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and epidemiological studies do not confirm these findings, these reports provide insufficient evidence for an association (see Chapter 8).


Based on the data available, the committee concludes that there is no convincing evidence to support clinically significant immunologic effects of silicone or silicone breast implants. This includes: insufficient evidence for an association of a particular HLA type in women with breast implants and health conditions; insufficient evidence for silicone as a super-antigen; insufficient or flawed evidence that silicone produces immune activation of cells of the immune system, silicone antibodies, delayed type hypersensitivity to silicone, cytokines as an immune response, antigen specific immune cellular infiltrates; and insufficient evidence for autoantibodies or T-cell self antigen activation. The paucity of significant, well controlled studies examining these questions is responsible for these conclusions. The committee finds that there is conclusive evidence that some silicones have adjuvant activity, but there is no evidence that this has any clinical significance. The committee has also concluded that evidence from experimental studies of the immunology of silicone does not support, or lend biologic plausibility to, associations of silicone breast implants with immune related human health conditions.

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