Hypothesis / aims of study
Stress urinary incontinence (SUI) is a common problem affecting women of all populations with significant negative implications on their quality of life. When conservative management had failed, the traditional procedure of choice was once insertion of a mid-urethral sling via either a retropubic or trans-obturator approach. This was the most common surgical procedure used to treat stress urinary incontinence (SUI) with 3.7 million meshes sold worldwide between 2005 and 203 (1). Initial outcomes where promising with patient reported success rates at 75% at 12 months (2). It was certainly seen as an attractive technique to treat SUI using a minimally invasive approach with promising outcomes. In recent years however the safety of these procedures has been the subject of international debate and scrutiny with court actions against mesh manufacturers underway in various countries. Complications associated with mesh procedures for SUI includes haemorrhage, organ perforation, mesh erosion, infection and pain which may require further surgery. In the UK, implant related complications are managed in national salvage centres and in this study we present our experience and outcomes of salvage procedures.
Study design, materials and methods
Patients were identified by reviewing a prospectively maintained database, populated by discussed cases at pelvic floor MDT of complications from implanted medical devices. The database included patients from Jan 2012 – March 2019
A total of 67 patients were identified. Presenting complaints included pain/dyspareunia (n=20), voiding dysfunction (n=15), LUTS/incontinence (n=6), recurrent UTI’s (n=9), visible vaginal erosion (n=10), bladder stone (n=3) and haematuria (n=4). Tape erosion had occurred in 46 cases (28 vaginal, 10 urethral and 8 bladder). The majority of the patients had their initial incontinence procedure at other units.
Overall, 57 patients underwent a salvage procedure. This ranged from; laparoscopic & cystoscopic assisted excision of eroded mesh + / - fistula repair (one required laparotomy), total/partial excision of vaginal part of tape + / - Martius vaginal flap. 4 of these patients required a re-do procedure for residual tape. 20 patients were discharged following complete resolution of their original complaint with no residual SUI. Ongoing SUI despite supervised pelvic floor exercise (PFE) was observed in 10 patients. These patient were successfully managed with either autologous fascial sling (n=4), Bulkamid (n=5) or a suprapubic catheter. A further 5 patients are awaiting review following PFE. 9 patients had mixed urinary incontinence with 6 requiring intravesical Botox and 1 having sacral nerve stimulation (SNS).
Interpretation of results
The most common mode of presentation in patients with a tape related complication was that of pain/dyspareunia. The vast majority of these complaints are reversible with a salvage procedure and most will not require a re-do. Based on our results, roughly one in 5 patients will have significant recurrent SUI which will require a further intervention to correct and this can be tailored to the patient. It is important to note that a salvage procedure often unmasks/leads to overactive symptoms and this may need addressing in the form of medication alone or intravesical Botox/SNS.
Our centre follows NHS England Mesh group, British Association of Urological Surgeons (BAUS) and British Society of Urogynaecology (BSUG) recommendations. In patients who have had previous implant procedures for SUI, it is important to be vigilant of the possibility of complications if/when the present with urinary symptoms/pelvic pain. A thorough assessment is required which includes a comprehensive history, examination, direct visualisation via cystoscopy and often cross-sectional imaging with MRI scanning. The choice of salvage procedure varies depending on the site/severity of complication and this is best carried out in a high volume centre whereby a multi-disciplinary approach can be adopted. This ensures utilisation of guidance and assistance from the wider team which includes pelvic colorectal surgeons, uro-gynaecologists and the pain management team.