Bibliographic record
Abstract
Introduction:In 2011, medical regulatory authorities issued warnings regarding use of polypropylene transvaginal mesh (tVm) to treat pelvic floor disorders due to rare but severe complications they may cause.Herein, we report a comprehensive histologic examination of explanted tVm to help better understand their biocompatibility and to compare the mechanism of biointegration and/or failure of these devices and their correlation with clinical histories.Methods: tissue samples were retrieved from the explants that were afterward worked up using a uniform protocol and then submitted to three analyses: goldpalladium coating for electron microscopy scanning, embedded in paraffin and subjected to various staining solutions for light microscopy, and transmission electron microscopy.Control sampling from identical commercially available devices was analyzed for baseline comparisons.Results: seven tVm had been implanted in seven patients (pelvic organ prolapse, n=4; stress urinary incontinence, n=3).Indications for explantation included vaginal mesh exposure (n=5), bladder mesh exposure (n=1), and recurrent prolapse requiring re-do surgery (n=1).the mean interval between implantation and explantation was 38 (4-81) months.the histologic examination of the explants revealed various morphologies, such as fractures in the oxidized surface layer of the polypropylene causing its degradation; dense encapsulations of the polypropylene fibers leading to the formation of scar tissue where bundles of collagen were stretched (rather than undulating) and ruptured as the result of shrinkage; or bacterial colonization associated with a considerable lysis in the collagen ingrowth and large amounts of white blood cells.Conclusions: our analysis demonstrated that the lack of biostability illustrated by continuous fragmentations in the oxidized surface is likely to exacerbate a continuous inflammatory reaction.more specifically, mishandling the polypropylene fibers is likely to initiate in vivo degradation and permanently damage the material.polypropylene then oxidizes on its surface, creating a skin that can be uplifted and fragmented.Flakes of polypropylene are then dispersed in the surrounding tissue, which exacerbates the foreign body tissue reaction.these findings may have significant implications for the implant procedure since such a degradation process may be a contributing factor to eventually developing a mesh-related complication.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.002 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.003 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.293 | 0.091 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".