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

Abstract

AbstractBackgroundCapsular contracture is a severe complication to breast implants, but the pathophysiology remains unclear, and consensus is lacking on how to analyze implant capsules histologically. In this study, we developed and validated a histological semiquantitative assessment tool for analyzing breast implant capsules.MethodsBiopsies of breast implant capsules from 480 patients who had undergone breast augmentation or reconstruction were collected and stained with hematoxylin and eosin. First, biopsies from 100 patients were used to select parameters for the semiquantitative assessment tool. Then, biopsies from the remaining 380 patients were used to determine intra- and interobserver agreement of two blinded observers and agreement with a pathologist. Finally, we tested the association between the parameters and capsular contracture.ResultsThe histological assessment tool consisted of ten parameters assessed on a two-, three-, or four-point scale. Intra- and interobserver agreement was almost perfect (0.83 and 0.80), and agreement with the pathologist was substantial (0.67). Inflammatory infiltration (p<0.01), thickness of the collagen layer (p<0.0001), fiber organization (p<0.01) and calcification (p<0.001) were significantly correlated with capsular contracture.ConclusionsThis is the first validated histological assessment tool for breast implant capsules that provides an objective and precise assessment of hematoxylin and eosin-stained sections of breast implant capsule biopsies which can be used in research and clinical practice.Level of evidenceNo Level Assigned