Abstract
The relative safety (or otherwise) of silicone gel filled breast implants remains a controversial issue. The Dark Agouti (DA) rat has been shown recently to have a high susceptibility for developing arthritis. This study determined the arthritogenic potential of silicone gel, silicone oil, and the low molecular weight octamethylcyclotetrasiloxane (D4), by either mixing it with bovine collagen II (BII) or by injecting silicone gel alone in DA rats. Three separate experiments were performed using 110 female DA rats with 10 rats per treatment group. The incidence of collagen induced arthritis was as follows: Experiment I (6 micrograms BII)- PBS = 0/10, silicone gel = 4/10, and IFA = 8/9; Experiment II (125 micrograms BII)- PBS = 0/10, silicone gel = 7/10, IFA = 10/10, 1,000 cs silicone oil = 3/10, D4 = 0/10, and 1% D4 in 1,000 cs silicone oil = 1/10; Experiment III (adjuvant alone)-IFA = 8/10, silicone gel = 0/10. Anti-BII antibodies were formed in most of the rats treated with either silicone gel or IFA mixed with BII and these groups of rats showed a positive DTH reaction. The PBS treated rats were negative for both anti-BII antibodies and DTH reaction. Silicone gel taken from a commercial breast implant thus is capable of mediating collagen induced arthritis in the DA rat. However, silicone gel alone does not appear to be arthritogenic.