The FDA panel convened to discuss the risk of upstaging uterine sarcoma cancer via minimally invasive laparoscopic power morcellation during uterine surgery for fibroids recommended upgrading the labeling of power morcellators and ensuring that patients are made aware of the risk prior to surgery, among other measures.
The suggestions are nonbinding, and no formal vote was taken, but the FDA's stern safety notice in April and industry's strong reaction in response (including Ethicon's decision to temporarily halt sales of the drill-like devices) suggested that a change in risk communication was already likely.
Will the agency go farther? The FDA moderator stressed that by asking the panel about changes to labeling, he was not ruling out the possibility that the agency will ban the device altogether. No consensus was reached among the panelists that this extreme step be taken. Another possibility is that the devices will be regulated as Class III devices, requiring a PMA, but the FDA didn't ask the panel to weigh in on that issue directly.
The panelists expressed a great deal of interest in requiring an informed consent form to be signed by both the patient and the doctor. The FDA's device arm, the Center for Devices and Radiological Health, has required this type of form recently for breast implant surgery and a type of eye implant, an agency official said.
The panelists said that a black-box label is insufficient because, unlike with medications, patients rarely see a device's packaging or read its manual since it is used by doctors--at least in the case of power morcellators. Although a black-box warning may make dissemination of the information more likely since it would be prominently located and is the FDA's strongest type of warning, the panelists concurred that an extra step is needed to ensure that the patient receives the information about the risk of upstaging cancer. Many speakers said during the open public hearing that their now-deceased loved ones were not informed prior to surgery of the risk of morcellation exacerbating unknown cases of uterine sarcoma.
Compared to hysterectomies, even less is known about the the prevalence and risk of upstaging cancer via fertility-preserving myomectomies. The panelists said they would generally only recommend the procedure for women under the age of 40 who wish to keep their uterus so they can preserve their fertility. Like hysterectomy, myomectomy can be performed invasively without morcellation.
The panel stressed the need to promote alternatives to laparoscopic surgery. Vaginal hysterectomies are the preferred option, but they are not always possible. Medical management of fibroids is also possible. According to the FDA, the benefits of laparoscopic surgery compared to the invasive alternative are less operative blood loss, fewer febrile episodes, fewer wound/abdominal wall infections and more rapid recovery; but since April the agency has discouraged the use of laparoscopic power morcellation due to the cancer risk.
It seems clear from the panel discussion that the development of risk-mitigation strategies for morcellation is an area ripe for research and commercialization. Some panelists questioned whether industry has an incentive to innovate if power morcellators are left on the market. An industry representative responded that competition ensures that companies will try to find new solutions.
In particular, the panelists discussed the use of surgical bags and other containment strategies to limit the dissemination of potentially cancerous tissue fragment in the abdomen. Intuition suggests this could be a good idea, the panelists said, but they stressed that there is no proof of bags' efficacy in this case, although they are used in other surgeries. No bag or containment strategy is currently indicated for use in laparoscopic hysterectomies or myomectomies.
Bench and animal testing is needed to prove the bags' efficacy, and a new containment strategy may be needed specifically for the issue under discussion, the panelists said.
Clinical trials and registries are difficult to develop due to the rarity of uterine sarcomas in women undergoing hysterectomy or myomectomy (one in 352 according to FDA estimates). However, dissemination of a more commonly occurring biological material following morcellation could be a surrogate marker, panelists suggested.
At the meeting's conclusion, FDA issued a reminder that the docket for accepting public comments remain open.
- read the meeting literature and agenda
- see more information from the FDA about the meeting
- read the FDA's April safety notice
- here's more information on hysterectomy from the American Congress of Obstetricians and Gynecologists