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”
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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.
KeywordsMesh FDA Transvaginal Prolapse Safety
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.
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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