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August 20, 2019  
MEDTECH NEWS: Latest Headlines

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  • FDA Panel Recommends Lifting Silicone Ban

    October 15, 2003

    WASHINGTON (AP) - Eleven years after most silicone-gel breast implants were prohibited, government advisers recommended on Wednesday that the ban be lifted despite lingering questions about safety and durability.

    But the Food and Drug Administration's advisers urged that Inamed Corp.'s sales be allowed only under certain conditions, including ensuring that all users get detailed brochures explaining the devices' known risks - such as a need for frequent reoperations for pain or breakage.

    Women will need annual exams to be sure their implants haven't silently begun leaking, the panel stressed. That will be expensive and hard to ensure, the scientists acknowledged, but crucial because implants can break without immediate symptoms and should be removed when that happens.

    "This is as important as your annual mammogram," said FDA adviser Barbara Manno, a Louisiana State University toxicologist.

    All implant recipients also must be enrolled in a registry to track their health.

    The vote was 9-6.

    The panel also said Inamed must do more research tracking women's health for 10 years after implants, a time when many say their devices begin breaking and causing painful disorders. So far, Inamed's research tracks women's health for three years.

    Still, after two days of debate, the panel ultimately agreed with Inamed's argument that it is not fair to restrict women's access to silicone implants when research suggests they break and cause other problems no more frequently than today's main alternative - implants filled with salt water.

    The decision came after emotional testimony pitting woman against woman: those who say implants broke inside their bodies to leave them permanently damaged and those who want implants they say feel more natural to repair cancer-ravaged breasts or make their breasts bigger.

    If women keep their implants long enough, they all may break eventually, panelists said.

    The question is how to tell: Saline-filled implants deflate so fast that women know they've broken, but silicone leaks slowly and may not cause immediate symptoms. Because women may not be able to get all the leaking silicone out of their bodies, "we have to hold this to a different standard," argued adviser Dr. Amy Newburger, a New York dermatologist.

    The FDA ended routine sales of silicone breast implants in 1992, restricting them to breast cancer patients in strictly controlled clinical trials.

    Seeking to restart broader sales, Inamed Corp. argued that the implants have been exonerated.

    Last updated: 15-Oct-03

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