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Long-term histologic study of a new carbon-carbon ossicular replacement prosthesis.

In a variety of structural forms, carbon possesses certain properties that render it suitable for implantation in the human body. This report analyzes biocompatibility of a new carbon-carbon prosthesis following long-term middle ear implantation in a prospective, controlled animal study. The prosthesis was placed in the left ear of 20 healthy guinea pigs and in the dorsal subcutaneous tissues for control. The right ear also served as control. Preoperative and postoperative auditory evoked potentials were recorded and compared. Samples of tissue from all three sites were evaluated at 3 and 6 months by light microscopy. The implants also were evaluated by scanning electron microscopy. Samples of lymph nodes, liver, spleen, and lungs also were examined. Fourteen animals (70%) demonstrated no change in auditory evoked potentials postoperatively. One animal developed unilateral dysfunction and three others developed bilateral dysfunction for unexplained reasons. No significant tissue destruction or inflammation of the tissues and no digestion or erosion of the implants were observed. No passage of carbon particles into the reticuloendothelial system was identified. These preliminary results suggest that this new carbon-carbon prosthesis may be biocompatible at 6 months follow-up in the guinea pig and encourage further investigation.