Transvaginal mesh kits--how "serious" are the complications and are they reversible?

Abstract

Objective: To review the merit of the U.S. Food and Drug Administration-issued warnings on the use of transvaginal mesh in women with pelvic organ prolapse because of escalating complications.

Materials and methods: On institutional review board approval, we reviewed the data from 2 tertiary institutions managing complications of transvaginal mesh. The data recorded included mesh type, details of surgical removal, and patient-reported clinical outcomes.

Results: From 2006 to March 2011, 58 women were evaluated. Their mean age was 54.6 years (range 32-80), with a mean follow-up of 13 months (range 6-67). The mean interval to mesh excision surgery from the original prolapse surgery was 21 months (range 2-60). Of the 58 women, 35 (60%) had undergone concurrent midurethral sling surgery with the transvaginal mesh surgery. Also, 21 of the 58 patients (36%) had undergone initial mesh removal attempts before their referral to either tertiary institution. Most women presented with multiple complaints, with mesh extrusion the most frequently reported (n=43 [74%]). Of the 58 women, 17 (29%) required re-excision of residual mesh, 13 once and 4 twice. Five women developed recurrent symptomatic pelvic organ prolapse (7%). The residual rate of dyspareunia and pelvic pain was 14% and 22%, respectively. Fourteen women (24%) were treated successfully, with complete resolution of all presenting symptoms.

Conclusion: As outlined in the Food and Drug Administration notifications, patients should be forewarned that some transvaginal mesh complications are life altering and might not always be surgically correctable.