| US removes ban on silicone breast implants |
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| Tuesday, 21 November 2006 | |
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However, some lobby groups condemned the move as dangerous, saying that they are not satisfied with the assurance provided by the FDA's ruling. "The message to women is let the buyer beware," said Diana M. Zuckerman, president of the National Research Center for Women & Families. The FDA's decision is couched with the caution that it can only offer a "reasonable assurance" that silicone implants are "safe and effective". However, they cautioned that silicone implants are subject to breakdown within the body and that breast implant surgery itself can cause complications such as contracture of the breasts, when scar tissue around the implant shell shrinks. Silicone implants are preferred by most cosmetic surgeons because they have a more natural look and feel than saline-filled ones, but they have been unavailable for use in cosmetic procedures since 1992, being permitted for use only in breast reconstruction procedures following cancer related mastectomies. The new ruling now allows for the use in cosmetic breast surgery for women aged 22 and older, but there is no age restriction in their use for reconstructive purposes. The age restriction for cosmetic surgery is to prevent teenage girls from having the implants until their bodies have fully developed, said Dr. Daniel Schultz, director of the FDA Center for Devices and Radiological Health. However, girls under 22 will still be able to have saline based implants used in cosmetic procedures. Numerous studies have found no correlation between silicone implants and cancer or any other life-threatening illnesses, although the FDA has said that it will continue to monitor for any such risks. One condition of the approval requires the manufacturers to conduct 10-year studies of 40,000 women to monitor for possible side effects such as cancer, connective tissue disease, breastfeeding difficulties and even suicide. The FDA has also recommended follow-up screening by magnetic resonance imaging — MRI — three years after the operation and every two years thereafter. However, Rep. Rosa DeLauro (D-Conn.), was unhappy with the decision and said she may hold hearings into the decision next year. "This appears to be yet another example of the FDA dismissing scientific evidence in order to appease corporate interests," said DeLauro, who will chair the House panel that controls the FDA's budget. |
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