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News From the Food and Drug Administration
February 16, 2016

Strengthening Surgical Mesh Safety

Author Affiliations

Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;315(7):648. doi:10.1001/jama.2016.0617

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.