Silicone elastomer cerebrospinal fluid shunt systems. Council on Scientific Affairs, American Medical Association.

A 1995 resolution of the American Medical Association House of Delegates, introduced by the American Academy of Neurology, the American Association of Neurological Surgeons, and the Congress of Neurological Surgeons, asked the American Medical Association Council on Scientific Affairs to add the use of hardened silicone shunts to its study of the effects of silicone gel used in breast implants. On consideration of the important differences between the two materials, silicone elastomer ("hardened silicone") and silicone gel, the Council on Scientific Affairs elected to address the subject of silicone elastomer shunt systems separately. This report describes the different types of medical-grade silicone used in medical devices, the incidence of hydrocephalus and its causes and treatment, and the use of cerebrospinal fluid shunt systems made of silicone elastomer. Published case reports of possible immunological disease in patients who have had silicone elastomer cerebrospinal fluid shunt systems implanted are reviewed. The Council on Scientific Affairs concluded that the evidence presented does not support the occurrence of immune-mediated systemic reactions to implanted silicone elastomer cerebrospinal fluid shunt systems. The local granulomatous or inflammatory responses observed in some patients with silicone shunt systems have not been shown to be immunologically mediated; similar reactions have been described with other implanted foreign bodies.