The power morcellation devices are typically used in laparoscopic hysterectomy or myomectomy surgery to reduce the invasiveness of the surgery. Typically, they are used to break up uterine fibroids. In some women, however, uterine fibroids being treated with the surgery were actually uterine sarcomas, and laparoscopic power morcellation can cause cells from the sarcoma to spread throughout the patient’s abdomen and pelvis. The spread of the cancer cells can decrease the patient’s changes of survival.
The FDA warned that approximately 1 in 350 women who undergo laparoscopic power morcellation for benign uterine fibroids actually have uterine sarcoma, and there is no way of knowing prior to the surgery whether the patient has benign or malignant fibroids.
Lawsuits have been filed against the makers of the power morcellation devices, alleging women were harmed by use of the morcellators. Those lawsuits were recently consolidated for pretrial proceedings into a multidistrict litigation (MDL). So far, about 45 lawsuits have been filed in state or federal court, although more lawsuits could be filed. Of those, around 20 were transferred to the MDL to US District Court for the District of Kansas. Centralization in an MDL is not a comment on the merits of a lawsuit but is done if the various suits involve similar questions of fact.
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“Hundreds, if not thousands of women in America are dead because of a medical device known as the laparoscopic power morcellator,” officials said in the letter, as quoted in The Wall Street Journal (8/7/15). The letter asked the GAO to examine whether the FDA was able to identify risks before the device was approved for the market, whether the device was properly monitored, and if the FDA is taking proper steps to ensure the device remains safe on the market.
The multidistrict litigation is MDL 2652, In Re: Power Morcellator Products Liability Litigation.