Robert J. Boumis  |  September 12, 2014

Category: Legal News

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uterine myomectomy cancerThe U.S. Food and Drug Administration (FDA) has begun discouraging the use of morcellators, a surgical tool, in hysterectomies. The FDA recommendation comes in response to concerns about morcellation cancer risks.

Morcellation is a process of cutting up tissue before removing it from the body. Morcellation plays a role in laparoscopic surgery. In laparoscopic surgery, specially trained surgeons use small tools to perform the bulk of the surgery inside a patient’s body through small incisions. Because laparoscopic surgery is less invasive than traditional surgeries, it typically has shorter recovery times. However, the use of powered morcellation in laparoscopic hysterectomies has come under fire over morcellation cancer concerns.

The concerns of morcellators in hysterectomy centers on cancer. In hysterectomies, the uterus is removed. A common cause of hysterectomies is a type of benign tumor called a uterine fibroid. These masses vary greatly in their seriousness, from causing no harm to causing pain and abnormal bleeding. A hysterectomy or several related procedures can cure this condition. But evidence is mounting that morcellation for uterine fibroids can cause serious problems.

The FDA recently held a conference to evaluate data pertaining to morcellation cancer risks in laparoscopic hysterectomies. Based on FDA data, roughly one in 350 women who have laparoscopic hysterectomies has uterine sarcomas embedded in their tissue, a type of cancer. A hysterectomy can remove this cancer unnoticed, but when morcellators are used, the cancer can be spread across the pelvis and abdomen, allowing it to spread unnaturally fast. Cancer spread throughout the body is harder to treat and typically more deadly.

Weighing the risks, benefits, and alternatives to morcellation, the FDA made the decision to issue a medical alert, advising against using powered morcellators in hysterectomies and related procedures due to concerns about morcellation risks. While concerns about uterine sarcomas and other morcellation cancers are strong, the FDA stopped short of a full-on ban or recall of power morcellators.

However, Johnson & Johnson, the market leader in morcellators has taken an additional step. Johnson & Johnson has recalled its own models of powered morcellators over the risk of spreading uterine sarcomas throughout the body. The Johnson & Johnson announcement came within days of the FDA’s announcement.

In general, morcellation cancer lawsuits are filed individually by each plaintiff and are not class actions.

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If you or a loved one were diagnosed with cancer in the uterus, pelvis or abdomen within two years of undergoing surgery for a myomectomy (removal of fibroids), hysterectomy (removal of the uterus), oophorectomy (removal of the ovaries), or salpingectomy (removal of fallopian tubes), you may have a legal claim. See if you qualify by filling out the short form below.

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