International Urogynecology Journal

, Volume 23, Issue 1, pp 5–9

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”

Authors

    • The Institute for Female Pelvic Medicine & Reconstructive Surgery
  • Adam Holzberg
    • Robert Wood Johnson Medical SchoolCooper University Hospital
  • Heather van Raalte
    • Princeton UrogynecologyUniversity Medical Center at Princeton
  • Neeraj Kohli
    • New England Center for UrogynecologyNewton-Wellesley Hospital/Brigham & Women’s Hospital, Harvard Medical School
  • Howard B. Goldman
    • Section of Female Pelvic Medicine and Reconstructive Surgery, Glickman Urologic and Kidney InstituteThe Cleveland Clinic
  • Vincent Lucente
    • The Institute for Female Pelvic Medicine & Reconstructive Surgery
  • on behalf of the Pelvic Surgeons Network
Debate: Transvaginal Mesh for POP -- The Recent FDA Update

DOI: 10.1007/s00192-011-1581-2

Cite this article as:
Murphy, M., Holzberg, A., van Raalte, H. et al. Int Urogynecol J (2012) 23: 5. doi:10.1007/s00192-011-1581-2

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.

Keywords

Mesh FDA Transvaginal Prolapse Safety

Supplementary material

192_2011_1581_MOESM1_ESM.docx (53 kb)
ESM 1 DOCX 53 kb

Copyright information

© The International Urogynecological Association 2011