Is there histological evidence supporting capsulectomy in patients with breast implant illness: A case-control study

BACKGROUND: Breast implant illness (BII) is a controversial and poorly understood condition reported by some patients with breast implants. We compared implant capsule histology from patients with BII versus a control group to identify potential markers of BII and assess the biological rationale for capsulectomy. METHODS: We performed a 1:10 matched case-control study using the Copenhagen Breast Implant biobank. Capsule biopsies from patients who reported BII symptoms were randomly matched with patients without BII by implant type, implantation time, age, body mass index, and Baker grade. Biopsies were stained with hematoxylin and eosin (H&E) and assessed using a validated histopathological scoring system to evaluate histological parameters associated with capsule fibrosis, inflammation, and foreign-body reaction. RESULTS: The study included 148 patients (198 capsules). Nine patients with BII contributed with 18 capsules which were matched with 180 capsules from 139 control patients. Median capsule thickness, synovial-like metaplasia, lymphocyte infiltration, multinucleated giant cells, fibroblast/macrophage density, collagen organization, stromal cellularity, vascularity, calcification, and quantified silicone volume did not differ between the groups (all P >.05). CONCLUSIONS: Breast implant capsules from patients with BII were histologically similar to those from asymptomatic patients. These findings provide no histological justification for routine capsulectomy in patients with BII. Further research is needed to clarify the etiology of BII and its surgical management.