TY - JOUR
T1 - Development and Validation of a Diagnostic Histopathological Scoring System for Capsular Contracture Based on 720 Breast Implant Capsules
AU - Larsen, Andreas
AU - Timmermann, Adam Mandrup
AU - Kring, Mikela
AU - Mathisen, Sif Birch
AU - Bak, Erik Eiler Frydshou
AU - Weltz, Tim Kongsmark
AU - Ørholt, Mathias
AU - Vester-Glowinski, Peter
AU - Elberg, Jens Jørgen
AU - Trillingsgaard, Jesper
AU - Mielke, Louise Vennegaard
AU - Hölmich, Lisbet Rosenkrantz
AU - Damsgaard, Tine Engberg
AU - Roslind, Anne
AU - Herly, Mikkel
N1 - © 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].
PY - 2024/5/15
Y1 - 2024/5/15
N2 - BACKGROUND: Capsular contracture is traditionally evaluated with the Baker classification, but this has notable limitations regarding reproducibility and objectivity.OBJECTIVES: The aim of this study was 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 by multivariable logistic regression to identify those most associated with capsular contracture. Significant parameters (P < .05) were selected for the scoring systems and assigned weighted scores (1-10). Validation was assessed from the area under the curve (AUC) and the mean absolute error (MAE).RESULTS: A total of 720 biopsies from 542 patients were included. Four parameters were selected for the augmentation scoring system, namely, 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 were 81% and 0.8%, which is considered strong. Three parameters were selected for the reconstruction scoring system, namely, fiber organization, collagen layer cellularity, and inflammatory infiltration, providing a combined maximum score of 19. The AUC and MAE of the reconstruction scoring system were 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 capsular contracture diagnosis in the clinical setting, for research, and for implant manufacturers and insurance providers in need of a confirmed capsular contracture diagnosis.
AB - BACKGROUND: Capsular contracture is traditionally evaluated with the Baker classification, but this has notable limitations regarding reproducibility and objectivity.OBJECTIVES: The aim of this study was 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 by multivariable logistic regression to identify those most associated with capsular contracture. Significant parameters (P < .05) were selected for the scoring systems and assigned weighted scores (1-10). Validation was assessed from the area under the curve (AUC) and the mean absolute error (MAE).RESULTS: A total of 720 biopsies from 542 patients were included. Four parameters were selected for the augmentation scoring system, namely, 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 were 81% and 0.8%, which is considered strong. Three parameters were selected for the reconstruction scoring system, namely, fiber organization, collagen layer cellularity, and inflammatory infiltration, providing a combined maximum score of 19. The AUC and MAE of the reconstruction scoring system were 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 capsular contracture diagnosis in the clinical setting, for research, and for implant manufacturers and insurance providers in need of a confirmed capsular contracture diagnosis.
KW - Adult
KW - Aged
KW - Biopsy
KW - Breast Implantation/adverse effects
KW - Breast Implants/adverse effects
KW - Breast/pathology
KW - Collagen
KW - Female
KW - Humans
KW - Implant Capsular Contracture/diagnosis
KW - Middle Aged
KW - Reproducibility of Results
KW - Retrospective Studies
KW - Severity of Illness Index
KW - Young Adult
UR - http://www.scopus.com/inward/record.url?scp=85193517743&partnerID=8YFLogxK
U2 - 10.1093/asj/sjae050
DO - 10.1093/asj/sjae050
M3 - Journal article
C2 - 38429010
SN - 1090-820X
VL - 44
SP - NP391-NP401
JO - Aesthetic surgery journal
JF - Aesthetic surgery journal
IS - 6
ER -