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. Questions? If you have questions, contact the Division of Industry and Consumer Education. |
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