Implantable silicones have been widely used in medicine and surgery during the past 4 decades. Recently, concerns have arisen regarding the safety and efficacy of some of these devices. In particular, questions have emerged regarding a possible association between implantation of silicone gel-filled breast prostheses used in augmentation mammoplasty and reconstructive surgery with the development of autoimmune disease.
Silicones are not entirely biologically inert. Local host tissue reactions range from a bland scarring response to evidence of chronic inflammation and fibroproliferation. Silicones are capable of migration in vivo and can elicit inflammation at sites distant from implantation. There is experimental evidence supporting the potential immunogenicity and adjuvanticity of these substances.
A variety of systemic connective tissue diseases have been reported in women with silicone gel-filled breast implants. Scleroderma-like illnesses are markedly over-represented in women with silicone implants and identifiable connective tissue disease. This mimics the earlier reported Japanese experience with injectable silicones. Although the association between silicone exposure and development of scleroderma is supported by clinical experience and seems biologically plausible, there are to date no adequate epidemiological data that definitively demonstrate a causal relationship.
Our clinical approach to managing patients with silicone implants and systemic disease is individualised, but may involve removal of the prosthesis, particularly when the disease is of adequate severity to otherwise warrant toxic or immunosuppressive pharmacotherapy.
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