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J&J's Ethicon Unit Recalls its Power Morcellator Devices After Warnings by Federal Regulators and Concern About Risk of Spreading Occult Cancer, Parker Waichman Comments
Date:8/1/2014

at are made in the body. The agency communication also indicated that power morcellators, when used in women who have an occult uterine sarcoma (cancer), may spread that cancer to other parts of the body.

Following the FDA’s warning, Johnson & Johnson, which is the largest maker of morcellator devices, announced it was discontinuing its power morcellator lines worldwide, including the “Gynecare Morcellex,” “Morcellex Sigma,” and “Gynecare X-Tract,” according to an April 29, 2014 The Wall Street Journal report. Also, several hospitals, such as the Cleveland Clinic, have ceased using power morcellators since the FDA recommendation was issued, according to The Washington Post.

A statement issued by an Johnson & Johnson Ethicon spokesperson indicated that “Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk,” according to the Reuters report.

“Thousands of women undergo minimally invasive surgeries for hysterectomy o
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