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. 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.) 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.