scholarly journals The international discussion and the new regulations concerning transvaginal mesh implants in pelvic organ prolapse surgery

2020 ◽  
Vol 31 (10) ◽  
pp. 1997-2002
Author(s):  
Nathalie Ng-Stollmann ◽  
Christian Fünfgeld ◽  
Boris Gabriel ◽  
Achim Niesel
Keyword(s):  
Urinary Incontinence ◽  
New Zealand ◽  
Pelvic Organ Prolapse ◽  
South America ◽  
General Public ◽  
Pelvic Organ ◽  
Transvaginal Mesh ◽  
The Usa ◽  
The Uk ◽  
Surgical Option

Abstract The use of transvaginal mesh implants for POP and urinary incontinence is currently being extensively debated among experts as well as the general public. Regulations surrounding the use of these implants differ depending on the country. Although in the USA, the UK, in Canada, Australia, New Zealand, and France, transvaginal mesh implants have been removed from the market, in most mainland European countries, Asia, and South America, they are still available as a surgical option for POP correction. The aim of this review is to provide an overview of the historical timeline and the current situation worldwide, as well as to critically discuss the implications of the latest developments in urogynecological patient care and the training of doctors.

scholarly journals The mesh controversy

F1000Research ◽  
2016 ◽  
Vol 5 ◽  
pp. 2423 ◽  
Author(s):  
Joshua A. Cohn ◽  
Elizabeth Timbrook Brown ◽  
Casey G. Kowalik ◽  
Melissa R. Kaufman ◽  
Roger R. Dmochowski ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Pelvic Organ Prolapse ◽  
Stress Urinary Incontinence ◽  
Pelvic Organ ◽  
Transvaginal Mesh ◽  
Class Iii ◽  
Regulatory Oversight ◽  
Mesh Placement ◽  
Recent Developments ◽  
Uncertain Future

Pelvic organ prolapse and stress urinary incontinence are common conditions for which approximately 11% of women will undergo surgical intervention in their lifetime. The use of vaginal mesh for pelvic organ prolapse and stress urinary incontinence rose rapidly in the early 2000s as over 100 mesh products were introduced into the clinical armamentarium with little regulatory oversight for their use. US Food and Drug Administration Public Health Notifications in 2008 and 2011, as well as reclassification of transvaginal mesh for prolapse to class III in early 2016, were a response to debilitating complications associated with transvaginal mesh placement in many women. The midurethral sling has not been subject to the same reclassification and continues to be endorsed as the “gold standard” for surgical management of stress urinary incontinence by subspecialty societies. However, litigators have not differentiated between mesh for prolapse and mesh for incontinence. As such, all mesh, including that placed for stress urinary incontinence, faces continued controversy amidst an uncertain future. In this article, we review the background of the mesh controversy, recent developments, and the anticipated role of mesh in surgery for prolapse and stress urinary incontinence going forward.

scholarly journals Clinical Outcomes and Urodynamic Effects of Tailored Transvaginal Mesh Surgery for Pelvic Organ Prolapse

2015 ◽  
Vol 2015 ◽  
pp. 1-9 ◽  
Author(s):  
Ting-Chen Chang ◽  
Sheng-Mou Hsiao ◽  
Chi-Hau Chen ◽  
Wen-Yih Wu ◽  
Ho-Hsiung Lin
Keyword(s):  
Quality Of Life ◽  
Urinary Incontinence ◽  
Pelvic Organ Prolapse ◽  
Stress Urinary Incontinence ◽  
Clinical Outcomes ◽  
Positive Impact ◽  
Pelvic Organ ◽  
Transvaginal Mesh ◽  
Mesh Surgery

Objective. To evaluate the clinical outcomes and urodynamic effects of tailored anterior transvaginal mesh surgery (ATVM) and tailored posterior transvaginal mesh surgery (PTVM).Methods. We developed ATVM for the simultaneous correction of cystocele and stress urinary incontinence and PTVM for the simultaneous correction of enterocoele, uterine prolapse, vaginal stump prolapse, and rectocele.Results. A total of 104 women enrolled. The median postsurgical follow-up was 25.5 months. The anatomic cure rate was 98.1% (102/104). Fifty-eight patients underwent urodynamic studies before and after surgeries. The pad weight decreased from 29.3 ± 43.1 to 6.4 ± 20.9 g at 3 months. Among the 20 patients with ATVM, 13 patients had objective stress urinary incontinence (SUI) at baseline while 8 patients came to have no demonstrated SUI (NDSUI), and 2 improved after surgery. Among the 38 patients who underwent ATVM and PTVM, 24 had objective SUI at baseline while 18 came to have NDSUI, and 2 improved after surgery. Mesh extrusion (n= 4), vaginal hematoma (n= 3), and voiding difficulty (n= 2) were noted postoperatively. Quality of life was substantially improved.Conclusions. Our findings document the advantages of these two novel pelvic reconstructive surgeries for pelvic organ prolapse, which had a positive impact on quality of life. ATVM surgery additionally provided an anti-incontinence effect. This clinical trial is registered at ClinicalTrials.gov (NCT02178735).

scholarly journals Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e017125 ◽  
Author(s):  
Carl J Heneghan ◽  
Ben Goldacre ◽  
Igho Onakpoya ◽  
Jeffrey K Aronson ◽  
Tom Jefferson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pelvic Organ Prolapse ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Pelvic Organ ◽  
Transvaginal Mesh ◽  
Safety Studies ◽  
The Usa ◽  
Randomised Controlled ◽  
The Impact

IntroductionTransvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of mesh approved for pelvic organ prolapse. We, therefore, assessed the evidence at the time of approval for transvaginal mesh products and the impact of safety studies the FDA mandated in 2012 because of emerging harms.MethodsWe used FDA databases to determine the evidence for approval of transvaginal mesh. To create a ‘family tree’ of device equivalence, we used the 510(k) regulatory approval of the 1985 Mersilene Mesh (Ethicon) and the 1996 ProteGen Sling (Boston Scientific), searched for all subsequently related device approvals, and for the first published randomised trial evidence. We assessed compliance with all FDA 522 orders issued in 2012 requiring postmarketing surveillance studies.ResultsWe found 61 devices whose approval ultimately relied on claimed equivalence to the Mersilene Mesh and the ProteGen Sling. We found no clinical trials evidence for these 61 devices at the time of approval. Publication of randomised clinical trials occurred at a median of 5 years after device approval (range 1–14 years). Analysis of 119 FDA 522 orders revealed that in 79 (66%) the manufacturer ceased market distribution of the device, and in 26 (22%) the manufacturer had changed the indication. Only seven studies (six cohorts and new randomised controlled trial) covering 11 orders were recruiting participants (none had reported outcomes).ConclusionsTransvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years. Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval.

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