FDA: Morcellators May Cause the Spread of Sarcoma in Women

Posted On August 1st, 2014 By CSSFIRM.COM

Pending a review by the U.S. Food and Drug Administration, Johnson & Johnson plans to ask doctors to return its laparoscopic power morcellators, surgical tools that may inadvertently spread cancer in women being treating for fibroid tumors. The company’s Ethicon unit suspended sales and distribution of the devices in April 2014.

Morcellators are used in hysterectomies, and also to cut up uterine masses in the uterus so that they can be more easily removed through non-invasive procedures. The problem is that uterine cancers commonly known as sarcomas sometimes appear to be benign fibroids and can’t be reliably detected before surgery. When the blade of the morcellators spins, it potentially spreads the cancer and worsens patient outcomes.

Johnson & Johnson is the world’s largest manufacturer of laparoscopic morcellators, holding an estimated 72 percent of the market in 2011, according to iData Research Inc. Smaller manufacturers, including the German companies Karl Storz GmbH and Rich Wolf GmbH, and Danish company LiNA Medical, haven’t responded to requests for comment regarding the morcellator controversy and their market plans.

The risks of cutting up cancer inside a human body have been known for some time, but the risk that a woman with presumed fibroids actually had cancer was always believed to be extremely small, 1 in 10,000, and most gynecologists did not consider it worth mentioning to patients. But in April 2014, the FDA stated that women undergoing surgery for fibroids actually have a 1 in 350 risk that the growths are cancerous, much greater than originally thought. A new study by Columbia University found that 1 in 368 women undergoing hysterectomies actually have hidden uterine cancer that is capable of being spread by a morcellator.

According to the FDA, the tool was being used in approximately 50,000 hysterectomies per year, and very commonly used to remove uterine fibroids as well.

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