April 22, 2019

FDA orders manufacturers to stop selling gynecologic mesh

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on April 16 announced that it had ordered manufacturers of surgical mesh products indicated for transvaginal repair of pelvic organ prolapse to stop selling and distributing their products in the US, immediately.

The FDA has determined that manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness of their mesh repair compared with the repair procedure without mesh.

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The companies have 10 days to submit their plans to withdraw their products from the market.


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