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FDA Yanks Transvaginal Mesh From US Market; Boston Sci 'Surprised'; Firms Have 10 Days To Submit Withdraw Plan

16 Apr 2019

• By Shawn M. Schmitt

Transvaginal mesh products made by Boston Scientific and Coloplast were ordered pulled from US shelves by the agency on Aug. 16. Under the rare FDA order, the two firms must immediately stop selling the mesh and have 10 days to submit plans to the agency outlining how they will recall their unimplanted devices.

Surgical knife and tension-free vaginal tape on lilac background - Image

Boston Scientific Corp. says it's "surprised" and "disappointed" after the US FDA on April 16 ordered transvaginal mesh products made by it and a second company, Coloplast AS, to be pulled from the market in the United States.

Under the rare agency order, Boston Scientific and Coloplast must immediately stop selling the mesh and have 10 days to submit plans to the FDA outlining how they will recall...