Skip directly to search Skip directly to A to Z list Skip directly to site content
CDC Home

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.

Use of trade names and commercial sources is for identification only and does not imply endorsement by the U.S. Department of Health and Human Services.

References to non-CDC sites on the Internet are provided as a service to MMWR readers and do not constitute or imply endorsement of these organizations or their programs by CDC or the U.S. Department of Health and Human Services. CDC is not responsible for the content of pages found at these sites. URL addresses listed in MMWR were current as of the date of publication.

All MMWR HTML versions of articles are electronic conversions from typeset documents. This conversion might result in character translation or format errors in the HTML version. Users are referred to the electronic PDF version ( and/or the original MMWR paper copy for printable versions of official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.

**Questions or messages regarding errors in formatting should be addressed to The U.S. Government's Official Web PortalDepartment of Health and Human Services
Centers for Disease Control and Prevention   1600 Clifton Road Atlanta, GA 30329-4027, USA
800-CDC-INFO (800-232-4636) TTY: (888) 232-6348 - Contact CDC–INFO
A-Z Index
  1. A
  2. B
  3. C
  4. D
  5. E
  6. F
  7. G
  8. H
  9. I
  10. J
  11. K
  12. L
  13. M
  14. N
  15. O
  16. P
  17. Q
  18. R
  19. S
  20. T
  21. U
  22. V
  23. W
  24. X
  25. Y
  26. Z
  27. #