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U.S. Food and Drug Administration Statements About Transvaginal Mesh and Changes in Apical Prolapse Surgery

Winkelman, William D. MD; Modest, Anna M. PhD, MPH; Richardson, Monica L. MD, MPH

doi: 10.1097/AOG.0000000000003488
Contents: Urogynecology: Original Research
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OBJECTIVE: To assess the effects of the U.S. Food and Drug Administration (FDA) safety communication and the reclassification of transvaginal mesh to a class III device on national trends in the treatment of apical prolapse.

METHODS: A retrospective cohort study of surgical cases from 2008 to 2017 from the American College of Surgeons National Surgical Quality Improvement Program was conducted. Patients were included if they underwent apical prolapse repair, as identified by Current Procedural Terminology codes.

RESULTS: We identified 36,523 eligible surgical cases. There were no clinically meaningful differences in postoperative complications when stratified by surgical approach. The use of transvaginal mesh decreased from 35.0% to 11.0% from 2008 to 2017. In the year immediately after the first FDA safety communication in 2011, there was a decrease in the proportion of apical procedures using transvaginal mesh of 4.4% per quarter (P<.001), and the proportion of intraperitoneal, extraperitoneal, and abdominal colpopexy all increased. The greatest increase was seen for abdominal colpopexy procedures, which rose by 2.6% per quarter (P<.001). In the year after the FDA reclassification of transvaginal mesh in 2016, there was no significant change in the proportion of apical procedures using transvaginal mesh (P=.56).

CONCLUSION: The first FDA safety communication in 2011 was associated with a significant decline in the use of transvaginal mesh and a concurrent rise in abdominal colpopexy procedures using transabdominal mesh. We speculate that the 2019 FDA ban of transvaginal mesh will result in an even more substantial shift toward abdominal colpopexy procedures.

The safety communication about transvaginal mesh in 2011 was associated with a significant increase in the use of transabdominal mesh for apical prolapse.

Department of Obstetrics and Gynecology, Mount Auburn Hospital, Cambridge, and the Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, and the Department of Obstetrics, Gynecology, and Reproductive Biology, Harvard Medical School, Boston, Massachusetts.

Corresponding author: Monica L. Richardson, MD, MPH, Department of Obstetrics and Gynecology, Beth Israel Deaconess Medical Center, Boston, MA; email: mlrichar@bidmc.harvard.edu.

Financial Disclosure Anna M. Modest is a paid statistical consultant for Tissue Regenix and Renovia Inc. Money has been paid to her institution from the Koch Foundation and she has a financial relationship with ABC Board Review. The other authors did not report any potential conflicts of interest.

Each author has confirmed compliance with the journal's requirements for authorship.

Peer reviews and author correspondence are available at http://links.lww.com/AOG/B540.

© 2019 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.