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.

journal_name

Int Urogynecol J

authors

Murphy M,Holzberg A,van Raalte H,Kohli N,Goldman HB,Lucente V,Pelvic Surgeons Network.

doi

10.1007/s00192-011-1581-2

subject

Has Abstract

pub_date

2012-01-01 00:00:00

pages

5-9

issue

1

eissn

0937-3462

issn

1433-3023

journal_volume

23

pub_type

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