FDA Orders Surgical Mesh Products Pulled From US Market

By Danielle Nichole Smith (April 16, 2019, 6:52 PM EDT) -- The U.S. Food and Drug Administration on Monday ordered Boston Scientific and Coloplast — the only two remaining manufacturers of surgical mesh meant for the transvaginal repair of pelvic organ prolapse — to stop selling those mesh products in the U.S.

The order stems from the agency's reclassification of the devices as high-risk in 2016, which required their manufacturers to submit premarket approval applications to continue marketing them in the U.S., according to the FDA. The order covers Boston Scientific Corp.'s Uphold Lite Vaginal Support System and Xenform Soft Tissue Repair System, and Coloplast AS' Restorelle DirectFix Anterior Mesh.

The two...

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