Prolapse
Research
The international discussion and the new regulations concerning transvaginal mesh implants in pelvic organ prolapse surgery
This study downplays suffering, saying chronic pain is muscle tears and erosion is infections. Two of the study’s authors have taken funding from industry – Serag-Wiessner.
International Urogynecology Journal 31: 1,997-2,002. July 2020.
Mesh-related complications of laparoscopic sacrocolpopexy
This study aimed to establish the incidence of complications following laparoscopic sacrocolpopexy. It looked at 660 procedures from 2005-17 and reported a vaginal mesh exposure rate of 0.7%. It concluded: “This large series suggests that laparoscopic sacrocolpopexy might confer a low risk of mesh exposure. Together with good anatomical and patient-reported outcomes, laparoscopic sacrocolpopexy is a safe option for patients presenting with post-hysterectomy vault prolapse.”
International Urogynecology Journal 30: 1,475-1,481. April 2019.
Predictors of sling revision after mid-urethral sling procedures: a case–control study
This paper suggests active smoking status, having had a previous hysterectomy, and undergoing concomitant surgery for pelvic organ prolapse are risk factors for requiring subsequent midurethral sling revision/removal.
BJOG 126(3): 419-426. February 2019.
– Wrong! Patient experience shows it is a Russian roulette risk. This commentary says more studies are needed to find out who is at risk, but Sling The Mesh says it is a waste of time as you cannot predict who will suffer.
Sexual activity and quality of life in Japanese pelvic organ prolapse patients after transvaginal mesh surgery
This study aimed to evaluate sexual activity and quality of life after transvaginal mesh (TVM) surgery in Japanese patients with pelvic organ prolapse. However, it only looks at long term success – it doesn’t look at long-term pain or sexual dysfunction. Also, it only cured 52% of women for stress urinary incontinence after five years and 79% of women with prolapse after five yrs.
The Journal of Obstetrics and Gynaecology Research 44(7): 1,302-1,307. July 2018.
Meshing around: long-term outcomes following vaginal reconstructive surgery with synthetic mesh augmentation
This research presented a retrospective chart review of patients who underwent vaginal prolapse surgery with synthetic mesh between May 1991 and October 2010 at a single academic institution. It found the rate of mesh-related complication was 34%; 30% had mesh extrusion into the vagina and 1% had mesh erosion into the bladder or rectum.
Presented at the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction Winter Meeting (SUFU 2018), held in Austin, Texas, from February 27-March 3.
Implants for genital prolapse: contra mesh surgery
“Alloplastic transvaginal meshes have become very popular in the surgery of pelvic organ prolapse (POP), as did alloplastic suburethral slings in female stress incontinence surgery, but without adequate supporting data… Since attending physicians do more and more prolapse surgeries without practising or teaching alternative techniques, expertise in these alternatives – which might be very useful in cases of recurrence, persistence or complications – is permanently lost.
“Although there is no dissent internationally about the available mesh data, thousands of lawsuits in the USA, insolvency of companies due to claims for compensation and unambiguous warnings from foreign urological societies leave German urogynecologists still unimpressed.”
Der Urologe 56(12): 1,583-1,590. December 2017.
Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process
This study assessed the evidence at the time of approval for transvaginal mesh products, and the impact of safety studies the US Food and Drug Administration mandated in 2012 because of emerging harms. It found some devices can be traced back to claimed equivalence to the ProteGen Sling, which was withdrawn in 1999 amid safety concerns.
BMJ Open 7: e017125. December 2017.
Quality of life after Uphold™ Vaginal Support System surgery for apical pelvic organ prolapse – a prospective multicenter study
Researchers studies the effects on quality of life in 207 women operated on for apical pelvic organ prolapse using the Vaginal Uphold system. It claimed most women experienced an “overall postoperative improvement in quality of life” at one-year follow-up; however, overall sexual function deteriorated significantly.
European Journal of Obstetrics & Gynecology and Reproductive Biology 208: 86-90. January 2017.
Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT)
The PROSPECT study says a vaginal repair for prolapse with mesh or graft material did not improve women’s outcomes in terms of effectiveness, quality of life, adverse effects, or any other outcome in the short term, but more than 1 in 10 women had a mesh complication.
The Lancet 389: 381-392. January 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.
Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial
This article describes the VUE trial, but does not show any results despite being published in 2016. The trial began recruiting in 2013 across 40 centres. Six-month and 12-month reviews were done, but no results have been published. Full results should have been published by February 2018.
Trials 17: 441. September 2016.
Graft and mesh use in transvaginal prolapse repair: a systematic review
This study reported that mesh erosion occurred in up to 36% of patients, but reoperation rates were low. – It is abundantly clear from this study that researchers are only seeing that the initial prolapse problem has been fixed. They are not looking at problems for more than a third of patients. Erosion is where the mesh cuts into nerves, organs and tissues, and causes exruciating lifelong pain.
Obstetrics and Gynecology 128(1): 81-91. July 2016.
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.
Transvaginal mesh kits – how “serious” are the complications and are they reversible?
This paper supported the merit of the US Food and Drug Administration’s warnings on the use of transvaginal mesh in women with pelvic organ prolapse because of escalating complications: “Patients should be forewarned that some transvaginal mesh complications are life altering and might not always be surgically correctable.”
Urology 81(1): 43-49. January 2013.
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.
Development of de novo prolapse in untreated vaginal compartments after prolapse repair with and without mesh: a secondary analysis of a randomised controlled trial
This 13-centre Dutch randomised controlled study says a repair with mesh runs a high risk of getting a prolapse in a new compartment. A total of 47% of mesh patients had prolapse in another compartment, versus 17% with non-mesh repair.
BJOG 119(3): 354-360. January 2012.
Vaginal mesh for prolapse: a randomised controlled trial
Sixty-five women were recruited from January 2007 to August 2009 for a double-blind, multicenter randomized controlled trial comparing traditional vaginal prolapse surgery without mesh, with vaginal surgery with mesh. The study was halted due to the predetermined stopping criteria for vaginal mesh erosion at a median follow-up of 9.7 months (range 2.4 to 26.7 months). The study found: “At three months, there is a high vaginal mesh erosion rate (15.6%) with no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs.”
Obstetrics and Gynecology 116(2 Part 1): 293-303. August 2010.
Commercial pressures and professional ethics: troubling revisions to the recent ACOG Practice Bulletins on surgery for pelvic organ prolapse
“Commercial interests are reshaping the practice of gynaecological surgery by promoting the use of trocar-and-mesh surgical ‘kits’ for the treatment of stress incontinence and pelvic organ prolapse. In this article, we discuss the ethical implications of changes in surgical practice that are driven by commercial interests. We point out the dangers inherent in the adoption of new procedures without adequate and documented evidence to support their safety and efficacy. We discuss the most recent American College of Obstetricians and Gynecologists (ACOG) Practice Bulletins on pelvic organ prolapse (numbers 79 and 85) which were altered without explanation to downplay the experimental nature of these commercial products. We suggest that in so doing, the ACOG is not meeting its fiduciary responsibilities to patients and is undermining important professional values.”
International Urogynecology Journal and Pelvic Floor Dysfunction 20(7): 765-767. July 2009.
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.
Functional and anatomical outcome of anterior and posterior vaginal prolapse repair with prolene mesh
This study aimed to evaluate the effects of prolene mesh on urinary, bowel and sexual function in prolapse surgery. It found dyspareunia increased by 20% and 13% had vaginal erosion of the mesh. “Although this study shows good anatomical results with the use of prolene mesh for prolapse repair, there was a high rate of morbidity.”
BJOG 112(1): 107-111. October 2004.
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
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
Ethicon to co-sponsor prolapse study – 2014
Ethicon co-sponsor a study, published in a prestigious US medical journal, to show prolapse mesh in a favourable light. Read trial documents
Meet Johnson & Johnson chief executive Alex Gorsky, who says “you don’t need to get it 100% – when you hit 60%, go”:
A six year retrospective audit of clinical and subjective outcomes of surgical vaginal prolapse repair with the insertion of mesh – circa 2012
This Welsh retrospective audit reveals that no information leaflets were given to patients in a six-year period from 2006-11. It concluded: “It is essential to adhere to national guidance on the use of mesh
in prolapse repair and to ensure adequate documentation. Patients should be fully informed on the issues and possible complications related to the use of mesh and encourage patients to visit reputable websites for further information. It is vital to be aware of national and international updates such as NICE and FDA guidance.” Read the audit
Prolapse mesh not used in Northern Ireland ‘for several years’
Q&A on the Health and Social Care Board website – which aims to inform and support decision-making by women in Northern Ireland who concerned about the use of vaginal mesh – says vaginal mesh has not been used for prolapse for some years:
“The differences in complications mean that vaginally placed mesh is no longer recommended by NICE in the treatment of pelvic organ prolapse. It has not been used in Northern Ireland for several years.”
Vaginal prolapse surgery with synthetic mesh augmentation in the UK: analysis of the British Society of Urogynaecologists’ (BSUG) database – August 2010
The Joint Annual Meeting of the International Continence Society and the International Urogynecological Association – held in Toronto, Canada – calls out the BSUG for failing to report to its databases as per NICE guidelines. Read more
Response to Wall and Brown: “Commercial pressures and professional ethics: troubling revisions to the recent ACOG Practice Bulletins on surgery for pelvic organ prolapse” – September 2009
In a letter the International Urogynecology Journal, Anne Weber – the author responsible for the controversial wording of the ACOG Practice Bulletin on pelvic orgal prolapse – explains why the ACOG decided to change the wording “over my strenuous objections”. Read the full letter
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
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