USA – FDA affirms increased risk with pelvic mesh products

The US Food and Drug Administration (FDA) announced on Monday that its review of final results from postmarket surveillance of transvaginal mesh devices meant to treat pelvic organ prolapse (POP) found that patients who received mesh repair had increased risk of mesh exposure and tissue erosion compared to patients whose prolapse was repaired with native tissue.

“Therefore, the FDA continues to believe that these devices do not have a favorable benefit-risk profile,” wrote FDA in an update to its webpage detailing the agency’s regulatory oversight of urogynecologic surgical mesh products…