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Changes in prolapse surgery trends relative to FDA notifications regarding vaginal mesh

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Abstract

Introduction and hypothesis

In 2008 and 2011, the US Food and Drug Administration (FDA) released notifications regarding vaginal mesh. In describing prolapse surgery trends over time, we predicted vaginal mesh use would decrease and native tissue repairs would increase.

Methods

Operative reports were reviewed for all prolapse repairs performed from 2008 to 2011 at our large regional hospital system. The number of each type of prolapse repair was determined per quarter year and expressed as a percentage of all repairs. Surgical trends were examined focusing on changes with respect to the release of two FDA notifications. We used linear regression to analyze surgical trends and chi-square for demographic comparisons.

Results

One thousand two hundred and eleven women underwent 1,385 prolapse procedures. Mean age was 64 ± 12, and 70 % had stage III prolapse. Vaginal mesh procedures declined over time (p = 0.001), comprising 27 % of repairs in early 2008, 15 % at the first FDA notification, 5 % by the second FDA notification, and 2 % at the end of 2011. The percentage of native tissue anterior/posterior repairs (p < 0.001) and apical suspensions (p = 0.007) increased, whereas colpocleisis remained constant (p = 0.475). Despite an overall decrease in open sacral colpopexies (p < 0.001), an initial increase was seen around the first FDA notification. We adopted laparoscopic/robotic techniques around this time, and the percentage of minimally invasive sacral colpopexies steadily increased thereafter (p < 0.001). All sacral colpopexies combined as a group declined over time (p = 0.011).

Conclusions

Surgical treatment of prolapse continues to evolve. Over a 4-year period encompassing two FDA notifications regarding vaginal mesh and the introduction of laparoscopic/robotic techniques, we performed fewer vaginal mesh procedures and more native tissue repairs and minimally invasive sacral colpopexies.

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Acknowledgments

This project was supported by the National Institutes of Health through grant numbers UL1 RR024153 and UL1 TR000005. We thank Dr. Neena Agarwala for her assistance with data collection.

Conflicts of interest

None.

Author information

Authors and Affiliations

  1. Pittsburgh, PA, USA

    Laura C. Skoczylas, Lindsay C. Turner, Li Wang, Daniel G. Winger & Jonathan P. Shepherd

  2. Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente West Los Angeles, Los Angeles, CA, USA

    Laura C. Skoczylas

  3. Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics, Gynecology, and Reproductive Sciences, Magee-Womens Hospital, University of Pittsburgh Medical Center, 300 Halket Street, Pittsburgh, PA, 15213, USA

    Lindsay C. Turner & Jonathan P. Shepherd

  4. Clinical and Translational Science Institute, Office of Clinical Research, University of Pittsburgh, Pittsburgh, PA, USA

    Li Wang & Daniel G. Winger

Authors
  1. Laura C. Skoczylas
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  2. Lindsay C. Turner
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  3. Li Wang
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Corresponding author

Correspondence to Jonathan P. Shepherd.

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Presentation Information

These findings were presented at the 33rd Annual Meeting of the American Urogynecologic Society, Chicago, IL, USA, October 2012.

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Skoczylas, L.C., Turner, L.C., Wang, L. et al. Changes in prolapse surgery trends relative to FDA notifications regarding vaginal mesh. Int Urogynecol J 25, 471–477 (2014). https://doi.org/10.1007/s00192-013-2231-7

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  • DOI: https://doi.org/10.1007/s00192-013-2231-7

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