FDA Proposes to Tighten Controls on Some Surgical Mesh

The Food and Drug Administration is proposing to reclassify surgical mesh used for transvaginal pelvic organ prolapse repair as high-risk Class III devices, and is also proposing to require premarket approval (here), after finding new health risks associated with the device. The reclassification would only cover surgical mesh for transvaginal prolapse repair, and would not cover surgical mesh used to treat stress urinary incontinence or for abdominal prolapse repair, hernia repair, and other non-urogynecologic indications, said FDA (here). FDA's proposed order would also reclassify urogynecologic surgical mesh instrumentation from Class I into Class II with additional "special controls." Comments are due July 29.