title: 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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: University of Texas Southwestern Medical Center, Dallas, Texas 75390-9110, USA.
authors.forename: Dominic
authors.initials: D
authors.lastname: Lee
authors.forename: Benjamin
authors.initials: B
authors.lastname: Dillon
authors.forename: Gary
authors.initials: G
authors.lastname: Lemack
authors.forename: Alex
authors.initials: A
authors.lastname: Gomelsky
authors.forename: Philippe
authors.initials: P
authors.lastname: Zimmern
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D059350:Chronic Pain / Q000209:etiology / Q000601:surgery; D020878:Device Removal / Q000009:adverse effects; D030881:Disclosure; D004414:Dyspareunia / Q000209:etiology / Q000601:surgery; D005260:Female; D006801:Humans; D007258:Informed Consent; D008875:Middle Aged; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D017699:Pelvic Pain / Q000209:etiology / Q000601:surgery; D011475:Prosthesis Failure / Q000009:adverse effects*; D012008:Recurrence; D012086:Reoperation; D012189:Retrospective Studies; D012725:Sexual Behavior; D053825:Suburethral Slings / Q000009:adverse effects*; D013526:Surgical Mesh / Q000009:adverse effects*; D062606:Tertiary Care Centers; D014481:United States; D014486:United States Food and Drug Administration; D014549:Urinary Incontinence / Q000209:etiology / Q000601:surgery; D016055:Urinary Retention / Q000209:etiology / Q000601:surgery; D014552:Urinary Tract Infections / Q000209:etiology