Evidence map›Paper›PMID 38849553›Full record

ArticleAesthetic plastic surgery2025

A Histological Assessment Tool for Breast Implant Capsules Validated in 480 Patients with and Without Capsular Contracture.

Andreas Larsen, Adam Mandrup Timmermann, Mikela Kring, Tim Kongsmark Weltz, Mathias Ørholt, Peter Vester-Glowinski, Jens Jørgen Elberg, Jesper Trillingsgaard, Louise Vennegaard Mielke, Lisbet Rosenkrantz Hölmich and 3 more

Abstract readValidation Study
In one paragraph

Article in Aesthetic plastic surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Andreas LarsenDepartment of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark. andreas.larsen@regionh.dk.ORCID 0000-0003-3851-7630
Adam Mandrup TimmermannDepartment of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Mikela KringDepartment of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Tim Kongsmark WeltzDepartment of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Mathias ØrholtDepartment of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Peter Vester-GlowinskiDepartment of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Jens Jørgen ElbergAmalieklinikken, Copenhagen, Denmark.
Jesper TrillingsgaardAK Nygart, Copenhagen, Denmark.
Louise Vennegaard MielkeAleris, Copenhagen, Denmark.
Lisbet Rosenkrantz HölmichDepartment of Plastic and Reconstructive Surgery, Herlev and Gentofte, Copenhagen University Hospital, Copenhagen, Denmark.
Tine Engberg DamsgaardDepartment of Plastic and Reconstructive Surgery, Odense and Little Belt Hospital, Odense University Hospital, Vejle, Denmark.
Anne RoslindDepartment of Pathology, Herlev and Gentofte, Copenhagen University Hospital, Copenhagen, Denmark.
Mikkel HerlyDepartment of Plastic Surgery and Burns Treatment, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.

Funding

Novo Nordisk Foundation 052198Research Fund of Rigshospitalet
6 · The paper itself

Abstract

backgroundUnderstanding the impact of breast implants on the histological response in the surrounding fibrous capsule is important; however, consensus is lacking on how to analyze implant capsules histologically. We aimed to develop a standardized histological assessment tool to be used in research potentially improving diagnostic accuracy and treatment strategies for capsular contracture.

methodsBiopsies of breast implant capsules from 480 patients who had undergone breast augmentation or reconstruction were collected and stained with hematoxylin and eosin. Initially, biopsies from 100 patients were analyzed to select histological parameters demonstrating the highest relevance and reproducibility. Then, biopsies from the remaining 380 patients were used to determine intra- and interobserver agreements of two blinded observers and agreement with a pathologist. Finally, we tested the association between the parameters and capsular contracture.

resultsThe histological assessment tool included ten parameters assessing the inflammatory, fibrotic, and foreign-body reaction to breast implants, each graded on two-, three-, or four-point scales. Intra- and interobserver agreements were almost perfect (0.83 and 0.80), and agreement with the pathologist was substantial (0.67). Four parameters were significantly correlated with capsular contracture, namely chronic inflammation with lymphocyte infiltration (p < 0.01), thickness of the collagen layer (p < 0.0001), fiber organization (p < 0.01), and calcification (p < 0.001).

conclusionsThis is the first validated histological assessment tool for breast implant capsules. The validated tool not only advances our understanding of capsular contracture but also sets a new standard for histological evaluation in breast implant research and clinical diagnostics. NO LEVEL ASSIGNED: This journal requires that authors assign a level of evidence to each submission to which Evidence-Based Medicine rankings are applicable. This excludes Review Articles, Book Reviews, and manuscripts that concern Basic Science, Animal Studies, Cadaver Studies, and Experimental Studies. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Indexed as

Breast ImplantationBreast ImplantsImplant Capsular ContractureAdultBiopsyBiopsy, NeedleCohort StudiesFemaleForeign-Body ReactionHumansMammaplastyMiddle AgedObserver VariationReproducibility of ResultsRetrospective StudiesYoung AdultBreast implantsCapsular contractureFibrosisForeign-body reactionHistologyInflammation

Identifiers

PMID38849553
PMCPMC11813994

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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.