Hypothesis / aims of study
In July 2018, the United Kingdom Secretary of State for Health and Social Care and the Chief Medical Officer announced a ‘pause’ in the use of synthetic mesh/tape to treat stress urinary incontinence (SUI) and urogynaecological prolapse (POP). This was as a direct result of recommendations made by the Independent Medicines and Medical Device Review following evidence given by women who had suffered complications from this type of surgery. The treatment of mesh complications is a relatively new sub-specialist discipline and the configuration of mesh complication services is now an urgent priority for the UK NHS. The aim of this study was to assess patient reported outcomes from preliminary series of women with mesh complications referred to a single recently-established UK centre.
Study design, materials and methods
Data was prospectively collected from 2016 onwards and supplemented by case note evaluation and an independent follow-up review to ascertain patient-reported outcome measures (PROMs). The indications, type of surgery, complications and outcomes were documented. Finally global outcomes were assessed by asking the patients the following questions
• How likely are you to recommend the surgery to a friend or family member?
• With hindsight of outcome would you still have gone through mesh complication surgery?
• How do you rate the improvement in your overall well-being following surgery?
Patients were asked to grade their answers on a 0-10 scale with 10 indicating the highest levels of satisfaction. Specific changes in the domains of pain, sexual function, urinary symptoms , UTI and mobility were also assessed using a 7 point Likert scale ranging from very much worse to very much better.
34 women who underwent surgical intervention for mesh complications were included. 22 had originally undergone mid-urethral tape placement alone (19 TVT, 3 TOT), 10 had multiple procedures at their original surgery which included mid-urethral tape placement and 2 had prolapse repair using mesh. The median length of time following original mesh surgery was 6 years. The main indication for surgery was pain in the majority (82%) with other indications including recurrent stress incontinence (9%), recurrent UTI (6%) and no symptoms (3%). The surgery undertaken was complete mesh removal in 14 patients, partial removal in 12 patients and repair of vaginal erosion in 8 patients. The removal was classified as partial if any of the mesh was left in situ whether this was planned before the procedure or if any fragments were unable to be excised at operation (due to anatomical factors such as proximity to blood vessels, nerves etc). The most commonly used surgical approach was a combined laparoscopic and vaginal dissection. 13 (42%) patients underwent a concomitant anti-incontinence procedure at the time of mesh removal and the majority (62%) of these were autologous fascial sling placement. Four (13%) patients had peri-operative complications which comprised one negative laparotomy for post-operative peritonism, one return to theatre for evacuation of pelvic haematoma, one wound infection and one incisional hernia. 31 (91%) patients provided outcome data with 3 patients unable to contact. The mean follow-up time was 7.8 months. 23 (74%) patients said they would give a 10/10 recommendation of the surgery to a friend or family member and the mean score for the whole group was 9.3/10. The mean likelihood of the patients going through the surgery with the hindsight of outcome was 8.5/10 and the mean improvement in overall well-being was 7/10. There was no difference in improvement in overall well-being between the full and partial removal groups. The major indication for the mesh salvage surgery was pain and 45% of patients reported significantly improved levels of pain post-procedure with a further 42% reporting minimal change. Only 13% reported any worsening of their pain post-surgery. In the domains of incontinence, urinary symptoms, sexual function, mobility and recurrent UTI the most commonly reported outcome was no change following surgery. Patients were more likely to report worsening symptoms within the domains of incontinence (39%) and urinary symptoms (42%).
Interpretation of results
These data confirm that satisfactory short-term surgical outcomes are achievable for high-volume mesh removal centres despite this field being a relatively new surgical sub-speciality. The post-operative assessment undertaken was independent of the operating surgeon which adds to its validity. The global PROMs chosen reflect overall improvement rather than specific changes in isolated domains which will always be dependent on indication. The majority of patients in this series had mesh salvage surgery for pain and despite the relatively short-term follow-up of only 7 months almost half of all patients already reported significant improvements in pain levels. The significant average improvement in overall well-being is a further reflection of the success of the surgical intervention. The improvements in urinary symptoms and incontinence were disappointing and may be due to the short term follow-up or that the majority (58%) did not want a concomitant anti-incontinence procedure. The lack of significant change in the domains of sexual function, mobility and recurrent UTI reported by the majority of patients are probably a reflection of the predominance of pain being the primary surgical indication. The major limitation of this study is the significant preponderance of TVTs therefore results are difficult to extrapolate to mesh removal surgery in general. A further limitation was the short duration of follow-up.