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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.

Female Pelvic Medicine & Reconstructive Surgery: July/August 2013 - Volume 19 - Issue 4 - p 191–198
doi: 10.1097/SPV.0b013e31829099c1
Original Article

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.

Synthetic mesh use in transvaginal prolapse surgery decreased after the 2011 FDA Safety Update, but synthetic mesh use for transabdominal prolapse repair and sling procedures did not decrease.

From the *MultiCare Health System, Tacoma, WA; †Massachusetts General Hospital, Boston, MA, ‡Yale University, New Haven, CT; §University of California, San Diego, CA; ∥Magee-Womens Hospital, University of Pittsburgh, Pittsburgh, PA ; ¶Oregon Health & Science University, Portland, OR; #UC San Diego Health System, San Diego, CA; **Women and Infants Hospital, Brown Medical School, Providence, RI; ††Stanford University Medical Center, Stanford, CA; and ‡‡Iowa City VA Health Care System and University of Iowa Carver College of Medicine, Iowa City, IA.

Reprints: Jeffrey L. Clemons, MD, 1901 S. Union Avenue, Suite B-2006 Tacoma, WA 98405. E-mail: drclemons@yahoo.com; Jeffrey.clemons@multicare.org.

The authors have declared that they have no conflicts of interest.

© 2013 by Lippincott Williams & Wilkins