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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