[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address 54.166.74.94. Please contact the publisher to request reinstatement.
[Skip to Content Landing]
Views 319
Citations 0
News From the Food and Drug Administration
February 16, 2016

Strengthening Surgical Mesh Safety

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.

First Page Preview View Large
First page PDF preview
First page PDF preview
×