title: Adverse events after first, single, mesh and non-mesh surgical procedures for stress urinary incontinence and pelvic organ prolapse in Scotland, 1997-2016: a population-based cohort study.
abstract: Concerns have been raised about the safety of surgery for stress urinary incontinence and pelvic organ prolapse using transvaginal mesh. We assessed adverse outcomes after first, single mesh procedures and comparable non-mesh procedures.
  
  
  
  We did a cohort study of women in Scotland aged 20 years or older undergoing a first, single incontinence procedure or prolapse procedure during 1997-98 to 2015-16 identified from a national hospital admission database. Primary outcomes were immediate postoperative complications and subsequent (within 5 years) readmissions for later postoperative complications, further incontinence surgery, or further prolapse surgery. Poisson regression models were used to compare outcomes after procedures carried out with and without mesh.
  
  
  
  Between April 1, 1997, and March 31, 2016, 16 660 women underwent a first, single incontinence procedure, 13 133 (79%) of which used mesh. Compared with non-mesh open surgery (colposuspension), mesh procedures had a lower risk of immediate complications (adjusted relative risk [aRR] 0·44 [95% CI 0·36-0·55]) and subsequent prolapse surgery (adjusted incidence rate ratio [aIRR] 0·30 [0·24-0·39]), and a similar risk of further incontinence surgery (0·90 [0·73-1·11]) and later complications (1·12 [0·98-1·27]); all ratios are for retropubic mesh. During the same time period, 18 986 women underwent a first, single prolapse procedure, 1279 (7%) of which used mesh. Compared with non-mesh repair, mesh repair of anterior compartment prolapse was associated with a similar risk of immediate complications (aRR 0·93 [95% CI 0·49-1·79]); an increased risk of further incontinence (aIRR 3·20 [2·06-4·96]) and prolapse surgery (1·69 [1·29-2·20]); and a substantially increased risk of later complications (3·15 [2·46-4·04]). Compared with non-mesh repair, mesh repair of posterior compartment prolapse was associated with a similarly increased risk of repeat prolapse surgery and later complications. No difference in any outcome was observed between vaginal and, separately, abdominal mesh repair of vaginal vault prolapse compared with vaginal non-mesh repair.
  
  
  
  Our results support the use of mesh procedures for incontinence, although further research on longer term outcomes would be beneficial. Mesh procedures for anterior and posterior compartment prolapse cannot be recommended for primary prolapse repair. Both vaginal and abdominal mesh procedures for vaginal vault prolapse repair are associated with similar effectiveness and complication rates to non-mesh vaginal repair. These results therefore do not clearly favour any particular vault repair procedure.
  
  
  
  None.
authors.affiliation: Information Services Division, National Health Service National Services Scotland, Edinburgh, UK; Division of Epidemiology and Public Health, University of Nottingham, Nottingham, UK.
authors.forename: Joanne R
authors.initials: JR
authors.lastname: Morling
authors.affiliation: Information Services Division, National Health Service National Services Scotland, Edinburgh, UK; Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
authors.forename: David A
authors.initials: DA
authors.lastname: McAllister
authors.affiliation: Obstetrics and Gynaecology Unit, Ayrshire Maternity Unit, University Hospital Crosshouse, Kilmarnock, UK.
authors.forename: Wael
authors.initials: W
authors.lastname: Agur
authors.affiliation: Information Services Division, National Health Service National Services Scotland, Edinburgh, UK.
authors.forename: Colin M
authors.initials: CM
authors.lastname: Fischbacher
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
authors.forename: Cathryn M A
authors.initials: CM
authors.lastname: Glazener
authors.affiliation: Department of Urogynaecology, Queen Elizabeth University Hospital, Glasgow, UK.
authors.forename: Karen
authors.initials: K
authors.lastname: Guerrero
authors.affiliation: Information Services Division, National Health Service National Services Scotland, Edinburgh, UK.
authors.forename: Leanne
authors.initials: L
authors.lastname: Hopkins
authors.affiliation: Information Services Division, National Health Service National Services Scotland, Edinburgh, UK. Electronic address: rachaelwood@nhs.net.
authors.forename: Rachael
authors.initials: R
authors.lastname: Wood
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008875:Middle Aged; D016017:Odds Ratio; D056887:Pelvic Organ Prolapse / Q000601:surgery*; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology / Q000601:surgery; D019651:Plastic Surgery Procedures / Q000009:adverse effects / Q000379:methods*; D012044:Regression Analysis; D012086:Reoperation; D012606:Scotland / Q000453:epidemiology; D053825:Suburethral Slings; D013526:Surgical Mesh; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D013520:Urologic Surgical Procedures / Q000009:adverse effects / Q000379:methods*; D014621:Vagina / Q000601:surgery