HUMAN IMMUNE-RESPONSE TO POLYDIMETHYLSILOXANE (SILICONE) - SCREENING STUDIES IN A BREAST IMPLANT POPULATION

Although initially it was thought that polydimethylsiloxane (silicone) was biologically inert, recent published studies have demonstrated va rying levels of IgG antibody reactive with this structure in humans. T he objective of our study was to determine whether silicone implanted in humans results in a measurable immune response directed against a 3 700 mol wt hydroxyl terminated silicone molecule and whether that resp onse could be correlated with the level of presumed silicone exposure as inferred by clinical history. In a blind study, sera from 111 patie nts, with and without breast implants, were sent to a laboratory using an enzyme-linked immunosorbent assay to determine specific anti-silic one IgG antibody levels. Test results showed that patients with implan ts demonstrated statistically significant elevation in anti-silicone a ntibodies compared with the unimplanted control, groups. The highest a nti-silicone antibody levels were measured in implanted women with eit her frank implant ruptures or leakage of their silicone gel implants.