interactions ~ silicone gel, FDA

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MEDICAL DEVICE INTERACTIONS WITH THE IMMUNE SYSTEM

Immunological Effects of Silicone

Key words: autoimmune disease, breast implants, silicone gel

Autoimmune diseases have been reported in women with silicone breast implants. The presence of autoantibodies in some of these women, as well as studies in experimental animals, suggest that silicone may have adverse effects on the immune system. The goal of this project is to determine if antibodies can be raised to homologous connective tissue proteins when rats are immunized with protein antigens mixed with silicone gel from a breast implant. Four different antigens were used: (1) human thyroglobulin (as a foreign antigen used as a positive control), (2) rat collagen (type I), (3) rat collagen (type II), and (4) rat fibronectin.

Preliminary results have shown that silicone gel can induce an autoimmune response indicated by the presence of antibodies in the serum of some of the test animals. Tissues have been collected and are being analyzed to determine if the autoimmune response may cause tissue damage. [ProA]

Continue to the Materials Toxicology section.Return to the Table of Contents.

BELOW is the link to the FDA site about interactions ........

Interactions... The presence of autoantibodies in some of these women, as well as studies ... proteinswhen rats are immunized with protein antigens mixed with silicone gel from a ... www.fda.gov/cdrh/ost/reports/fy95/interactions.html - 04-22-2002 - Cached[ More results from www.fda.gov/cdrh/ost/reports ]

Start the year off right. Easy ways to stay in shape in the new year.

[Guest guest]

MEDICAL DEVICE INTERACTIONS WITH THE IMMUNE SYSTEM

Immunological Effects of Silicone

Key words: autoimmune disease, breast implants, silicone gel

Autoimmune diseases have been reported in women with silicone breast implants. The presence of autoantibodies in some of these women, as well as studies in experimental animals, suggest that silicone may have adverse effects on the immune system. The goal of this project is to determine if antibodies can be raised to homologous connective tissue proteins when rats are immunized with protein antigens mixed with silicone gel from a breast implant. Four different antigens were used: (1) human thyroglobulin (as a foreign antigen used as a positive control), (2) rat collagen (type I), (3) rat collagen (type II), and (4) rat fibronectin.

Preliminary results have shown that silicone gel can induce an autoimmune response indicated by the presence of antibodies in the serum of some of the test animals. Tissues have been collected and are being analyzed to determine if the autoimmune response may cause tissue damage. [ProA]

Continue to the Materials Toxicology section.Return to the Table of Contents.

BELOW is the link to the FDA site about interactions ........

Interactions... The presence of autoantibodies in some of these women, as well as studies ... proteinswhen rats are immunized with protein antigens mixed with silicone gel from a ... www.fda.gov/cdrh/ost/reports/fy95/interactions.html - 04-22-2002 - Cached[ More results from www.fda.gov/cdrh/ost/reports ]

Start the year off right. Easy ways to stay in shape in the new year.