Silicone has been used with apparent safety in implanted medical devices since 1952. Despite the long history of clinical use of this material, concern has been expressed in some quarters about systemic disease etiologically related to silicone implantation. The first report concerning this phenomenon was in 1964 when Miyoshi et al. published 2 cases in the Japanese literature of patients with vague clinical syndromes occurring after the injection of probably adulterated silicone material into breasts for purposes of augmentation. Since that time there have been numerous case reports and series (<400 patients) reporting a variety of rheumatic diseases occurring after the implantation of silicone gel prosthesis. Approximately 20 epidemiological studies have been published investigating the possible relationship between silicone breast implants and rheumatic disease. Several studies have found very weak, but statistically significant, effects showing either a negative or positive association with connective disease syndrome. However, in the aggregate the existing epidemiology strongly supports the lack of association between the presence of silicone gel breast implants and any detectable risk of or protection from systemic disease. This presentation will review the existing clinical and epidemiologic data relating to the use of silicone breast implants.
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