FACT: After several years of rigorous review by the
FDA, and separate evaluation by an
FDA Advisory Panel, FDA determined that these products meet PMA standards of safety and effectiveness. Mentor has worked closely with FDA to construct labeling (documentation) that will permit patients full, informed decisions when they consider the option of
MemoryGel™ silicone breast implants. Mentor's labeling states that, although there are no current established methods for accurately detecting silicone levels in breast milk, a study measuring silicon (one component in silicone) levels did not indicate higher levels in breast milk from women with silicone gel-filled implants when compared to women without implants (Lugowski, S.J., et al. 2000.) Analysis of silicon in human tissues with special reference to silicone breast implants. J.Trace Elem. Med. Biol. 14(1):31-42.