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A -- SILICONE MIGRATION STUDY SOL 223-92-6002 DUE 070795 POC Susan Gane, Contracting Officer (301) 443-4420 The Food and Drug Administration, Office of Science and Technology, Center for Devices and Radiological Health intends to award a modification with Georgetown University Medical Center to recruit and enroll 50 women in a pilot study of silicone migration from gel-filled breast implants. The primary purpose of the study will be to develop a magnetic resonance spectroscopy method for detecting exogenous silicone in the livers of women with and without gel filled breast implants. A secondary objective is to determine if there is preliminary evidence that the amount of detected silicone can be correlated with the presence and severity of connective tissue disorders. Four groups of women will be enrolled in the study 1) 20 women with a history of silicone gel-filled breast implants; 2) 10 women with confirmed autoimmune disease and a history of silicone gel-filled breast implants; 3) 10 women with confirmed autoimmune disease and no history of silicone gel-filled breast implants; and 4) 10 women with no evidence of autoimmune disease and no history of silicone gel-filled breast implants. See Note 22. (0143)

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