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 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.

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