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Jan 18, - These implants were approved for augmentation in women age 18 and older and for reconstruction in women of any age. The FDA approved Mentor's IDE study (i.e., Core Study) for its silicone gel-filled breast implants for a limited number of augmentation, reconstruction, and revision patients at a limited number of sites. Silicone gel filled breast implants have been approved by the US Food and Drug Administration for use in women aged 22 years or older for cosmetic purposes and for reconstruction after breast cancer surgery or in women with traumatic or congenital breast defects.