In this study we define insertion to mean the introduction of a mesh for the treatment of SUI, repair to mean a further procedure on a previously inserted mesh renewal to mean a procedure to remove a previously inserted mesh and to replace it with a new mesh and removal to mean the complete or partial removal of a previously inserted mesh. 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.Įpisodes were removed which were exact duplicates (of patient identifier, admission date and method, discharge date, destination and method, hospital, gender, age, all procedure codes and all diagnostic codes (International Statistical Classification of Diseases 10 th revision, ICD-10), Supplementary Table S1) and for patients with: an admission not coded as female age missing or under 18 years an invalid or missing admission method a missing admission date episodes after a reported date of death. Four systematic reviews have identified a lack of long-term outcome data 12, 15– 17. However, 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. Some manufacturers have withdrawn their products from sale 11, 12.Ĭomplications associated with mesh procedures for SUI include haemorrhage, organ perforation, mesh erosion, infection and pain 10, 13, which may require further surgery. In the UK, safety concerns have led to parliamentary questions 6, a mandatory national audit 7, a national campaign “Hear Our Voice” 8, 9, and in Scotland, an independent inquiry 10. In the USA, the FDA has proposed to raise the risk classification of urogynaecological meshes, requiring premarket notification and special controls 5. However the safety of these procedures is the subject of international debate and scrutiny 3 with court actions against mesh manufacturers underway in various countries, including Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, Scotland, USA, and Venezuela 4. Mesh insertion is the most common surgical procedure used to treat stress urinary incontinence (SUI) in women 1, with 3.7 million meshes sold worldwide between 20 2. The complication rate within 5 years of the mesh procedure was 9.8 % This evidence can inform future decision-making on this procedure. Complication rates were higher in the potentially confounded cohort. Peri-procedural and 30-day complication rates in the unconfounded cohort were 2.4 % and 1.7 % respectively 5.9 % 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. 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. Outcomes included number and type of procedures, including those potentially confounded by concomitant procedures, and frequency, nature and timing of complications. Cases were identified from the Hospital Episode Statistics database.
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. 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. Complications of surgical mesh procedures have led to legal cases against manufacturers worldwide and to national inquiries about their safety.