Debate: Transvaginal Mesh for POP -- The Recent FDA Update

International Urogynecology Journal

, Volume 23, Issue 1, pp 5-9

First online:

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”

  • Miles MurphyAffiliated withThe Institute for Female Pelvic Medicine & Reconstructive Surgery Email author 
  • , Adam HolzbergAffiliated withRobert Wood Johnson Medical School, Cooper University Hospital
  • , Heather van RaalteAffiliated withPrinceton Urogynecology, University Medical Center at Princeton
  • , Neeraj KohliAffiliated withNew England Center for Urogynecology, Newton-Wellesley Hospital/Brigham & Women’s Hospital, Harvard Medical School
  • , Howard B. GoldmanAffiliated withSection of Female Pelvic Medicine and Reconstructive Surgery, Glickman Urologic and Kidney Institute, The Cleveland Clinic
  • , Vincent LucenteAffiliated withThe Institute for Female Pelvic Medicine & Reconstructive Surgery
  • , on behalf of the Pelvic Surgeons Network

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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