Power Morcellators and Cancer Risk

Studies suggest a link between power morcellator devices and the upstaging (the advancement of a person’s stage of cancer) of undiagnosed uterine cancer, which can dramatically decrease their chances for survival. Serious risks associated with power morcellator devices have led the FDA to discourage the use of the device during certain surgical procedures, and in response, Ethicon, a subsidiary of Johnson & Johnson and one of the largest power morcellator manufacturers, issued a voluntary market withdrawal of the power morcellator. However, the device remains in use in hospitals throughout the United States.

Power morcellator is a surgical device designed to break down and remove large tissue masses through a small incision site, allowing surgeons to perform minimally invasive surgery of large tissue. Power morcellators are commonly used in minimally invasive procedures including liver, kidney, spleen, fibroid, and uterine (hysterectomy and myomectomy) removal surgeries. In addition to increased risk of upstaging, the tissue disseminated by the rotating blades of the power morcellation may cause displaced and implanted tissue on organs, potentially leading to abnormal growths, inflammation, and obstructions, requiring further surgical procedures to remedy.

FDA Action

April 2014: Issued a safety communication warning against the use of power morcellators during laparoscopic, or minimally invasive, procedures in the removal of the uterus (hysterectomy) or fibroids (myomectomy). Furthermore, the FDA stated that “there is no reliable method for predicting whether a woman with fibroids may have a uterine sarcoma.”

November 2014: Updated the device label box warning for women being treated for uterine fibroid. The box warning states that “the use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients.” An estimated 1 in 350 women undergoing surgical procedures for fibroids, such as hysterectomy or myomectomy, is found with unsuspected uterine sarcoma.

How We Can Help

If you or a loved one has been diagnosed with a uterine sarcoma after a surgery involving a power morcellator device, we want to hear your story. For more information, or to speak with someone about your potential case, please call us at 1.800.887.8029. You can also fill out our free case review form. Zimmerman Reed is experienced in helping individuals injured by a medical device and we welcome your questions.