Anti-silicone antibodies and silicone containing breast implants

The detection of anti-silicone antibodies in patients with silicone breast implants (SBI) has been undertaken principally in the USA. We undertook a study of 20 women with SBI from different manufacturers from 6 weeks to 20 years after surgery, including those with ruptured implants. They were compared with three control groups: 20 women without implants, 20 women with auto-immune disease and 20 anonymous blood donors. Potential anti-silicone antibodies (IgG) were tested against a variety of silicone polymer antigens using an enzyme linked immunosorbent assay (ELISA) technique which had previously detected positive results in an uncontrolled series. Silicone-free collecting tubes were used. No differences were found between the patients with SBI and controls. However, samples that had been stored for the longest time, or frozen and thawed several times, had the highest levels. These false positives appear to be due to an unknown but human specific IgG binding phenomenon. We conclude that there is no demonstrable anti-silicone antibody formation in these patients with SBI and we would caution that the effect of storage may have been an important factor in previously published assay methods. This study supports the safety of silicone containing breast implants.