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Two final orders from the FDA have targeted serious complications linked with surgical mesh used for transvaginal repair of pelvic organ prolapse.
The agency reclassified the mesh as a high-risk device and will require manufacturers to submit a premarket approval application demonstrating the safety and effectiveness of their product (http://1.usa.gov/1MPbStj). The orders don’t apply to surgical mesh for other indications such as stress urinary incontinence or abdominal repair of pelvic organ prolapse.
Voelker R. Strengthening Surgical Mesh Safety. JAMA. 2016;315(7):648. doi:10.1001/jama.2016.0617
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