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Observational Study
. 2017 Sep 20;7(1):12015.
doi: 10.1038/s41598-017-11821-w.

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women

Kim Keltie  1   2 , Sohier Elneil  3 , Ashwani Monga  4 , Hannah Patrick  5 , John Powell  5   6 , Bruce Campbell  7 , Andrew J Sims  8   9
Affiliations
Observational Study

Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women

Kim Keltie et al. Sci Rep. .

Abstract

Complications of surgical mesh procedures have led to legal cases against manufacturers worldwide and to national inquiries about their safety. The aim of this study was to investigate the rate of adverse events of these procedures for stress urinary incontinence in England over 8 years. This was a retrospective cohort study of first-time tension-free vaginal tape (TVT), trans-obturator tape (TOT) or suprapubic sling (SS) surgical mesh procedures between April 2007 and March 2015. Cases were identified from the Hospital Episode Statistics database. Outcomes included number and type of procedures, including those potentially confounded by concomitant procedures, and frequency, nature and timing of complications. 92,246 first-time surgical mesh procedures (56,648 TVT, 34,704 TOT, 834 SS and 60 combinations) were identified, including 68,002 unconfounded procedures. Peri-procedural and 30-day complication rates in the unconfounded cohort were 2.4 [2.3-2.5]% and 1.7 [1.6-1.8]% respectively; 5.9 [5.7-6.1]% were readmitted at least once within 5 years for further mesh intervention or symptoms of complications, the highest risk being within the first 2 years. Complication rates were higher in the potentially confounded cohort. The complication rate within 5 years of the mesh procedure was 9.8 [9.6:10.0]% This evidence can inform future decision-making on this procedure.

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Conflict of interest statement

A.M. declares personal fees from Pfizer, personal fees from Astellas, personal fees from SEP Pharma, outside the submitted work. All remaining authors (K.K., S.E., H.P., J.P., B.C., A.J.S.) declare no competing financial interests.

Figures

Figure 1
Figure 1
Flow diagram for study participants. “Combn” indicates that more than one type of surgical mesh was inserted.
Figure 2
Figure 2
Annual activity of surgical mesh insertions for SUI in England, 2007/8 to 2014/15 (Key to symbols: ● = TVT; ▲ = TOT; += SS).
Figure 3
Figure 3
Hazard of readmission for further mesh surgery or due to complications from previous mesh surgery (in units of events per 1000 patient years) for those having surgical mesh insertion in the absence of concomitant procedures likely to influence outcomes.
Figure 4
Figure 4
Kaplan-Meier curve for time to first readmission for further mesh surgery or for complications from previous mesh surgery (solid lines) and 95% confidence limits (dashed lines) for those having surgical mesh insertion in the absence of concomitant procedures likely to influence outcomes. Dash-dot lines indicate the proportions of patients free from mesh-related admission at 5 years (with 95% confidence intervals).
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