THERAPY COSMESIS

THE OBJECTIVE OF THIS PROPOSED PROGRAM IS THE DEVELOPMENT OFTWO TYPES OF BREAST PROSTHESIS FOR COSMETIC CORRECTION OF THE EFFECTS OF MINIMAL BREAST SURGERY AND/OR RADIATION THERAPY. THE PROSTHESES EMPLOY A TEXTURED SURFACE TO PROMOTE TISSUE ATTACHMENT AND MINIMIZE THE FORMATION OF A TISSUE CAPSULE, AND THEIR INTERNAL VOLUME IS PERCUTANEOUSLY ADJUSTABLE TO PERMIT SUBSEQUENT OPTIMIZATION OF THE VOLUME OCCUPIED BY THE PROSTHESIS OR THE DEGREE OF FIRMNESS DESIRED. A READILY METABOLIZED, NONTOXIC FLUID IS USED AS THE CHARGING MEDIUM, AND THE DEVICES THEMSELVES ARE FAB- RICATED FROM SILICONE RUBBER WITH AN INTEGRALLY TEXTURED SURFACE BEING SEPARATELY DEVELOPED. A SERIES OF 18 ANIMAL EXPERIMENTS ARE TO BE USED TO (1) EXAMINE HEALING AROUND THEDEVICES UNDER A WIDE RANGE OF VOLUME AND FIRMNESS; (2) EVALUATE THE SUITABILITY OF THE PERCUTANEOUS FILLING SYSTEM THAT HAS BEEN DESIGNED; AND (3) EVALUATE THE VOLUME STABILITY OF THE IMPLANTED DEVICES. BECAUSE THE TISSUE CAPSULE THICKNESS AROUND THE DEVICES IS CONTROLLED, THE TACTILE SURFACE AND VOLUME OF THE IMPLANTED DEVICES SHOULD BE READILY ADJUSTABLE TO COMPENSATE FOR LATE TISSUE CHANGES OR CONTINUED THERAPY.