Abstract

Abstract Background Systemic symptoms associated with breast implants (SSBI) is a term used to describe a group of patients who attribute a variety of symptoms to their implants. Previous studies have shown symptom improvement after implant removal in these patients irrespective of whether part or all the implant capsule has been removed. Objectives The aim of this study was to evaluate implant removal with no capsule removed in symptomatic and control subjects. Methods Eligible study subjects were sequentially enrolled at 5 investigator sites. The SSBI Cohort included patients with systemic symptoms they attributed to their implants who requested explantation. The Non-SSBI Cohort included subjects without systemic symptoms attributed to their implants who requested explantation with or without replacement. All subjects agreed to undergo explantation without removal of any capsule. Results Systemic symptom improvement was noted in SSBI subjects without removal of the implant capsule, comparable to the results of our previously published study. SSBI patients showed a 74% reduction in self-reported symptoms at 6 months with no capsulectomy which was not statistically different from partial or total capsulectomies (P = .23). Conclusions Explantation with or without capsulectomy provides symptom improvement in patients with systemic symptoms they associate with their implants. Level of Evidence: 3

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