ReviewBMJ open2017
Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process.
Review in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
36 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Pain and other complications of pelvic mesh: a systematic review of qualitative studies and thematic synthesis of women's accounts.BMJ open · 2024Pooled it
- Women's Experiences of and Perspectives on Transvaginal Mesh Surgery for Stress Urine Incontinency and Pelvic Organ Prolapse: A Qualitative Systematic Review.The patient · 2022Pooled it
- Patch augmentation surgery for rotator cuff repair: the PARCS mixed-methods feasibility study.Health technology assessment (Winchester, England) · 2021Pooled it
- Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomised controlled trials.BMJ (Clinical research ed.) · 2019Pooled it
- No mesh versus mesh in the treatment of anterior vaginal wall prolapse: prospective, randomised, controlled trial, long-term follow-up.International urology and nephrology · 2020Trial
- Outcomes and patient satisfaction after pelvic organ prolapse surgery with and without mesh: a retrospective cohort study with prospective follow-up.Archives of gynecology and obstetrics · 2026Article
- Thermal Post-Processing of 3D-Printed Poly(glycerol dodecanedioate) Controls Mechanics and Shape Memory Properties.Polymer science & technology (Washington, D.C.) · 2025Article
- Scoping review on regulation, implementation and postmarket surveillance of medical devices.PloS one · 2025Article
- Mesh-associated pain syndrome: predictors for continence and prolapse mesh removal surgery in a single centre.BMC women's health · 2024Article
- Extent, transparency and impact of industry funding for pelvic mesh research: a review of the literature.Research integrity and peer review · 2024Article
- Patients' perspectives on quality and patient safety failures: lessons learned from an inquiry into transvaginal mesh in Australia.BMC health services research · 2024Article
- Trends in Urogynecology-Transvaginal Mesh Surgery in Germany.Journal of clinical medicine · 2024Article
- The Appropriateness of Medical Devices Is Strongly Influenced by Sex and Gender.Life (Basel, Switzerland) · 2024Review
- Lifecycle evaluation of medical devices: supporting or jeopardizing patient outcomes? A comparative analysis of evaluation models.International journal of technology assessment in health care · 2024Article
- Gaps in the evidence underpinning high-risk medical devices in Europe at market entry, and potential solutions.Orphanet journal of rare diseases · 2023Review
- Transvaginal mesh in Australia: An analysis of news media reporting from 1996 to 2021.Health expectations : an international journal of public participation in health care and health policy · 2023Article
- Knowledge mapping and visualization analysis of pelvic organ prolapse repair with mesh from 2001 to 2021.Frontiers in bioengineering and biotechnology · 2023Article
- Medical Devices, Invisible Women, Harmful Consequences.International journal of environmental research and public health · 2022Article
- Path-related pain after implantation of anterior transvaginal mesh: perspective from anatomical study.International urogynecology journal · 2022Article
- Development and in vitro investigation of a biodegradable mesh for the treatment of stress urinary incontinence.International urogynecology journal · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Indexed as
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.