Isolation and quantitation of debris particles around failed silicone orthopedic implants

Silicone elastomer implants have a relatively low rate of complications, but inflammatory reactions to debris have been reported. To characterize the size and number of debris particles, we isolated and quantified the debris particles present in the periarticular tissues of 10 patients with failed silicone wrist, elbow, or finger implants. Five rheumatoid synovia without implants were used for negative controls. The number of particles ranged from 0.99 to 24.8 x 10(9) per gram (dry weight) of tissue, and nearly all particles were silicone, as determined by x-ray spectroscopy. The implantation duration ranged from 3.2 to 10.6 years, and for the five wrist implants, the number of particles correlated with duration in vivo. The particles were small (mode particle diameter was 0.59 +/- 0.057 micron). These results suggest that billions of particles, most of which are smaller than 1 micron, are present adjacent to failed silicone implants, and may be associated with inflammation and bone resorption.