Silicone Breast Implants Breast implants filled with silicone gel were first introduced for breast reconstruction in 1962. Over the course of the next three decades they were also used for breast augmentation. By the late 1980s increasing reports of problems with ruptures and concerns about long term safety led FDA to demand stringent safety reporting and submission of premarket approval applications from silicone breast implant manufacturers. In 1992 FDA removed from the market silicone gel-filled breast implants for augmentation. In 2006 the agency approved two silicone gel-filled breast

Silicone Breast Implants Breast implants filled with silicone gel were first introduced for breast reconstruction in 1962. Over the course of the next three decades they were also used for breast augmentation. By the late 1980s increasing reports of problems with ruptures and concerns about long term safety led FDA to demand stringent safety reporting and submission of premarket approval applications from silicone breast implant manufacturers. In 1992 FDA removed from the market silicone gel-filled breast implants for augmentation. In 2006 the agency approved two silicone gel-filled breast implants based on the manufacturers’ clinical studies and required post-approval studies to better understand the long-term performance of the devices.

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