Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”

Abstract

In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse.” The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996–2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.

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References

  1. 1.

    Barber MD, Visco AG, Weidner AC et al (2000) Bilateral uterosacral ligament vaginal vault suspension with site-specific endopelvic fascia defect repair for treatment of pelvic organ prolapse. Am J Obstet Gynecol 183:1402–1411

    PubMed  Article  CAS  Google Scholar 

  2. 2.

    Maher CF, Feiner B, DeCuyper EM et al (2011) Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Am J Obstet Gynecol 204(360):e1-7

    Google Scholar 

  3. 3.

    Nygaard IE, McCreery, Brubaker L et al (2004) Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol 104(4):805–823

    PubMed  Article  Google Scholar 

  4. 4.

    Abed H, Rahn DD, Lowenstein L et al (2011) Incidence and management of graft erosion, wound granulation, and dyspareunia following vaginal prolapse repair with graft materials: a systematic review. Int Urogynecol J 22:789–798

    PubMed  Article  Google Scholar 

  5. 5.

    Withagen MI, Milani AL, den Boon J et al (2011) Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Obstet Gynecol 117(2):242–250

    PubMed  Article  Google Scholar 

  6. 6.

    Whitehead WE, Bradley CS, Brown MB et al (2007) Gastrointestinal complications following abdominal sacrocolpopexy for advanced pelvic organ prolapse. Am J Obstet Gynecol 197:78.e1–78.e7

    Article  Google Scholar 

  7. 7.

    Maher C, Feiner B, Glazener CMA. (2010) Surgical management of pelvic organ prolapse in women. Cochrane Database of Systematic Reviews. (4): CD004014

  8. 8.

    Benson JT, Lucente V, McClellan E (1996) Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Am J Obstet Gynecol 175(6):1418–1421

    PubMed  Article  CAS  Google Scholar 

  9. 9.

    Lo TS, Wang AC (1998) Abdominal colposacropexy and sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. J Gynecol Surg 14(2):59–64

    Article  Google Scholar 

  10. 10.

    Maher CF, Qatawneh AM, Dwyer PL et al (2004) Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Am J Obstet Gynecol 190:20–26

    PubMed  Article  Google Scholar 

  11. 11.

    Hiltunen R, Nieminen K, Takala T et al (2007) Low-weight polypropylene mesh for anterior vaginal wall prolapse: a randomized controlled trial. Obstet Gynecol 110(2):455–462

    PubMed  Article  Google Scholar 

  12. 12.

    Sivaslioglu AA, Unlubilgin E, Dolen I et al (2008) A randomized comparison of polypropylene mesh surgery with site-specific surgery in the treatment of cystocele. Int Urogynecol J 19:467–471

    Article  CAS  Google Scholar 

  13. 13.

    Nguyen JN, Burchette RJ (2008) Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Obstet Gynecol 111(4):891–898

    PubMed  Article  Google Scholar 

  14. 14.

    Nieminen K, Hiltunen R, Heiskanen E et al (2008) Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh. Int Urogynecol J 19:1611–1616

    Article  Google Scholar 

  15. 15.

    Carey M, Higgs P, Goh J et al (2009) Vaginal repair with mesh versus colporrhaphy for prolapse: a randomised controlled trial. BJOG 116(10):1380–1386

    PubMed  Article  CAS  Google Scholar 

  16. 16.

    Lopes ED, Lemos NL, Carramao SS et al (2010) Transvaginal polypropylene mesh versus sacrospinous ligament fixation for the treatment of uterine prolapse: 1-year follow-up of a randomized controlled trial. Int Urogynecol J 21:389–394

    PubMed  Article  Google Scholar 

  17. 17.

    Iglesia CB, Sokol AI, Sokol ER et al (2010) Vaginal mesh for prolapse: a randomized controlled trial. Obstet Gynecol 116(2):293–303

    PubMed  Article  Google Scholar 

  18. 18.

    Nieminen K, Hiltunen R, Takala T et al (2010) Outcomes after anterior vaginal wall repair with mesh: a randomized, controlled trial with a 3 year follow-up. Am J Obstet Gynecol 203(235):e1–e8

    PubMed  Google Scholar 

  19. 19.

    Altman D, Vayrynen T, Engh ME et al (2011) Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. N Engl J Med 364(19):1826–1836

    PubMed  Article  CAS  Google Scholar 

  20. 20.

    Brubaker L, Nygaard I, Richter HE et al (2008) Two-year outcomes after sacrocolpopexy with and without Burch to prevent stress urinary incontinence. Obstet Gynecol 112(1):49–55

    PubMed  Article  Google Scholar 

  21. 21.

    Deitz HP, Erdmann M, Shek KL (2011) Mesh contraction: myth or reality? Am J Obstet Gynecol 204(173):e1–e4

    Google Scholar 

  22. 22.

    Olsen AL, Smith VJ, Berfstrom JO et al (1997) Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol 89:501–506

    PubMed  Article  CAS  Google Scholar 

  23. 23.

    Clark AL, Gregory T, Smith VJ, Edwards R (2003) Epidemiologic evaluation of reoperation for surgically treated pelvic organ prolapse and urinary incontinence. Am J Obstet Gynecol 189:1261–1267

    PubMed  Article  Google Scholar 

  24. 24.

    Whiteside JL, Weber AM, Meyn LA, Walters MD (2004) Risk factors for prolapse recurrence after vaginal repair. Am J Obstet Gynecol 191:1533–1538

    PubMed  Article  Google Scholar 

  25. 25.

    Nilsson CG, Palva K, Rezapour M, Falconer C (2008) Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of stress urinary incontinence. Int Urogynecol J 19(8):1043–1047

    Article  CAS  Google Scholar 

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Acknowledgments

We would like to thank Tracy Papsun for her efforts in compiling the list of surgeons from the Pelvic Surgeons Network who have endorsed this manuscript.

Funding

No funding was received for the preparation of this manuscript.

Conflicts of interest

Miles Murphy is a consultant and research site for Ethicon Women’s Health & Urology and American Medical Systems, research site for Bard; Adam Holzberg is a consultant and research site for Boston Scientific; Heather van Raalte is a consultant and research site for Ethicon Women’s Health & Urology, research site for Bard; Howard B. Goldman is a consultant for Ethicon Women’s Health & Urology; Neeraj Kohli has no disclosures; Vincent Lucente is a consultant and research site for Ethicon Women’s Health & Urology, Bard, and American Medical Systems.

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Correspondence to Miles Murphy.

Additional information

References 11, 14, and 18 report on the same RCT at three different lengths of follow-up.

This manuscript has been endorsed by over 600 members of the Pelvic Surgeons Network. A listing of the endorsing physicians of this commentary can be found at https://docs.google.com/leaf?id = 0B1tkV5dMf-zIMjhjN2M4Y2ItMDNjMi00NmNmLWIzOWQtMTJmODkwMjY5YTA4&hl = en_US. Further contributions to this debate can be found at doi:10.1007/s00192-011-1580-3, doi:10.1007/s00192-011-1596-8, and doi:10.1007/s00192-011-1597-7.

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Murphy, M., Holzberg, A., van Raalte, H. et al. Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: “UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse”. Int Urogynecol J 23, 5–9 (2012). https://doi.org/10.1007/s00192-011-1581-2

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Keywords

  • Mesh
  • FDA
  • Transvaginal
  • Prolapse
  • Safety