Mesh Medical Device News Desk, February 10, 2017 ~ The GAO report on power morcellators finds there were 25 requests to market new power morcellator devices submitted to the FDA over a 23 year period, all were cleared for the marketplace.
The U.S. Government Accountability Office (GAO) has just issued a report (here) on the use of power morcellators. Power morcellators are used during “minimally invasive” surgery on women to grind up uterine fibroids.
The alternative is an abdominal hysterectomy or removal of fibroids, which a larger incision.
During the morcellation process, undetected, hidden cancers can be spread throughout the body cavity, as was the case with Dr. Amy Reed. She and her husband, Dr. Hooman Noorchashm, both medical doctors with six childeren, have headed an aggressive campaign to get morcellators off the market, however, they remain in use with some awareness by the FDA and users.
This report finds the FDA system has failed this couple and hundreds of Americans. Read their story here.
Instead of a one in 10,000 chance of a undetected cancer as previously thought, the risk is now thought to be one in 350. There are 50,000 power morcellator procedures a year, reports the GAO.
Had Dr. Reed’s aggressive cancer been removed whole, she would have a 50% survival rate at five years. Instead, after the morcellator spread cancer debris within her body, those chance of survival drop from 0 to 20%.
From 1991 to 2014, there were 25 submissions for laparoscopic power morcellators to the U.S. Food and Drug Administration. They were all cleared for market through the 510(k) fast-track clearance process. Manufacturers include Cook, Gynecare, Cuto, SKEA Steiner and FemRx, among others.
All of them had the same intended use, to pulverize fibroids in order to remove them from the uterus. A uterine sarcoma is a cancer of the muscle and supportive tissue. Less than 4% of uterine cancers are uterine sarcomas, finds the GAO.
Leiomyosarcoma is a type of uterine cancer difficult to diagnose because it resembles fibroids. That is the cancer Dr. Reed has been fighting since her diagnosis of a stage 4 cancer following her power morcellator procedure.
An FDA safety communication in November 2014 issued guidance to doctors and to manufacturers to add a boxed warning.
In 2014, the FDA discouraged the use of power morcellators in hysterectomys or myomectomys (removal of fibroids).
By July 2014, the FDA convened an expert panel overseeing morcellators.
By December 2015, the FDA inspected select hospitals with high numbers of adverse event reports of injuries from the morcellators. They found a failure to report adverse events within the time frames required and a lapse in maintaining files on medical devices.
The GAO concludes the medical device reporting system is “passive” and relies on doctors and manufacturers to identify harm. Before November 2014, doctors or hospitals would not consider the spread of an unsuspected cancer following a power morcellator procedure to be a reportable adverse event.
Since September 2016, the FDA has identified 285 adverse event reports of spreading cancer following a power morcellation.
From Philadelphia Magazine: But as always in this couple’s struggle, it’s one step forward, one step back. As noted by the New York Times, the GAO report comes just as the Trump administration has called for loosening, not tightening, regulations for approval of drugs and medical devices. “Instead of being 9,000 pages, it’ll be 100 pages,” Trump promised of FDA regs.