Evidence review for management of mesh complications
Evidence review L
NICE Guideline, No. 123
Authors
National Guideline Alliance (UK).Management of mesh complications
Review questions
This evidence report contains information on 5 evidence reviews relating to the management of mesh complications:
- What are the most effective management options for vaginal complications (including exposure, extrusion, erosion and infection) after mesh surgery?
- What are the most effective management options for sexual dysfunction after mesh surgery?
- What are the most effective management options for pain after mesh surgery?
- What are the most effective management options for urinary complications after mesh surgery?
- What are the most effective management options for bowel symptoms after mesh surgery?
Introduction
Complications following surgery for urinary incontinence or pelvic organ prolapse (POP) using mesh can cause significant morbidity and may occur years after initial surgery. Mesh complications may occur after synthetic mid-urethral mesh sling surgery or vaginally or abdominally placed synthetic mesh for pelvic organ prolapse. These can include vaginal complications, such as exposure or extrusion, infection, sexual dysfunction, pain, as well as urinary and bowel complications. There is no consensus as to how these complications should be managed and whether removal of mesh, either partially or completely, is necessary.
A standardised approach to care would help to guide clinicians when managing such complex cases and ensure women receive appropriate care. The Mesh Oversight Group Report, July 2017, advised that women with mesh complications should be seen in a specialised mesh centre offering a multidisciplinary team approach consisting of urogynaecology, urology, specialist radiology, specialist pain management and specialist diagnostic medical / allied health professional team members. This review aims to determine the most effective management strategies for complications following mesh surgery.
Summary of the protocols
Table 1, Table 2, Table 3, Table 4 and Table 5 present a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of the protocols for the 5 mesh complications reviews. These are related to the management of vaginal, sexual dysfunction, pain, urinary and bowel complications after mesh or mesh sling surgery respectively.
Table 1
Summary of protocol (PICO table) for management of vaginal complications after mesh or mesh sling surgery.
Table 2
Summary of protocol (PICO table) for management of sexual dysfunction complications after mesh or mesh sling surgery.
Table 3
Summary of protocol (PICO table) for management of pain complications after mesh or mesh sling surgery.
Table 4
Summary of protocol (PICO table) for management of urinary complications after mesh or mesh sling surgery.
Table 5
Summary of protocol (PICO table) for management of bowel complications after mesh or mesh sling surgery.
For further details see review protocols in appendix A.
Methods and process
This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual. Methods specific to this review question are described in the review protocol in appendix A and appendix N (network meta-analysis). For a full description of the methods see supplementary material C
Declarations of interest were recorded according to NICE’s 2014 conflicts of interest policy until 31 March 2018. From 1 April 2018, declarations of interest were recorded according to NICE’s 2018 conflicts of interest policy. Those interests declared until April 2018 were reclassified according to NICE’s 2018 conflicts of interest policy (see Register of Interests).
Clinical evidence
Included studies
Due to the paucity of available evidence for each individual complication, the committee decided to consider some of the excluded studies that did not strictly meet the inclusion criteria of the individual mesh complications reviews for in order to inform the recommendations about the management of mesh complications. As such, it was decided to include case series studies with more than 50 participants, reporting outcomes of women with a variety of mesh complications (see the ‘General section on mesh complications’ below).
For a summary of the included studies see Tables 6 to 12. See also the literature search strategies in appendix B, study selection flow charts in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix F.
Management of vaginal complications after mesh or mesh sling surgery
No RCT were identified for this review. Five observational studies - 1 prospective cohort Domingo 2005), 1 retrospective cohort (Jambusaria 2016), and 3 case series (Begley 2005; Cheng 2017; Kohli 1998) – were included in this review.
Two cohort studies compared partial to complete removal of a synthetic mesh sling in women with SUI and mesh sling erosion or exposure (Domingo 2005; Jambusaria 2016).
Two one-arm case series studies (Begley 2005; Kohli 1998) examined the management of mesh erosion by partial or complete removal in women with POP who had abdominal sacrocolpopexy
One case series study (Cheng 2017) examined the management of mesh erosions by conservative management or if this failed mesh removal in women with greater than stage 1 POP-Q who had vaginal mesh kit repair.
Management of sexual dysfunction and pain complications after mesh or mesh sling surgery
No RCT studies were identified for either of these reviews. Three observational studies - including one prospective cohort (Hou 2014), one retrospective cohort (Jambusaria 2016) and 1 single-arm case series study (Danford 2015) were identified as relevant to this review.
All 3 studies examined synthetic mesh sling removal or mesh sling revision surgery in women with pain-related (including sexual dysfunction) complications after mesh sling surgery for treatment of SUI. No study was identified that was relevant only to the population of interest for the separate review questions.
Management of urinary complications after mesh or mesh sling surgery
No RCT or cohort studies were identified for this review. One single-arm case series study (Crescenze 2016) was identified that examined the management of mesh complications in women with a variety of lower urinary tract symptoms after mesh sling surgery for treatment of SUI.
Management of bowel complications after mesh or mesh sling surgery
A systematic review of the clinical literature was conducted but no studies were identified which were applicable to this review question.
General management of mesh complications after mesh or mesh sling surgery
Seventeen observational studies - 3 retrospective cohort (Hokenstad 2015; Ramart 2017; Shaw 2017) and 14 case series (Abbott 2014; Cardenas-Trowers 2017; Crosby 2014; Fabian 2015; George 2013; Lee 2013; Marcus-Braun 2010; Misrai 2009; Parden. 2016; Pickett 2015; Rac 2017; Renezeder 2011; Skala 2011; Warembourg 2017) were identified that examined the treatment and management of women with SUI and/or POP who had complications after the insertion of mesh or mesh sling. The participants in these studies were referred for treatment because of a variety of mesh related complications, with the majority of treatments consisting of mesh (e.g. revision or removal) surgery. Most studies had a follow up of less than 12 months.
Three retrospective cohort studies (Hokenstad 2015; Ramart 2015; Shaw 2017) were identified that examined different types of mesh surgery in women with pure SUI, stress-predominant mixed UI, and/or POP. Two of the retrospective cohort studies (Shaw 2017; Ramart 2017) examined surgery to treat mesh complications in women who had previously had synthetic mesh sling inserted to treat SUI, with one study comparing mesh sling division to mesh sling removal, whilst the other compared the removal of retropubic synthetic mesh slings to that of transobturator synthetic mesh slings. The other study (Hokenstad 2015) compared partial removal to complete removal of vaginally-placed mesh for the treatment of women with POP.
The majority of the participants in the case series studies had partial or complete mesh or mesh sling removal surgery and were referred for mesh surgery for the treatment and management of more than one complication.
Excluded studies
Studies not included in this review with reasons for their exclusion are provided in appendix K. For a list of excluded studies relevant to the general sections on the management of mesh complications, please see the excluded studies lists of the individual reviews in appendix K.
Summary of clinical studies included in this review
Summary of cohort studies included in the evidence review
Table 6 provides a brief summary of the 2 included cohort studies (Domingo 2005; Jambusaria 2016) in the review of the management of vaginal complications after mesh or mesh sling surgery, both of which compared partial to complete vaginal mesh removal in women after mesh surgery for treatment of POP.
Table 10 provides a brief summary of the 2 included cohort studies in the review of the management of sexual dysfunction and/or pain complications (Hou 2014; Jambusaria 2016), both of which compared partial to complete mesh sling removal in women with sexual dysfunction and/or pain complications after mesh sling surgery for treatment of SUI.
Table 15 provides a brief summary of the 1 included retrospective cohort study (Hokenstad 2015) in the review of the general management of complications after mesh surgery that compared partial to complete removal of mesh in women who had vaginally-placed mesh for the treatment of POP.
Table 16 provides a brief summary of the 1 included retrospective cohort study (Shaw 2017) in the review of the general management of complications after mesh sling surgery that compared mesh division to partial or complete removal of mesh in women who had synthetic mesh sling for the treatment of SUI. See appendix D for full evidence tables.
Table 17 provides a brief summary of the 1 included retrospective cohort study (Ramart 2017) in the review of the general management of complications after mesh sling surgery that compared removal of transobturator mesh sling to that of retropubic mesh sling in women who had synthetic mesh sling for the treatment of SUI. See appendix D for full evidence tables.
See appendix D for full evidence tables of included studies.
Summary of case series studies included in the evidence review
Table 7 lists the characteristics of the 3 case series studies included in the review of vaginal complications after mesh or mesh sling surgery (Begley 2005; Cheng 2017; Kohli 1998), and Table 8 provides a summary of the results.
Table 11 lists the characteristics of the 1 case series study (Crosby 2014) identified for the review of the management of sexual dysfunction and/or pain complications after mesh or mesh sling surgery, and Table 12 provides a summary of the results
Table 13 lists the characteristics of the 1 case series study (Crescenze 2014) identified for the review of the management of urinary complications after mesh or mesh sling surgery, and Table 14 provides a summary of the results.
Table 18 lists the characteristics of the 14 case series studies included in the review of the general management of mesh complications after mesh or mesh sling surgery (Abbott 2014; Cardenas-Trowers 2017; Crosby 2014; Fabian 2015; George 2013; Lee 2013; Marcus-Braun 2010; Misrai 2009; Parden. 2016; Pickett 2015; Rac 2017; Renezeder 2011; Skala 2011; Warembourg 2017), whilst Table 19 provides a summary of the results.
See appendix D for full evidence tables of all included studies.
Table 6
Summary of included studies for complete mesh vaginal removal versus partial mesh vaginal removal in review of management of vaginal complications.
Table 7
Study characteristics of case series studies in review of management of vaginal mesh complications.
Table 8
Outcomes of case series studies on mesh removal in women who had abdominal sacrocolpopexy for treatment of POP.
Table 9
Outcomes of case series studies on mesh removal in women who had vaginal mesh kit for treatment of POP.
Table 10
Summary of included studies for complete mesh sling removal versus partial mesh sling removal in review of management of sexual dysfunction and/or pain mesh complications.
Table 11
Study characteristics of case series studies in review of management of pain and/or sexual dysfunction complications.
Table 12
Pain status outcomes after mesh surgery (sling division or mesh sling removal) in women with or without mesh exposure.
Table 13
Study characteristics of case series studies in review of management of urinary mesh complications.
Table 14
Outcomes of mesh surgery to resolve urinary mesh sling complications.
Table 15
Study characteristics of included cohort studies for partial versus complete mesh removal in review of management of mesh complications.
Table 16
Study characteristics of included cohort studies for mesh division versus complete or partial mesh removal in review of management of mesh sling complications.
Table 17
Study characteristics of included cohort studies for removal of synthetic transobturator versus retropubic mesh sling for management of women with mesh complications.
Table 18
Study characteristics of included case series studies on the general management of mesh complications.
Table 19
Outcomes of surgery to resolve mesh complications for review of general management of complications.
Quality assessment of studies included in the evidence review
The Cochrane ROBINS-I checklist was used to assess the risk of bias for observational studies (e.g. cohort and case series studies). See appendix F for the full GRADE table for comparative outcomes.
Economic evidence
Included studies
A systematic review of the economic literature was carried out but no studies were identified which were applicable to this review question. See supplementary material D for further information.
Excluded studies
No studies were identified which were applicable to this review question.
Summary of studies included in the economic evidence review
No economic evaluations were identified which were applicable to this review question.
Economic model
This question was not prioritised for economic modelling because the evidence to base this on was anticipated to be limited.
Clinical evidence statements
Management of vaginal complications after mesh sling surgery
Partial vaginal mesh removal versus complete vaginal mesh removal
Continued or repeated exposure/extrusion/infection
No evidence was identified to inform this outcome.
Adverse events
No evidence was identified to inform this outcome.
Complications at ≤1 year and >1 year
- Very low quality evidence from 1 retrospective cohort study (n=94) showed no clinically important difference between partial and complete vaginal mesh sling removal in women with vaginal mesh sling complications on pain (RR 0.4 [95% CI 0.12–1.33]) and de novo urgency (RR 0.81 [95% CI 0.33–1.96) at mean 5.9 weeks follow up.
- Very low quality evidence from 1 retrospective cohort study (n=56) showed there may be a clinically important difference favouring partial over complete vaginal mesh sling removal in women with vaginal mesh sling complications on recurrent SUI at mean 28.6 weeks follow up, RR 0.36 (95% CI 0.11–1.16).
- Very low quality evidence from 1 retrospective cohort study (n=56) showed no clinically important difference between partial and complete vaginal mesh sling removal in women with vaginal mesh sling complications on de novo urgency at mean 28.6 weeks follow up: RR 0.78 (95% CI 0.36–1.68).
Health-related quality of life
No evidence was identified to inform this outcome.
Patient satisfaction
No evidence was identified to inform this outcome.
Repeat surgery
- Very low quality evidence from 1 retrospective cohort study (n=56) showed a clinically important difference favouring partial over complete vaginal mesh sling removal in women with vaginal mesh sling complications on repeat surgery for any reason at mean 28.6 weeks follow up: RR 0.19 (95% CI 0.05–0.76).
Recurrent urinary incontinence or prolapse
- Very low quality evidence from 2 observational cohort studies (n=65) showed a clinically important difference favouring partial over complete vaginal mesh sling removal in women with vaginal mesh sling complications on recurrent SUI: RR 0.33 (95% CI 0.15–0.71)
Non-comparative data
Data from 3 case series studies, all of which were at serious risk of bias, showed that
- The recurrent erosion rate in 1 case series study (n=5) of women who had vaginal mesh removal after abdominal sacrocolpopexy for prolapse was 0%; however, the rate of repeat surgery for mesh extrusion/exposure in the other case series study (n=7) was 57.1%
- The rate of POP recurrence in 1 case series study (n=7) of women who had vaginal mesh removal after abdominal sacrocolpopexy for prolapse at mean 15.5-month follow up was 29%.
- The rate of recurrent mesh extrusion/exposure and the rate of repeat surgery for mesh extrusion/exposure in 1 case series study (n=36) of women who had vaginal mesh removal after vaginal mesh kit for prolapse was 16.7%
Management of sexual dysfunction and/or pain complications after mesh or mesh sling surgery
Partial mesh removal versus complete mesh sling removal
Continued or repeated sexual dysfunction
No evidence was identified to inform this outcome.
Pain
No evidence was identified to inform this outcome.
Adverse events
No evidence was identified to inform this outcome.
Patient satisfaction
No evidence was identified to inform this outcome.
Health-related quality of life
No evidence was identified to inform this outcome.
Repeat surgery
- Very low quality evidence from 1 retrospective cohort study (n=92) showed no clinically important difference between partial and complete mesh sling removal for pain or dyspareunia in women with SUI who need repeat surgery for SUI at mean 29 weeks follow up: RR 2.6 (95% CI 0.7–9.7).
Complications
- Very low quality evidence from 1 retrospective cohort study (n=151) showed no clinically important difference between partial and complete mesh sling removal for pain and/or sexual dysfunction in women with SUI on postoperative pain (RR 0.86 [95% CI 0.41–1.83]) urge incontinence (RR 0.51 [95% CI 0.23–1.16]) at mean 6.4 weeks follow up.
- Very low quality evidence from 1 retrospective cohort study (n=92) showed no clinically important difference between partial and complete mesh sling removal for pain or dyspareunia in women with SUI on postoperative pain (RR 0.56 [95% CI 0.2–1.58]) and urge incontinence (RR 0.7 [95% CI 0.29–1.66]) at a mean 29 weeks follow up.
Recurrent urinary incontinence or prolapse
- Very low quality evidence from 1 retrospective cohort study (n=151) showed no clinically important difference between partial and complete mesh sling removal for pain and/or sexual dysfunction on the number of women who have SUI at mean 6.4 weeks follow up: RR 0.65 (95% CI 0.36–1.18).
- Very low quality evidence from 1 retrospective cohort study (n=92) showed there may be a clinically important difference favouring partial over complete mesh sling removal for pain and/or sexual dysfunction in women with SUI on recurrent SUI at mean 29 weeks follow up: RR 0.44 (95% CI 0.19–1.02).
Mesh for prolapse versus mesh sling for SUI
Continued or repeated sexual dysfunction
No evidence was identified to inform this outcome.
Pain
No evidence was identified to inform this outcome.
Adverse events
No evidence was identified to inform this outcome.
Patient satisfaction
- Very low quality evidence from 1 retrospective cohort study (n=123) showed there may be a clinically important difference favouring removal of mesh sling for SUI over removal of mesh for prolapse on the number of women with SUI and/or POP whose pain is resolved (RR 0.82 [95% CI 0.66–1.01]) and the number of women who have persistent pain (RR 2.87 [95% CI 0.84–9.78]) at mean 3 years follow up.
Health-related quality of life
No evidence was identified to inform this outcome.
Repeat surgery
No evidence was identified to inform this outcome.
Complications at ≤1 year and >1 year
No evidence was identified to inform this outcome.
Recurrent urinary incontinence or prolapse
No evidence was identified to inform this outcome.
Non-comparative data
Data from 1 case series study (n=233), which was at serious risk of bias, of women who had mesh removal surgery for the treatment of sexual dysfunction and/or pain complications showed that
- 77% of women who had concurrent mesh exposure showed an improvement in pain compared to 67% of those who did not.
- 18% of women who had concurrent mesh exposure showed no change in pain compared to 5% of those that did not.
- 5% of women who had concurrent mesh exposure showed a worsening of pain compared to 12% of those that did not.
Management of urinary complications after mesh or mesh sling surgery
Non-comparative data
Data from 1 cases series study (n=107), which was at serious risk of bias, of women that had mesh revision or mesh removal surgery after mesh sling for SUI showed that
- 78.9% of the women no longer had obstructive voiding symptoms, 95.8% no longer needed to use a catheter, and 65.8% no longer had recurrent UTI.
- 57% of the women had SUI (35.5% de novo).
General management of complications after mesh or mesh sling surgery
Partial mesh removal versus complete mesh removal
Adverse events
No evidence was identified to inform this outcome.
Complications
No evidence was identified to inform this outcome.
Health-related quality of life
- Very low quality evidence from 1 retrospective cohort study (n=41) showed a clinically important difference favouring complete mesh removal over partial mesh removal on the number of women with POP who show an improvement on the mental component of the SF-12 (Medical Outcomes Study Short Form) at range 4 to 14 years follow up: MD −8.92 (95% CI −14.19 to −3.65).
- Very low quality evidence from 1 retrospective cohort study (n=41) showed no clinically important difference between partial and complete mesh removal on the number of women with POP who show an improvement on either the physical component of the SF-12 (Medical Outcomes Study Short Form; MD +0.56 [95% CI −7.13 to +8.25]) or the PFDI-SF 20 (Pelvic Floor Distress Inventory Short Form; MD −27.95 [95% CI −60.67 to +4.77]) at range 4 to 14 years follow up.
- Very low quality evidence from 1 retrospective cohort study (n=33) showed no clinically important difference between partial and complete mesh removal on the number of women with POP who are sexually active and experience dyspareunia at range 4 to 14 years follow up RR 1.0 (0.7–1.42).
Patient-satisfaction
- Very low quality evidence from 1 retrospective cohort study (n=41) showed no clinically important difference between partial and complete mesh removal on the number of women with POP who show an improvement in mesh complications at range 4 to 14 years follow up: RR 0.66 (95% CI 0.34–1.26)
Repeat surgery
No evidence was identified to inform this outcome.
Recurrence of urinary incontinence or prolapse
No evidence was identified to inform this outcome.
Mesh division versus mesh removal
Adverse events
No evidence was identified to inform this outcome.
Complications
No evidence was identified to inform this outcome.
Health-related quality of life
No evidence was identified to inform this outcome.
Patient-satisfaction
No evidence was identified to inform this outcome.
Repeat surgery
- Very low quality evidence from 1 retrospective cohort study (n=102) showed a clinically important difference favouring mesh sling division over mesh sling removal on the number of women who have repeat surgery for SUI at range 1.5 to 48 months follow up: RR 0.16 (95% CI0.04–0.65).
Recurrence of urinary incontinence or prolapse
- Very low quality evidence from 1 retrospective cohort study (n=102) showed a clinically important difference favouring mesh sling division over mesh sling removal on the number of women who have a recurrence of SUI at range 1.5 to 48 months follow up: RR 0.24 (95% CI0.11–0.52).
Transobturator mesh sling removal versus retropubic mesh sling removal
Adverse events
No evidence was identified to inform this outcome.
Complications
No evidence was identified to inform this outcome.
Health-related quality of life
No evidence was identified to inform this outcome.
Patient-satisfaction
No evidence was identified to inform this outcome.
Repeat surgery
- Very low quality evidence from 1 retrospective cohort study (n=117) showed no clinically important difference between the removal of transobturator mesh sling and retropubic mesh sling on the number of women with SUI who have repeat surgery for SUI at 3-months follow up: RR 0.88 (95% CI 0.54–1.45).
Recurrence of urinary incontinence or prolapse
No evidence was identified to inform this outcome.
Non-comparative data
Mesh removal (partial or complete)
Data, calculated as weighted averages, on the outcomes of mesh removal surgery to resolve mesh complications from 11 case series studies, all of which were at serious risk of bias, showed that:
- 31.1% of women in 4 case series studies (n=257) no longer had any mesh complications;
- 90.7% of women in 2 case series studies (n=86) no longer had mesh erosion/extrusion/exposure complications;
- 58.4% of women in 5 case series studies (n=231) no longer had pain;
- 32.3% of women in 4 case series studies (n=127) no longer had dyspareunia;
- 37% of women in 2 case series studies (n=127) showed that 37% no longer had any urinary complication;
- 63.6% of women in 1 case series studies (n=11) no longer had urgency urinary complications; had mesh removal to resolve mesh complications in 1 case series study (n=6) no longer had non-urgency urinary complications;
- 100% of women in 1 case series study (n=7) no longer had bowel complications;
- 3.4% of women in 4 case series studies (n=614) experienced an adverse event during mesh removal surgery;
- 15.5% of women in 7 case series studies (n=728) had repeat surgery for any reason;
- 24% of women in 1 case series study (n=75) had recurrent SUI;
- 10.2% of women in 3 case series studies (n=177) had recurrent POP;
- 11.9% of women in 2 case series studies (n=134) had a pain complication;
- 6.7% of women in 1 case series study (n=12) had a fistula complication;
- 11.9% of women in 2 case series studies (n=327) had an infection complication.
Various treatment strategies
Data, calculated as weighted averages, on the outcomes of women who had general mesh surgery management from 4 case series studies, all of which were at serious risk of bias, showed that:
- 1.0% of women in 2 case series studies (n=103) experienced an adverse event during general mesh surgery management;
- 20.4% of women in 3 case series studies (n=450) had repeat surgery for any reason;
- 16.9% of women in 1 case series study (n=83) had recurrent SUI;
- 7.3% of women in 3 case series studies (n=138) had recurrent POP;
- 18.2% of women in 2 case series studies (n=55) had a pain complication;
- 0.8% of women in 2 case series studies (n=123) had a fistula complication;
- 7.5% of women in 1 case series study (n=40) had an infection complication;
- 0% of women in 1 case series study (n=40) had a wound complication.
Economic evidence statements
No economic evidence on the cost effectiveness of interventions to manage mesh complications including mesh complications, vaginal complications, sexual dysfunction and pain, and urinary complications in women with UI, POP or both was available.
The committee’s discussion of the evidence
Interpreting the evidence
The outcomes that matter most
The committee agreed that the critical outcomes for each review should be successful alleviation of the relevant mesh complication and the risks of adverse events for each intervention.
For the evidence review on the management of vaginal mesh complications, the committee agreed that continued or repeated exposure, extrusion or infection, adverse events, and complications more than 1 year after surgery, were the critical outcomes on which to base recommendations, and that validated measures of health-related quality of life, patient satisfaction, repeat surgery for mesh complications, and recurrence of urinary incontinence or prolapse were the most important.
For the evidence review on the management of sexual dysfunction, the committee agreed that continued or repeat sexual dysfunction, adverse events, and patient satisfaction were the critical outcomes on which to base recommendations, and that those of health-related quality of life, repeat surgery and complications >12 months were the most important. For the evidence review of the management of pain complications, the committee agreed that validated pain scales, patient satisfaction, adverse events, health-related quality of life, repeat surgery, complications >12-months and recurrence of UI or POP were the critical outcomes on which to base recommendations. But no studies were identified that used validated pain scales or reported continued or repeat sexual dysfunction
For the evidence review of the management of urinary complications, the committee agreed that the outcomes of continued or repeated urinary complications, adverse events, and complications >12 months were the critical outcomes on which to base recommendations, and that those of continence-specific health-related quality of life, patient satisfaction and repeat surgery were the most important.
For the evidence review on the management of bowel mesh complications, the committee agreed that reduction in bowel symptoms, adverse events, and health-related quality of life were the critical outcomes on which to base recommendations, and that those of complications, patient satisfaction, repeat surgery, and recurrence of urinary incontinence or prolapse were the most important.
For general management of mesh complications, the committee agreed that the outcomes common to all the reviews of specific mesh complications – persistence of symptoms, adverse events, repeat surgery, recurrent SUI/POP and complications of surgery to resolve mesh complications (pain, fistula, infection, and wound complications) were the most important on which to base recommendations.
The quality of the evidence
Overall the quality of the evidence from the six cohort studies included for the five reviews was very low because only two of the relevant outcomes could be pooled, the observational nature of the data, and the confidence intervals associated with the effect estimates are relatively wide. Although the review found two observational cohort studies of women who had partial or complete vaginal mesh sling removal for the treatment of vaginal complications, pooling of the outcomes was only possible in one instance (recurrent SUI). No relevant evidence was found for the review on the management of bowel complications, but the committee agreed that the current NICE guideline CG49 on faecal incontinence should be followed. The committee acknowledged that there was currently no NICE guideline on the treatment of obstructive defecation but that locally-agreed protocols should be used. No relevant evidence was found involving interventions such as pus drainage, antibiotics, pain management, and those for the functional and non-functional bowel complications.
The 19 included case series studies were all assessed using the Cochrane ROBINS-I tool as being at serious risk of bias because of concerns over confounding, selection of participants, and measurement of outcome data. Sixteen studies examined mesh division, revision or removal, and three studies used more than two specific treatments. Fourteen of the 19 case series studies did not meet the inclusion criteria for the specific reviews. However, because of the paucity of data the committee decided to consider studies that included women referred for a variety of mesh complications.
Benefits and harms
The limited available comparative evidence was observational in nature, mainly retrospective, of very low quality and limited to a short follow-up of one year and so could not support strong recommendations. Therefore 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 be informative for their decision-making on the general management of mesh complications and the treatment of specific complications. The committee noted that the evidence from the included case series studies was wide-ranging, involving data from women with a variety of both mesh complications and associated synthetic mesh products, and accepted that the data were very uncertain. The committee agreed that the non-comparative data was consistent with both the comparative data and what would be clinically expected. They agreed that this suggested that mesh removal can sometimes resolve mesh complications but that its success varies widely with the specific mesh complication (e.g. vaginal, pain, urinary incontinence) and the complexity of the complications, and that some women who have complete removal of mesh will experience complications and recurrence of SUI and POP (or both), and need to have more surgery for these problems. The committee therefore based the majority of the recommendations on their expertise and experience and developed them by consensus.
General recommendations regarding management of mesh complications
The committee discussed the difficulties involved in managing mesh complications. They noted that women often have multiple mesh complications, which can be long lasting and impacting on quality of life by affecting many activities of daily living. These require the input of many professionals during their treatment and management. The committee therefore agreed, based on their expertise and experience, that women who are contemplating mesh removal for mesh-related complications need the opportunity to discuss their own cases with relevant specialists of a regional or supra-regional MDT that can call on the relevant expertise to manage the specific complication(s).
The committee recognised that although removal of synthetic mesh may be the preferred option for some women who experience mesh complications, the evidence was not enough to recommend its use as a first-line treatment as a matter of course. To support shared decision-making women need to be informed of the possible risks and benefits of mesh removal surgery so that they can make an informed choice. The committee agreed that synthetic mesh material can be difficult to remove completely and that it is not always possible to do so, and that partial removal may be as effective. They also agreed that it was important to emphasise that partial or complete removal of mesh may lead to a recurrence of urinary incontinence or prolapse because the source of organ support has been removed.
Three retrospective cohort studies of women who had surgery to resolve a variety of mesh complications provided three individual comparisons. In addition to the study comparing mesh division to mesh removal, one study of women who had partial or complete mesh removal suggested an increased probability of having an improved ‘mental’ quality of life (SF-12 mental component score) for complete compared to partial removal, although there was no difference between them in improving mesh complications, improving physical quality of life (SF-12 physical component score), continence-specific health-related quality of life (PDFI-SF 20 score), and the number of women with dyspareunia. One study of women who had either transobturator or retropubic mesh sling removal surgery showed no difference between the two routes on the number of women who had repeat surgery for SUI.
The committee noted that the evidence on the comparison of complete to partial removal of mesh sling suggested that partial removal had an increased risk of pain at approximately 29 weeks follow up, an increased risk of recurrent SUI, and an increased risk that repeat surgery will be needed. The committee recognised that this is not unexpected because there may still be some support to the urethra after partial removal, and so the risk of recurrent SUI is likely to be lower than after complete removal. In contrast, one cohort study that examined partial compared to complete removal in women with mesh complications showed complete mesh removal was associated with an increased probability of an improvement in mental quality of life (SF-12 mental component score). The committee noted that this was a common clinical finding and interpreted it as possibly reflecting the psychological relief felt after the removal of the problematic synthetic mesh.
Management of vaginal complications
On the management of vaginal complications, the committee noted that all the women in the included case series studies had unsuccessfully received conservative treatment before having surgery to resolve the complications. Given the limited evidence on the long-term effectiveness and safety of vaginal mesh removal, and based on their expertise and experience, the committee recommended that initial conservative treatment of an area of exposed mesh <1 cm2 using topical vaginal oestrogen could be for at least 3 months before surgical options are considered. Although there was no evidence on the size of the mesh exposure that should be treated, the committee agreed, on the basis of their expertise and experience that vaginal oestrogen applied to exposed mesh with an area of ≥1cm2 is not likely to be effective. Despite the limited evidence available, the committee wanted to make a relatively strong recommendation on the use of topical oestrogen cream. As it is a low risk intervention, it means the woman does not have to have surgery straight away, but if her exposure does not improve, she then has the option for further treatment. The committee noted that some women who present with mesh exposure/extrusion may experience vaginal discharge, which may be diagnosed as an infection rather than as a sign of exposure/extrusion. So, based on their expertise and experience, the committee recommended that in such cases, imaging should be offered in order to clarify the source of discharge.
Based on their experience and knowledge and decisions related to conservative treatment above, the committee decided that for women in whom conservative treatment has been unsuccessfully tried for 3 months or who have a mesh sling exposure or extrusion that is larger than ≥1cm2 partial or complete removal of the vaginal portion of mesh sling should be considered.
In addition to the general recommendations on mesh removal (for example, that complete removal may not be possible), the committee agreed that some recommendations were needed on the specific type of vaginal mesh or mesh sling and condition (incontinence or prolapse) that women can present with. One cohort study comparing complete with partial vaginal mesh sling removal contributed most of the evidence and suggested there was an increased risk of pain at approximately 29 weeks follow up, recurrent SUI, and repeat surgery following complete removal, but no difference between the two on pain and de novo urgency at approximately 6 weeks and the latter at approximately 29 weeks follow up. The committee agreed that these results were consistent with their knowledge and experience and that it was important to tell women that there may be an increased risk of recurrent SUI with complete mesh sling removal compared to partial. Moreover, they agreed that there are a priori reasons to think that there will also be a decreased risk of subsequent mesh extrusion due to the simple fact that there will be less or no synthetic mesh material to support the urethra that can become extruded.
For mesh inserted to resolve prolapse or abdominally-placed mesh, the committee agreed that attempting the complete removal of mesh carries with it the inherent risk that prolapse will recur because of the lack of organ support. Consistent with this, one small case series study of less than 10 women, showed that almost 1 in 3 women had a recurrence of POP after complete mesh removal. Although there was no evidence on the risk of urinary tract and bowel injury following the attempted removal of either mesh for POP (e.g. transvaginal mesh kit) or abdominally-placed mesh to resolve vaginal complications, the committee agreed by consensus, based on their knowledge and experience, that there is a risk of these injuries because the urinary tract and bowel are very close to the mesh, which can make surgery difficult. Two small case series studies provided evidence on the rate of recurrent erosion associated with complete mesh removal after abdominal sacrocolpopexy, with one study reporting a rate of zero per cent and the other a rate over 50%. The committee agreed that this evidence was consistent with the difficulties associated with the attempt to completely remove synthetic mesh material. For abdominally-placed mesh in particular, the committee noted that abdominal surgery may be indicated if parts of the mesh are not accessible by other routes or if there is evidence of infection or there have been previous unsuccessful attempts to remove the mesh vaginally
Management of sexual dysfunction and/or pain complications
The committee recognised that the management of sexual dysfunction and pain requires specialist assessment and agreed by consensus, based on their expertise and experience, that women who present with pain or painful sexual intercourse should be referred for this if they present in primary care. Even though evidence was limited the committee agreed (based on consensus) that this would be a strong recommendation for referral because of the impact that this complication has on the woman’s life. They furthermore agreed that if these symptoms are confirmed to be related to the insertion of synthetic mesh, then advice should be sought from a regional or supra-regional MDT.
One retrospective cohort study of women who had partial or complete mesh sling removal for treatment of sexual dysfunction and/or pain complications suggested no difference on the majority of outcomes (pain, urge incontinence, repeat surgery for SUI) at both approximately 6 and approximately 29 weeks follow up. However, the same study indicated that that there may also be an increased risk of postoperative SUI at approximately 29 weeks follow-up for complete compared to partial removal.
Evidence from another retrospective cohort study of women who had either mesh removal or mesh sling removal for treatment of sexual dysfunction and/or pain complications suggested that there is an increased probability of pain resolution and decreased risk of persistent pain when removing mesh sling for SUI compared to removing mesh for prolapse.
Given the relative lack of evidence, the committee agreed by consensus, using their knowledge and experience, that conservative treatments for pain and/or sexual dysfunction should be initially offered if no mesh abnormalities are detected and that advice from a regional or supra-regional MDT should be sought if these fail.
Management of urinary complications
The committee discussed the complexities of managing urinary complications and agreed by consensus, using their knowledge and experience, that women who have mesh that is perforating the lower urinary tract should be referred to a mesh complications centre for assessment and management with the requisite expertise. They agreed that this should be a strong recommendation for referral, despite a lack of evidence, because of the impact that these complications have on women’s quality of life.
Given the uncertainty about the effectiveness and safety of mesh removal, the committee agreed by consensus that it was important that women are told that there is no guarantee that it will be successful in resolving urinary symptoms, that new symptoms or SUI may occur and indeed are more likely if removal is complete, and that there is a risk of both perioperative injury such as urinary tract fistula and repeat surgery.
The committee agreed that one retrospective cohort study of women with a variety of mesh complications, although not directly applicable to the review of urinary complications, was relevant to the recommendations. The study of women who had either mesh division or mesh removal showed an increased risk from the latter compared to the former on recurrence of SUI and risk of repeat surgery for SUI. The committee noted that almost all the women in whom mesh division was performed had voiding dysfunction, while those who had mesh removal had either mesh sling erosion or pain. Furthermore, they recognised that mesh division for the treatment of voiding dysfunction is standardly used to relieve tension in the mesh to permit successful voiding. The committee therefore agreed that mesh division, which can be performed in an outpatient setting, should be considered for resolving voiding dysfunction. However, they noted that women who had persistent voiding dysfunction should be referred to an appropriate mesh complications centre for appropriate diagnosis and management.
One case series study of women with lower urinary tract complications (e.g. obstructive voiding, recurrent urinary tract infection) who had either mesh revision or mesh removal suggested that the overall effectiveness of such surgeries for resolving specific urinary complications was variable and that there is some risk of persistent or de novo SUI. With this study in mind, the committee agreed by consensus, using their knowledge and experience, that it be explained to women considering surgery to resolve voiding symptoms that mesh removal has higher risk of recurrent SUI than mesh division and that further surgery may be needed.
Bowel complications
On the treatment of bowel complications associated with mesh or mesh sling, the committee recognised that there is a dearth of evidence but agreed that functional bowel disorders should be managed according to the NICE CG49 guideline for faecal incontinence, and the management of obstructed defecation should follow locally-agreed protocols. In line with the recommendations on the general management of mesh complications, the committee agreed by consensus that an individualised treatment plan for women with non-functional bowel complications – that is, those related to the placement of synthetic mesh (e.g. erosion) – should be created with a regional or supra-regional MDT that has the relevant expertise.
In addition to the general point that complete removal of mesh may not be possible, the committee agreed that it was important that women should be told that there is a risk (albeit uncertain) that bowel symptoms will persist or recur at some (unknown) point in the future after mesh removal and that a temporary or even permanent stoma may be needed after removal surgery for bowel complications.
Due to the limited evidence for chronic pain management following mesh surgery, the committee made a research recommendation. This is important because, chronic pain and sexual dysfunction after mesh surgery can be debilitating and have a severe impact on a woman’s quality of life. The committee were aware that there was very little evidence to support recommendations about the most appropriate management options for sexual dysfunction after mesh surgery or the most effective management options for women presenting with chronic pain 3 months after mesh surgery. Women are also requesting to have mesh removed in the expectation that it will improve their pain but there is insufficient evidence to guide women and their clinicians on the likelihood of pain improvement or resolution after mesh removal. In order to manage the sexual dysfunction and chronic pain most effectively for this group of patients research needs to be undertaken comparing the different management options currently practised.
Cost effectiveness and resource use
The committee acknowledged the lack of clinical and economic evidence on the management of vaginal complications, sexual dysfunction and/or pain, urinary complications, bowel complications, and general mesh complications in women with UI, POP or both.
The committee explained that the recommendations in this area may have resource implications, for example, more MDT reviews and individualised treatment plans, more imaging such as CT or MRI scans, more referrals to specialist centres for assessments, and an increase in the consultation times to explain the risks associated with the removal of mesh. The committee agreed that improving the chances of successfully treating women with mesh-related complications was essential and that these changes are likely to achieve this. The committee explained that timely treatment of these complications may improve outcomes and overall cost savings to the NHS, given that delays in appropriate management may result in worse problems needing more resource intensive management. Also, the committee explained that timely identification and appropriate management of mesh-related complications may reduce the overall burden of symptoms these women experience and have a significant positive impact on their quality of life, especially as some mesh–related complications can last for many years and require expensive long-term management.
Other factors the committee took into account
The committee took into account recommendations from the NICE guideline on faecal incontinence which would also be relevant to the treatment of some of the bowel complications women may experience in the context urinary incontinence and they therefore decided to cross refer to it.
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Appendices
Appendix A. Review protocols
Review protocol for review question: What are the most effective management options for vaginal complications (including exposure, extrusion, erosion and infection) after mesh surgery?
Table 20. Review protocol for management options for vaginal complications after mesh surgery
Review protocol for review question: What are the most effective management options for sexual dysfunction after mesh surgery?
Table 21. Review protocol for management options for sexual dysfunction after mesh surgery
Review protocol for review question: What are the most effective management options for pain after mesh surgery?
Table 22. Review protocol for management options for pain after mesh surgery
Review protocol for review question: What are the most effective management options for urinary complications after mesh surgery?
Table 23. Review protocol for management options for urinary complications after mesh surgery
Review protocol for review question: What are the most effective management options for bowel symptoms after mesh surgery?
Table 24. Review protocol for management options for bowel symptoms after mesh surgery
Appendix B. Literature search strategies
Literature search strategies for review question: Management of vaginal complications and/or pain complications after mesh or mesh sling surgery
Database: Medline & Embase (Multifile)
Last searched on Embase Classic+Embase 1947 to 2017 November 29, Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1946 to Present.
Date of last search: 29th November 2017.
Database: Cochrane Library via Wiley Online
Date of last search: 29th November 2017.
Literature search strategy for review question: Management of sexual dysfunction and/or pain complications after mesh or mesh sling surgery
Database: Medline & Embase (Multifile)
Last searched on Embase Classic+Embase 1947 to 2017 November 20, Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1946 to Present.
Date of last search: 20th November 2017.
Database: Cochrane Library via Wiley Online
Date of last search: 20th November 2017.
Literature search strategy for review question: Management of urinary complications after mesh or mesh sling surgery
Database: Medline & Embase (Multifile)
Last searched on Embase Classic+Embase 1947 to 2017 September 19, Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1946 to Present.
Date of last search: 20th September 2017.
Database: Cochrane Library via Wiley Online
Date of last search: 20th September 2017.
Literature search strategy for review question: Management of bowel complications after mesh or mesh sling surgery
Database: Medline & Embase (Multifile)
Last searched on Embase Classic+Embase 1947 to 2018 March 23, Ovid MEDLINE(R) In-Process & Other Non-Indexed Citations and Ovid MEDLINE(R) 1946 to Present.
Date of last search: 26th March 2018.
Database: Cochrane Library via Wiley Online
Date of last search: 26th March 2018.
Appendix C. Clinical evidence study selection
Clinical evidence study selection for review question: What are the most effective management options for vaginal complications (including exposure, extrusion, erosion and infection) after mesh surgery?
Clinical evidence study selection for review question: What are the most effective management options for sexual dysfunction and/or pain complications after mesh or mesh sling surgery
Clinical evidence study selection for review question: What are the most effective management options for urinary complications after mesh or mesh sling surgery
Clinical evidence study selection for review question: What are the most effective management options for bowel complications after mesh surgery?
Appendix D. Clinical evidence tables
Clinical evidence tables for review question: What are the most effective management options for vaginal complications (including exposure, extrusion, erosion and infection) after mesh surgery?
Table 25. Clinical evidence tables for management options for vaginal complications after mesh surgery (PDF, 245K)
Clinical evidence tables for review question: What are the most effective management options for sexual dysfunction after mesh surgery?
Table 26. Clinical evidence tables for management options for sexual dysfunction after mesh surgery (PDF, 216K)
Clinical evidence tables for evidence review: What are the most effective management options for urinary complications after mesh surgery?
Table 27. Clinical evidence tables for management options for pain after mesh surgery (PDF, 168K)
Clinical evidence tables for evidence review: What are the most effective management options for urinary complications after mesh surgery?
Clinical evidence tables for evidence review: What are the most effective management options for bowel symptoms after mesh surgery?
There were no studies identified for this review, therefore there are no evidence tables for this review question.
Appendix E. Forest plots
Forest plots for review question: What are the most effective management options for vaginal complications (including exposure, extrusion, erosion and infection) after mesh surgery?
Partial mesh removal versus complete mesh removal
Forest plots for review question: what are the most effective management options for sexual dysfunction and/or pain complications after mesh or mesh sling surgery?
It was not possible to conduct meta-analysis as no comparative studies were identified for this review question. Therefore no forest plots are included in this appendix.
Forest plots for review question: what are the most effective management options for urinary complications after mesh or mesh sling surgery
It was not possible to conduct meta-analysis as no comparative studies were identified for this review question. Therefore no forest plots are included in this appendix.
Forest plots for review question: What are the most effective management options for bowel complications after mesh or mesh sling surgery
No comparative studies were identified for this review question. Therefore no forest plots are included in this appendix.
General management of mesh complications after mesh or mesh sling surgery
It was not possible to conduct meta-analysis as only 1 comparative cohort study was identified for this review. Therefore no forest plots are included in this appendix.
Appendix F. GRADE tables
Full GRADE tables for the comparisons examined appear below.
Note that the GRADE tables for the review questions on the management of sexual dysfunction and the management of pain are combined as the relevant studies did not allow a delineation of outcomes for each mesh complication.
Full GRADE tables for the comparisons examined in the section on the general management of mesh complications, for which there is no protocol, are also available
GRADE tables for review question: What are the most effective management options for vaginal complications after mesh surgery?
GRADE tables for review question: What are the most effective management options for sexual dysfunction after mesh surgery? And GRADE tables for review question: What are the most effective management options for pain after mesh surgery?
GRADE tables for review question: What are the most effective management options for urinary complications after mesh surgery?
No studies were identified which were applicable to this review question.
GRADE tables for review question: What are the most effective management options for bowel symptoms after mesh surgery?
No studies were identified which were applicable to this review question.
GRADE tables for general management of mesh complications after mesh or mesh sling surgery
Appendix G. Economic evidence study selection
Economic evidence study selection for review question: What are the most effective management options for vaginal complications (including exposure, extrusion, erosion and infection) after mesh surgery?
One global search was conducted for this review question. See supplementary material D for further information.
Economic evidence study selection for review question: What are the most effective management options for sexual dysfunction after mesh surgery?
One global search was conducted for this review question. See supplementary material D for further information.
Economic evidence study selection for review question: What are the most effective management options for pain after mesh surgery?
One global search was conducted for this review question. See supplementary material D for further information.
Economic evidence study selection for review question: What are the most effective management options for urinary complications after mesh surgery?
One global search was conducted for this review question. See supplementary material D for further information.
Economic evidence study selection for review question: What are the most effective management options for bowel symptoms after mesh surgery?
One global search was conducted for this review question. See supplementary material D for further information.
Appendix H. Economic evidence tables
Economic evidence tables for review question: What are the most effective management options for vaginal complications (including exposure, extrusion, erosion and infection) after mesh surgery?
No economic evidence was identified which was applicable to this review question.
Economic evidence tables for review question: What are the most effective management options for sexual dysfunction after mesh surgery?
No economic evidence was identified which was applicable to this review question.
Economic evidence tables for review question: What are the most effective management options for pain after mesh surgery?
No economic evidence was identified which was applicable to this review question.
Economic evidence tables for review question: What are the most effective management options for urinary complications after mesh surgery?
No economic evidence was identified which was applicable to this review question.
Economic evidence tables for review question: What are the most effective management options for bowel symptoms after mesh surgery?
No economic evidence was identified which was applicable to this review question.
Appendix I. Economic evidence profiles
Economic evidence profiles for review question: What are the most effective management options for vaginal complications (including exposure, extrusion, erosion and infection) after mesh surgery?
No economic evidence was identified which was applicable to this review question.
Economic evidence profiles for review question: What are the most effective management options for sexual dysfunction after mesh surgery?
No economic evidence was identified which was applicable to this review question.
Economic evidence profiles for review question: What are the most effective management options for pain after mesh surgery?
No economic evidence was identified which was applicable to this review question.
Economic evidence profiles for review question: What are the most effective management options for urinary complications after mesh surgery?
No economic evidence was identified which was applicable to this review question.
Economic evidence profiles for review question: What are the most effective management options for bowel symptoms after mesh surgery?
No economic evidence was identified which was applicable to this review question.
Appendix J. Economic analysis
Economic analysis for review question: What are the most effective management options for vaginal complications (including exposure, extrusion, erosion and infection) after mesh surgery?
No economic analysis was conducted for this review question.
Economic analysis for review question: What are the most effective management options for sexual dysfunction after mesh surgery?
No economic analysis was conducted for this review question.
Economic analysis for review question: What are the most effective management options for pain after mesh surgery?
No economic analysis was conducted for this review question.
Economic analysis for review question: What are the most effective management options for urinary complications after mesh surgery?
No economic analysis was conducted for this review question.
Economic analysis for review question: What are the most effective management options for bowel symptoms after mesh surgery?
No economic analysis was conducted for this review question.
Appendix K. Excluded studies
Excluded studies for review question: What are the most effective management options for vaginal complications (including exposure, extrusion, erosion and infection) after mesh surgery?
Clinical studies
Table 35. Excluded clinical studies with reasons for exclusion
Economic studies
No economic evidence was identified for this review. See supplementary material D for further information.
Excluded studies for review question: What are the most effective management options for sexual dysfunction after mesh surgery? And excluded studies for review question: What are the most effective management options for pain after mesh surgery?
Clinical studies
Economic studies
No economic evidence was identified for this review. See supplementary material D for further information.
Excluded studies for review question: What are the most effective management options for urinary complications after mesh surgery?
Clinical studies
Table 37. Excluded clinical studies with reasons for exclusion
Economic studies
No economic evidence was identified for this review. See supplementary material D for further information.
Excluded studies for review question: What are the most effective management options for bowel symptoms after mesh surgery?
Clinical studies
Table 38. Excluded clinical studies with reasons for exclusion
Economic studies
No economic evidence was identified for this review. See supplementary material D for further information.
General management of mesh complications after mesh or mesh sling surgery
See list of excluded studies for individual complications reviews.
Appendix L. Research recommendations
Research recommendations for the review questions
- What are the most effective management options for vaginal complications (including exposure, extrusion, erosion and infection) after mesh surgery?
- What are the most effective management options for sexual dysfunction after mesh surgery?
- What are the most effective management options for pain after mesh surgery?
- What are the most effective management options for urinary complications after mesh surgery?
- What are the most effective management options for bowel symptoms after mesh surgery?
What is the effectiveness of pain management for women who present with chronic pain 3 months after mesh surgery for stress urinary incontinence or pelvic organ prolapse?
Why is this important?
Chronic pain and sexual dysfunction after mesh surgery can be debilitating and have a severe impact on a woman’s quality of life. The committee was aware that there was very little evidence to support recommendations about the most appropriate management options for sexual dysfunction after mesh surgery or the most effective management options for women presenting with chronic pain 3 months after mesh surgery. Women are also requesting to have mesh removed in the expectation that it will improve their pain but there is insufficient evidence to guide women and their clinicians on the likelihood of pain improvement or resolution after mesh removal. In order to manage the sexual dysfunction and chronic pain most effectively for this group of patients research needs to be undertaken comparing the different management options currently practised.
Table 39. Research recommendation rationale
Table 40. Research recommendation modified PICO table v1
Table 41. Research recommendation modified PICO table v2 (deprioritised)
Table 42. Research recommendation modified PICO table v3 (deprioritised)
Table 43. Research recommendation modified PICO table v4 (deprioritised)
Final
Evidence reviews
These evidence reviews were developed by the National Guideline Alliance hosted by the Royal College of Obstetricians and Gynaecologists
Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.
NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.
