Power Morcellator Controversy: GAO Asked to Investigate FDA
The U.S. Food & Drug Administration’s (FDA) regulation of medical devices is coming under renewed scrutiny, thanks to the ongoing controversy surrounding power morcellators and their potential to spread uterine cancer. Earlier this month, a dozen members of the U.S. Congress wrote to the Government Accountability Office (GAO), urging it to open a new investigation of the FDA and its handling of the issue.
Asserting that “hundreds, if not thousands of women are dead” due to uterine morcellation, Rep. Mike Fitzpatrick (R., Pa.), Rep. Louise Slaughter (D., N.Y.) and 10 of their colleagues asked that the GAO determine why the FDA’s morcellator cancer warnings “came decades after some studies were already pointing to a serious problem.”
“Despite these studies, as late as last year, the FDA, the medical device industry and many gynecologists pointed to the risk of a hidden cancer as being low, only one-in-ten thousand,” the lawmakers wrote in their August 7th missive. “How did they get it so wrong for so long?”
Among other things, the letter asks the GAO to investigate whether the FDA’s 510(k) approval process – which doesn’t require human clinical trials – sufficiently identified risks before morcellators were cleared for sale, as well as what steps the agency is taking to determine whether or not the devices are safe enough to remain on the market.
FDA Response to Power Morcellator Concerns
Power morcellators are used to shred uterine tissue and fibroids during minimally-invasive hysterectomies and myomectomies. According to a report from The Wall Street Journal, the FDA recognized early on that the devices could spread dangerous cancer cells, but the agency maintains that the true magnitude of this risk wasn’t recognized until late 2013.
In April, 2014, the FDA issued its first morcellator cancer warning, and discouraged doctors from using the devices in hysterectomies and myomectomies. The warning was circulated after an agency review suggested that 1 in 350 women undergoing hysterectomy or myomectomy actually have undiagnosed uterine sarcoma. The FDA noted that there is no reliable way to screen for these malignancies prior to surgery, and cautioned that their dissemination beyond the uterus greatly reduces a woman’s odds of long-term survival.
In November 2014, the FDA went further, and warned that uterine morcellation should not be used in the vast majority of women who require hysterectomy and myomectomy. It also called for the inclusion of a new black box warning – its strongest safety alert – on all morcellator labels.
Power Morcellator Lawsuit Consultations
Numerous power morcellator lawsuits are now pending in courts throughout the U.S. If you or a loved one were diagnosed with advanced uterine cancer following a morcellator hysterectomy or myomectomy, please call 1-877-779-1414 for a free, no-obligation legal review.