FDA reclassifies mesh for POP

January 6, 2016

Surgical mesh for pelvic organ prolapse (POP) is a class III or high-risk medical device requiring premarket approval application (PMA) following new action by the Food and Drug Administration (FDA).

Editor's note: A previous version of this article contained an erroneous headline. The article has been updated.

 

Surgical mesh for pelvic organ prolapse (POP) is a class III or high-risk medical device requiring premarket approval application (PMA) following new action by the Food and Drug Administration (FDA). The agency issued two final orders about the product after giving numerous warnings about their safety to physicians and patients over an 8-year period.

FDA previously considered surgical mesh for POP a class II medical device, meaning that it was moderate risk. Through the rigorous PMA pathway, manufacturers will now be required to demonstrate the safety and efficacy of the product and address concerns about its association with severe pelvic pain and organ perforation. The orders apply only to surgical mesh marketed for transvaginal treatment of POP and not the device’s use for indications such as stress urinary incontinence or abdominal repair of POP. 

Manufacturers of surgical mesh already on the market for the transvaginal indication will have 30 months to submit a PMA and a PMA must be submitted for any new mesh proposed for use for transvaginal repair of POP.

Surgical mesh was first approved as a class II device for transvaginal repair of POP in 2002. Since then, the FDA has received thousands of reports about complications associated with its use, including pain during intercourse, infection, and erosion into surrounding tissues. The agency issued safety communications about the device beginning in 2008 and proposed orders for the reclassification and PMA requirement in May 2014. 

Further reading:

Vaginal reconstructive surgery: A case for and against mesh use

Imaging innovation in urogynecology