DETERMINING THE SAFETY OF THE SILICONE ENVELOPE - IN SEARCH OF A SILICONE ANTIBODY

In the controversy surrounding breast implants, one of the crucial que stions is whether patients can form antibodies directed against the si licone shell of the implant. If this were the case, implications for c urrent breast implant development, indeed, for all silicone medical de vices, are farreaching. To evaluate this hypothesis, sera from 18 pati ents who had tissue expanders and 15 control patients who had no silic one implant exposure were tested retrospectively for antibodies to the silicone using an enzyme-linked immunosorbent assay previously docume nted as a case report in the literature. Contrary to previous studies, no significant difference in antibody levels was found between test s ubjects and the controls. Additionally, this enzyme-linked immunosorbe nt assay for silicone antibodies was poorly reproducible. This study c alls into question the existence of specific antibodies to the silicon e shell. It also provides further data that the enzyme-linked immunoso rbent assay may not be reliable as a silicone antibody test.