Elsevier

Urology

Volume 91, May 2016, Pages 46-51
Urology

Female Urology, Urodynamics, Incontinence, and Pelvic Floor Reconstructive Surgery
Pelvic Organ Prolapse Surgery in Academic Female Pelvic Medicine and Reconstructive Surgery Urology Practice in the Setting of the Food and Drug Administration Public Health Notifications

https://doi.org/10.1016/j.urology.2015.12.057Get rights and content

Objective

To understand the effect of the Food and Drug Administration (FDA) public health notifications regarding transvaginal placement of surgical mesh for pelvic organ prolapsed (POP) on surgeon practice patterns in tertiary care academic medical centers.

Materials and Methods

Surgical volume for procedures performed primarily by fellowship trained Female Pelvic Medicine and Reconstructive Surgery at a sampling of 8 academic institutions across the US were collected using current procedural technology codes for POP repair and revision surgeries from 2007 to 2013. SAS statistical software was used to analyze data for trends and to assess differences in number of procedures across years by performing Spearman correlation analysis and Pearson's chi-squared test. Significance of trend was defined as P <.05 for both analysis methods.

Results

There has been a substantial reduction in transvaginal mesh–augmented repair of POP since the FDA warning statements of 2008 and 2011. Mesh revision surgery has increased over this same period. However, the total number of interventions for POP has remained stable over the study period. Abdominal sacrocolpopexy has increased as a whole but represents only a small percentage of total cases.

Conclusion

Surgical correction of POP comprises a large portion of Female Pelvic Medicine and Reconstructive Surgery practice that continues to evolve in the aftermath of the FDA public health notifications. The utilization of transvaginal placement of surgical mesh augmented POP repair has decreased among practicing urologists at a sampling of academic institutions across the United States. Indications for surgery, complications, and outcomes were not evaluated during this retrospective study; however, such data may provide alternative insights into the reasons for the observed trends.

Section snippets

Materials and Methods

Surgical volume for procedures performed by FPMRS specialists at eight academic institutions were collected using Current Procedural Terminology (CPT) codes for POP [45560, 57120, 57240, 57250, 57260, 57265, 57267, 57268, 57270, 57280, 57282, 57283, 57284, 57285, 57423, 57425] as well as mesh revision surgery [57295, 57296] but excluding procedures for SUI. The study was approved by the Medical University of South Carolina institutional review board and was inclusive of all participating

Results

This multi-institutional collaborative study included a total of 6680 interventions for POP performed during the time period January 1, 2007 to December 31, 2013. POP repair with mesh performed by practicing FPMRS at these academic centers has decreased substantially since 2007 (Fig. 1). The decreasing trend in POP mesh implant surgeries was found to be statistically significant (P ≤.0001). When the data were stratified by center, it was observed that there was a decreasing trend at each of the

Discussion

Current surgical trends in POP surgery have previously not been well defined in this era of increased scrutiny over procedures using transvaginal mesh. We found that there has been a dramatic shift in the use of TVM for POP surgery and a steady increase in the number of mesh revision surgeries performed at several tertiary care centers across the United States over the past 7 years. The observed trends are generally uniform among participating centers. Total surgical volume for POP has remained

Conclusion

This study and others before it are important for both a public health perspective and for practicing FPMRS as it pertains to changing practice patterns in POP surgery during this time of increased scrutiny regarding TVM. The use of TVM for POP among FPMRS in academic centers has drastically decreased over the last 7 years. In light of the current medico-legal and regulatory atmosphere, practice patterns and approaches for POP repair continue to evolve. The exact role for TVM for POP remains

Acknowledgment

The authors appreciate contributions by the biostatistics department at the Medical University of South Carolina.

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There are more references available in the full text version of this article.

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Financial Disclosure: The authors declare that they have no relevant financial interests.

Funding Support: The project and analysis described in the materials and methods section was supported by Award Number UL1TR000062 from the National Center for Advancing Translational Sciences. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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