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Will the FDA Ban Morcellators for Hysterectomies?

Will the FDA Ban Morcellators for Hysterectomies?

June 17, 2014 — The Wall Street Journal reports that an advisory panel to the U.S. Food and Drug Administration (FDA) will meet next month and consider banning morcellators due to the risk of spreading cancer.

In April, the FDA recommended against using morcellators in hysterectomies because about 1 in 350 women who undergo this procedure has undiagnosed uterine cancer. Morcellators can leave behind malignant cells and “seed” a woman’s abdomen with highly-aggressive cancer.

Soon after this announcement, Johnson & Johnson, the largest manufacturer of power morcellators, reported that they would halt sales of the devices. Many doctors and hospitals have also stopped using morcellators while awaiting further guidance from the FDA.

The panel will hear arguments from gynecology groups, who say that morcellators remain a valuable tool in some circumstances. For example, women under 35 have a very low risk of uterine cancer. This risk is further reduced when surgeons use a containment bag to avoid leaving tissue behind.

Many surgeons like using morcellators because they save time during the hysterectomy. Morcellators are commonly used in supracervical hysterectomies, which are minimally-invasive procedures that remove the uterus but spare the cervix.

Critics say these potential benefits must be weighed against life-threatening side effects, such as uterine cancer and leiomyosarcoma (LMS). It is possible that the FDA will re-classify morcellators from a “moderate-risk” device to a “high-risk” (Class III) device. Manufacturers might be asked to conduct new safety studies. Morcellators were approved through the 510(k) loophole, which allows new devices to enter the market without safety studies so long as they are “substantially equivalent” to a device that is already on the market.

Do I have a Morcellator Lawsuit?

The Schmidt Firm, PLLC is currently accepting power morcellator induced injury cases in all 50 states. If you or somebody you know has been injured by cancer after a hysterectomy, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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