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THE CURRENT controversy over silicone runs deeper than the problem of breast implants that rupture or bleed through their silicone shells (JAMA. 1992;267:2439-2442). At the heart of the controversy is the body's reaction to the polymer that for three decades has been championed as inert, noncytotoxic, and biocompatible.
As a class of materials, silicone polymers are considered nontoxic in both animal and tissue culture studies. Millions of patients worldwide have received silicone implants, yet many researchers say that the long-term biocompatibility of silicone has never been thoroughly established scientifically. Only recently has the Food and Drug Administration begun to require the manufacturers of silicone breast, penile, and testicular implants to submit data from rigorous trials (JAMA. 1992;267:2578-2579).
However these scientific questions are resolved, the result is likely to influence the fate not only of breast implants, but also the entire gamut of implants and devices that contain silicone.
Randall T. Less Maligned, but Cut From the Same Cloth, Other Silicone Implants Also Have Adverse Effects. JAMA. 1992;268(1):12-13. doi:10.1001/jama.1992.03490010014004