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July 27, 1994

Silicone Gel Breast Implants

Author Affiliations

Orange, Calif

JAMA. 1994;272(4):272. doi:10.1001/jama.1994.03520040031025

To the Editor.  —Dr Kessler and colleagues label the recommendation for patient choice of breast implants by the CSA "insupportable" and call the practice of implanting silicone gel implants "an abrogation of responsibility on the part of physicians."1Kessler et al cite recent studies to support their concern for systemic adverse health effects of silicone. What they do not mention is that another recent animal study demonstrated no adjuvant effect of silicone on the immune system.2 Furthermore, many human studies from around the world have failed to show a connection between silicone gel implants and clinical evidence of rheumatic disease.3,4Kessler et al repeatedly explain the FDA's legal responsibility to demonstrate a medical device is "safe." Safety is subjective, a weighing of the balance of risks and benefits. The FDA's "adjunct study" allows silicone gel implants to be used in women after mastectomy, with congenital or traumatic

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