In the controversy surrounding breast implants, one of the crucial questions is whether patients can form antibodies directed against the silicone shell of the implant. If this were the case, implications for current breast implant development, indeed, for all silicone medical devices, are farreaching. To evaluate this hypothesis, sera from 18 patients who had tissue expanders and 15 control patients who had no silicone implant exposure were tested retrospectively for antibodies to the silicone using an enzyme- linked immunosorbent assay previously documented as a case report in the literature. Contrary to previous studies, no significant difference in antibody levels was found between test subjects and the controls. Additionally, this enzyme-linked immunosorbent assay for silicone antibodies was poorly reproducible. This study calls into question the existence of specific antibodies to the silicone shell. It also provides further data that the enzyme-linked immunosorbent assay may not be reliable as a silicone antibody test.
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