Medical grade silicone rubber manufactured by Dow Corning Corporation was implanted subcutaneously in beagle dogs. At specified time intervals, the implants were removed at which time physical properties and weight changes were determined. A change in the physical properties was observed after six months implantation. Tensile strength decreased 7%, elongation 10% and the modulus at 200% extension increased 8%. After two years implantation, tensile strength had decreased 8%, elongation 15%, and 200% modulus increased 16%. After two weeks implantation, a 0.4% weight gain was seen, and after four weeks implantation the samples had gained 0.7%. However, after four weeks the weight gains stabilized and from four weeks to two years, they never exceeded 0.91%. The increase was due mainly to lipid absorption. No phospholipid or protein was detected. A chloroform/methanol extraction of the samples before implantation demonstrated 1.7% extractable silicone polymer. Samples not extracted before implantation, but extracted after implantation also demonstrated 1.7% extractable silicone polymer. This data suggests extractable silicone polymer does not leach from the medical grade silicone rubber during implantation.
The data also suggests that the rubber is not being degraded to extractable silicone polymers during implantation. There were no significant differences in percent lipid up-take or the lipid profiles between samples which had extractable silicone polymer extracted before implantation and/or those which were not extracted before implantation.
It should be pointed out that the slight changes in physical properties measured in this study should not be great enough to alter the performance of the rubber in the subcutaneous environment.