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Female Pelvic Medicine & Reconstructive Surgery:
doi: 10.1097/SPV.0b013e31829099c1
Original Article

Impact of the 2011 FDA Transvaginal Mesh Safety Update on AUGS Members’ Use of Synthetic Mesh and Biologic Grafts in Pelvic Reconstructive Surgery

Clemons, Jeffrey L. MD*; Weinstein, Milena MD; Guess, Marsha K. MD; Alperin, Marianna MD, MS§; Moalli, Pamela MD, PhD; Gregory, William Thomas MD; Lukacz, Emily S. MD#; Sung, Vivian W. MD, MPH**; Chen, Bertha H. MD††; Bradley, Catherine S. MD, MSCE‡‡ ; on behalf of the AUGS Research Committee.

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Abstract

Objective

To describe the frequency of use and recent change in use of synthetic mesh and biologic grafts in pelvic organ prolapse (POP) and stress urinary incontinence surgery by American Urogynecology Society (AUGS) members.

Methods

An electronic survey of AUGS members was conducted between December 2011 and January 2012. Frequency of graft use in POP (overall and by transvaginal and transabdominal approaches) and stress urinary incontinence surgery was queried relative to the timing of the 2011 Food and Drug Administration (FDA) safety update. Rates of materials’ use before and after the statement were compared using Wilcoxon signed rank test.

Results

Fifty-three percent (507/962) of AUGS members responded and were included in analysis; 79% were urogynecologists. Before the FDA warning, in POP surgery, most (90%) used synthetic mesh and fewer (34%) used biologic grafts; 99% used synthetic mesh slings. After the FDA statement, respondents reported an overall decrease in the percent of POP cases in which they used synthetic mesh (P < 0.001) but no change in biologic graft use for POP (P = 0.37) or synthetic mesh sling use (P = 0.10). Specifically, transvaginal mesh use decreased: 40% reported decreased use and 12% stopped use. However, transvaginal mesh was still used by 61% of respondents in at least some cases. No change (62%) or increased use (12%) of mesh was reported for transabdominal POP procedures.

Conclusions

Synthetic mesh use in transvaginal POP surgery decreased after the 2011 FDA safety update, but synthetic mesh use for transabdominal POP repair and sling procedures and overall biologic graft use in POP surgery did not decrease.

Copyright © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins

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