Evidence
Appendix A: Summary of studies identified
Appendix A: Summary of studies identified
Eight studies identified in searches and considered pertinent but not directly relevant to the surveillance review are summarised here (Shakir et al. 2020, Goodall et al. 2019, Dray et al. 2019, Kershaw et al. 2019, Salima et al. 2019, Mazloomdoost et al. 2018, Leonard et al. 2018). Note that these studies did not report data comparting full removals with partial removals.
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Four studies assessed stress urinary incontinence (SUI) populations (Shakir et al. 2020, Kershaw et al. 2019, Dray et al. 2019, Goodall et al. 2019).
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Four studies assessed mixed populations (SUI, pelvic organ prolapse; POP or hernia) (Mazloomdoost et al. 2018, Salima et al. 2019, Younan et al. 2019, Leonard et al. 2018).
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Two studies were conducted in the UK (Kershaw et al. 2019, Goodall et al. 2019), 1 of these studies was multicentre (Kershaw et al. 2019).
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Other studies were single centre studies and were conducted in the US (5) or France (2).
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One study was a narrative systematic review of observational studies on the management of synthetic mesh erosion of the rectum (Younan et al. 2019).
SUI population studies
One retrospective study reported outcomes of women undergoing full suburethral sling removal placed for the management of SUI in a single institution in the US (Shakir et al. 2020). Authors reviewed a prospectively maintained database of women undergoing suburethral sling removal and assessed outcomes before and after the procedure. A total of 230 women were included and the mean follow up was 30 months. The most common symptoms at presentation were storage/irritative voiding, pain, and urinary incontinence. Forty-two percent of the patients with recurrent urinary tract infections, had no evidence of recurrent urinary tract infection at their last follow up. Twenty-three percent of the patients with dyspareunia reported a complete resolution of the symptoms, and 11 of those with SUI prior to the mesh removal. Patients also reported new symptoms after the mesh removal including recurrent urinary tract infections, SUI, urgency urinary incontinence, and mixed urinary incontinence. Sixty-four patients with SUI have a subsequent procedure post mesh removal. There was statistically significant improvement in the UDI-6 score before and after the procedure (50 pre-surgery, 38 last follow up, p<0.001). Fifty-three percent of the patients achieved success by UDI-6 (success defined by UDI-6 score of 25). Authors reported a multi-composite ideal outcome of resolution of incontinence, pain, resumption of sexual activity, and no need for further anti-incontinence procedures. Ten percent of the patients achieved this outcome at 6 months to 12 months and most recent follow up. This percentage improved up to 49% if 1 minimal intervention was allowed and the sexual activity was excluded. Authors concluded that after a full suburethral sling removal, there was a sustained improvement of the symptoms in the around a half of the patients studied.
One observational study assessed the surgical management of mesh-related complications in women who underwent midurethral sling in 2 NHS Trusts in the UK (Kershaw et al. 2019). A total of 127 patients returned to the theatre at least once during the period assessed: 71 for the management of mesh complications (mesh exposure, pain, voiding dysfunction) or treatment failures (repeat SUI surgery) and 56 for diagnostic procedures (cystoscopy). Mean follow-up time was 60 months, and the time from the primary mesh surgery and the second surgery was 22 months. Common symptoms at presentation were chronic postoperative pain (with or without mesh exposure), voiding dysfunction, overactive bladder, or recurrent/persistent SUI. Different types of surgical procedures for the management of mesh complications or treatment failures were performed. These included shortening, reburying, incision or midurethral sling surgery excision, steroid injections along the midurethral sling surgery tract, surgical management of detrusor overactivity or further stress incontinence surgery, among others. In 2 patients the chronic pain was not resolved after surgery (1 or more interventions). Authors concluded that there was a low incidence of mesh removal following midurethral sling surgery, and outcomes improved after the surgical management of the mesh-related complications.
A retrospective analysis of medical records in a single hospital in the US assessed the efficacy of sling revision or removal for the management of mesh-related complications in women with synthetic mid urethral slings (Dray et al. 2019). A total of 430 women who received transobturator tape, retropubic mid urethral sling or mini-sling between 2004 and 2016 were included in the study. The main complaints reported were mesh incontinence, pain or dyspareunia, exposure or erosion, and bladder outlet obstruction. One hundred and nine were partial vaginal mesh excisions and 247 complete vaginal mesh excisions. Eighty-one patients had a prior sling revision. The American Urological Association Symptom Index significantly decreased after removal or revision of the mesh as well as the Michigan Incontinence Symptom Index and bother scores. Symptoms were not resolved in 40% of patients with pain and 20% of those with obstruction, and 5% of those with mesh exposure or erosion developed recurrent mesh complains. Authors concluded that symptoms improve after mesh revision or removal, but it is unlikely to achieve a complete resolution of all the symptoms after revision.
An observational study identified all women with chronic pain who underwent laparoscopic removal of midurethral sling for SUI between 2011 and 2016 in a single hospital in the UK (Goodall et al. 2019). The study assessed operative safety, pain, symptom severity and satisfaction. A total of 56 women were identified most of them with vaginal, abdominal and groin pain. They also reported other symptoms, including urinary tract infection (persistent and recurrent), lower-limb swelling and chronic fatigue. All patients received conservative measures before going to surgery. Nine women had previous mesh surgery for mesh complications. The combined laparoscopic and vaginal approach was used for complete removals, and laparoscopic approach only for partial removals with preservation of at least the suburethral component. Most of the patients reported a complete improvement of their symptoms (48%) at 12 weeks, 30% reported partial improvement and 11% no improvement. De novo or worse SUI was associated with excision of the suburethal portion of the mesh (odds ratio 10.75; 95% confidence interval [95% CI] 1.10 to 104.00). All patients were contacted via questionnaire (median follow up 22 months, range 1 month to 60 months), 26 (46%) returned the questionnaire. Most of these patients reported that they would recommend the procedure (46%). Authors concluded that laparoscopic removal is feasible, but the risk of early and late complications as well as the unpredictable efficacy should be considered in the decision-making process with the patients.
Mixed population (SUI, POP, hernia)
An observational study assessed the characteristics and outcomes after surgery of 93 women who underwent surgical management for mesh-related complications (Mazloomdoost et al. 2018). They conducted a retrospective chart review of women treated for mesh-related complaints between 2010 and 2014 in a single centre in the US. They contacted the patients and followed them up using a validated questionnaire. The questionnaire included questions about health, sexual functioning, postoperative improvement, and satisfaction. Most of the women had a midurethral sling mesh only, followed by a prolapse-related mesh only, or both. The most common causes of surgical revision of a midurethral sling were pain or dyspareunia, mesh exposure and voiding dysfunction. The most common causes of surgical revision of POP mesh were pain or dyspareunia. Women with mesh exposure were younger, more likely to present with POP grade 2, and less likely to present with pain compared with those without mesh exposure. Eighty percent of the women were contacted via questionnaire, 75% agreed to participate. No differences were identified in SF-12 scores and PISQ-12 scores before and after the procedure. Participants reported symptom improvement after surgery with low symptom severity and high satisfaction with the surgery. There were no changes in health or sexual function after treatment.
An observational study retrospectively assessed functional outcomes in women who underwent a tape/mesh surgical revision in a single institution in France between 2008 and 2016 (Salima et al. 2019). A total of 140 women undergoing tape removal (partial or complete), tape division, mesh removal (partial or complete) or tape and mesh removal were included (patients with previous revisions or with neurogenic disease were also included). The main indication for tape removal was voiding symptoms, for mesh removals it was vaginal erosion/extrusion. Mean time between tape/mesh insertion and revision was 52.1 months (range 5 days to 16 years). Most of the tape complications were related to the urinary tract and were asymptomatic. Most of the mesh complications were associated with a vaginal exposure (more than 1 cm) and were symptomatic or asymptomatic. Voiding symptoms were resolved in 63% of the patients and storage in 38% of the patients. Fifty-two percent of the patients with recurrent or persistent SUI underwent an additional surgical procedure. Only 1 patient presented a POP recurrence. Authors concluded that there is an improvement of the symptoms, but patients need to be informed that symptoms may persist after revision or removal.
An observational study assessed the efficacy of surgical removal of prosthetic material for the management of chronic postoperative pain caused by the placement of the prosthetic material (Leonard et al. 2018). The study included a total of 107 patients managed between 2004 and 2016 in a single centre in France for SUI, POP or hernia. The mean follow up was 8.4 months (standard deviation 10.3) and the mean time between insertion to removal of prosthetic material was 41.2 months (SD 35.4). Sixty-one percent of the patients (65) experienced pain at presentation. 18 percent erosion (19), 9% (10) infection, and 12% urinary symptoms (13). Sixty-seven percent of the patients reported a reduction of at least 50% of the pain at last follow up. However, 45% relapsed from the condition for which the mesh was placed. Sixty-two percent of the patients experienced a recurrence of the urinary incontinence after the removal of transobturador suburethral tape. Authors concluded that the removal of the prosthetic material has a positive impact on the pain in most of the patients, but there is a risk of recurrence of the initial disorder.
A systematic review assessed the management of synthetic mesh erosion of the rectum after urogynaecological surgery (Younan et al. 2019). A total of 14 observational studies were identified, all of them reporting a total of 14 rectal mesh erosions. Given the low number of cases identified, the management of those cases were reported narratively. The rectal erosion of the mesh caused all the rectal complications in the cases assessed, rectal bleeding being the most common symptom reported. The rectal mesh erosions were managed by major surgery, transanal approach or no surgery. Authors concluded that rectal mesh erosion could be managed by the transabdominal or transanal approach and with partial or complete excision of the mesh. A non-surgical management of the mesh erosion can be considered before deciding a surgical one.
ISBN: 978-1-4731-3953-4
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