ArticleInternational urogynecology journal2012
Time to rethink: an evidence-based response from pelvic surgeons to the FDA Safety Communication: "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse".
Article in International urogynecology journal, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 161 papers, 7 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
161 citing papers in PubMed, 7 syntheses or guidelines pooled it, 208 citations in OpenAlex.
- Could robotic-assisted surgery reduce mesh-related complications after ventral mesh rectopexy? Experience of a tertiary centre and systematic review of the literature.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2024Pooled it
- Mesh-related complications and recurrence after ventral mesh rectopexy with synthetic versus biologic mesh: a systematic review and meta-analysis.Techniques in coloproctology · 2022Pooled it
- Negative pressure wound therapy for burn patients: A meta-analysis and systematic review.International wound journal · 2021Pooled it
- Observational analysis of mesh related complications in urogynecologic procedures.Journal of robotic surgery · 2020Pooled it
- Mesh sacrocolpopexy compared with native tissue vaginal repair: a systematic review and meta-analysis.Obstetrics and gynecology · 2015Pooled it
- Where to for pelvic organ prolapse treatment after the FDA pronouncements? A systematic review of the recent literature.International urogynecology journal · 2013Pooled it
- Outcomes of robotic sacrocolpopexy: a systematic review and meta-analysis.Female pelvic medicine & reconstructive surgeryPooled it
- Feasibility and safety of biologic OviTex mesh in ventral mesh rectopexy: a prospective pilot study.Techniques in coloproctology · 2025Trial
- Subjective outcomes 12 years after transvaginal mesh versus native tissue repair in women with recurrent pelvic organ prolapse; a randomized controlled trial.International urogynecology journal · 2023Trial
- Partially absorbable mesh or native tissue repair for pelvic organ prolapse: a randomized controlled trial.International urogynecology journal · 2019Trial
- Long-term outcome of vaginal mesh or native tissue in recurrent prolapse: a randomized controlled trial.International urogynecology journal · 2018Trial
- General or Spinal Anaesthetic for Vaginal Surgery in Pelvic Floor Disorders (GOSSIP): a feasibility randomised controlled trial.International urogynecology journal · 2015Trial
- A randomized controlled trial comparing anatomical and functional outcome between vaginal colposuspension and transvaginal mesh.International urogynecology journal · 2014Trial
- Comparison between trans-obturator trans-vaginal mesh and traditional anterior colporrhaphy in the treatment of anterior vaginal wall prolapse: results of a French RCT.International urogynecology journal · 2013Trial
- Lower exposure rates of partially absorbable mesh compared to nonabsorbable mesh for cystocele treatment: 3-year follow-up of a prospective randomized trial.International urogynecology journal · 2013Trial
- A new rectovaginal fascial plication technique for treatment of rectocele with obstructed defecation: a proof of concept study.International urogynecology journal · 2013Trial
- Immunomodulatory piezoelectric master electrospun membranes for pelvic floor repair.Journal of nanobiotechnology · 2026Article
- Developing a procedure mimicking transvaginal mesh implantation in women in a modified POP rat model.Frontiers in medicine · 2025Article
- Article
- Mesh-associated pain syndrome: predictors for continence and prolapse mesh removal surgery in a single centre.BMC women's health · 2024Article
101 more citing papers are in PubMed but not listed here.
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 at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In July of 2011 the U.S. Food and Drug Administration (FDA) released a safety communication entitled "UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse." The stated purpose of this communication is to inform health care providers and patients that serious complications with placement of this mesh are not rare and that it is not clear that these repairs are more effective than nonmesh repair. The comments regarding efficacy are based on a systematic review of the scientific literature from 1996-2011 conducted by the FDA. Our review of the literature during this time yields some different conclusions regarding the safety and efficacy of mesh use in prolapse repair. It may be useful to consider this information prior to making recommendations regarding mesh use in prolapse surgery according to the recent UPDATE.
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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.