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

Int Urogynecol J. 2014 Apr;25(4):471-7. doi: 10.1007/s00192-013-2231-7. Epub 2013 Oct 1.


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.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Female
  • Gynecologic Surgical Procedures / trends*
  • Humans
  • Laparoscopy / trends
  • Middle Aged
  • Pelvic Organ Prolapse / surgery*
  • Retrospective Studies
  • Robotics / trends
  • Surgical Mesh / adverse effects
  • Surgical Mesh / trends*