Development and Validation of a Diagnostic Histopathological Scoring System for Capsular Contracture Based on 720 Breast Implant Capsules

Andreas Larsen, Adam Mandrup Timmermann, Mikela Kring, Sif Birch Mathisen, Erik Eiler Frydshou Bak, Tim Kongsmark Weltz, Mathias Ørholt, Peter Vester-Glowinski, Jens Jørgen Elberg, Jesper Trillingsgaard, Louise Vennegaard Mielke, Lisbet Rosenkrantz Hölmich, Tine Engberg Damsgaard, Anne Roslind, Mikkel Herly

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Abstract

BACKGROUND: Capsular contracture is traditionally evaluated using the Baker classification. However, this classification has notable limitations in reproducibility and objectivity.

OBJECTIVES: To develop and validate procedure-specific histopathological scoring systems to assess capsular contracture severity.

METHODS: Biopsies of breast implant capsules were used to develop histopathological scoring systems for patients following breast augmentation and breast reconstruction. Ten histological parameters were evaluated using multivariable logistic regression to identify those most associated with capsular contracture. Significant parameters (p < 0.05) were selected for the scoring systems and assigned weighted scores (1-10). Validation was performed using area under the curve (AUC) and mean absolute error (MAE).

RESULTS: A total of 720 biopsies from 542 patients were included. Four parameters were selected for the augmentation scoring system including collagen layer thickness, fiber organization, inflammatory infiltration, and calcification, providing a combined maximum score of 26. The AUC and MAE for the augmentation scoring system was 81% and 0.8% which is considered strong. Three parameters were selected for the reconstruction scoring system including fiber organization, collagen layer cellularity, and inflammatory infiltration, providing a combined maximum score of 19. The AUC and MAE of the reconstruction scoring system was 72% and 7.1% which is considered good.

CONCLUSIONS: The new histopathological scoring systems provide an objective, reproducible, and accurate assessment of capsular contracture severity. We propose these novel scoring systems as a valuable tool for confirming the capsular contracture diagnosis in the clinical setting, for research, and for implant manufacturers and insurance providers in need of a confirmed capsular contracture diagnosis.

Original languageEnglish
JournalAesthetic Surgery Journal
Volume44
Issue number6
Pages (from-to)NP391-NP401
ISSN1090-820X
DOIs
Publication statusPublished - 2024

Bibliographical note

© The Author(s) 2024. Published by Oxford University Press on behalf of The Aesthetic Society. All rights reserved. For permissions, please e-mail: [email protected].

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