On Thursday, the U.S. Food and Drug Administration (FDA) cautioned doctors about the use of a procedure in hysterectomy and uterine fibroid tumor removal that could unexpectedly spread cancerous tissue into the patient’s abdomen.
The procedure, power morcellation, involves a device to cut tissue into pieces that can be removed through the tiny incisions made during minimally invasive surgery, The New York Times reports. But, according to FDA data, approximately one in every 350 women with fibroids could have a uterine sarcoma and slicing up the cancerous tissue could allow it to spread in the patient’s abdomen, reducing the patient’s long-term survival rate, according to Law360. Though the FDA stopped short of removing power morcellators from the market, it warned doctors to consider other treatment methods for symptomatic fibroids. Surgeons are taught, the Times explains, that cancers or potentially cancerous tissue should be removed whole and not broken up or cut, to avoid spreading the disease.
William Maisel, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health said there is “no reliable way to determine if a uterine fibroid is cancerous prior to removal,” and therefore the FDA “is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy,” Law360 reports.
Of the 500,000 hysterectomies performed annually, approximately 11 percent are done with power morcellators via laparoscopic surgery, according to the FDA. This procedure may be the best available for some patients, and the FDA is leaving those decisions up to the individuals and their doctors, Law360 says.
Maisel said doctors have been aware of the clinical risks associated with power morcellators since their original FDA approval in 1995 under the 510(k) procedure, Law360 reports. “There is no medical device that we have authorized for marketing that doesn’t carry some risk,” Maisel said in a call with reporters on Thursday. Thursday’s safety communication stresses the importance of the FDA’s post-market surveillance of medical devices.
The FDA will convene an advisory panel discussion to determine whether the devices should carry a boxed warning emphasizing the risk of spreading undetected cancer, but doesn’t anticipate asking the panel whether the devices should come off the market, according to Law360.
