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.
Highlights
Complications associated with mesh procedures for SUI include haemorrhage, organ perforation, mesh erosion, infection and pain[10,13], which may require further surgery
101,081 patients had at least one surgical mesh insertion for SUI; 564,463 inpatient episodes of care were recorded for these patients. 2832 episodes were excluded from analysis because they were duplicates, or from patients with missing or ineligible demographic information (Fig. 1)
The median length of stay for unconfounded surgical mesh insertions was one day, with 9537/68,002 (14.0%) staying longer than one night, and two days for insertions done with concomitant procedures, with 15,853/24,244 (65.4%) staying longer than one night
Summary
Complications associated with mesh procedures for SUI include haemorrhage, organ perforation, mesh erosion, infection and pain[10,13], which may require further surgery. There is uncertainty about the rates of complications during surgery and in the longer term, and concern that rates in everyday practice may be higher than previously identified[13,14]. Four systematic reviews have identified a lack of long-term outcome data[12,15,16,17]. The primary aim of the study was to assess peri-procedural and post-procedural (within 30-days and long-term) outcomes following surgical mesh insertions for SUI using the administrative Hospital Episode Statistics (HES) database used in England[18]
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