A January 4th action by the US Food and Drug Administration (FDA) reclassified transvaginal mesh implants for pelvic organ prolapse (POP) as class III (or high-risk) medical devices requiring premarket approval application (PMA).
A January 4th action by the US Food and Drug Administration (FDA) reclassified transvaginal mesh implants for pelvic organ prolapse (POP) as class III (or high-risk) medical devices requiring premarket approval application (PMA). The action followed numerous warnings from the FDA about the implants’ safety over the past 8 years. Transvaginal mesh implants were previously classified as class II (moderate risk) devices. Notably, the change applies 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. Specifically, the change does not apply to full-length retropubic and transobturator midurethral slings or sacral colopopexy meshes, all of which have extensive clinical data showing safety and efficacy. 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.
Experts in urogynecology welcomed the change. “It is very challenging for the FDA to keep up with the thousands of new medical procedures that are developed each year across hundreds of disciplines and the rapidly changing technologies,” noted John O DeLancey, MD, Professor of Gynecology and Fellowship Director in Female Pelvic Medicine and Reconstructive Surgery, University of Michigan Medical School, Ann Arbor, and a member of the Contemporary OB/GYN editorial board. “Thirty years ago, when the original regulations were developed, saying something was substantially similar to existing products was something that surgeons welcomed and that allowed rapid progress. However, new complex surgical technologies have unique risks and change rapidly, and it is time to make sure that there are adequate safety and efficacy data before approving new techniques, devices, and products. It is what the public expects from the FDA and what all of us would want for our own health care.”
Douglass S Hale, MD, FACOG, FACS, is President of the American Urogynecologic Society (AUGS) and Director of Female Pelvic Medicine and Reconstructive Surgery at IU Health and a Clinical Professor at Indiana University School of Medicine. He commented on the reclassification in his blog at AUGS.org, writing, “Prior to [January 4th], transvaginal mesh devices were approved by the FDA through the relatively simple 510(k) process, which required only that a prior similar device had been approved and did not require laborious and expensive new clinical trials. Transvaginal mesh implants for POP were originally approved using full-length midurethral slings as the prior approved device. However, the FDA can require more detailed information be provided should excess complications arise from new 510(k)-approved devices through a process known as Section 522, and can also require post-market surveillance of such 510(k) approved devices.
Thus, the FDA now requires:
1. New transvaginal mesh POP devices be moved from class II to class III devices and do through the more rigorous PMA process; and
2. Existing transvaginal mesh POP devices to complete Section 522 studies.”
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.