Monday, August 16, 2021

Women's Health Alert

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US Food and Drug Administration
e-Alert
   
August 16, 2021 www.fda.gov/womens
   

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

Dear Stakeholders,

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.

Sincerely,

FDA Office of Women's Health


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