Incontinence
Research
Patient Information Leaflet for Gynecare TVT Scroll to page P7 to see the list of appalling risks, most of which are not communicated to patients ahead of surgery.
Erosion of soft tissue by polypropylene mesh products
Surgical mesh products made from polypropylene have been extensively used in the treatment of stress urinary incontinence, pelvic organ prolapse and other conditions. Since the onset of the use of such implants, major complications have been reported. Mesh erosion, where neighbouring tissues are worn from the rubbing of mesh, occurs in a significant number of cases.
Journal of the Mechanical Behavior of Biomedical Materials 115: 104281. March 2021.
Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomised controlled trials
A total of 175 randomised controlled trials – assessing a total of 21,598 women – were studied to compare the effectiveness and safety of surgical interventions for women with stress urinary incontinence. It found: “Retropubic MUS [midurethral sling], transobturator MUS, traditional sling, and open colposuspension are more effective than other procedures for stress urinary incontinence in the short to medium term. Data on long-term effectiveness and adverse events are, however, limited, especially around the comparative adverse events profiles of MUS and non-MUS procedures.
“A better understanding of complications after surgery for stress urinary incontinence is imperative.”
BMJ 365: l1842. June 2019.
Mesh in urological surgery in the UK – background, reviews and current status
This article downplays patient suffering: “It has become clear that whilst mesh surgery for stress urinary incontinence offers a simple, effective treatment for the majority of women, a small but significant number suffer life-changing complications.” – While this is great news, the downside to this study was that a “failed” tension-free vaginal tape is left in situ.
Urology News 23(4). May/June 2019.
Laparoscopic colposuspension for recurrent stress incontinence after tension-free vaginal tape
This study reported how this technique “offers a viable mesh-free option for the treatment of recurrent stress incontinence in women who have had failed TVT”.
Journal of Minimally Invasive Gynecology 26(3): 402-403. March/April 2019.
Surgical treatments for women with stress urinary incontinence: the ESTER systematic review and economic evaluation
This study aimed to evaluate the clinical effectiveness, safety and cost-effectiveness of surgical treatment for stress urinary incontinence (SUI) in women and explore women’s preferences. It found: “Overall, the quality of the clinical evidence was low, with limited data available for the assessment of complications. Furthermore, there is a lack of robust evidence and significant uncertainty around some parameters in the economic modelling.” It called for robust clinical data in future work, particularly around long-term complication rates.
Health Technology Assessment 13(14). March 2019.
Results of the British Association of Urological Surgeons female stress urinary incontinence procedures outcomes audit 2014-2017
The British Association of Urological Surgeons publishes its outcomes from mesh surgery for stress urinary incontinence. It reports good short-term outcomes – at three months. – What about at six months, a year, two years, three years, five years, and so on?
BJU International 123(1): 149-159. January 2019.
Debate: There is still a place for vaginal mesh in urogynaecology
A British Journal of Obstetrics and Gynaecology debate, published in 2019, offered opposing views on TVT mesh:
The failure of polypropylene surgical mesh in vivo
With the use of polypropylene for certain surgical operations being questioned, this study reviewed the existing state of knowledge and used some simple biomechanics analysis to make recommendations for future work. Study author David Taylor concluded: “On balance my conclusion is that stress-corrosion failure is the most likely explanation but currently no experimental results exist to prove conclusively that this failure mechanism occurs in vivo. Further work is needed, especially the analysis of explanted material, to resolve this urgent problem.”
Journal of the Mechanical Behavior of Biomedical Materials 88: 370-376. December 2018.
Long-term rate of mesh sling removal following midurethral mesh sling insertion among women with stress urinary incontinence
This cohort study of women who underwent midurethral sling insertion for stress urinary incontinence at hospitals in England between 2006-15 investigated rates of sling removal or reoperation for incontinence. The rate of mesh sling removal at nine years was estimated as 3.3%, while 6.8% had some kind of re-operation. It concluded: “These findings may guide women and their surgeons when making decisions about surgical treatment of stress urinary incontinence.” – At Sling The Mesh, we say removals or re-operations are only a small chapter in the story behind the mesh disaster.
Journal of the American Medical Association 320(16): 1,659-1,669. October 2018.
Outcomes after laparoscopic removal of retropublic midurethral slings for chronic pain
This paper reports: “Patients may attribute highly diverse symptoms due to mesh insertion, including chronic pelvic pain, chronic fatigue, fibromyalgia and pain distant from the pelvis. There is limited evidence to support the causality of mesh in these distant symptoms. Patients may also have psychological morbidity rooted in anxieties about long-term harm from mesh.”
International Urogynecology Journal 30: 1,323-1,328. September 2018.
Delayed presentation of cecal perforation with tension-free vaginal tape
This case report discusses how a postmenopausal woman with persistent stress urinary incontinence (SUI) presented more than one year after tension-free vaginal tape (TVT) placement with bowel perforation incidentally discovered on routine screening colonoscopy. She underwent removal of the TVT and subsequent placement of a fascial sling, with postoperative resolution of SUI. The report concluded: “This case provides additional evidence for bowel injury as a postoperative TVT complication.”
Obstetrics and Gynecology 131(3): 499-502. March 2018.
Road to recovery after transvaginal surgery for urethral mesh perforation: evaluation of outcomes and subsequent procedures
Nineteen women underwent transvaginal sling excision for urethral mesh perforation. At follow-up, 92% reported urinary incontinence (UI). Patient global impression of improvement data was available for 13 patients, of whom 7 (54%) rated their postoperative condition as very much better or much better. The paper concluded: “Most women reported resolution of their pelvic pain and a high rate of satisfaction with their postoperative condition despite high rates of incontinence.”
International Urogynecology Journal 29: 887-892. January 2018.
Surgery for recurrent stress urinary incontinence: the views of surgeons and women
This 2017 study said 78% of the UK surgeons surveyed just leave the old tape in place and put another on top if it fails. – This is why UK removal rates aren’t an indication of the true complication rates for sling tapes. No wonder they are panicking…
International Urogynecology Journal 29(1): 45-54. January 2018.
Five quotes to make your eyes roll:
- This is “a consequence of training and experience rather than an actual preference. It appeared that many respondents were unable to offer alternative procedures because they had not received training in procedures such as Burch colposuspension or autolgoous sling”.
- “This is an important finding not only for future research plans, but also as a training and clinical governance issue, bearing in mind the increasing concerns about mid-urethral tape complications, how they are managed, and the possibility of providing women with alternative choices.”
- “From the patients’ perspective, the variability and inconsistency of surgeons’ responses in general is a finding that will generate considerable concern, particularly given that this survey was only sent to those with specific training and a declared interest in pelvic floor dysfunction.”
- “Patients hope and expect that doctors know what they are talking about and that treatments offered are the most suitable/effective. However, it is clear from the data that the treatments women may be offered may depend largely upon the discipline and training of the surgeon, and that the choice of treatments offered depends upon the surgeon’s skills, experience and opinion rather than any evidence.”
- “This highlights the importance of comprehensive and appropriate training, in addition to the need for research addressing the specific issue of failed continence surgery, to avoid and reduce the variability in patient choice that is currently present and to provide greater consistency of care provision.”
This article also reckoned mesh removal rates for mesh slings are 3.3%, yet Keltie et al found risk of an overnight stay with a serious complication to be 9.8%. Then The Guardian, working on HES data, found it to be 6.5%. So, who is correct?
Tumor-like reaction to polypropylene mesh from a mid-urethral sling material resembling giant cell tumor of vagina
This paper reports on the case of a 49-year-old woman with a history of stress urinary incontinence that required a sling, who presented with a hard, tender, immobile mass on the anterior vaginal wall. Pathological analysis of the mass revealed a tumor-like reaction to the polypropylene material that resembled a giant cell tumor of soft tissue. The paper concluded: “The use of polypropylene in surgery is ubiquitous across disciplines; thus, consideration for a tumor-like reaction to the material should exist for patients who present with a mass near the surgical site.”
Case Reports in Obstetrics and Gynecology 2017: 6701643. December 2017.
Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence
This study evaluated the efficacy and safety of midurethral slings compared with other surgical treatments for female stress urinary incontinence. “A systematic review and meta-analysis of the literature was performed using the Medline, Scopus, and Web of Science databases to update our previously published analyses.”
This analysis confirmed the “superiority” of midurethral slings over Burch colposuspension, compared to Ward and Hilton (2002; below), which found they were about the same in effectiveness. How? By looking at secondary outcomes. It also included a study that was not a true comparison of an open Burch colposuspension versus mesh.
European Urology 72(4): 567-591. October 2017.
Consensus statement of the European Urology Association and the European Urogynaecological Association on the use of implanted materials for treating pelvic organ prolapse and stress urinary incontinence
With implantable materials having been adopted for the treatment of female and male stress urinary incontinence, and female pelvic organ prolapse, this paper offered a consensus review of existing data based on published meta-analyses and reviews. It found complications were 12%, which is one in eight women suffering.
It summarised: “Synthetic slings can be safely used in the surgical treatment of stress incontinence in both male and female patients. Patients need to be aware of the alternative therapy and potential risks and complications of this therapy. Synthetic mesh for treating prolapse should be used only in complex cases with recurrent prolapse in specialist referral centres.”
European Urology 72(3): 424-431. September 2017.
Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women
The aim of this study was to investigate the rate of adverse events of these procedures for stress urinary incontinence in England over a period of eight years. It found the complication rate within five years of the mesh procedure was 9.8%. It concluded: “This evidence can inform future decision-making on this procedure.”
Scientific Reports 7: 12015. September 2017.
Midurethral slings in the mesh litigation era
This paper claimed only prolapse mesh is a problem and “skewed“ media reports are saying incontinence mesh – such as mid-urethral slings like TVT, TVTO and TOT – are a risk. They also claim women are only making a fuss as they are attracted by “big payouts” (see screenshot below).
Translational Andrology and Urology 6(Suppl 2): S68-S75. July 2017.
Surgery for recurrent stress urinary incontinence: the views of surgeons and women
No consensus exists among surgeons about preferred treatment options for recurrent stress urinary incontinence, and personal experience and training dominate decision-making, according to this study. For patients, choices were usually based on an elimination of options, including that of a repeat failed procedure. This contrasts with surgeons, who mostly preferred a repeat midurethral tape above other options. The study concluded: “Any future comparative study will be challenging.”
International Urogynecology Journal 29: 45-54. June 2017.
The one-year experience of tape and mesh removal at a urological tertiary referral centre
There is increasing controversy surrounding the use of synthetic materials in transvaginal tape and vaginal
mesh for stress incontinence and pelvic organ prolapse. The aim of this study was to review the caseload and operative management of a tertiary referral urology centre dealing with surgical complications of these procedures within Scotland. It found that following mesh removal, 75% of women had reduced pain and 50% remained continent.
Journal of Clinical Urology 10(4): 336-339. January 2017.
Mesh removal after vaginal surgery: what happens in the UK?
This paper finds only 27% of surgeons report all of their mesh removals to the MHRA database. – Reason? It is not mandatory to do so. Black holes in data collection.
International Urogynecology Journal 28: 989-992. December 2016.
Safety and efficacy of PVDF (DynaMesh®-SIS Soft) retropubic midurethral slings in stress urinary incontinence in women
New mesh” has been trialled in England and Northern Ireland since 2016. They are trialling it as they admit shrinkage with the polypropylene mesh is a problem.
“The sling being studied is DynaMesh®SIS soft, made of polyvinylidene fluoride (PVDF) which has improved biocompatibility with tissues, meaning reduced scar formation and less mesh shrinkage.” – it is poly, so is still plastic, and still introduces a foreign body into a clean, contaminated field using large hooks and inserted blindly.
There are 11 centres and it is currently used in 4 – Norwich (main research centre), Antrim and Belfast in the UK, and Munich in Germany. It will be introduced in London, Cambridge, Wirral, Solihull, Huntingdon and Kilmarnock in the UK, and Wurzbug in Germany.
Classic short term follow-up of one year, then for a further year by postal questionnaire. Clinical follow-up is at 3 and 12 months postoperatively and as required if any concerns.
The use of synthetic materials in the treatment of stress urinary incontinence
This paper reports: “Within a year of the procedure, a mesh positioned evenly underneath the urethra may shrink up to 20-30% after the implantation, whereas if it is wrongly positioned and folded, it may shrink up to 75% of its volume. The above mechanisms may lead to obstruction in the urine flow and consequently to the erosion of the urethra.”
Menopause Review 15(2): 76-80. June 2016.
EU Scientific Committee on Emerging and Newly Identified Health Risks: opinion on the safety of surgical meshes used in gynecological surgery
This report suggested that sling surgery was effective, with an approximate mesh exposure rate of 4% (page 4). However, the paper referred to stated serious complications were 20% and adverse events were 42%.
Opinion approved on 3 December 2015.
Transobturator tape versus retropubic tension-free vaginal tape for stress urinary incontinence: 5-year safety and effectiveness outcomes following a randomised trial
In a randomised trial comparing transobturator tape (TOT) to retropubic tension-free vaginal tape (TVT) for women with stress urinary incontinence (SUI), vaginal examination at 12 months showed that tapes were palpable for 80% of the TOT group versus 26.7% of the TVT group. Therefore, the authors of this study hypothesised that this difference would lead to more women in the TOT group experiencing vaginal mesh erosion or other serious adverse events compared to women in the TVT group five years post-surgery. However, it found serious adverse events and tape effectiveness did not differ much between groups at five years – 27.6% of women suffer complications following a TVT and 21.8% for a TOT.
International Urogynecology Journal 27: 879-886. December 2015.
The ‘learning curve’ for retropubic mid-urethral sling procedures: a retrospective cohort study
Mid-urethral tape procedures brought a paradigm shift in surgery for stress incontinence; little research into the development and maintenance of surgical competence for the procedure exists. The hypothesis behind this study is that the “learning curve” for retropubic mid-urethral sling procedures, judged by the surrogate of bladder perforation, is longer than previously thought.
The study said: “Whilst seductively simple in concept, mid-urethral tape procedures are not without risk; their inherently ‘blind’ nature makes them difficult to teach. The ‘learning curve’ to independent practice may be longer than previously considered.”
International Urogynecology Journal 27: 565-570. October 2015.
Safety considerations for synthetic sling surgery
This research found: “Considering the additional risks of refractory overactive bladder, fistulas and bowel perforations, among others, the overall risk of a negative outcome after synthetic midurethral sling implantation surgery is ≥15%.”
Nature Reviews Urology 12: 481-509. August 2015.
Urethral complications after tension-free vaginal tape procedures: a surgical management case series
This Swedish study followed women with mesh complications and showed problems can cut in early or as late as 11 years post-insertion – in this case, slicing through a woman’s urethra.
World Journal of Nephrology 4(3): 396-405. July 2015.
Management of mesh complications after SUI and POP repair: review and analysis of the current literature
This research found only retrospective studies on PubMed for complications relating to the implantation of mesh material for urogynaecological indications. The rate of mesh-related complications was 15-25%, and mesh erosion is up to 10% for pelvic organ prolapse and stress urinary incontinence repair. Mesh explantation is necessary in about 1-2% of patients due to complications. It concluded: “The data on the management of mesh complication is scarce. Revisions should be performed by an experienced surgeon and a proper follow-up with prospective documentation is essential for a good outcome.”
BioMed Research International 2015: 831285. April 2015.
Stress urinary incontinence and LUTS in women – effects on sexual function
The sexual impact of urinary incontinence in women depends on a host of parameters, including physical, psychological, social and cultural dimensions. Evaluation of the effects of stress urinary incontinence (SUI) and lower urinary tract symptoms on sexual function is often biased by their common association with other pelvic floor disorders, such as pelvic organ prolapse, which also affect sexual satisfaction. This study describes the nature of sexual dysfunction in women with incontinence, including coital incontinence.
Nature Reviews Urology 11: 565-578. September 2014.
Evaluation and management of complications from synthetic mesh after pelvic reconstructive surgery: a multicenter study
This study showed 347 patients sought help for synthetic mesh-related complications. A total of 30% had dyspareunia (lost or reduced sex lives), 42.7% of the patients had mesh erosion and 34.6% had pelvic pain. It said 77% had a grade 3 or 4 (severe) complication.
American Journal of Obstetrics and Gynecology 210(2): 163.e1-163.e8. February 2014.
Complications of sub-urethral sling procedures
This article focused on intraoperative and postoperative complications of sling techniques in anti-incontinence surgery. It concluded: “The complications of sling procedures are frequent – they occur in up to 40% of cases. Minor voiding difficulties that resolve with expectant management, transient pain and intraoperative issues of minimal clinical significance constitute the majority of them. However some of those complications, including chronic pain, detrusor instability or insufficient therapeutic effect, may become indications for surgial reintervention.
“Taking the abovementioned problems into consideration, it seems to be of major importance to improve diagnostic techniques, including ultrasound examinations in different presentations, and to propose optimal treament, including conservative management.”
Ginekologia Polska 85(7): 536-540. January 2014.
Three-year results from a randomised trial of a retropubic mid-urethral sling versus the Miniarc single incision sling for stress urinary incontinence
This study found a significantly higher three-year failure rate for the single-incision sling versus the retropubic midurethral sling. Both procedures had reduced efficacy over time.
International Urogynecology Journal 24: 2,059-2,064. May 2013.
Tension-free vaginal tape and beyond: our challenges and the future of anti-incontinence therapy
Surgeon Firouz Daneshgari – from the Department of Urology, Case Western Reserve University, Cleveland, US – says: “Almost two decades after the introduction of TVT and midurethral slings into clinical practice, and by any modern industrial standards of quality, a 30-40% rate of adverse events is simply unacceptable.
“Whether or not this is due to changes in names or mechanisms of action is not relevant.
“Can any of us imagine what would happen if one-third of all cars, computers, food packages, or any other commodity we purchase would fail or result in recalls?
“Moreover, it is unlikely that the manufacturer would remain in business after such recalls and failures.
“In either a single-institution case series or multi institution, we impose an adverse event on at least one third of our patients. In the Serati et al report, up to 30% of patients developed de novo urgency.
“Similarly, results of two of the largest RCTs involving midurethral slings revealed a nearly 42% rate of side effects. One can attempt to tease out the differences in types of adverse events, but the big picture remains the same.”
European Urology 61(5): 947-948. May 2012.
Tension-free vaginal tape for the treatment of urodynamic stress incontinence: efficacy and adverse effects at 10-year follow-up
This research evaluated the outcomes of women with retropubic tension-free vaginal tape (TVT) for urodynamic stress incontinence (USI) after 10-year follow-up. The conclusion stated: “The 10-year results of this study seem to demonstrate that TVT is a highly effective option for the treatment of female SUI, recording a very high cure rate with low complications after a 10-year follow-up.”
European Urology 61(5): 939-946. May 2012.
Mesh complications in female pelvic floor reconstructive surgery and their management: A systematic review
In this study, researchers reviewed the incidence, predisposing factors, presentation and management of complications related to the use of synthetic mesh in the management of stress urinary incontinence and pelvic organ prolapse repair. Among the findings were:
- A mesh erosion rate of up to 33%.
- Pain of up to 40% in TVTO and 24.4% in prolapse.
- Loss of sex life rate of 9.1%.
The study concluded: “It is important not to fall prey to industry-driven treatment options, but to follow evidence-based medicine… It is important to cautiously analyse results of various published studies in the literature.”
Indian Journal of Urology 28(2): 129-153. April-June 2012.
A real-world comparative assessment of complications following various midurethral sling procedures for the treatment of stress urinary incontinence
This study, which included three people working for Johnson & Johnson, aimed to evaluate clinical outcomes of different mid-urethral sling products with respect to postsurgery complications. It claimed to “confirm the low overall rate of complications for midurethral sling procedures, while, at the same time, suggesting that product choice may also have an impact on complication rates”…
Journal of Long-Term Effects of Medical Implants 22(4): 329-340. 2012
The TVT Worldwide Observational Registry for Long-Term Data: safety and efficacy of suburethral sling insertion approaches for stress urinary incontinence in women
This study examined the clinical effectiveness of a single incision sling in women with stress urinary incontinence, and obtained comparative perioperative and postoperative data on retropubic and transobturator slings. The authors concluded this registry ”demonstrates the high effectiveness of all three approaches.” – TVT Worldwide Registry, funded by Johnson and Johnson, downplaying complications…
The Journal of Urology 186(6): 2,310-2,315. December 2011.
OAB. Are we barking up the wrong tree? A lesson from my dog
This presentation discusses whether overactive bladder (OAB) is a condition that not many understand, have no idea how to diagnose and has limited treatments. Many women with OAB have side effects such as cognitive function, which can lead to falls in elderly women. Also note the International Continence Society 2002/2006 definition of OAB (slide 6) as being “urgency, with or without urgency incontinence usually with increased daytime frequency and nocturia”. – Which leaves Sling The Mesh wondering: is industry making a mint out of a little-understood condition?
Neurourology and Urodynamics 30(8): 1,410-1,411. November 2011.
Adverse events over two years after retropubic or transobturator midurethral sling surgery: findings from the Trial of Midurethral Sling (TOMUS) study
The objective of this study was to describe surgical complications in 597 women over a 24-month period after randomisation to retropubic or transobturator midurethral slings. A total of 383 adverse events were observed among 253 of the 597 women (42%), with 78 of these (20%) classified as serious. – Yes the authors said mesh is still acceptable to use.
American Journal of Obstetrics and Gynecology 205(5): 498.E1-498.E6. November 2011.
There are 11 authors and only 5 declared “no conflict of interest”. The other six are all MDs except for Yan XU, who has a master’s degree.
Among the non-declared conflicts of interest (COI), Gary Lemack received $136 832 in 2013-2015. To check his COI, visit this site. This paper claims pain beyond six weeks was 2.3%, which seems unlikely.
This same TOMUS study was followed up after five years and the adverse events suddenly fell to 10%. – Smell a rat? We do! Also in this study, the efficacy was 51.3% – which means a failure rate of 48.7%.
Outcomes and complications of the Remeex® system in women with recurrent stress urinary incontinence and sphincteric deficience
This study aimed to evaluate the outcomes and complications of adjustable tension-free sling Remeex
in patients with intrinsic sphincteric deficiency (ISD) or recurrent stress urinary incontinence (SUI). It said of 85 patients who underwent a procedure, 78 (91.8%) were considered cured, while two improved and five cases were considered a failure of the procedure.
The report stated: “This technique is not free of complications. There are abdominal problems due to the Varitensor, which, being a foreign body, predisposes to wound problems. It also has the intrinsic risk for extrusion like any other mesh and possibly an added risk because it is a dynamic system.
“Despite complications it seems to be a good option for these difficult cases where other techniques have failed or are not likely to succeed.”
Circa 2011.
Midterm Prospective Evaluation of TVT-Secur Reveals High Failure Rate
Study shows that “despite its good short-term efficacy, TVT-Secur [a minimally invasive sling] is associated with a high recurrence rate of stress urinary incontinence (SUI). Therefore, TVT-Secur does not seem appropriate for SUI first-line management in women”.
European Urology 58(1): 157-161. July 2010.
A 2-year observational study to determine the efficacy of a novel single incision sling procedure (MinitapeTM) for female stress urinary incontinence
This prospective observational study of 60 women who underwent the Minitape procedure for urodynamic stress incontinence found “at two years following Minitape insertion, six women (10%) were defined as cured”. – In other words, 90% of mesh slings failed.
BJOG 117(3): 356-360. January 2010.
GyneIdeas of Glasgow was the manufacturer for the Minitape in this trial, which received funding from Mpathy Medical, later bought out by Coloplast.
Read the substantial equivalent notification for this sling. It has been approved because it is found to be substantially equivalent to hernia mesh, TVT and other regular mid-urethral slings. Yet the Single Incision Mini Sling is a very different concept.
Here is Companies House information for GyneIdeas. It was dissolved in 2014.
National audit of incontinence surgery in the United Kingdom
The aim of the study was to describe the experience, current trends and management of incontinence surgery for urodynamic stress incontinence in the UK. This study was carried out in 2002, but wasn’t published until 2009. It also reported a 10% mesh erosion rate – yet this study was ignored by the MHRA in its 2012 York report, which said mesh complications were 1% to 3%…
Journal of Obstetrics and Gynaecology 24(7): 785-793. July 2009.
Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow-up
This study provided an update on a study carried out in 2002, comparing the long-term outcomes of tension-free vaginal tape (TVT) and colposuspension as primary treatment for stress incontinence. It concluded that a significant difference could not be detected between TVT and colposuspension at five years.
BGOJ 115(2): 226-233. January 2008.
Reported complications of tension-free vaginal tape procedures: a review
This study quoted a figure of 22.3% risk of suffering urinary tract infections after having TVT mesh and 19.7% risk of urinary retention.
It said: “The various tape procedures offer an innovative approach to the treatment of urinary stress incontinence and offer good clinical results in the hands of the well-trained, experienced surgeon. Nonetheless, there are complications that have been noted in the literature and in our experience. Some complications can be very difficult to treat, such as post-op pelvic discomfort and voiding dysfunction, and patients should be aware of these complications prior to surgery.”
BC Medical Journal 49(9): 490-494. November 2007.
Vaginal mesh for incontinence and/or prolapse: caution required!
“Even if the rates of these devastating complications are fairly low, they are life-changing for the patient, sometimes irreversible and often sources of litigation.”
Expert Review of Medical Devices 4(5): 675-679. 2007.
Presentation and management of major complications of midurethral slings: Are complications under-reported?
The purpose of this study was “to report the presentation and treatment of major complications from these minimally invasive treatments presented to a tertiary referral practice, and to highlight a discrepancy in major complications between literature and the US Food and Drug Administration device failure database”.
It concluded: “Although rare, major complications of midurethral slings are more common than appear in literature. Devastating complications involving urethral and bladder perforations can present with mild urinary symptoms and thus are likely under-diagnosed and under-reported.”
Neurourology and Urodynamics 26(1): 46-52. December 2006.
The tension-free vaginal tape reviewed: an evidence-based review from inception to current status
This research explores how much of the data for tension-free vaginal tape are from non‐peer‐reviewed small case series often “published” as abstracts. As a result, the conclusions should be interpreted cautiously.
BJOG 112(5): 534-546. May 2005.
Clinical audit of the use of tension-free vaginal tape as a surgical treatment for urinary stress incontinence, set against NICE guidelines
This article claimed TVT was a good treatment option and used this as an audit so mesh was used routinely in hospitals circa 2003. But it also showed almost a third of women (27%) had to self-catheterise afterwards. Also, 57.9% had this mesh as primary surgery, while 41.6% had it for a failed previous incontinence surgery.
Journal of Obstetrics and Gynaecology 24(5): 534-538. 2004.
Vaginal colposuspension: a new approach to an established continence procedure
Had the Ward Hilton study (BMJ 325: 67; below) not been published, it is likely that the vaginal colposuspension would have become the gold standard – as per this paper. Instead, mesh took off and surgeons lost their traditional skills
Journal of Obstetrics and Gynaecology 23(6): 687-688. November 2003.
The effect of tension-free vaginal tape (TVT) procedure on sexual function in women with stress urinary incontinence
This study found the tension-free vaginal tape (TVT) procedure negatively affected sexual function in women with stress urinary incontinence (SUI).
International Urogynecology Journal 14: 390-394. November 2003.
Systematic review of the clinical effectiveness and cost-effectiveness of tension-free vaginal tape for treatment of urinary stress incontinence
The conclusion in this report calls for unbiased trials of more than five years on tension-free vaginal tape (TVT). It also says research is needed on possible long-term complications of TVT. – When did this happen? It didn’t…
Health Technology Assessment 7(21). August 2003.
Trials of surgery for stress incontinence – thoughts on the ‘Humpty Dumpty principle’
This commentary looks at issues of randomisation and blinding, the most appropriate population for analysis, the definition of cure or primary outcome variable, external validity and statistical power.
BJOG 109(10): 1,081-1,088. October 2002.
Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence
This multicentre randomised comparitive trial compared tension-free vaginal tape with colposuspension as the primary treatment for stress incontinence, and found they were similar in efficiency. The study measured if it stopped women leaking. Even in secondary outcomes it was not clear if they measured new onset of pain or UTIs. The authors took funding from Johnson and Johnson for this study.
BMJ 325: 67. July 2002.
Sling techniques in the treatment of genuine stress incontinence
Linda Cardozo writes in 2000 that slings need more randomised controlled trials and follow-up for five years. This wasn’t happening almost two decades later…
BJOG 107(2): 147-156. February 2000
The use of mesh in gynecologic surgery
The aim of this review was to “compare properties of the most commonly used synthetic meshes and describe their use in gynecologic procedures”. It reported mesh-related complications rates were frequent, with up to a 35% removal rate.
International Urogynecology Journal and Pelvic Floor Dysfunction 8(2): 101-115. 1997.
News and discussion
Independent Medicines and Medical Devices Safety Review: Vladimir Iakovlev response to questions – October 2019.
Vladimir Iakovlev, of the University of Toronto, responds to questions posed at a teleconference as part of the Independent Medicines and Medical Devices Safety Review. Read his answers
Freedom of Information request to University College London Hospitals – April 2019
A request to University College London Hospitals under the Freedom of Information Act shows alternative provision during Suzy Elneil’s suspended service has very little experience. Read the full response
Carlino & Carlino vs Ethicon product liability hearing – April 2019
During a product liability hearing, Ethicon’s medical director Piet Hinoul admitted a third of TVT slings fail. Yet the success rate is reported as being greater than 90%. See page 50 of this document – Ethicon fudge figures!
Being a mesh specialist centre in the UK does not guarantee competency
Being a specialist mesh centre only means it ticks boxes for staff within the team. It does not guarantee they can successfully remove mesh or, indeed, have any experience of doing so. Read the letter
Pause without delay in the use of surgical mesh for stress urinary incontinence – July 2018
As part of her review into surgical mesh, Baroness Cumberlege concludes there should be a pause without delay in the use of surgical mesh for stress urinary incontinence (SUI). She also set out six criteria that should be met ahead of the resumption of mesh procedures used to treat SUI:
- Surgeons should only undertake operations for SUI if they are appropriately trained, and only if they undertake operations regularly.
- Surgeons report every procedure to a national database.
- A register of operations is maintained to ensure every procedure is notified and the woman identified who has undergone the surgery.
- Reporting of complications via MHRA is linked to the register.
- Identification and accreditation of specialist centres for SUI mesh procedures, for removal procedures and other aspects of care for those adversely affected by surgical mesh.
- NICE guidelines on the use of mesh for SUI are published.
Read the Update on the Independent Medicines and Medical Devices Safety Review, made in Parliament on 10 July 2018.
- The pause was strongly opposed by the British Society of Urogynaecology. Read its statement
Synthetic vaginal mesh tape procedure for the surgical treatment of stress urinary incontinence in women: patient information leaflet – May 2017.
This leaflet used to be accessible to hospitals to cherry-pick the risks they warned women about. Read the leaflet – Makes the risk warnings a postcode lottery.
Are synthetic slings safe? No – July/August 2016
This letter and full-length article in the International Brazilian Journal of Urology says most reports do not follow up women after the one year mark. Mesh complications can take months or years to cut in. It reckons the chronic pain risk could be as high as 31%.
It reads: “Like all new technologies, the synthetic midurethral sling (SMUS) is not perfect. But it has been beneficial to large numbers of women, restoring their ability to function in society without incontinence. The recognition, comprehensive characterisation, and deeper understanding of the many complications after SMUS could lead to the development of better, lower-risk implants with better durability for all patients. We owe it to them.”
Comment on the nature of complications from polypropylene slings for female stress urine incontinence – July 2015
Letter by Lise Hanne Christensen and Thomas Bjarnsholt, of the University of Copenhagen, discusses how the true incidence of complications is not known as fewer than 25% of patients return with their sling problems to the same surgeon. Under-reporting is a major issue. Read the letter
An operation for stress incontinence: tension free vaginal tape patient information leaflet – circa 2015
An example of a patient information leaflet for stress incontinence written by the Bladder and Bowel Foundation, and used by hospitals across the UK. This one is from Peterborough, circa 2015. Note how the explanation of painful intercourse is cleverly worded to look as if this is a temporary post-surgery risk… Read the leaflet
British Society of Urogynaecology annual meeting – November 2011
The minutes of the 2011 British Society of Urogynaecology annual meeting reveal the society took funding from four mesh makers. See honorary treasurer’s report on page 2 of the minutes
Antimuscarinic drugs – September 2004
One in five women give up anitmuscarinic medication because of side affects. This Nursing Times article explains the medication and a bit more about urinary incontinence. Read the article
Multicentericity as a pitfall for otherwise carefully planned RCT on surgical techniques – November 2003
Professor Bernhard Schuessler, of Lucerne, wrote to the BMJ to express concern about the Ward and Hilton study comparing tension-free vaginal tape to colposuspension. He said the scientific community – and, hence, patient expectations – could be misled by improperly planned studies. Read his letter
TVT rushed into NHS use, exposing thousands of women to harm – 2003
In 2003, the Health Technology Assessment programme admitted tension-free vaginal tape (TVT) was brought into widespread use before its safety was known. “This approach exposed thousands of women to an incompletely evaluated procedure in a poorly controlled way.”
The committee said there should be unbiased trials of more than five years on the TVT (tension free vaginal tape) for incontinence. They called for research on long-term complications.
Breakdown of key points:
- Research is needed on possible long-term complications of TVT; this would provide either reassurance of safety or earlier warning of unanticipated adverse effects.
- If the indications for TVT are likely to be broadened to include women who are currently managed conservatively, this should be formally evaluated, ideally in an RCT, before widespread adoption.
- As new evidence about the effectiveness, safety and costs of TVT emerges, this should be incorporated in updated cost-effectiveness analyses.
- Evidence of efficacy from case series led to the rapid, widespread adoption of TVT before its relative effectiveness (its place within NHS care) and long-term safety were known. Although current evidence suggests that TVT probably is effective and safe, this approach exposed thousands of women to an incompletely evaluated procedure in a poorly controlled way.
- Future research to evaluate new procedures of this type could avoid this by earlier and wider use of pragmatic RCTs and rigorously organised population-based registries.
TVT mesh reclassification by Safety and Efficacy Register of New Internventional Procedures – 2000
The advisory committee of the Safety and Efficacy Register of New Internventional Procedures (SERNIP) – the forerunner to the National Institute for Clinical Excellence (NICE) – upgrades TVT incontinence mesh from C to A following complaints by Johnson & Johnson that remaining at C will affect sales.
In January 1998, the TVT is category C. By October 1999, the TVT is still rated as C, pending the results of randomised controlled trials (RCTs). Just three months later – in January 2000 – the TVT is upgraded to A with no long-term, large-scale RCTs.
Read the SERNIP Advisory Committee minutes
Data
Hospital Episode Statistics for mesh insertion and removal – April 2019 to March 2020
Count of Finished Consultant Episodes where a procedure for treatment of urogynaecological prolapse or stress urinary incontinence (insertion or removal) is recorded, by procedure code and month reported. View the data
NICE Technology Appraisal Guidance No. 56 – February 2003
A brochure from the early days of NICE shows TVT use went from 200 to 2,700 in two years. Read the guidance document – did women suddenly become more incontinent? I think not! Aggressive marketing at its finest.
Surgical care for female urinary incontinence – research protocol
This research protocol complements a project to improve the delivery and organisation of surgical services for women with urinary incontinence (UI) in England. The project looked to assess the availability and use of surgical services for UI across England, and identify factors that explain observed variation in use – including the impact of data issues, patients’ experiences and expectations, clinicians’ judgement, and organisational and contextual factors. It also outlined a shift in treatment from secondary (hospitals) to primary (GP surgeries). Read the protocol
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