Urinary incontinence and pelvic organ prolapse in women: management

Information considered when developing the guideline

The NICE guideline includes a section on managing complications associated with mesh surgery and covers aspects related to general considerations before removing mesh, managing vaginal complications, urinary complications, and bowel symptoms.

Full or partial mesh removals are considered as options of treatment for women who do not wish to have treatment with topical oestrogen or if the area of vaginal mesh sling exposure is 1 cm² or larger or if there is vaginal mesh extrusion or if there has been no response to non-surgical treatment after 3 months (recommendation 1.11.5). Adverse events and complications after mesh removal are also included (recommendations 1.11.7, 1.11.8, 1.11.9, 1.11.12 and 1.11.8). However, specific guidance about when to offer a partial or full mesh removal is not included.

When the section on managing complications associated with mesh surgery was developed in 2019, limited comparative evidence was identified. The evidence was observational (retrospective studies of very low quality) and limited to a short follow-up time. Case series were also identified, involving data from women with a variety of synthetic mesh products and different associated mesh complications. The committee agreed that some of the studies that did not meet the inclusion criteria for the individual reviews but reported on the general management of mesh complications would inform their decision-making on the general management of mesh complications and the treatment of specific complications.

The committee developed most of the recommendations by consensus based on their experience. They agreed that mesh removal can sometimes resolve mesh complications but that its success varies widely depending on the specific mesh complication (for example location, pain, urinary incontinence) and its complexity. The also noted that some women who have complete removal of mesh will experience complications and recurrence of the SUI or POP (or both) and need further surgery to resolve these problems.

New evidence identified

A retrospective observational study assessed the impact of mesh removal on women experiencing POP mesh-related complications (Bergersen et al. 2020). The study was conducted in a single institution in the US. A total of 78 patients were included, 45 (45/78, 57.6%) underwent complete mesh removal and 33 (33/45, 42.4%) partial mesh removal. The most common signs and symptoms at presentation were pain, dyspareunia, mesh exposure, and recurrent urinary tract infections. Forty-six percent of the patients (36) had undergone a prior attempt at mesh removal. No differences were identified in the resolution or improvement of symptoms between partial and complete mesh removals. Complete removals were associated with a higher rate of recurrent symptomatic POP, but the differences were not statistically significant (31.1% complete removal, 15.2% partial removal, p=0.12). Twenty-three patients (23/78, 30.3%) needed additional surgery. Overall, in 67 patients (67/78, 85.9%), painful symptoms were resolved or improved and in 9 (9/78, 23.23%) were unresolved (2 lost to follow up). The authors concluded that any degree of removal has a positive impact on complications associated with POP mesh.

One matched cohort study assessed the risk of prolapse recurrence in women after sacrocolpopexy mesh removal (Sassani et al. 2020). Surgical records of sacrocolpopexy procedures done between 2010 and 2019 in a single centre in the US were identified. A total of 26 mesh removals (full or partial) were included, most of them due to mesh exposure or pain. The cases were matched with 76 controls (women who underwent sacrocolpopexy but without subsequent mesh removal). The mean time from mesh insertion to mesh removal was 52 months. The most common symptoms before the removal were exposure, pain, and vaginal bleeding. In 50% of the cases, the mesh was completely removed. In the partial removal group (13 cases), 2 patients had persistent symptoms, and one full mesh removal was required. Three patients had a bladder injury and 2 patients had a bowel injury during the mesh removal, all resolved during the surgery. This study did not report if these 3 patients received a full or partial removal. Women who had mesh removal were more likely to have a prolapse recurrence than those without it (adjusted hazard ratio 15.4; 95% confidence interval 1.3 to 54.8). Authors reported that given the lower number of cases further subanalysis (such as recurrence compartment by location of mesh removed) were not conducted.

The other studies identified did not report comparative data between partial and full mesh removals for the management of mesh-related complications. They reported different degrees of symptom improvement after surgery and the need in some cases for more than 1 surgical procedure for managing symptoms and complications. They also cautioned about the risk of recurrence or development of new symptoms after the surgery (see appendix A).

Patient experience and quality of life

We have identified 4 relevant studies in the area (Brown 2020, Kowalik et al. 2019, Huang et al. 2018, and Javadian et al. 2018). The first study assessed the experiences lived by 7 women with pelvic surgical mesh complications (Brown 2020). Semi-structured interviews were conducted, and the quality of life was assessed using a modified version of the ICIQ-LUTSqol questionnaire. Most of the women had surgical mesh for POP and urinary incontinence, 2 for urinary incontinence and 1 for POP only. The quality of life was significantly affected in all of them (mean ICIQ-LUTSqol 62.2, standard deviation 10.01). The analysis showed the following emerging themes: feeling powerless in the medical space, living in a shrinking world, living with unrelenting pain, inhabiting a body that can no longer be relied on, living the gap between what was and what could be, suffering in silence, have other(s) as a source of strength. The second study compared the quality of life after mesh surgery in women with or without mesh complications after surgery (Kowalik et al. 2019). A total of 126 women (29, 23% with mesh-related complications) who had a vaginal mesh between 2007 and 2012 in a Dutch hospital were included. Quality of life was assessed using different questionnaires including the Urogenital Distress Inventory-6 (UDI-6), Incontinence Impact Questionnaire (IIQ), Defecation Distress Inventory, and Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). No differences were identified in the domain scores of the quality of life questionnaires used between the groups assessed. Huang et al. (2018) evaluated the impact of surgical failure and complications on the quality of life of 78 women who underwent transobturator sling surgery for urodynamic stress incontinence (median follow up 13.5 months after surgery). Quality of life was assessed using the Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaire (IIQ-7), preoperatively and 12 months after surgery. The analysis found that the quality of life improved even in the presence of surgical failure or complications. The last study assessed the disability impact and associated cost per disability in women who had undergone vaginal prolapse mesh revision or removal due to complications (Javadian et al. 2018). A total of 62 women who attended a single hospital between 2009 and 2014 in the US were included. They used the Sheehan Disability Scale and Years of life Lived with Disability questionnaires. Almost a third of cases were extremely disabled patients (18, 29%), and nearly 60% did not improve after mesh removal (37, 59.6%). Participants reported a median loss of 12 months of school or work due to mesh complications. Authors concluded that complications of transvaginal prolapse mesh kits have a sustained impact on disability, even after mesh removal.