FDA Discourages Use of Laparoscopic Power Morcellators for Hysterectomy, Fibroids

Citing a risk of spreading unsuspected cancer, the FDA is advising against the use of laparoscopic power morcellators in the removal of the uterus or fibroids in the majority of women.

The FDA is also calling for the manufacturers of the morcellators to issue a boxed warning on their labeling with 2 contraindications, according to a press release.

The warning would communicate that uterine tissue may contain unsuspected cancer, so the use of laparoscopic power morcellators during fibroid surgery could spread the disease and decrease the chances of survival, according to the FDA.

The contraindications warn that the morcellators should not be used for the removal of uterine tissue containing suspected fibroids in patients who are peri- or postmenopausal, or candidates for en bloc tissue removal through the vagina or mini-laparotomy incision. The laparoscopic power morcellators should also not be used in gynecologic surgery where tissue to be morcellated is known or suspected to be cancerous, according to the FDA.

About 1 in 350 women who undergoes hysterectomy or myomectomy for fibrioids is found to have an unsuspected uterine sarcoma, and if laparoscopic power morcellation is performed, there is a risk of spreading the cancerous tissue, the FDA stated.

“The FDA strongly encourages doctors to inform their patients of the risk of spreading unsuspected cancer from the use of these devices in fibroid surgery and discuss the benefits and risks associated with all treatment options,” said William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, in a press release.