Biocompatibility testing of a silicone maxillofacial prosthetic elastomer: soft tissue study in primates.

Little information exists on the biocompatibility of maxillofacial prosthetic materials. Cosmesil material is a purpose-designed facial prosthetic elastomer that has an established clinical profile in humans but results of biocompatibility testing have not been published. Cosmesil, acrylic resin (positive control), black surgical gutta-percha (negative control), and Silastic 382 material (Dow Corning, Midland, Mich.) (reference control) were processed as custom-designed implants. The implants were inserted into five chacma baboons for a 12-week period in intraosseous, subperiosteal, submucosal, and intramuscular sites. The histologic assessment was based on a modified form of the FDI-ISO Technical Report 7405 for subcutaneous implants. An evaluation was made of capsule formation and inflammatory response. The statistical analysis involved a three-way ANOVA and a Tukey-Kramer Student range test. The critical level of statistical significance chosen was p less than 0.05. The study found that gutta-percha provoked a statistically significantly thicker capsule and a severe inflammatory response. Acrylic resin, Cosmesil material, and Silastic 382 material produced capsule formations and an inflammatory response that did not differ significantly. Cosmesil material is not manufactured as an implant material, but from the present findings it is considered acceptably biocompatible for its intended use where there may be contact with internal tissue spaces that are contiguous to external surfaces.