Boston Scientific’s Sec. 522 Studies On Pelvic Mesh Show It’s Too Risky, FDA Says

The US FDA says final data from two Boston Scientific postmarket studies have reinforced the agency’s position that the company’s transvaginal mesh to treat pelvic organ prolapse (POP) has a poor benefit-risk profile. The firm’s mesh has been off the US market since 2019.

Surgical knife and tension-free vaginal tape on pink background - Image

More than two years after the US Food and Drug Administration forced transvaginal mesh products off the market, the agency says results from two final postmarket studies by Boston Scientific Corp. reaffirm that the mesh is indeed too risky to be used on people.

The FDA in January 2012 ordered Boston Scientific and 32 other makers of mesh to treat pelvic organ prolapse (POP) to conduct 88 separate Sec. 522 studies; by January 2013...

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