Monday, August 16, 2021

Transvaginal Mesh: Final Results of Postmarket Studies

Boston Scientific meshes for pelvic organ prolapse considered not favorable by the FDA, based on review of available evidence.

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FDA - Center for Devices and Radiological Health

FDA Announces Results of Boston Scientific Transvaginal POP Mesh Postmarket Surveillance Studies

Today, the U.S. Food and Drug Administration (FDA) announced the availability of the final results of the postmarket surveillance studies on Boston Scientific transvaginal mesh for pelvic organ prolapse (POP).

In 2019, the FDA ordered mesh manufacturers to stop selling devices for transvaginal repair of pelvic organ prolapse in the United States. Based on the review of the available evidence, the FDA continues to believe the benefits do not outweigh the risks of surgical mesh placed transvaginally to treat POP.

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