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Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators

Medical Devices: Cancer Risk Led FDA to Warn Against Certain Uses of Power Morcellators and Recommend New Labeling, GAO-17-231: Published: Feb 7, 2017. Publicly Released: Feb 8, 2017.

“In 1991, FDA allowed the first laparoscopic power morcellator—a device that cuts tissue into small pieces, which can be removed during minimally invasive surgeries—on the U.S. market. In late 2013, the agency began to receive reports that these devices may spread a difficult-to-diagnose cancer when used to treat uterine fibroids. In April 2014, FDA estimated that the risk of having the type of uterine cancer identified in these first reports was higher than previous estimates. The agency warned against the use of power morcellators to treat fibroids and recommended new labeling, which all current manufacturers followed…”

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