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| Johnson & Johnson suspended sales of its Ethicon morcellation devices in April. |
Panelists were concerned about the lack of data on the prevalence of uterine sarcoma among women undergoing hysterectomy or myomectomy surgeries during the first day of the FDA panel on the risks of upstaging uterine cancer via minimally invasive laparoscopic power morcellation during uterine surgery for fibroids.
The FDA estimates that one in 352 such women have the rare and difficult-to-diagnose cancer, but obstetrician-gynecologist Elizabeth Pritts presented data during the public hearing from a so-far-unpublished paper which found that the ratio is one in 7,450. The panelists called for both sides to work together and produce a reconciled estimate. Meanwhile, the American Congress of Obstetricians and Gynecologists believes that one in 500 women undergoing hysterectomy or myomectomy has uterine sarcoma.
In spite of the uncertainty, a consensus emerged that the magnitude of the risk is too large for the field to ignore the problem. The panelists concurred that unknowingly morcellating sarcomas during a hysterectomy or myomectomy surgery significantly increases the mortality risk. Although there have been only a few studies on the topic, the FDA estimates that uterine sarcoma is upstaged to often-fatal stages following morcellation in about 25% to 65% of the surgeries.
During day two, the panelists will discuss the use of surgical techniques and tools to mitigate the risk of upstaging cancer, including the use of laparoscopic specimen bags. The FDA presented the results of various studies on the use of laparoscopic specimen bags during its day one presentation.
Another upcoming discussion question is whether it is possible to determine which women have sarcomas prior to initiating the minimally invasive surgery. Doing so accurately would essentially put the issue to bed. Conducting an MRI prior to surgery is helpful but does not always allow physicians to distinguish between fibroids and sarcomas, said radiologist Susan Ascher of Georgetown University during her presentation to the panel: "Many degenerative fibroids we [radiologists] get right but then there is a subset that overlaps with sarcomas."
Furthermore, the panel members agreed that it would be cost prohibitive and impractical to perform an MRI on every woman. They discussed the possibility of creating an algorithm for diagnosing sarcomas prior to surgery with MRI on only high-risk patients that takes into account risk factors like race, age and family history--for instance, African-Americans are more likely to suffer from both fibroids and uterine sarcoma.
Many presenters spoke of the need for a data registry to collect more information on the topic, but FDA officials seemed averse to the idea and said there are no plans for one so far. Fortunately, cases of tumor upstaging from morcellation are rare, but that also limits the utility of a registry, others pointed out. Still, everyone agreed that more definitive data are needed, especially from the FDA's data-gathering systems on adverse events and other complications.
The meeting began emotionally, as the family members of women who died from uterine sarcoma following morcellation told their stories and called for power morcellation to be banned. Some expressed anger against the American Congress of Obstetricians and Gynecologists (ACOG), whose representative argued during the public hearing that morcellation should not be banned. Later during the day, an FDA official asked some of the audience members to refrain from distracting behavior or else to leave the meeting.
So far today on day two, the American Association of Gynecologic Laparoscopists (AAGL) made a similar argument against banning power morcellation, saying the technique should be made safer instead. A representative from the National Cancer Institute said that power morcellators should be regulated as Class III devices needing a PMA, instead of a 510(k), as is currently the case.
Everyone agreed on the need to improve the safety of power morcellation and communicate its risk effectively, and changes to the labeling of power morcellators will be discussed on day two. The family members of the deceased women said they were not informed of the risk of spreading cancer prior to the surgery, but given the risk's increased publicity that seems unlikely to occur today.
Promoting alternatives to minimally invasive hysterectomies requiring power morcellation is another option, speakers said. In fact, according to the FDA, invasive total abdominal hysterectomy is the most common procedure for removing the uterus, but it may not be optimal for women with large fibroids and a narrow pelvis. Doctors' organizations AAGL and ACOG pointed out that the invasive approach has risks of its own in their argument against banning the device.
The Wall Street Journal reports that gynecologist Andrew Brill removed himself from the advisory panel prior to the meeting because the FDA found that he accepted consulting fees from Johnson & Johnson ($JNJ), whose Ethicon division makes power morcellators. The company temporarily halted sales of the devices following previous safety alerts from the FDA over their potential to spread cancer.
At the conclusion of meeting's second and final day, panel members will be asked for recommendations on a variety of topics including power morecellators' risks and benefits, appropriate regulations and labeling.
- watch day two of the advisory committee hearing (reg. req.)
- read the meeting literature and agenda
- more information from the FDA about the meeting
- here's the WSJ story (sub. req.)