FDA Discourages Use of Laparoscopic Morcellation to Treat Uterine Fibroids

By Kelly Young

The FDA is discouraging clinicians from using laparoscopic power morcellation for uterine fibroids because the procedure can cause undiagnosed uterine cancer to spread, the agency announced on Thursday. It stopped short of banning the procedure.

An FDA analysis found that roughly 1 in 350 women undergoing hysterectomy or myomectomy for fibroids has unsuspected uterine sarcoma. In such cases, laparoscopic morcellation, which involves cutting tissue into smaller pieces for easier removal, can spread the cancer within the abdomen and pelvis.

Roughly 50,000 of these procedures are done in the U.S. annually, and the FDA has received about a dozen reports of cancer being spread.

"We think, in general, the procedure should not be performed," said the FDA's William Maisel, adding that "there still may be individual patients who benefit."

The FDA is outrightly recommending against laparoscopic morcellation in women with suspected or known uterine sarcoma.

Asked to comment, NEJM Journal Watch Women's Health editor-in-chief Andrew Kaunitz said, "The current controversy ... is focusing attention on tissue extraction alternatives, including manual or electronic morcellation within an endoscopic bag, as well as specimen removal either through laparoscopic-aided mini-laparotomy or through a vaginal incision. In addition, some hospitals have instituted policies on the use of electric morcellation during minimally invasive gynecologic surgeries."