FDA Issues Sterner Warning on Devices Used in Uterine Surgery

The FDA says that laparoscopic power morcellators—surgical devices commonly used to remove fibroid tumors from the uterus or the entire uterus—should not be used to perform these procedures in the vast majority of women because they can spread unsuspected cancer.

The FDA’s Immediately in Effect (IIE) guidance, issued November 24, updates a safety communication issued by the agency in April that discouraged doctors from using morcellators but didn’t ban them.

While the latest FDA announcement also doesn’t ban the devices it warns that in the vast majority of women, morcellation should not be performed. It also recommends that manufacturers include on morcellator packaging a boxed warning and two contraindications (cases where morcellators should not be used).
The boxed warning, says the FDA, should state that uterine tissue may contain unsuspected cancer, which according to new data may be present in as many as 1 in 350 women (previous estimates put the risk as low as 1 in 10,000).

The first contraindication advises against using the devices in menopausal or near-menopausal women as well as in patients whose uterine tissue can be removed intact through a small incision. The second contraindication says that morcellation shouldn’t be used for tissue known or suspected to be cancerous.

“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” said Dr. William Maisel of the FDA’s Center for Devices and Radiological Health. “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 benefit and risks associated with all treatment options,” added Maisel. A small group of women, however, including younger women who wish to keep their uterus intact, may be good candidates for morcellation, says the FDA.

Mixed Reactions to FDA Announcement
The American College of Obstetricians and Gynecologists praised the FDA strategy, says the New York Times, because morcellation—a minimally invasive procedure that allows for a shorter recovery period and fewer complications than procedures requiring a larger incision—is beneficial for certain women. But the vice president of the College, Dr. Hal Lawrence, told NBC News that the FDA announcement came without consulting his group and that its language is “a little confusing.”

The problem, says Lawrence, is that “the overwhelming majority of fibroids are totally benign” but there’s no good test to distinguish between benign and cancerous (or pre-cancerous) growths.

One opponent of morcellation, though, Dr. Hooman Noorchashm, says the new FDA guidance is a “massive failure” and that the agency has been “captured” by the device industry, according to the Times. Dr. Noorchashm’s wife had a hysterectomy performed with a morcellator in 2013 at the age of 40. The procedure spread a hidden sarcoma in Reed and upstaged (advanced to a more deadly form) her cancer to Stage 4.

Some gynecologists advocate the use of technique in which a bag covers to tissue to be morcellated, which in theory encapsulates and prevents from spreading any cancer cells, but the FDA’s Maisel notes that the procedure is not a failsafe way to prevent cancer upstaging.
For now, the reaction to morcellator risks remains divided not only among doctors and hospitals—some of which have stopped using the devices for fibroid removal—but also among device makers.

Johnson & Johnson’s Ethicon unit, the largest manufacturer of the devices, in July removed its three morcellator products from the market, although other companies have yet to follow suit.

As the Wall Street Journal reports, the new FDA warning could raise legal exposure for manufacturers or physicians that do not follow the agency’s recommendations. In a separate article, the Journal says that morcellator lawsuits have already begun piling up.

Get Legal Advice About Your Post-Morcellation Cancer
Andrus Wagstaff PC, a Denver-based personal injury firm with a national scope, is currently investigating potential lawsuits on behalf of victims whose cancer may have been spread and worsened through the use of power morcellators.

To discuss your case, free of charge, with an experienced dangerous medical device attorney, please call us toll free at 866-534-5014 or send us an online message.