Aetna, the third-largest health insurance company in the U.S., will no longer cover power morcellator surgery for most women who require hysterectomies or myomectomies.

“The policy takes into account the latest FDA warnings about the risk that morcellation can spread unsuspected uterine sarcoma in the abdomen and pelvis,” an Aetna spokesperson told The Wall Street Journal last month.

Under the insurer’s new guidelines, which are to take effect in June, doctors will need to obtain pre-certification before performing uterine morcellation on any Aetna patient. The only instances where doctors may request an exception include cases involving pre-menopausal women who want to preserve their fertility, but have no other viable option. Women who face a risk of severe or life threatening complications from alternative procedures will also qualify for exemptions.

Over the past year, a number of other health insurers have moved to limit power morcellator coverage, amid growing concerns that the devices can disseminate undetected uterine cancer cells into a woman’s peritoneal cavity, thereby allowing the malignancy to reach a more advanced and deadly stage.

FDA Acts on Power Morcellators

The FDA first discouraged doctors from using power morcellators to perform hysterectomies and fibroid removals in April 2014, due to their potential to spread and upstage uterine cancers. In a second communication issued in November, the agency noted that the prevalence of unsuspected uterine sarcoma in patients undergoing hysterectomy or fibroid removal surgery is 1 in 352, while the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498. Both of these estimates are higher than the clinical community previously understood.

In its November update, the FDA cautioned against the use of power morcellators in the majority of women undergoing hysterectomies or myomectomies. The agency also ordered the manufacturers of power morcellators to add a new black box warning – the agency’s strongest safety alert – to their product’s labels regarding their risks.

The FDA’s action was disappointing to some patient advocates, who had been urging the agency to ban power morcellators entirely. However, a number of hospitals have banned uterine morcellation, and Johnson & Johnson’s Ethicon, Inc. unit decided last year to end its power morcellator sales.

Power Morcellator Lawsuit Evaluations

A growing number of power morcellator lawsuits have been filed in U.S. courts, and the first is set to go to trial in November. If you or a woman you love experienced the spread of uterine cancer following a hysterectomy or myomectomy that involved the use of a power morcellator, please call 1-877-779-1414 to discuss your case with the legal staff at Bernstein Liebhard LLP.

Published May 19, 2015 by