Spallation and migration of silicone from blood-pump tubing in patients on hemodialysis.

Spalled particles of silicone were observed in the livers of patients with chronic renal failure treated by hemodialysis. The refractile particles of silicone were associated with various degrees of hepatic inflammation and fibrosis, and granulomatous hepatitis was evident in nine cases. Retrospective examination revealed the material in 18 of 38 liver-biopsy samples from patients on hemodialysis who had clinical hepatic dysfunction. Of 31 autopsies of patients who had undergone hemodialysis, 22 revealed silicone in the liver, and silicone was also present in the spleen in all cases and in the marrow, lungs, and nodes in some. Giant cells containing silicone were also observed in these organs. Silicone was present in patients who had undergone hemodialysis for six weeks to 84 months (mean, 24 months). The identity of the material was confirmed by atomic absorption and by electron microprobe analysis. The silicone was traced to a segment of silicone tubing located in the roller pump of the dialysis machine.