Markos
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 Posted: 11/22/06 - 19:48 Post subject: Silicone Gel-Filled Breast Implants Approved by the FDA |
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Based on a thorough investigation done by the manufacturing companies, studies performed by independent scientific bodies and outside experts, U.S. Food and Drug Administration has decided to approve the use and marketing of silicone gel-filled breast implants.
Silicone gel-filled breast implants have been approved for two purposes: breast reconstruction in women of all ages and breast augmentation in women ages 22 and older.
The reason the age restrictions were made is that the FDA finds that many young women are not mature enough to make an informed decision about the risks and even more because women’s breasts continue to develop through their late teens and early 20s.
Previously, certain independent studies have linked silicone gel-filled breast implants to connective tissue disease or cancer. New studies concluded that the implants were safe and effective but the FDA still conditioned the marketing of the implants by requiring a large postapproval study, core study through 10 years, a focus group study of the patient labeling and continued laboratory studies to monitor the device failure.
The FDA has also required that all the risks and benefits of the implants are found on the package labels. The labels need to contain all the information needed for making an educated decision. The most important information are that the “breast implants are not lifetime devices and a woman will likely need additional surgeries on her breast at least once over her lifetime, that many of the changes to a woman’s breast following implantation are irreversible and that rupture of a silicone gel-filled breast implant is most often silent and only visible by MRI’s, which would be needed every two years after the surgery took place.
The postapproval studies ordered by the FDA will be collection information about the rupture, local complications, connective tissue disease, neurological disease, effects on offspring of women with breast implants, effects on reproduction and lactation, cancer, suicide and interference of breast implants with mammography. |
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