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FDA Warns Against Use of Morcellation During Uterine Fibroid Surgery

FDA Warns Against Use of Morcellation During Uterine Fibroid Surgery

April 21, 2014 — FDA on Thursday issued a safety communication notice discouraging the use of a procedure performed on tens of thousands of U.S. women undergoing uterine surgery each year, the New York Times reports (Grady, New York Times, 4/17).

The procedure -- called laparoscopic power morcellation -- was developed as an alternate to invasive surgery for women with symptomatic uterine fibroids, which are responsible for about 40% of the 500,000 hysterectomies performed each year in the country (Kamp/Levitz, Wall Street Journal, 4/17). It uses a power device to grind uterine tissue so it can be removed through a tiny incision (AP/Modern Healthcare, 4/17).

However, the procedure has come under fire in recent years for its potential to spread a type of cancer -- known as a uterine sarcoma -- within the body. In its safety notice, FDA cited estimates that uterine sarcoma affects about one in 350 women undergoing fibroid removal procedures and that laparoscopic power morcellation could significantly worsen the chances of long-term survival.

"For this reason, and because there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma, the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for uterine fibroids," the notice states (Wall Street Journal, 4/17).

FDA is not seeking to ban morcellation, or the two dozen approved devices used to perform it, according to the Washington Post. However, hospitals and surgeons are unlikely to continue using the procedure given the potential liabilities.

Following FDA's announcement on Thursday, the heads of obstetrics and gynecology at Massachusetts General Hospital and Brigham and Women's Hospital notified staff to stop using the procedure until further notice. Temple University Hospital in February also limited the use of the procedure (Dennis, Washington Post, 4/17).