We will not update the NICE guideline on urinary incontinence and pelvic organ prolapse in women.
This exceptional surveillance review was triggered by publication of First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review (IMMDS review) and subsequent NICE discussions (see NICE's board paper from September 2020). This surveillance review examined the report's 'actions for improvement' around use of pelvic mesh implants and any potential impact on the NICE guideline, particularly guidance on transvaginal tension free vaginal tape-obturator use and full and partial mesh removals for managing mesh-related complications.
The exceptional surveillance process consisted of:
Considering the new information that triggered the exceptional review (the IMMDS report).
Literature searches to identify relevant evidence on full and partial mesh removals for the management of mesh-related complications in women with stress urinary incontinence (SUI) or pelvic organ prolapse (POP).
Assessing the new evidence against current recommendations to determine whether the guideline needs updating.
For further details about the process and the possible update decisions that are available, see ensuring that published guidelines are current and accurate in developing NICE guidelines: the manual.
We conducted literature searches to identify new evidence on partial or complete mesh removals for managing mesh-related complications published between 1 November 2017 and 9 November 2020 and found 605 studies.
We followed the inclusion and exclusion criteria described in the protocols of the review questions related to the management of mesh complications (see evidence review L of the NICE guideline) but focused on those studies that compared partial with complete mesh removals for the management of mesh-related complications. Given the concerns that were raised in the IMMDS report around the experiences of women and the impact of mesh-related complications on their lives, we included studies that assessed those aspects alongside those assessing the surgical management of the complications.
As with the original guideline, most of the references identified in the searches were observational (retrospective) studies. These studies varied in terms of the populations, interventions, outcomes and follow-up times evaluated. Fourteen references were initially identified, but after further assessment, only 6 studies were considered directly relevant. Two of these 6 studies were quantitative studies examining POP mesh (Bergersen et al. 2020, Sassani et al. 2020) and 4 examined life experiences and quality of life of women with mesh-related complications (Brown 2020, Kowalik et al. 2019, Huang et al. 2018, Javadian et al. 2018). For completeness, details of the additional 8 references identified are provided in appendix A. Although these references assessed mesh removals, they did not provide data comparing full removals with partial removals and were excluded from the review.
First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review (IMMDS review)
The IMMDS review assessed 'how the health care system in England responds to reports about harmful side effects from medicines and medical devices and to consider how to respond to them more quickly and effectively in the future'. The review focused on 3 main areas: hormone pregnancy test, sodium valproate, and pelvic mesh implants. It concluded that 'the system is not safe enough for those taking medications in pregnancy or being treated using new devices and techniques. Patients are being exposed to a risk of harm when they do not need to be'.
The IMMDS review includes 9 recommendations and several 'actions for improvement'. These recommendations include specific actions to address the main concerns raised in the IMMDS review and put in place mechanisms to improve patients care, safety and avoid further harm.
Although the IMMDS report doesn't make any specific recommendations for NICE, the 'actions for improvement' were relevant. Actions that might impact on the NICE guideline, are as follows:
'NICE's most recent guidance states that the transvaginal tension free vaginal tape-obturator (TVT-O) should not be offered routinely. In the future, we feel the TVT-O should only be used in exceptional circumstances, if at all.'
'A consensus needs to be reached on whether it is better to carry out full or partial removals. This is a clinical matter, and it must be done collaboratively, including consulting international experts. This consensus should be validated by carrying out follow up on those who have removals at the specialist centres. We strongly recommend that NICE actively monitor the situation and update their guidance promptly once a consensus has been reached.'
The IMMDS review highlights that 'NICE's most recent guidance states that the TVT-O should not be offered routinely. In the future, we feel the TVT-O should only be used in exceptional circumstances, if at all'.
Recommendation 1.5.10 states: 'Do not offer a transobturator approach unless there are specific clinical circumstances (for example, previous pelvic procedures) in which the retropubic approach should be avoided.' The recommendation is a 'do not offer recommendation' and an example of an 'exceptional circumstance' is provided. It is considered that the recommendation is in line with what was suggested in the IMMDS report and no amendment is needed.
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.
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).
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.
New evidence identified in this exceptional surveillance review comes from observational studies of very low quality. The studies assessed different populations, interventions and outcomes and provided limited comparative data.
The studies of patient experiences showed how mesh-related complications impact on women's lives, confirming the findings of the IMMDS review. Only 1 study provided data comparing full removals with partial removals in women experiencing POP mesh-related complications. No differences were identified in the resolution or improvement of the symptoms or the recurrence of symptomatic POP between full removal compared with partial removal of mesh. Most of the studies identified described some degree of symptom improvement after surgical management of mesh-related complications but also cautioned about the unpredictability of the efficacy of the interventions and the risk of developing new symptoms or recurrence of previous ones. The studies also advocated a shared decision-making approach before undertaking any mesh removal, including a full discussion of the patient's symptom burden and possible surgical outcomes and complications.
NICE's guideline does not recommend offering the transobturator approach except in exceptional circumstances. This reflects the IMMDS report and the guideline does not need amending.
Given the limited evidence identified on partial and full removals for managing mesh-related complications, it was considered that it is not possible to update the guideline at this time. We will monitor the situation and update it if required.
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