GETMESHJUSTICE.COM

In April 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of pelvic organ prolapse to stop sales and distribution of their products immediately. Following a review of their premarket approval process, the FDA determined manufacturers Boston Scientific and Coloplast "did not demonstrate reasonable assurance of safety and effectiveness for these devices, which is the premarket standard that applies to transvaginal mesh for pelvic mesh prolapse since the agency reclassified them into class III (high risk) in 2016.

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