Benzinga | Aug 17, 2021 12:27PM EDT

Post Market Studies Reinforce Unfavorable Risk-Benefit Profile For Boston Scientific's Vaginal Mesh

* Final results from postmarket surveillance studies of Boston Scientific Corporation's (NYSE:BSX) transvaginal mesh for pelvic organ prolapse (POP) have reinforced the FDA's unfavorable view of the benefit-risk profile.

* FDA said final reports from the 36-month studies found additional risks associated with transvaginal POP mesh repairs, such as mesh exposure and erosion.

* The FDA has asked 34 surgical mesh manufacturers for transvaginal repair of POP to perform postmarket surveillance studies.

* Related content: Benzinga's Full FDA Calendar.

* The request prompted most mesh manufacturers to drop out of the market, but Boston Scientific and Coloplast sought to adapt to the new regulatory requirements.

* Boston Scientific submitted results from postmarket studies last year. The studies found that the devices were non-inferior to native tissue repair for safety.

* There were no reports of mesh erosion in either study. However, almost 5% of recipients in the trial experienced mesh exposure within 36 months.

* Price Action: BSX shares are are up 1.25% at $45.22 during the market session on the last check Tuesday.