Vaginal Mesh for Prolapse: An Epidemiologic and Historical Perspective

Abstract

The process for introducing new surgical devices differs from drug evaluations. The US Food and Drug Administration (FDA) often clears medical devices through the 510(k) process, which evaluates safety by substantial equivalence to another device. New drug evaluations, however, assess both premarket efficacy and safety. Transvaginal mesh kits for pelvic organ prolapse were initially cleared in 2004 based on predicate synthetic suburethral slings and hernia mesh. Reported serious complications associated with transvaginal mesh use led to a 2008 FDA public health notification and 2011 safety communication. Subsequently, the FDA issued 522 orders for post-market surveillance data to all manufacturers of transvaginal mesh kits. Some companies ceased transvaginal mesh manufacturing, while others invested millions in research to satisfy these orders. Recently, the American Urogynecologic Society (AUGS) partnered with the FDA, other major medical societies, manufacturers, and representatives from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), to develop the Pelvic Floor Disorders Registry (PFDR), which launched the initial 522 studies. In addition, AUGS and the American College of Obstetricians and Gynecologists (ACOG) published and reaffirmed a committee document on vaginal placement of mesh in 2011 and 2015. In 2012, AUGS published guidelines for credentialing surgeons on transvaginal mesh use. Finally, in 2016, the FDA reclassified vaginal mesh devices from class II to class III, requiring manufacturers to provide premarket data. Careful patient selection, better surgeon training, advances in mesh design, and increased post-market surveillance of transvaginal mesh devices will lead to improved safety, decreased complications, and better long-term outcomes for women.