title: Pelvic mesh complications in women before and after the 2011 FDA public health notification.
abstract: OBJECTIVE
  On July 13, 2011, the US Food and Drug Administration (FDA) released a public health notification with concerns regarding vaginal mesh for the treatment of pelvic organ prolapse. Our study compares the frequency and type of mesh complications related to female pelvic floor disorders presenting to our center before and after this notification.
  
  
  METHODS
  We performed a retrospective cohort study comparing the percentage of women found to have mesh complications related to pelvic floor disorders for the year preceding and the 6 months following the FDA notification. The 2011 International Urogynecological Association/International Continence Society (IUGA/ICS) guidelines were used to classify mesh complications.
  
  
  RESULTS
  We identified 109 women in the 12 months before and 98 women in the 6 months after the FDA notification who presented for new consultation with a history of pelvic mesh placement. Of the women with prior mesh, a higher percentage had a mesh complaint after the FDA notification (31.2% before vs 45.9% after notification; P = 0.029). There was no difference in the frequency of diagnosed mesh complications (38.5% before vs 43.9% after notification; P = 0.435) or the types of complications seen as classified by the IUGA/ICS guidelines. The rate of complications among women with a prior sacral colpopexy (35%) or midurethral sling (30%) was higher than expected for both time periods.
  
  
  CONCLUSIONS
  Whereas the number of patient-perceived mesh complications increased after the FDA notification, neither the frequency, type, or location of complications changed. The complications were not limited to transvaginal mesh, and an unexpectedly high proportion of the complications were related to sacral colpopexy and midurethral sling procedures.
authors.affiliation: From the *Division of Female Pelvic Medicine and Reconstructive Surgery, and †Department of Biostatistics, Vanderbilt University, Nashville, TN.
authors.forename: Nicklaus Trent
authors.initials: NT
authors.lastname: Rice
authors.forename: Yan
authors.initials: Y
authors.lastname: Hu
authors.forename: James Chris
authors.initials: JC
authors.lastname: Slaughter
authors.forename: Renee Melva
authors.initials: RM
authors.lastname: Ward
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D008875:Middle Aged; D061214:Patient Safety; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011634:Public Health; D012189:Retrospective Studies; D053825:Suburethral Slings; D013526:Surgical Mesh / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration; D014550:Urinary Incontinence, Stress / Q000601:surgery; D055815:Young Adult