The objective of this program is the development of improved mammary prostheses for plastic and reconstructive surgery. Excessive tissue capsule formation or contracture of the tissue capsule are complications of undesirably high incidence with currently available prostheses, which are manufactured almost exclusively with smooth polymeric surfaces. The approach of this program is to use an integrally textured silicone rubber surface on the exterior of the implant. Tissue adhesion and ingrowth into the textured surface are thought to minimize mechanical trauma at the interface and potentially render the implant site more resistant to bacterial colonization. In the proposed Phase II program, the optimal textured surface for obtaining tissue adhesion and a reduced-thickness tissue capsule will be determined. The implant site infection rate of that surface will then be compared with smooth surface control implants. The textured surface also is to be evaluated for possible use on tissue expansion prostheses for reconstructive surgery. Finally, a series of long term (1 year) experiments using a large animal model and full-size devices is to be conducted to study end-stage tissue capsule morphology and ultrastructure from textured surface versus smooth surface prostheses. This experimental program is designed to demonstrate the advantages of the textured surface in reducing the incidence of the most serious complications associated with currently available prostheses in anticipation of subsequent clinical trials with textured surface devices.
