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Power morcellators are medical devices used during various laparoscopic surgeries, such as hysterectomies and myomectomies, that aggressively cut uterine tissue into small pieces. This permits the tissue to be removed through a small incision site, with the proposed benefits including shorter recovery periods, fewer complications, and less pain.
However, due to recent scrutiny and a rise in reports in the medical literature, the FDA issued a safety alert in April 2014 discouraging the use of these devices in uterine and fibroid removal procedures, as they may spread an undetected or unsuspected uterine sarcoma. In this safety alert the FDA also noted there is no reliable method for accurately detecting uterine sarcoma prior to hysterectomy or myomectomy. In addition, according to the FDA, an estimated 1 in 350 women who undergo these procedures may have undiagnosed uterine cancer.
Voluntary Market Withdrawal of Morcellator Devices
In response to this FDA communication, Johnson & Johnson’s power morcellator manufacturing unit, Ethicon, suspended all worldwide sales and distribution of power morcellators and ordered a voluntary market withdrawal, affecting all Johnson & Johnson morcellator products, including its Gynecare Morcellex, Gynecare X-Tract, and Morcellex Sigma.
Severe Complications Linked to Power Morcellators
The inherent risk of power morcellation is the dissemination of the broken-up tissue. Benign tissue can become implanted on abdominal structures and organs, resulting in conditions such as fibroids, endometriosis, and adenomyosis, potentially requiring further surgery. Furthermore, power morcellators can spread malignant tissue from an undiagnosed uterine cancer, including leiomyosarcoma, endometrial stromal sarcoma, carcinosarcoma, and endometrial adenocarcinoma, and significantly worsen a patient’s prognosis from treatable to deadly.