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Notice to Readers Diagnostic Tests for Silicone Breast Disease

During August 1992, the Food and Drug Administration (FDA) became aware of diagnostic testing profiles offered by commercial laboratories for evaluating silicone breast disease. These profiles comprise a variety of tests that consist of three basic types: 1) tests measuring chemical constituents of the implant, such as silicone (methylpolysiloxane) or breakdown products (toluene diamines) of the implant; 2) tests that measure circulating serum antibodies to silicone; and 3) tests that measure "autoantibodies" to a number of allegedly "silicone-modified" host proteins, such as fibrin, laminin, and myelin.

None of these products have been cleared (510k process) or approved (Premarket Approval) by the FDA. Their diagnostic accuracy is not established, and the value and usefulness of these tests remain speculative. In managing patients with silicone breast implants, the Public Health Service advises clinicians to continue to rely on established techniques: history, physical examination, conventional and established laboratory tests for immunologic disease, and radiologic imaging.

In some instances, tests for silicone breast disease are being marketed under a label "For Research Use Only; not for Use in Diagnostic Procedures." These tests are intended for research use and should not be used for patient diagnosis or management. Additional information is available from Steve Gutman, M.D., Director, Division of Clinical Laboratory Devices, Office of Device Evaluation, FDA, telephone (301) 594-3084.



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