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Topic: Religion
Number of pages / Number of words: 11 / 2990
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Most of the implants consisted of a rubber silicone envelope filled with silicone gel; about 10 percent were filled with saline (salt water).

Silicone gel-filled breast implants (a 52K JPEG file)

Saline-filled breast implants (a 42K JPEG file)

Under the 1976 law, implants and many other devices already in use were allowed to remain on the market, with the understanding that the agency would at some time ask manufacturers to submit scientific data showing these "grandfathered" products were safe and effective...


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The data submitted did not prove the devices safe, as required by law, so the agency restricted their use to clinical trials designed to resolve the safety questions.

Between Jan. 1, 1985, and Sept. 17, 1996, FDA received 103,343 adverse reaction reports associated with silicone breast implants and 23,454 reports involving the saline implants...


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