Capsulectomy Following Breast Implant Removal: Evidence-Based Indications and a Framework for Clinical Decision-Making.

Abstract

The question of when capsulectomy is genuinely indicated at the time of breast implant removal has important implications for clinical practice, surgical risk, and patient counselling. This review defines the evidence-based indications for capsulectomy, evaluates the evidence for each of the additional contexts in which it is commonly proposed, and provides a clinical decision framework to assist surgeons in counselling patients and documenting clinical reasoning. No published study directly compares outcomes of explantation with capsulectomy versus explantation alone; the most rigorous prospective data show that explantation without capsulectomy produces symptom improvement statistically indistinguishable from partial or total capsulectomy. The only pre-registered controlled cohort study (n = 9590) found no difference in BII symptom prevalence between women with and without implants, and silicone particle migration to lymph nodes is not reduced by capsulectomy in controlled analyses. The proposed capsular contaminants (biofilm, fungal elements, and heavy metals) have each been examined in controlled tissue analyses; none differentiates symptomatic from asymptomatic patients. A 2024 European expert consensus recommending capsulectomy for macrotextured implants constitutes Level V consensus from a panel composed exclusively of surgeons who perform the procedure. Capsulectomy carries a higher complication rate than explantation alone, and no published evidence documents harm from leaving a capsule in situ after benign explantation. Four indications are supported by the available evidence: confirmed BIA-ALCL, confirmed capsular malignancy, symptomatic capsular calcification with demonstrable mammographic impairment, and Grade III-IV contracture where capsulotomy is insufficient. A clinical decision framework is provided to facilitate evidence-based practice and structured informed consent. Level of Evidence V This journal requires that authors assign a level of evidence to each article. 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 .