Long-term Rate of Mesh Sling Removal Following Midurethral Mesh Sling Insertion Among Women With Stress Urinary Incontinence

Importance There is concern about outcomes of midurethral mesh sling insertion for women with stress urinary incontinence. However, there is little evidence on long-term outcomes. Objective To examine long-term mesh removal and reoperation rates in women who had a midurethral mesh sling insertion for stress urinary incontinence. Design, Setting, and Participants This population-based retrospective cohort study included 95 057 women aged 18 years or older who had a first-ever midurethral mesh sling insertion for stress urinary incontinence in the National Health Service hospitals in England between April 1, 2006, and December 31, 2015. Women were followed up until April 1, 2016. Exposures Patient and hospital factors and retropubic or transobturator mesh sling insertions. Main Outcomes and Measures The primary outcome was the risk of midurethral mesh sling removal (partial or total) and secondary outcomes were reoperation for stress urinary incontinence and any reoperation including mesh removal, calculated with death as competing risk. A multivariable Fine-Gray model was used to calculate subdistribution hazard ratios as estimates of relative risk. Results The study population consisted of 95 057 women (median age, 51 years; interquartile range, 44-61 years) with first midurethral mesh sling insertion, including 60 194 with retropubic insertion and 34 863 with transobturator insertion. The median follow-up time was 5.5 years (interquartile range, 3.2-7.5 years). The rate of midurethral mesh sling removal was 1.4% (95% CI, 1.3%-1.4%) at 1 year, 2.7% (95% CI, 2.6%-2.8%) at 5 years, and 3.3% (95% CI, 3.2%-3.4%) at 9 years. Risk of removal declined with age. The 9-year removal risk after transobturator insertion (2.7% [95% CI, 2.4%-2.9%]) was lower than the risk after retropubic insertion (3.6% [95% CI, 3.5%-3.8%]; subdistribution hazard ratio, 0.72 [95% CI, 0.62-0.84]). The rate of reoperation for stress urinary incontinence was 1.3% (95% CI, 1.3%-1.4%) at 1 year, 3.5% (95% CI, 3.4%-3.6%) at 5 years, and 4.5% (95% CI, 4.3%-4.7%) at 9 years. The rate of any reoperation, including mesh removal, was 2.6% (95% CI, 2.5%-2.7%) at 1 year, 5.5% (95% CI, 5.4%-5.7%) at 5 years, and 6.9% (95% CI, 6.7%-7.1%) at 9 years. Conclusions and Relevance Among women undergoing midurethral mesh sling insertion, the rate of mesh sling removal at 9 years was estimated as 3.3%. These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence.

[1]  Andrew J. Sims,et al.  Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women , 2017, Scientific Reports.

[2]  J. Cody,et al.  Mid-urethral sling operations for stress urinary incontinence in women. , 2017, The Cochrane database of systematic reviews.

[3]  P. Austin A Tutorial on Multilevel Survival Analysis: Methods, Models and Applications , 2017, International statistical review = Revue internationale de statistique.

[4]  E. Finazzi Agró,et al.  Long-term outcomes of TOT and TVT procedures for the treatment of female stress urinary incontinence: a systematic review and meta-analysis , 2017, International Urogynecology Journal.

[5]  C. Fischbacher,et al.  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 , 2017, The Lancet.

[6]  J. Cody,et al.  Mid-urethral sling operations for stress urinary incontinence in women. , 2015, The Cochrane database of systematic reviews.

[7]  Andrew J. Sims,et al.  Identifying complications of interventional procedures from UK routine healthcare databases: a systematic search for methods using clinical codes , 2014, BMC Medical Research Methodology.

[8]  Jennifer M Wu,et al.  Lifetime Risk of Stress Urinary Incontinence or Pelvic Organ Prolapse Surgery , 2014, Obstetrics and gynecology.

[9]  C. Nager,et al.  Position Statement on Mesh Midurethral Slings for Stress Urinary Incontinence , 2014, Female pelvic medicine & reconstructive surgery.

[10]  K. Bhaskaran,et al.  Completeness and usability of ethnicity data in UK-based primary care and hospital databases , 2013, Journal of public health.

[11]  R. Pietrobon,et al.  Perceptions about female urinary incontinence: a systematic review , 2014, International Urogynecology Journal.

[12]  Communities,et al.  English Indices of Deprivation , 2013 .

[13]  P. Ziprin,et al.  Systematic review of discharge coding accuracy. , 2012, Journal of public health.

[14]  M. Remzi,et al.  Reporting and grading of complications after urologic surgical procedures: an ad hoc EAU guidelines panel assessment and recommendations. , 2012, European urology.

[15]  K. Coyne,et al.  Urinary incontinence and its relationship to mental health and health-related quality of life in men and women in Sweden, the United Kingdom, and the United States. , 2012, European urology.

[16]  A. Wittmann,et al.  Ten-year follow-up after the tension-free vaginal tape procedure. , 2011, American journal of obstetrics and gynecology.

[17]  Patrick Royston,et al.  Multiple imputation using chained equations: Issues and guidance for practice , 2011, Statistics in medicine.

[18]  J. van der Meulen,et al.  Identifying co‐morbidity in surgical patients using administrative data with the Royal College of Surgeons Charlson Score , 2010, The British journal of surgery.

[19]  Firouz Daneshgari,et al.  Re: FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence , 2009 .

[20]  R. Parker,et al.  Communities and Local Government , 2008 .

[21]  H Putter,et al.  Tutorial in biostatistics: competing risks and multi‐state models , 2007, Statistics in medicine.

[22]  U. Ulmsten,et al.  An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence , 2005, International Urogynecology Journal.

[23]  P. Hilton,et al.  Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence , 2002, BMJ : British Medical Journal.

[24]  Robert Gray,et al.  A Proportional Hazards Model for the Subdistribution of a Competing Risk , 1999 .

[25]  K. Jenpanich,et al.  [Drug administration]. , 1976, Thai journal of nursing.