Morcellators Get Black Box Warning

Morcellators Get Black Box Warning

Posted By Golomb & Honik, P.C. || 30-Dec-2014

Laparoscopic power morcellators, used during hysterectomies and for the removal of uterine fibroids, have been given a Black Box warning by the U.S. Food and Drug Administration (FDA). After nearly one year of debate, the FDA decided in November to issue its strongest possible warning against the morcellators rather than ban them. Power morcellators have been in use since the 1990s, with their popularity booming recently with the advent of robotic surgery. A black box warning is the strongest warning the FDA requires and it signifies that the medical device or drug carries a significant risk for causing serious or life-threatening complications.

Power Morcellator Risks and Side Effects

The power morcellators are used as a minimally invasive means of destroying uterine tissue and fibroids by disintegrating the tissue for removal. As the spinning blades of the morcellators grind up tissue, they can leave behind small pieces. This process is not an issue on benign fibroids. The problems arise when the fibroids are not benign, but actually uterine sarcoma- a form of cancer, which is indistinguishable from benign fibroids until after surgery. During morcellation, the tissue is disseminated throughout the abdomen, literally "seeding" potentially cancerous tissue, greatly decreasing a woman's chances for survival.

Two contraindications exist on the morcellators label:

  1. The power morcellators should not be used in women who are peri- or post-menopausal, or who could otherwise have the tissue removed intact, and
  2. The device should not be used on women in which the tissue being morcellated is suspected or known to be cancerous.

It is impossible to know, however, whether a fibroid is actually undiagnosed cancer prior to surgery. It is estimated that 1 in 350 women who has surgery for a suspected fibroid actually has uterine sarcoma, and 1 in 500 has leiomyosarcoma- a rare, but aggressive form of uterine cancer.

Some doctors and hospitals have already discontinued use of the power morcellators. HCA Holdings, a company that manages nearly 300 medical centers in the United States and England, has banned the use of power morcellators in all its facilities. Although the FDA has not banned the devices, the agency strongly cautions that women should not undergo a power morcellation hysterectomy due to the risk of disseminating cancer. In its report, the FDA noted that there are other options available to women with uterine fibroids, including traditional surgery, laparoscopic hysterectomy and myomectomy without morcellation.

Power Morcellator Lawsuits

In March 2014, a man filed a hysterectomy cancer lawsuit in the U.S. District Court, Eastern District of Pennsylvania, when his wife lost her life to uterine cancer less than a year after undergoing a power morcellation hysterectomy to treat uterine bleeding. Meanwhile, a woman in New York has filed a case after she was diagnosed with cancer following a robot-assisted power morcellation hysterectomy.

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