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Updated: Aug 10, 2026

Biological Compatibility Profile on Biomaterials for Bone Regeneration
Published on: November 16, 2018
Tissue humoral response to intact and ruptured silicone gel-filled prostheses
J R Sanger1, R A Komorowski, D L Larson
1Department of Plastic and Reconstructive Surgery, Medical College of Wisconsin, Milwaukee, USA.
Abstract:
Biopsies of the fibrous capsule in 31 women undergoing explanation of gel-filled breast prostheses and in 3 women with silicone gel-associated granulomas were tested for the presence of IgG, IgM, IgA, C3 complement, and fibrin using fluorescent antisera. Of a total of 41 prostheses removed, 9 were found to be ruptured but contained within the fibrous capsule or immediately adjacent to it. In the 3 women undergoing granuloma excision only, the sites were the arm (2) and the chest/axilla (1). In one patient, IgG, C3, and fibrin were detected in the capsule of an intact prosthesis. C3 and fibrin were present in the capsule surrounding one ruptured prosthesis. Fibrin was detected in the capsule of one other patient. Bilateral capsules surrounding intact prostheses removed from 4 patients with collage-vascular diseases were negative for C3, fibrin, and immunoglobulins, as were the 3 granulomas from distant sites. Hematoxylin and eosin stains revealed a typical foreign-body response to gel in almost all cases. Both T- and B-cell lymphocytes are present in the infiltrate surrounding silicone gel. In this study, chronic exposure to silicone gel-filled prostheses did not result in antibody deposition or complement activation in the fibrous capsule or in the tissue surrounding gel droplets.

