A panel of advisors convened by the U.S. Food & Drug Administration (FDA) agreed on Friday that there is probably no way to completely eliminate the risk that a power morcellator might spread undetected uterine cancer cells during minimally-invasive gynecological surgeries. Despite this consensus, the 15—member panel could not reach an agreement as to whether the use of the devices in laparoscopic hysterectomies and fibroid procedures should be banned entirely.
“There is at present no safe way to offer laparoscopic power morcellation as part of any minimally invasive surgery,” said Craig Shriver, a surgical oncologist at Walter Reed National Military Medical Center. According to The Wall Street Journal, Dr. Shriver was among the advisors who called for a ban on the devices at the conclusion of two days of testimony.
But others on the panel asserted that uterine morcellation could still benefit certain women. Some argued for the addition of a black-box warning – the FDA’s strongest safety alert – to the products’ labels in lieu of an all-out ban.
Power morcellators are used during laparoscopic gynecological surgeries to shred tissue and fibroids so that it can be easily removed via a small abdominal incision. In April, the FDA warned that as many as 1 in 350 women with uterine fibroids have cancer cells in that tissue. Those undetected cells can be spread via a morcellator into a woman’s peritoneal cavity. Such an event might upstage the cancer and diminish a patient’s odd of long-term survival.
Since the FDA alert was issued, a number of medical device makers have been targeted in morcellator lawsuit filings that accuse the companies of failing to provide patients with adequate warnings about the risks associated with uterine morcellation. A number of hospitals have either stopped using power morcellators pending further action by the FDA, while others have strictly limited the procedures.
The FDA panel was convened to recommend ways in which this risk could be mitigated. During the hearing, its members listened to emotional testimony from a dozen victims of morcellator cancer, as well as their survivors, many of whom want the devices pulled from the market.
“Would you permit your wife or sister to undergo a procedure that has a one in 351 chance of spreading cancer throughout the body?” Colleen Daley asked. According to an Associated Press Report, Ms. Daley’s sister, Patricia, died of a rare form of uterine sarcoma in 2011 following a hysterectomy where a power morcellator was used.
“Why do we use these terrible things? Why are we fighting to protect them?” Amy Reed, a 41-year-old anesthesiologist and mother of 6, asked. She and her husband, Hooman Noorchashm, a thoracic surgeon, launched a petition to ban uterine morcellation last year, after Dr. Reed was diagnosed with stage 4 cancer spread via a morcellator.
In the end, the FDA panel did agree that women should be asked to sign a consent form prior to uterine morcellation to ensure they are fully aware of the risks associated with the surgeries. The panel also concluded that there was little evidence to indicate that the use of containment bags to catch tissue spread by a power morcellator would make the procedures any safer. And finally, the panel members agreed that there were few ways to reliably screen women for uterine cancers prior to such surgeries.
The FDA has not indicated when it would act on any of the panel’s recommendations.