Power Morcellator Recalled Due to Increased Risk of Uterine Cancer

Power Morcellators are surgical instruments utilized for laproscopic surgeries such as hysterectomies and myomectomies. The morcellator functions by cutting uterine tissue. The tissues are then extracted from the abdomen. The first electric morcellator was introduced on the market in 1993. Ethicon, a subsidiary of Johnson & Johnson, owns the majority share of morcellator products including Gynecare Morcellex, Gynecare X-Tract and Morcellex sigma. Approximately 50,000 women undergo surgery utilizing the power morcellator each year.

Recently, there have been growing concerns related to the spreading of cellular material of the morcellated tissue. Studies have shown that there is an increase in the development of leiomyosarcoma. On April 17, 2014, the FDA issued a safety communication discouraging the use of uterine procedures. Specifically, the FDA warned that “when used for hysterectomy or myomectomy in women with uterine fibroids, laparascopic power morcellation poses a risk of spreading unsuspected cancer tissue, notably uterine sarcomas, beyond the uterus.”

The FDA further warned that it is estimated that 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. This type of cancer has a significant mortality rate.

Particularly disturbing is the fact that Johnson & Johnson was warned by a pathologist in 2006 that the morcellators carried significant risks. The company failed to act on this warning and continued actively marketing morcellator products. More than 8 years later, they have recalled the products given this increased risk of developing uterine cancer.

Leiomyosarcoma, also known as “LMS”, frequently requires extensive radiation and chemotherapy and often surgical intervention. The fatality rate for this type of cancer is high given the lack of pre-screening tests and the quick development of the cancer.

Pierce | Skrabanek PLLC

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