title: 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.
authors.affiliation: The Institute for Female Pelvic Medicine & Reconstructive Surgery, 1010 Horsham Rd, North Wales, PA 18103, USA. milesmurphy@comcast.net
authors.forename: Miles
authors.initials: M
authors.lastname: Murphy
authors.forename: Adam
authors.initials: A
authors.lastname: Holzberg
authors.forename: Heather
authors.initials: H
authors.lastname: van Raalte
authors.forename: Neeraj
authors.initials: N
authors.lastname: Kohli
authors.forename: Howard B
authors.initials: HB
authors.lastname: Goldman
authors.forename: Vincent
authors.initials: V
authors.lastname: Lucente
mesh_terms: D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D061214:Patient Safety; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011475:Prosthesis Failure; D019919:Prosthesis Implantation; D013526:Surgical Mesh / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration
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