Vaginal Mesh for Prolapse: An Epidemiologic and Historical Perspective
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.
KeywordsTransvaginal mesh Pelvic organ prolapse Prolapse surgery Synthetic polypropylene mesh Surgical mesh complications Pelvic Floor Disorders Registry
- 2.Surgical mesh for treatment of women with pelvic organ prolapse and stress urinary incontinence. FDA Executive Summary, ObGyn Devices Advisory Committee, Sept 8–9, 2011. https://wayback.archive-it.org/7993/20170404140406/https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/UCM270402.pdf. Accessed 7 Sept 2017.
- 3.Littman PM, Culligan PJ. The rapid evolution of vaginal mesh delivery systems for the correction of pelvic organ prolapse, Part 1: clinical data. The Female Patient. 2009;34:32–8.Google Scholar
- 7.Chughtai B, Mao J, Buck J, Kalan S, Sedrakyan A. Use and risks of surgical mesh for pelvic organ prolapse surgery in women in New York state: population based cohort study. BMJ. 2015;350:h2685. Correction: BMJ 2015;350:h3060.Google Scholar
- 9.FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks. FDA News Release, 4 Jan 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm479732.htm. Accessed 7 Sept 2017.
- 12.Vaginal placement of synthetic mesh for pelvic organ prolapse. Committee Opinion No. 513. American College of Obstetricians and Gynecologists. Obstet Gynecol 2011;118:1459–64.Google Scholar
- 13.Guideline for providing privileges and credentials to physicians for transvaginal placement of surgical mesh for pelvic organ prolapse. Female Pelvic Med Reconstr Surg. 2012;18:194–6.Google Scholar