FDA Warning About Surgical Tool That May Spread Cancer

On Monday, the Food and Drug Administration (FDA) updated an earlier safety alert to advise that the power morcellator should no longer be used in uterine surgeries for “the vast majority” of women because of the risk of spreading cancer.

The power morcellator cuts uterine tissue into small pieces that can be removed through tiny incisions made during minimally invasive surgery, and this makes it a popular tool for fibroid removal and some hysterectomies. But if a woman has an undetected cancer, the rapidly spinning blades can fling malignant cells around inside her abdomen, spreading the cancer, the New York Times reports. Though fibroids are benign, they can hide uterine sarcoma, an aggressive cancer that can be rapidly fatal once it spreads.

The FDA estimates that one in 350 women having fibroid surgery has an undetected sarcoma. Morcellating a sarcoma, the FDA said, “may spread cancer and decrease the long-term survival of patients.” Until recently, gynecologists thought the risks of hidden sarcomas were much smaller, somewhere between one in 500 and one in 10,000.

The FDA did not ban morcellators, as some have called for, but warned doctors against using them in most hysterectomies and fibroid surgery, according to the Times. The FDA also recommends label changes warning of the cancer risk and of two specific instances in which morcellators should not be used. The agency said morcellators should be avoided in women who are at or near menopause or in patients whose tissue can be removed intact through the vagina or via a small abdominal incision. The second contraindication is that morcellators should not be used when the tissue is known or suspected to be cancerous.

This is the first time the FDA has used a new type of directive called “immediately in effect guidance,” in which it skips the usual procedure of issuing a draft and allowing time for public comments before the guidance becomes final, the Times report. The April safety alert discouraged the use of morcellators and some manufacturers, including the Ethicon division of Johnson & Johnson, have taken their power morcellators off the market.  But some hospitals and doctors continue to use the device.

 

 

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