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Power Morcellator Lawsuit Settles Prior to Trial

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The first laparoscopic power morcellator lawsuit expected to go to trial has been settled for an undisclosed amount, according to a report in the Wall Street Journal.

The case was filed against morcellator maker Lina Medical ApS by a man whose 53-year-old wife died in 2013, eleven months after a morcellator-aided hysterectomy. After the surgery, the woman learned that she had a hidden cancer known as leiomyosarcoma. The lawsuit, as with other morcellation court actions, alleged that the company failed to warn consumers, including the plaintiff’s wife, about the risk of spreading cancer.

Leiomyosarcoma and Morcellation: A Deadly Combination

Leiomyosarcoma is a rare and aggressive soft tissue cancer that forms in the smooth muscle cells of the body, most commonly in the uterus. The exact cause of Leiomyosarcoma is unknown, and there are no known recommendations regarding how to prevent its development. Because Leimyosarcoma cannot be reliably detected before surgery, and because the blades of the power morcellator slice up tissue for removal through small incisions, morcellation has been found to spread and worsen this type of cancer. 

FDA Warns Against Morcellator Use

The U.S. Food and Drug Administration (FDA) warned in 2014 about the risks of morcellation, and the agency’s intervention, along with adverse publicity surrounding power morcellators, have caused a steep drop in the use of the device.

In November 2014, the FDA issued a black box warning, its strongest caution, on power morcellators and recommended that the tool not be used in the majority of women contemplating minimally-invasive fibroid surgery or hysterectomy. As a result, many hospitals have limited use of the device, insurers are refusing to cover procedures utilizing it, and former top morcellator manufacturer Johnson & Johnson voluntarily stopped making and marketing the tool in July 2014.