FDA OKs Types of Silicone Implants, Ending Ban The Food and Drug Administration this evening has approved broad marketing of two types of silicone breast implants, ending a 14-year moratorium on their use in this country for most women. Proponents say they're safe; opponents cite problems from scar tissue to immune disorders and cancer.
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FDA OKs Types of Silicone Implants, Ending Ban

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FDA OKs Types of Silicone Implants, Ending Ban

FDA OKs Types of Silicone Implants, Ending Ban

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MICHELE NORRIS, host:

Today the Food and Drug Administration approved broad marketing of two types of silicone breast implants, ending a moratorium on their use in this country for most women. But the agency has ordered manufacturers to monitor women's experiences with the implants for the next ten years, in case problems arise.

NPR's Richard Knox has the story.

RICHARD KNOX: The debate over the safety of silicone breast implants has been long, complicated and emotional. Proponents say they're safe and provide the best cosmetic result. Opponents cite instances when women appear to have suffered a range of side effects, from scar tissue to immune disorders and even cancer after silicone leaked out or the implants ruptured. Dr. William Schultz of the FDA says the agency has gone through all the accumulated evidence.

Dr. WILLIAM SCHULTZ (Food and Drug Administration): Weighing these data, we concluded that there is reasonable assurance that silicone gel filled breast implants are safe and effective and that there is adequate information about these products to enable women to make informed decisions.

KNOX: The approval is for two devices made by Allergan and Mentor. It allows implants for breast reconstruction for any woman, for instance, following cancer surgery. And it allows implants for cosmetic purposes, augmenting breast size, for instance, for women who are 22 years and older. Up to now, the FDA has permitted silicone implants only for women who've had breast cancer or have developmental deformities.

Unidentified Woman: They have demonstrated that they should be able to withstand the forces that they should experience in a woman's body up to at least ten years. But women do need to understand that these are not permanent devices and they will probably need to be replaced.

KNOX: The debate over silicone implants isn't over. Critics are already saying that the FDA has already made a big mistake.

Richard Knox, NPR news.

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