Medical Devices: Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators and Recommend New Labeling
Published: 2017-02-07T00:00:00

Fast Facts:
In 1991, FDA allowed the first laparoscopic power morcellator—a device that cuts tissue into small pieces, which can be removed during minimally invasive surgeries—on the U.S. market. In late 2013, the agency began to receive reports that these devices may spread a difficult-to-diagnose cancer when used to treat uterine fibroids.
In April 2014, FDA estimated that the risk of having the type of uterine cancer identified in these first reports was higher than previous estimates. The agency warned against the use of power morcellators to treat fibroids and recommended new labeling, which all current manufacturers followed.

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.

section_title: Letter
paragraphs: Americans depend on the Food and Drug Administration (FDA), an  agency within the Department of Health and Human Services (HHS), to  oversee the safety and effectiveness of medical devices marketed in the  United States. Beginning in late 2013, media reports raised concerns  regarding the safety of one particular medical device, a laparoscopic  power morcellator, which cuts tissue into small pieces for removal during  minimally invasive surgery. Specifically, these reports described the  experience of a patient who underwent surgery involving the use of a  power morcellator for the treatment of uterine tumors, known as fibroids,  which, by definition, are presumed to be noncancerous. However,  according to these reports, this patient also had an unsuspected and  difficult to diagnose type of cancer and the use of a power morcellator  was thought to have resulted in the spreading of cancerous tissue and  worsening the likelihood of her long-term survival.
FDA’s oversight of medical devices begins before a new device is brought  to the market and continues after a device is on the market. For most  medical devices that require premarket review, including power  morcellators, FDA determines whether they should be allowed to be  marketed in the United States through the agency’s premarket notification  process established under section 510(k) of the Federal Food, Drug, and  Cosmetic Act. Specifically, under this process, FDA reviews information  submitted by the device manufacturer (in a 510(k) submission) and  determines whether the new device is substantially equivalent to another  legally marketed device, known as a predicate device. To be substantially  equivalent, a device must (1) have the same intended use as a 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. A device determined to be substantially equivalent is  cleared to be marketed in the United States. As part of its postmarket  oversight efforts, FDA requires medical device manufacturers, importers,  and user facilities (such as hospitals) to report events in which a  marketed device may have caused or contributed to a death or serious  injury, known as an adverse event. FDA also encourages voluntary  reporting of adverse events from healthcare professionals, patients,  caregivers, and consumers. FDA received the first adverse event reports  describing the spread of cancer after the use of a power morcellator to  treat uterine fibroids about the same time the first media reports raising  concerns over the use of the devices were published in December 2013.
Given concerns about the safety of power morcellators, you asked us to  examine FDA’s clearance of the devices for the U.S. market, the agency’s  response to adverse event reports, and relevant information and training  on the use of power morcellators. This report examines  1.  the number of 510(k) submissions for power morcellators FDA cleared  for the U.S. market, and the extent to which the agency determined  the devices had the same intended uses or technological  characteristics as predicate devices;  2.  FDA’s understanding of any concerns with the use of power  morcellators to treat uterine fibroids prior to receiving adverse event  reports, and what actions the agency has taken in response to these  reports; and  3.  the professional standards and guidance for physicians regarding the  use of power morcellators, and the instructions for use and training  provided by device manufacturers.
To determine the number of 510(k) submissions for power morcellators  FDA cleared for the U.S. market, and the extent to which the agency  determined they had the same intended uses or technological  characteristics, we examined information from FDA’s publicly available  510(k) database and FDA’s files of 510(k) submissions. The 510(k)  database contains information on devices cleared through FDA’s 510(k)  premarket review process, including the device, the device  manufacturer’s name, the date FDA determined the device was  substantially equivalent to a predicate device, and an FDA-assigned  product code that can be linked to a medical specialty. We searched the  510(k) database files in order to identify potential power morcellators and  then reconciled those identified to a list of power morcellators provided by  FDA. To determine the extent to which these devices had the same  intended uses and same technological characteristics as predicate  devices, we conducted a review of information from FDA’s 510(k)  submission files in July 2016. During this file review, we collected data  concerning the steps FDA officials took to reach a determination that the  devices were substantially equivalent to predicate devices. This included  the incremental decisions FDA made concerning the intended use and  technological characteristics, and in sum, defined the path the FDA  reviewers took to reach a determination of substantially equivalent for  each submission. We recorded the individual decisions made for each  power morcellator, and analyzed the results. In addition, we reviewed  relevant FDA policy and guidance documents, and interviewed  knowledgeable agency officials regarding the clearance of power  morcellators.
To identify FDA’s understanding of any concerns regarding 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, we reviewed device labeling for power morcellators, information  from FDA’s adverse event databases, and FDA documentation regarding  agency actions, including policy and guidance documents and safety  communications issued. We examined FDA’s public adverse event data  for reports the agency received from January 1996 through June 2016 to  corroborate information we received from FDA on adverse event reports  (both the date the agency received the first report and the number of  reports received) about the potential spread of cancer following the use of  a power morcellator to treat uterine fibroids. We conducted a literature  search for articles regarding the prevalence of uterine cancer and risks of  spreading cancer when using a power morcellator to treat uterine fibroids  that were published in peer-reviewed journals between January 1980 and  March 2016. We interviewed FDA officials knowledgeable about the  agency’s understanding of the risk related to power morcellation and  FDA’s actions in response to adverse event reports involving the spread  of cancerous tissue when using a power morcellator. We also contacted  officials from 10 professional societies and other stakeholder  organizations that have a potential interest in the use of power  morcellators. We selected these professional societies and other  stakeholders to include organizations (1) that represent member  physicians that may use power morcellators to treat uterine fibroids, (2)  that accredit individual physicians and hospitals, and (3) that represent  device manufacturers. Of the 10, we interviewed officials and/or reviewed  information from 6 organizations. The perspectives of the officials from  these selected professional societies and other stakeholder organizations  are not generalizable, but they provided insight on these issues.
To identify professional standards and guidance for physicians regarding  the use of power morcellators, and the instructions for use and training  provided by device manufacturers, we interviewed officials from the  selected professional societies and three selected health care providers.  We selected health care providers that performed gynecological  procedures that could involve the use of a power morcellator, which  included two hospitals that had an accredited surgical residency program  for the 2016–2017 academic year and a physicians group. The  perspectives of the officials from selected health care providers are not  generalizable, but provided us with valuable insight on the training  requirements for physicians who use power morcellators. We also  contacted all 12 manufacturers for the power morcellators FDA cleared  for the U.S. market and asked about their instructions for use and  training. We received information from three manufacturers. Other  manufacturers we contacted did not provide information, citing ongoing  litigation involving their power morcellator devices, or that their power  morcellators were no longer marketed in the United States, among other  reasons.
To assess the reliability of FDA’s data on 510(k) submissions and  adverse event reports, we reviewed relevant documentation and traced  some data to FDA source documentation. On this basis, we determined  that these data were sufficiently reliable for our purposes.
We conducted this performance audit from February 2016 to February  2017 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: Uterine Fibroids and Treatment  Uterine fibroids are noncancerous growths  that develop from the muscular tissue of the  uterus. Most women will develop uterine  fibroids at some point in their lives, although  most cause no symptoms. In some cases,  however, uterine fibroids can cause  symptoms, including heavy or prolonged  menstrual bleeding, pelvic pressure or pain, or  frequent urination, requiring medical or  surgical therapy.  Treatment for uterine fibroids includes   surgical procedures to remove the uterus  (hysterectomy) or to remove the fibroids  (myomectomy). These surgical procedures  can be done via minimally invasive  laparoscopic procedures or through traditional  surgical procedures, such as an abdominal  hysterectomy. Other treatments   for uterine fibroids include, for example,   high-intensity focused ultrasound, and   drug therapy.
Power morcellators are medical devices used during laparoscopic  (minimally invasive) surgeries. Morcellation refers to the cutting of tissue  into smaller fragments for removal from the body. In laparoscopic surgical  procedures, morcellation facilitates the extraction of large pieces of tissue  through small incisions. Over time, laparoscopic surgeons have applied  different manual methods of morcellation using scalpels, forceps, and  other tools that require repetitive manual motions, such as twisting. Power  morcellators generally use an electromechanical motor to spin a  cylindrical blade within a tube for cutting and removing tissue.
Power morcellators can be used during different types of laparoscopic  surgeries, including general surgical procedures, such as spleen and liver  surgeries; urological surgical procedures, such as kidney removal  surgeries; and gynecological surgical procedures. These laparoscopic  gynecological procedures include two types of surgeries used to treat  uterine fibroids: (1) the removal of the uterus, known as hysterectomy;  and (2) the removal of individual fibroids, known as myomectomy. Some  women may prefer laparoscopic hysterectomies and myomectomies,  because these procedures are associated with such benefits as a shorter  post-operative recovery time and, for laparoscopic hysterectomies, a  reduced risk of infection compared to open procedures.
Medical devices, including power morcellators, are regulated by FDA. The  agency classified most power morcellators as class II devices, meaning  that FDA generally considers them to be higher-risk than class I devices  and lower-risk than class III devices. For most class II devices, FDA  determines whether they should be legally marketed in the United States  through the agency’s 510(k) premarket notification process. 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. Figure 1 shows FDA’s decision- making flowchart for its 510(k) premarket notification process in effect  when FDA cleared the 510(k) submissions for power morcellators prior to  July 2014.
Once a new medical device is on the market, medical device user  facilities, manufacturers, and importers must comply with medical device  reporting requirements. Under these requirements, these parties must  report device-related adverse events, including events that reasonably  suggest a device has or may have caused or contributed to a death or  serious injury, in a timely manner. For example, user facilities must report  such deaths and serious injuries within 10 work days of becoming aware  of information reasonably suggesting the device may have caused or  contributed to the death or serious injury. Within this time frame, deaths  must be reported to both FDA and the manufacturer, if known, and  serious injuries must be reported to the manufacturer, or, if the  manufacturer is unknown, to FDA. Consumers and other parties may  voluntarily report adverse events directly to FDA. The agency maintains  databases that house both mandatory and voluntary reports of device- related adverse events.
While adverse event reports may provide the first signal that a problem  exists with a device or its use, or both, FDA and others have reported that  information from these reports can be limited. Examples of identified  limitations include the following  Incomplete or erroneous reporting. Adverse event reports can  include incomplete reporting, where key data are not reported, or  erroneous reporting, where the information provided is not accurate.
Reports that are not timely. Adverse event reporting does not  always reflect real time reporting, as some reports document events  that occurred years earlier.
Underreporting. Adverse events may not always be reported. (See  app. I for additional information on medical device reporting  requirements.)
In addition to adverse event reporting, FDA conducts other postmarket  surveillance activities to obtain information about devices after they are  on the market. For example, FDA may order a manufacturer to conduct a  postmarket surveillance study if failure of a class II or class III device  would be reasonably likely to have serious adverse health  consequences.
section_title: FDA Cleared 25 Power Morcellators; Most Devices Had the Same Intended Use and Technological Characteristics, and Could Be Used for Gynecological Surgeries
paragraphs: FDA documentation shows the agency cleared 25 510(k) submissions for  power morcellators to be marketed in the United States between 1991  and 2014. In clearing the first of the 25 power morcellators in 1991, FDA  determined the new device was substantially equivalent to an  electromechanical system for cutting tissue during minimally invasive  surgeries performed on joints, known as an arthroscopic surgical  system. (For more information on this predicate device, see app. II.)  FDA determined the other 24 power morcellators—the most recent of  which was cleared in May 2014—were substantially equivalent to at least  one previously cleared power morcellator. We also found that for most  power morcellators the documentation we reviewed referenced more than  one predicate device. As shown in table 1, the additional devices  referenced by manufacturers included other previously marketed devices,  such as manual morcellators, forceps, and various accessories used for  laparoscopic surgeries. FDA officials stated that the additional devices referenced likely informed FDA’s decision-making for all 25 power  morcellators. However, FDA’s determinations of substantial equivalence  were based on only one predicate device, the arthroscopic surgical  system for the first power morcellator cleared and a previously cleared  power morcellator for the other 24 devices, according to agency  officials. (For more information on each of the 25 power morcellators  cleared by FDA, see app. III.)
Among the 25 cleared morcellators, we found that FDA determined that  all had the same intended use and 19 had the same technological  characteristics as their predicate devices; the agency also reviewed  performance data for 11 of them. (See fig. 2.)
In our review of the FDA documentation for power morcellators, we found  that the agency determined that all 25 devices had the same intended  use as their predicate devices. In making this determination, FDA also  determined that 4 power morcellators had different indication statements  compared to the predicate devices, but the differences did not alter the  intended use of each device. In general, the indication statements for the  4 power morcellators identified new or fewer procedures during which the  devices were to be used compared to the predicates. For example, the  indication statement for a power morcellator FDA cleared in 2000  specifically identified use in hysterectomies where the predicate’s  indication statement only identified myomectomies. In another example,  the indication statement of a power morcellator cleared in 2011 only  identified use in gynecological procedures where the predicate identified  general surgical and urological procedures, in addition to gynecological.  For all 4 devices, however, FDA determined that the differences in  indication statements did not alter the intended effect of the devices or  raise new questions of safety or effectiveness, and determined, overall,  that the power morcellators had the same intended use as their  predicates.
We also found that FDA determined that 19 of the 25 power morcellators  had the same technological characteristics as their predicate devices,  while 6 devices did not. According to FDA officials, the technological  characteristics of these 6 power morcellators that were different included  the change from the use of a vacuum to suction tissue into the  morcellator to the use of forceps to grasp tissue for this purpose;  the change from single use, disposable body or blade to ones that are  reusable;  the change from a rotary cutting action to one that is reciprocating;  and  the addition of the ability to control suction with a foot switch.
In addition, for 11 power morcellators, we found that FDA reviewed  performance data. These included 3 power morcellators for which FDA  determined that different technological characteristics could affect safety  and effectiveness, and 8 other power morcellators for which the device  description was not sufficient to determine whether the devices were  substantially equivalent to predicate devices. For these 11 devices, FDA  reviewed performance data—which, according to agency officials,  included data such as those from testing the wear of components,  electrical safety, and electromagnetic compatibility—and determined that  the devices were substantially equivalent to predicates.
Based on our review of FDA documentation, we also found nearly all of  the 25 power morcellators were indicated for use in gynecological surgical  procedures. We found the indications for use for 14 power morcellators  specifically identified laparoscopic gynecological procedures, such as  myomectomies and hysterectomies:  the indications for use of 4 devices identified gynecological  procedures only,  the indications for use of 2 devices identified general surgery and  gynecological procedures, and  the indications for use of 8 devices included general surgery,  gynecological, and urological procedures.
For the 11 other devices, 9 power morcellators had indications for use for  general surgical procedures, which could include gynecological  procedures. (See table 2.)
section_title: 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
paragraphs: 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. However, questions remain regarding the  use of power morcellators to treat uterine fibroids, and FDA continues to  monitor available information.
subsections: section_title: 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
paragraphs: 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. We found that  this awareness was reflected in the labeling for 12 of the 25 devices  cleared by FDA. The labeling for these power morcellators recommended  the use of a bag when cutting cancerous (diagnosed or suspected) tissue  and any other tissue that may be considered harmful if spread.
FDA officials noted that articles reporting the risk of spreading tissue  following the use of a power morcellator to treat uterine fibroids were  published prior to the agency receiving the first adverse event reports in  December 2013. Agency officials, however, noted that at the time, there  was no consensus within the clinical community regarding the risk of this  occurring, particularly for cancerous tissue. We identified 30 such articles  published between 1980 and 2012 that mentioned or concluded a risk of  tissue dissemination following the use of a power morcellator, or the need  for a physician to remove all fragments of tissue following a surgery. Most  of these articles involved case studies or were limited in scope. For  example, one case study published in 2010 looked at a single patient  who, after undergoing a hysterectomy to treat a uterine fibroid, was found  to have a previously unsuspected sarcoma (a type of cancer), and  concluded that there is a potential risk of spreading the unsuspected  cancer following morcellation. None of the articles that we identified  estimated the risk of spreading tissue, cancerous or noncancerous,  during power morcellation.
Uterine Sarcoma  Uterine sarcoma is a cancer of the muscle  and supportive tissues of the uterus. Uterine  sarcoma is one of two types of uterine cancer  (endometrial carcinoma is the other, more  common type of uterine cancer). The  American Cancer Society estimates that less  than 4 percent of uterine cancers are uterine  sarcoma. Of the two types of uterine cancer,  uterine sarcoma tends to be more aggressive,  more difficult to diagnose before surgery, and  have worse prognoses. Leiomyosarcoma is a  type of uterine sarcoma that, similar to  fibroids, develops in the muscular tissue of the  uterus. Leiomyosarcoma can resemble a  fibroid and, as a result, can be difficult to  diagnose before surgery.
Though the risk of spreading tissue during power morcellation was  known, FDA officials stated that prior to December 2013, the general  understanding was that the risk of a woman undergoing treatment for  fibroids having unsuspected cancer—specifically, a difficult to diagnose  cancer called uterine sarcoma—was low. Therefore, the risk of a power  morcellator spreading a uterine sarcoma would be expected to be low, as  it could be no higher than the risk of having a uterine sarcoma. In  addition, FDA officials were not aware of any definitive scientific  publications regarding the actual risk of cancer in uterine fibroids (by  definition presumed to be noncancerous), which is generally consistent  with statements by two professional societies. FDA officials noted that  published estimates for an unsuspected cancer (specifically uterine  sarcoma) in a woman with a presumed uterine fibroid varied from about 1  in 1,000 women to 1 in about 10,000 women. These estimates of the risk  of cancer depended on several factors, including the cancer diagnosis  (e.g., uterine sarcoma or a category of uterine sarcoma called  leiomyosarcoma), the type of treatment for uterine fibroids (e.g.,  hysterectomy or myomectomy), or the patient population included in the  estimate (e.g., women of reproductive age or women who are older). One  2012 study that examined 1,091 instances of uterine morcellation at one  hospital, however, reported that the rate of unsuspected cancer (uterine  sarcoma) after laparoscopic morcellation was 9 times higher than the rate  quoted to patients at the time (1 in 10,000), and concluded that uterine  morcellation carries a risk of spreading unsuspected cancer.
section_title: FDA’s Response to First Adverse Event Reports Included Estimating Cancer Risk, Warning Against the Use of Power Morcellators, and Recommending New Labeling
paragraphs: 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. (See fig. 3.) See appendix IV  for a more detailed timeline of FDA actions and other events related to  power morcellators.
FDA’s actions included the following
Convening a signal review team. In December 2013, FDA began  forming a signal review team to coordinate and lead the agency’s  evaluation and response to the potential safety issue related to power  morcellators. According to FDA officials, the team started meeting  weekly and collecting information on the devices, adverse event  reports, and scientific literature in January 2014.
Estimating the prevalence of cancer in women undergoing  surgical treatment for uterine fibroids. In April 2014, FDA  published the results of a review of scientific literature to estimate the  prevalence of cancer (specifically sarcoma and leiomyosarcoma) in  women undergoing surgical treatment for uterine fibroids. 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  also estimated that about 1 in 500 such women were at risk for having  one certain type of uterine sarcoma, leiomyosarcoma. FDA officials  told us that these estimates were significantly higher than what had  been traditionally quoted (1 in 1,000 to 1 in 10,000).
Issuing an initial safety communication. In April 2014, FDA issued  a safety communication discouraging the use of power morcellators in  surgical procedures (hysterectomies and myomectomies) to treat  uterine fibroids. In discouraging this use, FDA cited the lack of a  reliable method for predicting whether a woman with uterine fibroids  may have an unsuspected cancer; specifically, a uterine sarcoma.  The agency also noted that if a power morcellator is used on women  with an unsuspected uterine sarcoma, the procedure may spread  cancerous tissue within the abdomen and pelvis, significantly  worsening the patient’s likelihood of long-term survival. The safety  communication also recommended that health care providers carefully  consider all the available treatment options for women with  symptomatic uterine fibroids and thoroughly discuss the benefits and  risks of all treatments with patients. FDA also noted that it had  instructed manufacturers that produced power morcellators used to  treat uterine fibroids to review their device labeling for accurate risk  information for patients and providers.
Convening a meeting of the Obstetrics and Gynecology Devices  Panel of FDA’s Medical Devices Advisory Committee. In July  2014, FDA convened an expert panel and guest speakers to present  their views and available data related to the potential power  morcellator safety issue. The panel discussed patient populations in  which power morcellators should not be used, specifically mentioning  patients with known or suspected cancer. The panel also discussed  mitigation strategies, including the possibility of adding a warning to  power morcellator labeling related to the risk of spreading an  unsuspected cancer.
Issuing guidance. FDA issued an “immediately in effect” guidance  document in November 2014. The guidance noted that recent  discussions with the patient and clinical communities, as well as the  peer-reviewed medical literature, had raised awareness of the risk of  spreading unsuspected cancerous tissue beyond the uterus when  power morcellators are used during surgeries intended to treat uterine  fibroids. For power morcellators with a general or gynecologic  indication for use, the guidance recommended the addition of specific  safety statements to the product labeling for laparoscopic power  morcellators, including two contraindications and a boxed warning that  the use of power morcellators during fibroid surgery may spread  cancer. (See fig. 4.) FDA also recommended that manufacturers  submit their revised labeling language to FDA, as well as to the  hospitals and other facilities that had previously purchased power  morcellators. We found that the manufacturers of the 10 power  morcellators with indications for use for general surgical or  gynecological procedures marketed as of November 2016 followed  the recommendation, providing FDA with updated labeling.  Information provided by FDA indicated that manufacturers also  contacted hospitals and other user facilities that purchased their  power morcellators, providing the updated labeling and instructing  them to switch out any old labeling. Half of the manufacturers also  instructed the user facilities to mail back a receipt of  acknowledgement regarding the safety alert to the manufacturer.
Issuing an updated safety communication. At the same time it  issued guidance in November 2014, FDA issued an updated safety  communication warning against the use of power morcellators in the  majority of women undergoing surgery (hysterectomy or  myomectomy) to treat uterine fibroids. This safety communication  recommended that doctors thoroughly discuss the benefits and risks  of all treatments with their patients. The updated safety  communication also specified that FDA considers the spread of  unsuspected cancer when using a power morcellator for hysterectomy  or myomectomy to treat uterine fibroids as a serious injury, which is a  reportable adverse event under the agency’s medical device reporting  requirements.
Inspecting selected user facilities for compliance with adverse  event reporting. 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. These inspections  included five hospitals that, according to FDA officials, were chosen  because there were reports of adverse events at these facilities  related to the spread of uterine cancer from the use of power  morcellators. FDA identified significant deviations from medical  device reporting requirements at these hospitals based on its review  of the inspection evidence. FDA investigators’ observations included  user facilities’ failure to report adverse events within required time  frames or to establish and maintain files for medical device  reporting—that is, adverse event reports. The agency determined  that corrective action plans presented by two of the five hospitals were  adequate, and according to FDA officials, the agency worked with the  three other hospitals to help ensure appropriate corrective actions  were taken.
section_title: Questions Remain Regarding the Use of Power Morcellators to Treat Uterine Fibroids, and FDA Continues to Monitor Available Information
paragraphs: 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. For example,  FDA officials noted there was limited information available to assess how  the risk of spreading cancerous tissue is affected when the morcellation is  performed using a power morcellator or through manual morcellation  (e.g., using a scalpel). Similarly, officials from one professional society  also stated that they were not aware of any reliable data showing that  power morcellation spreads tissue any worse than other morcellation  techniques. In addition, professional societies have questioned or noted  concerns with FDA’s estimate of the risk of cancer (uterine sarcoma) in  women who undergo surgical treatment of uterine fibroids, citing  limitations related to FDA’s methodology. One professional society’s open  letter to FDA included concerns regarding the keywords FDA officials  used to find the studies included in their estimate, stating that those  keywords may have limited the number of studies used to develop the  agency’s estimate. The letter also asserted that FDA’s estimate was  higher than a more appropriate estimated risk of uterine cancer of about 1  in 1,500 to 1 in 2,000. FDA officials have acknowledged limitations,  such as the small number of studies, in their estimate, but stated that  estimates in more recently representative published studies have  generally been consistent with the agency’s estimate.
Continuing questions also include the long-term effects of FDA’s  guidance on patients, according to the stakeholders we interviewed. Two  professional societies we contacted have expressed concern that FDA’s  decision to discourage the use of power morcellators in laparoscopic  surgeries (hysterectomies and myomectomies) to treat uterine fibroids  limits women’s health options. According to officials from the two  societies, the reduction or elimination of laparoscopic surgery using a  power morcellator to treat uterine fibroids—in response to FDA’s safety  communication and guidance—may lead to an increased use of  abdominal hysterectomies, a surgical procedure that typically does not  involve the use of power morcellators, but is associated with other risks.  One professional society noted that abdominal hysterectomies require  larger incisions, slower recovery time, and present the patient with higher  mortality rates and complications than laparoscopic hysterectomies.  However, FDA officials noted that one 2016 study reported a decline in  the use of power morcellators in hysterectomies since the agency issued  its November 2014 guidance, and found no increase in complications  from abdominal hysterectomies.
While these questions remain, FDA officials stated that the agency  continues to review scientific literature regarding the use of power  morcellators to treat uterine fibroids as new studies have been conducted  since 2014. We found more than 50 articles on the risk of uterine cancer  in women or the use of morcellation in women undergoing gynecologic  surgeries like hysterectomy and myomectomy—including peer-reviewed  articles, case studies, and opinion pieces—that have been published  since December 2013.
FDA also continues to monitor available adverse event information  regarding the use of power morcellators, while acknowledging the  limitations of the available information. FDA reported that, as of  September 2016, the agency had identified 285 adverse event reports  about the spread of an unsuspected cancer following the use of a power  morcellator. According to FDA officials, the majority (over 88 percent) of  these reports were mandatory reports submitted by manufacturers. The  remainder were voluntary reports from patients and their families, as well  as physicians (about 10 percent) and mandatory reports from hospitals  and other user facilities (less than 2 percent). According to FDA officials,  of the 285 adverse event reports regarding power morcellators and the  spread of unsuspected cancer that the agency received through  September 2016, 5 were related to events occurring after FDA issued its  guidance and updated safety communication in November 2014. FDA  officials noted, however, the limitations in the current, passive, medical  device reporting system, which relies on people to identify that a harm  occurred or a risk is present, recognize that the harm or risk is associated  with the use of a particular device, and take the time to report it. For  power morcellators, officials from three health care providers (two  hospitals and one physician group) that we spoke to stated that prior to  November 2014, physicians would likely not have considered the  spreading of an unsuspected cancer following the use of a power  morcellator as a reportable adverse event, because the device would  have performed as intended (e.g., cutting and extracting tissue). FDA’s  inspections of manufacturers of power morcellators and hospitals that use  them have also identified issues related to medical device reporting of  adverse events. (See app. I for more information on FDA inspections  related to medical device reporting.)
Recognizing the limitations in its current postmarket surveillance  activities, the agency reported plans to generate better information in the  future. For example, in October 2016, the agency reported plans to work  with hospitals to identify a system that quickly identifies life-threatening  problems caused by medical devices. FDA officials also noted they will  continue to review new technologies, such as morcellation containment  systems, and work on a national registry to collect data on the treatment  of fibroids. In addition, FDA is working to establish a National Evaluation  System for health Technology to more efficiently generate better evidence  for medical device evaluation and regulatory decision-making.
section_title: Professional Societies Provided Guidance Regarding the Use of Power Morcellators, While Device Manufacturers Provided Instructions and Technical Training
paragraphs: 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. The training requirements for physicians performing  procedures like hysterectomies are typically determined at the hospital  level. All power morcellator manufacturers provided instructions for use,  and some offered technical training.
subsections: section_title: Professional Societies Do Not Have Specific Standards on the Use of Power Morcellators, but Some Provided Guidance on Procedures That Could Involve the Device
paragraphs: Officials from three professional societies we contacted—AAGL (formerly  the American Association of Gynecologic Laparoscopists), the American  Board of Obstetrics and Gynecology (ABOG), and the American  Congress of Obstetricians and Gynecologists (ACOG)—stated that there  are no professional standards issued by their societies that apply to  member physicians specifically regarding the use of power morcellators.  ABOG, which certifies obstetricians and gynecologists in the United  States, does not deal directly with training recommendations or  requirements related to the use of power morcellators. AAGL and ACOG,  which are professional societies representing member physicians; The  Joint Commission, which accredits hospitals; and three health care  providers, which included two hospitals and a physician group, we  contacted stated that training requirements for physicians performing  specific procedures, such as procedures to treat uterine fibroids, are  generally governed by hospital credentialing and privileging.
While the professional societies that we contacted did not set standards  or requirements for using power morcellators, some provided guidance  and educational resources for their members on the procedures that  could involve the use of power morcellators. For example, in May 2014,  the American College of Obstetricians and Gynecologists (ACOG’s  companion organization) published a special report on clinical  recommendations and scientific issues related to hysterectomies or  myomectomies. This special report touched on topics related to proper  diagnosis and evaluation before a hysterectomy or myomectomy, the use  of a bag during morcellation in gynecologic surgery, and patient  counseling and informed consent information that should be discussed  with a patient if a power morcellator is being considered for use during the  procedure.
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). The officials also noted that, after completing their  medical residency, physicians who want to use power morcellators for  laparoscopic surgery would likely seek out training, such as individual  training from another physician with experience using the device.  According to health care provider officials, physicians’ privileges to  perform laparoscopic hysterectomies and myomectomies could be part of  broader privileges—for example, they said that some hospitals may grant  permission for a physician to use a power morcellator as part of a general  list of procedures for gynecologists, or a hospital could require specific  permission for use of the device.
section_title: Manufacturers Provided Instructions and Offered Technical Training on the Use of Power Morcellators
paragraphs: 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. FDA regulations  require that the labeling for a prescription device like a power morcellator,  which is not safe for use except under the supervision of a licensed  practitioner, must provide information on the device’s use, including  precautions under which practitioners can use the device safely and the  purpose for which the device is intended. 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. One power morcellator  manufacturer that responded to our request for information stated that it  has a standard procedure to review the instructions for use with new  users of its power morcellator. In addition to providing instructions for use,  two manufacturers that provided us with information also offered technical  training to physicians on their power morcellators, such as demonstrating  how to set-up or operate their devices. FDA does not require  manufacturers to provide clinical training for power morcellators, that is,  training on the actual morcellation of tissue during a surgical procedure.  One manufacturer we spoke to stated that clinical training is typically part  of a surgeon’s accredited residency and fellowship program.
section_title: Agency Comments
paragraphs: We provided a draft of this report to the Secretary of Health and Human  Services. HHS provided technical comments that were incorporated as  appropriate.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to the appropriate  congressional committees, the Secretary of Health and Human Services,  and other interested parties. In addition, the report will be available at no  charge on the GAO website at http://www.gao.gov.
If you or your staff have any questions about this report, please contact  me at (202) 512-7114 or crossem@gao.gov. Contact points for our  Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made key contributions to this  report are listed in appendix V.
section_title: Appendix I: Food and Drug Administration’s Adverse Event Reporting System and Process for Monitoring Compliance
paragraphs: The Food and Drug Administration (FDA) uses information gathered  through adverse event reporting to monitor and track potential safety  issues associated with medical devices after they are marketed in the  United States. According to FDA, adverse event reports are best used for  two purposes. First, they are used to capture qualitative snapshots of  adverse events for a particular device or device type, such as the types of  malfunctions or clinical events, or both, associated with the device.  Second, they are used to detect safety signals, such as identifying  unexpected events associated with a particular device or device type.
Adverse event reports are submitted to FDA through mandatory and  voluntary sources. Mandatory adverse event reporting by medical device  importers, manufacturers, and user facilities enables FDA to obtain  specific safety data related to medical devices from these reports. FDA  regulations require medical device importers, manufacturers, and user  facilities that become aware of information suggesting that a device may  have caused or contributed to a death or serious injury to provide  information to FDA. Manufacturers and importers also must report  certain device malfunctions—manufacturers must report the information  to FDA and importers must report the information to the manufacturer.  (See table 3 for summaries of these reporting requirements.) FDA also  encourages healthcare professionals, patients, caregivers, and  consumers to submit voluntary adverse event reports or problems with  medical devices.
According to FDA officials, while the agency has enforcement authority  over mandatory adverse event reporting by user facilities, the agency has  generally focused its enforcement resources on manufacturers—which  are required to investigate each reportable event. According to FDA  officials, of the 2,185 device inspections conducted in fiscal year 2015,  875 included a review of medical device reporting. Of these inspections,  FDA reported that the agency found 284 to have inspection observations  related to medical device reporting requirements. Of the 12  manufacturers of power morcellator medical devices, FDA reported  inspecting 11 of them in the past 5 years (including inspections for  devices other than power morcellators). As a result of these inspections,  FDA reported identifying problems related to medical device reporting  such as manufactures not reporting adverse events within required time  frames or not implementing medical device reporting procedures. For  three manufacturers, the inspections resulted in FDA issuing warning  letters that cited, among other things, violations of medical device  reporting requirements.
FDA may also inspect user facilities’ compliance with medical device  reporting requirements, for example, in situations where the user facility  perspective is essential to understanding the public health issue.  Recently, in light of several high-profile device safety issues occurring in  hospitals, the agency initiated inspections at 17 hospitals in December  2015. According to the director of FDA’s Center for Devices and  Radiological Health, these hospitals were chosen because there were  reports of events at these facilities related to the spread of uterine cancer  from the use of power morcellators or the spread of infections associated  with another device called a duodenoscope. The director noted that  while these events appeared to be the kind that would have fallen under  the agency’s medical device reporting requirements, the agency did not  see corresponding adverse event reports submitted to FDA’s adverse  event report database. He further reported that from these inspections,  the agency learned several things, including
Some hospitals did not submit required reports for deaths or serious  injuries related to devices used at their facilities; and in some cases,  they did not have adequate procedures in place for reporting device- related deaths or serious injuries to FDA or to the manufacturers.  Based on the number of user facilities in the United States and the  number of reports FDA receives, the agency believes that these  hospitals are not unique, in that there is limited to no reporting to FDA  or to the manufacturers at some hospitals.
Hospital staff often were not aware of nor trained to comply with all of  FDA’s medical reporting requirements.
The director also noted that FDA wants to work with hospitals to address  issues of limited or nonreporting, and to work with hospitals to get the  real-world information FDA needs. For example, following the inspections,  FDA held regulatory meetings with certain hospitals to help identify  corrective actions. In addition, FDA hosted a public workshop in  December 2016 to discuss how to improve hospitals’ role in monitoring  medical device safety.
section_title: Appendix II: History of Predicate Devices for the First Laparoscopic Power Morcellator
paragraphs: 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. According to FDA  officials, this device, known as an arthroscopic surgical system, was one  of a number of devices cited by the manufacturer in the 510(k)  submission; however, the agency based its determination of substantial  equivalence primarily on the arthroscopic surgical system. As shown in  table 4, FDA documentation shows that the device can be traced back to  a surgical system also used for cutting during knee surgeries that FDA  determined in 1978 to be substantially equivalent to a predicate device  that was marketed prior to the enactment of the Medical Device  Amendments of 1976 (May 28, 1976).
section_title: Appendix III: General Characteristics of the 25 510(k) Submissions for Laparoscopic Power Morcellators Cleared by the Food and Drug Administration
paragraphs: Between 1991 and 2014, the Food and Drug Administration cleared 25  laparoscopic power morcellators to be marketed in the United States.  Figure 5 shows the device type, medical specialty, and indications for use  for 11 power morcellators still being marketed in the United States in  November 2016. Figure 6 provides the same information for the other 14  devices that were no longer being marketed in November 2016.
section_title: Appendix IV: Detailed Timeline of Events Related to Laparoscopic Power Morcellators
paragraphs: Table 5 shows key events related to laparoscopic power morcellators and  the actions the Food and Drug Administration has taken in relation to  safety concerns of the spread of unsuspected uterine cancer following the  use of power morcellators in the treatment of uterine fibroids.
section_title: Appendix V: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Kim Yamane (Assistant Director),  Aaron Holling (Analyst-in-Charge), Jazzmin Cooper, and Kate Tussey  made key contributions to this report. Also contributing were Leia  Dickerson, Sandra George, Drew Long, and Vikki Porter.