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Media, FDA Join W&L in Warning Women of Morcellation DangersDec. 1, 2014
Expanding news coverage of the cancer-spread risks posed by power morcellators is helping show why women are right to seek compensation from the makers of the surgical devices, Weitz & Luxenberg said.
The most recent reports of injuries to women appeared in The Wall Street Journal, which in late November ran two major stories on power morcellator dangers.
These stories preceded by days the U.S. Food and Drug Administration’s issuance of a severe black box warning and specific contraindications against the use of power morcellators.
In one of The Wall Street Journal articles, readers learned of the death of Boston resident Erica Kaitz.
Ms. Kaitz was just 52 when she succumbed in late 2013 to leiomyosarcoma, an extremely rare and difficult-to-detect cancer, the Journal reported.
Ms. Kaitz in 2012 had been admitted to Brigham and Women’s Hospital for a scheduled hysterectomy due to suspected benign fibroids, the Journal said.
The surgeon who performed the procedure did so with the aid of a power morcellator, the newspaper added.
According to the Journal, the leiomyosarcoma then became much worse, upstaged and spread to her abdomen.
The Journal quoted a sarcoma expert at Dana-Farber Cancer Institute who later treated Ms. Kaitz as saying that the morcellation literally “seeded her abdomen” with the deadly cancer.
Ironically, just as Ms. Kaitz was nearing death, Brigham and Women’s announced that the results of its own research into power morcellator risks had convinced the hospital to curb its use of the devices, the Journal said.
Earlier this year, Brigham and Women’s stopped using power morcellators entirely, the Journal reported, noting that the hospital was the nation’s first to do so.
Morcellation Labeling Recommendations Issued
Other hospitals, including the Cleveland Clinic, have followed in these footsteps and are no longer using power morcellators during gynecologic surgery.
Meanwhile, the U.S. Food and Drug Administration is monitoring the situation and will keep the public updated as developments unfold.
The FDA’s current thinking on morcellators is reflected in newly issued recommendations to manufacturers.
In those recommendations, the FDA suggested a black-box warning and specific contraindications be added to the labeling of power morcellators.
The FDA’s most severe alerts come in the form of black-box warning labels.
The FDA’s recommendations also included adding to those labels two contraindications for power morcellation. Importantly, these contraindications apply to almost every woman. Specifically, power morcellation should be contraindicated for peri- or post-menopausal women, and for any woman who is a candidate for en bloc tissue removal.
In issuing these recommendations, the FDA stressed this labeling does not seek to discourage minimally invasive surgery for women, just the use of power morcellators during minimally invasive surgery.
The FDA emphasized that women still have many other options for gynecologic surgery.