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ARTICLE |

A Call for Higher Standards for Breast Implants FREE

David A. Kessler, MD; Ruth B. Merkatz, PhD, RN; Renie Schapiro, MPH
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Reprint requests to the Office of the Commissioner, Food and Drug Administration, HF-1, Rockville, MD 20857 (Dr Kessler).


JAMA. 1993;270(21):2607-2608. doi:10.1001/jama.1993.03510210093034
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THE COUNCIL on Scientific Affairs report on silicone gel breast implants, adopted by the AMA House of Delegates and published in this issue of The Journal,1 represents a missed opportunity. The Council encourages physicians to become fully informed about the current scientific data on these implants, but this report fails to provide a comprehensive safety review or a balanced discussion of the issues. The Council faults others for the controversies associated with these devices today, but it overlooks the serious failings of physicians and never articulates their responsibility with regard to the safety of medical devices. The Council makes policy recommendations that ignore the FDA's statutory authority and public health responsibilities and minimize the uncertainties and concerns that continue to surround these devices.

The Council report states that it reflects the scientific literature as of December 1992. However, since then, other important studies have been published. Recent animal studies

REFERENCES

Council on Scientific Affairs, American Medical Association.  Silicone gel breast implants. JAMA . 1993;;270:2602-2606.
Naim JO, Lanzafame RJ, van Oss CJ.  The adjuvant effect of silicone-gel on antibody formation in rats. Immunol Invest . 1993;;2:151-161.
Bridges AJ, Conley C, Wang G, Burns DE, Vasey FB.  A clinical and immunological evaluation of women with silicone breast implants and symptoms of rheumatic disease. Ann Intern Med . 1993;;118:929-936.
Teuber SS, Rowley MJ, Yoshlda SH, Ansari AA, Gershwin ME.  Anti-collagen autoantibodies are found in women with silicone breast implants. J Autoimmun . 1993;;6:367-377.
Kessler DA. The basis of the FDA's decision on breast implants. N Engl J Med 1992;;326:1713-1715.
Merkatz RB, Bagley GP, McCarthy JE.  A qualitative analysis of self-reported experiences among women encountering difficulties with silicone breast implants. J Worn Health . 1993;;2:105-108.

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Council on Scientific Affairs, American Medical Association.  Silicone gel breast implants. JAMA . 1993;;270:2602-2606.
Naim JO, Lanzafame RJ, van Oss CJ.  The adjuvant effect of silicone-gel on antibody formation in rats. Immunol Invest . 1993;;2:151-161.
Bridges AJ, Conley C, Wang G, Burns DE, Vasey FB.  A clinical and immunological evaluation of women with silicone breast implants and symptoms of rheumatic disease. Ann Intern Med . 1993;;118:929-936.
Teuber SS, Rowley MJ, Yoshlda SH, Ansari AA, Gershwin ME.  Anti-collagen autoantibodies are found in women with silicone breast implants. J Autoimmun . 1993;;6:367-377.
Kessler DA. The basis of the FDA's decision on breast implants. N Engl J Med 1992;;326:1713-1715.
Merkatz RB, Bagley GP, McCarthy JE.  A qualitative analysis of self-reported experiences among women encountering difficulties with silicone breast implants. J Worn Health . 1993;;2:105-108.
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