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FDA Discourages Use of Laparoscopic Morcellation to Treat Uterine Fibroids — Physician’s First Watch

Medical News |
April 18, 2014

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."

Reader Comments (3)

Marianna Bassan, MD, Physician, Obstetrics/Gynecology, Lodi Hospital, Italy

I'm not concerned about sarcoma wich is quite rare (I agree with Dr Barron) but pelvic dissemination of metastatic leyomiomatosis is quite common and spreading since laparascopic morcellation has raised. I agree that using endoscopic bag may reduce this risk (studies are warranted to confirm this hypothesis).

RICHARD THORNTON Physician, Obstetrics/Gynecology, Retired

This the FDA analysis available to gynecologists. Is it published anywhere. If not, why not??

Kenneth Barron, MD Physician, Obstetrics/Gynecology, Women & Infants Hospital of RI

A statement from the FDA citing a sarcoma rate of 1 in 350 is flabbergasting. There is no consensus literature that supports that high a number, the society of GYN oncology group reports 1 in a 1000 and if 30% of our 600,000 hysterectomies a year are for fibroids as the data states and 1 in 350 of them has a sarcoma, then there would be an epidemic of sarcomas, over 500 a year, which we don't see. We will however see a lot more large laparotomy scars now...

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