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News From the Food and Drug Administration
March 21, 2017

Morcellator Risk Was Known

JAMA. 2017;317(11):1110. doi:10.1001/jama.2017.1585

The FDA was aware that laparoscopic power morcellators could spread cancerous tissue when the agency approved the first such device in 1991, according to a recent report from the US General Accountability Office (GAO).

The GAO launched its 2015 investigation in response to a bipartisan request from 12 US Representatives led by former Rep Mike Fitzpatrick (R, Pennsylvania) and Rep Louise Slaughter (D, New York). The request came after married physicians Hooman Noorchashm, MD, PhD, and Amy Reed, MD, PhD, mounted a prominent campaign to ban power morcellators, which slice fibroids or uterine tissue into small fragments during minimally invasive surgery. After undergoing a routine hysterectomy with power morcellation to remove a fibroid in 2013, Reed was diagnosed with leiomyosarcoma that spread throughout her abdomen during the procedure.

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