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

Abstract

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. 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. 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). 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.