The detection of anti-silicone antibodies in patients with silicons breast
implants (SBI) has been undertaken principally in the USA. We undertook a s
tudy of 20 women with SBI from different manufacturers from 6 weeks to 20 y
ears after surgery, including those with ruptured implants. They were compa
red with three control groups: 20 women without implants, 20 women with aut
o-immune disease and 20 anonymous blood donors. Potential anti-silicone ant
ibodies (IgG) were tested against a variety of silicone polymer antigens us
ing an enzyme linked immunosorbent assay (ELISA) technique which had previo
usly detected positive results in an uncontrolled series. Silicone-free col
lecting tubes were used. No differences were found between the patients wit
h SBI and controls. However. samples that had been stored for the longest t
ime, or frozen and thawed several times, had the highest levels. These fals
e positives appear to be due to an unknown but human specific IgG binding p
henomenon. 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 impla
nts. (C) 2000 The British Association of Plastic Surgeons.