FDA Allows Morcellators to Remain on Market, with Black Box Warning

The FDA announced this week that power morcellators, the surgical device linked to the spread of unsuspected cancer in women undergoing laparoscopic uterine fibroid surgery, will not be recalled, but will remain on the market with a “black box” warning. Dr. William Maisel, deputy principal for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said that “updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.” Activists, lawmakers, and families of women diagnosed with advanced stage uterine cancer disagree, wanting the FDA to completely remove the device from the market.

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