Robert J. Boumis  |  September 26, 2014

Category: Legal News

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uterine myomectomy cancer

As the U.S. Food and Drug Administration (FDA), medical device manufacturers, and medical organizations weigh in on the alleged cancer risk of power morcellators, the American College of Obstetricians and Gynecologists issued a special report on the issue.

The report evaluates the risks associated with power morcellators and makes some recommendations about how to lessen some of the potential dangers.

Power morcellators are a type of surgical tool used in laparoscopic surgery, including laparoscopic or robotic hysterectomies. In laparoscopic surgery, specialized tools are used to perform most of a surgery within a patient’s body. This can greatly reduce the risk of many complications seen in traditional surgery, since surgeons have to cut through less healthy tissue to perform these procedures. However, concerns over morcellator cancer have led many surgeons, regulators, and even medical companies to question the procedure.

Morcellation is a part of many types of laparoscopic surgery, including the laparoscopic hysterectomy. Since laparoscopic surgery uses small incisions, surgeons need to cut tissue into smaller pieces to get them through these smaller cuts. However, some medical experts suspect that powered morcellators, which use small cutting blades similar to tiny circular saws, may throw small bits of tissue around inside the body. If there are undiagnosed cancer cells in this tissue, it could spread cancer quickly, making it harder to treat.

The report from the American College of Obstetricians and Gynecologists’ report on morcellation cancers acknowledges that some data has supported the idea of an increased risk of several types of cancers with laparoscopic hysterectomies and related surgeries, including a type of uterine cancer called a leiomyosarcoma.

However, the report states that most of the studies on the matter have relatively small sample sizes, making it very difficult to accurately assess the risk. The report goes on to acknowledge the benefits of laparoscopic procedures over traditional surgery, including lower rates of complications, deaths, and faster recovery times. In light of these facts, the report declines to advise strong action, instead calling for larger studies. In lieu of a recall or switch to older surgical styles, the report puts forth several methods of decreasing risks associated with this procedure. This includes looking for evidence of hidden leiomyosarcomas before surgery, using a surgical bag for the uterus during the procedure, and stressing informed consent and counseling, so that patients can make their own choices about the procedure.

However, despite the lack of a recommendation in the report, other groups have taken a stronger stance on the issue. The FDA, which used some of the same data in the report, discouraged the use of powered morcellators in hysterectomy in a Safety Announcement. However, the FDA stopped short of a full ban — awaiting stronger evidence to make such a determination. But the market leader in powered morcellators, Johnson & Johnson, has taken the step of recalling its morcellators preemptively, taking nearly half of powered morcellators out of circulation.

Legal action has been initiated, with the filing of numerous morcellation cancer lawsuits. These lawsuits allege that medical device manufacturers have failed to adequately assess the risks associated with power morcellators, and have not done enough to protect the public from these risks. The individual lawsuits over power morcellators will most likely be combined into a group litigation called a multidistrict litigation, or MDL, similar to a morcellator cancer class action lawsuit.

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

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