FDA considers restricting or banning laparoscopic morcellation.

The U.S. Food and Drug Administration is considering restricting or banning morcellation in minimally invasive hysterectomies and myomectomies (removal of fibroids) because of new reports of higher incidence of undiagnosed sarcoma in women undergoing these procedures. Research now links morcellation to the spread, or upstaging, of undetectable gynecological cancers. In July, FDA convened a 2-day Obstetrics and Gynecology Devices Advisory Committee meeting to discuss risks and benefits of morcellation and to determine ways to reduce risk of upstaging cancers. In December 2013, after receiving the first report of an upstaged cancer due to morcellation, FDA sent out a safety communication to discourage morcellation in laparoscopic gynecologic surgeries. Women whose cancers upstaged after morcellation live a median of 11.5 months after the procedure. About 50,000 U.S. women per year undergo morcellation. Other risks include visceral and vascular injuries, Craig J. Sobolewski, M.D., assistant professor at Duke University in Durham, N.C., said at the meeting. Owing to the report and the FDA warning, several U.S. medical centers have stopped using laparoscopic power morcellation (LPM), and Johnson & Johnson’s Ethicon device subsidiary has stopped marketing its morcellator. Previously thought to be much rarer, uterine sarcomas, and especially leiomyosarcomas, are lethal and virtually impossible to detect. In April, FDA increased the estimate of sarcoma risk for women undergoing hysterectomy or myomectomy for presumed fibroids from between 1 in 500 and 1 in 10,000 to about 1 in 352 for unsuspected uterine sarcomas, and 1 in 498 for leiomyosarcomas. The most recent study, by Jason Wright, M.D., chief of gynecologic oncology at Columbia University in New York, found that cancer risk in women undergoing hysterectomy for symptomatic fibroids is 1 in 370 (JAMA online, July 22, 2014). The study also detected other malignancies and precancerous abnormalities.