat uterine  fibroids was at risk for having an unsuspected uterine sarcoma. FDA issued an “immediately in effect” guidance  document in November 2014. In December 2015, FDA initiated inspections at  selected hospitals to review their compliance with medical device  reporting requirements, which specify that hospitals and other user  facilities must report certain device-related events to FDA and to  manufacturers when the manufacture is known. Questions Remain Regarding the Use of Power Morcellators to Treat Uterine Fibroids, and FDA Continues to Monitor Available Information

Questions remain regarding the use of power morcellators in the  treatment of uterine fibroids, which include varying stakeholder opinions  regarding the risks related to the use of power morcellators. Professional Societies Provided Guidance Regarding the Use of Power Morcellators, While Device Manufacturers Provided Instructions and Technical Training

The professional societies we contacted did not have any professional  standards or training requirements for physicians specifically regarding  the use of power morcellators, but some societies issued guidance to  physicians related to procedures that could involve the use of power  morcellators. Officials from the three health care providers that we interviewed  indicated that physicians may receive training in using power morcellators  during their medical residency (for example, if their attending physician  used the device). Manufacturers Provided Instructions and Offered Technical Training on the Use of Power Morcellators

All of the 25 power morcellators cleared by FDA included instructions  from the manufacturers for using the device, and some of the  manufacturers offered technical training for physicians. We found the labeling for the  25 power morcellators included instructions for use (submitted by the  manufacturers to FDA as part of the agency’s premarket review of the  devices), which provided information such as device assembly, use,  disassembly, and safety information. Agency Comments

We provided a draft of this report to the Secretary of Health and Human  Services. HHS provided technical comments that were incorporated as  appropriate. According to FDA  officials, of the 2,185 device inspections conducted in fiscal year 2015,  875 included a review of medical device reporting. Appendix II: History of Predicate Devices for the First Laparoscopic Power Morcellator

In clearing the first laparoscopic power morcellator in 1991 through the  510(k) premarket notification process, the Food and Drug Administration  (FDA) determined the device was substantially equivalent to an  electromechanical system for cutting tissue during minimally invasive  surgeries performed on knees and other joints.
Why GAO Did This Study

In December 2013, media reports raised concerns regarding the use of power morcellators in the surgical treatment of women with uterine fibroids. These concerns focused on the spread of an unsuspected uterine cancer after such use of the devices.
GAO was asked to review power morcellator medical devices. This report examines (1) the number of 510(k) submissions for power morcellators FDA cleared, and the extent to which the agency determined the devices had new intended uses or new technological characteristics; (2) FDA's understanding of any concerns with the use of power morcellators to treat uterine fibroids prior to receiving adverse event reports, and the actions FDA has taken in response to these reports; and (3) the professional standards and guidance for physicians regarding the use of power morcellators, and the information device manufacturers provided. GAO reviewed documentation of FDA's decision-making and guidance and manufacturers' device labeling, and interviewed FDA officials. In addition, GAO reviewed documents and contacted officials from 10 professional societies and other organizations that have a potential interest in the use of power morcellators, and three health care providers that performed gynecological procedures that could involve the use of the devices. GAO also contacted all 12 manufacturers for the power morcellators FDA cleared for the U.S. market.
The Department of Health and Human Services provided technical comments on a draft of this report, which were incorporated as appropriate.

What GAO Found

Between 1991 and 2014, the Food and Drug Administration (FDA)—the federal agency responsible for the oversight of medical devices—cleared 25 submissions for laparoscopic power morcellators for the U.S. market. FDA cleared the submissions for these devices, which cut tissue into small pieces to facilitate removal through small incision sites of gynecological and other types of minimally invasive surgeries, through its premarket notification process. Under this process, established under section 510(k) of the Federal Food, Drug, and Cosmetic Act, FDA reviews information submitted by a device manufacturer and determines whether the new device is substantially equivalent to another legally marketed device, known as a predicate device. In making this determination, FDA assesses whether a device has (1) the same intended use; and (2) the same technological characteristics as a predicate device, or has different technological characteristics but submitted information demonstrates the device is as safe and effective as the predicate device, and does not raise different questions of safety or effectiveness. A device determined to be substantially equivalent is cleared to be marketed. For power morcellators, FDA determined the devices in all 25 of the 510(k) submissions had the same intended use as their predicates, while 6 had new technological characteristics.
Prior to receiving adverse event reports, FDA understood the risk of having an unsuspected cancer that could be spread using a power morcellator as low; in response to such reports, the agency has taken several actions. According to FDA officials, the agency was aware of the potential for power morcellators to spread tissue (cancerous and noncancerous) when the agency cleared the first device in 1991. FDA officials noted that, at the time, the risk of having a type of uterine cancer that can resemble noncancerous uterine tumors, called fibroids, was thought to be low based on available information. After receiving reports in December 2013 about the spread of an unsuspected cancer following the use of power morcellators in surgeries to treat fibroids, FDA estimated the cancer risk to women undergoing these surgeries to be about 1 in 350 for one type of cancer. FDA issued a safety communication in November 2014 warning against certain uses of power morcellators—specifically in treating uterine fibroids. The agency also issued guidance recommending that manufacturers add a boxed warning to their device labeling, which all current manufacturers followed, and conducted inspections to review hospitals' compliance with medical device reporting requirements. As questions remain related to the use of power morcellators, FDA has continued to monitor adverse event reports, among other actions.
Professional societies provided some guidance to physicians regarding the use of power morcellators, while manufacturers of the devices provided instructions and some technical training. According to officials at professional societies that GAO contacted, there are no professional standards specific to the use of power morcellators, but some guidance and educational resources are available for surgical procedures to treat uterine fibroids in which the devices may be used. Training requirements for physicians using power morcellators generally occur at hospitals as part of the processes to ensure that physicians have suitable experience and abilities. Manufacturers provide instructions for use, and some offer technical training that demonstrates device set-up, operation, and cleaning.