Vaginal Mesh for Prolapse: An Epidemiologic and Historical Perspective

  • Cheryl B. Iglesia
  • Pakeeza A. Alam


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.


Transvaginal mesh Pelvic organ prolapse Prolapse surgery Synthetic polypropylene mesh Surgical mesh complications Pelvic Floor Disorders Registry 


  1. 1.
    Ward K, Hilton P. Prospective multicentre randomized trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002 Jul 13;325(7355):67.CrossRefGoogle Scholar
  2. 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. Accessed 7 Sept 2017.
  3. 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
  4. 4.
    Challoner DR, Vodra WW. Medical devices and health—creating a new regulatory framework for moderate-risk devices. N Engl J Med. 2011;365:977–9.CrossRefGoogle Scholar
  5. 5.
    Curfman GD, Redberg RF. Medical devices—balancing regulation and innovation. N Engl J Med. 2011;365:975–7.CrossRefGoogle Scholar
  6. 6.
    Rogo-Gupta L, Rodriguez LV, Litwin MS, Herzog TJ, Neugut AI, Lu Y, et al. Trends in surgical mesh use for pelvic organ prolapse from 2000 to 2010. Obstet Gynecol. 2012;120(5):1105–15.PubMedGoogle Scholar
  7. 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
  8. 8.
    Sedrakyan A, Chughtai B, Mao J. Regulatory warnings and use of surgical mesh in pelvic organ prolapse. JAMA Intern Med. 2016;176(2):275–7.CrossRefGoogle Scholar
  9. 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. Accessed 7 Sept 2017.
  10. 10.
    Bradley CS, Visco AG, Weber LeBrun EE, Barber MD. The pelvic floor disorders registry: purpose and development. Female Pelvic Med Reconstr Surg. 2016;22(2):77–82.CrossRefGoogle Scholar
  11. 11.
    Weber LeBrun EE, Adam RA, Barber MD, Boyles SH, Iglesia CB, Lukacz ES, et al. Pelvic floor disorders registry: study design and outcome measures. Female Pelvic Med Reconstr Surg. 2016;22:70–6.CrossRefGoogle Scholar
  12. 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. 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
  14. 14.
    Eilber KS, Alperin M, Khan A, Wu N, Pashos CL, Clemens JQ, Anger JT. The role of the surgeon on the outcomes of vaginal prolapse surgery with mesh. Female Pelvic Med Reconstr Surg. 2017;23(5):293–6.CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Cheryl B. Iglesia
    • 1
  • Pakeeza A. Alam
    • 1
  1. 1.Section of Female Pelvic Medicine and Reconstructive Surgery, MedStar Washington Hospital Center, Departments of Obstetrics/Gynecology and Urology, Georgetown University School of MedicineWashington, DCUSA

Personalised recommendations