The FDA is the world’s highest body to monitor the quality and safety of medical products. The so-called cohesive silicone Memory Gel used by Mentor has, in addition to CE certification, also the FDA approval *. Only 3 brands of silicone breast implants have received the US FDA approval.
Because not all breast prostheses used in the Netherlands are FDA approved, it is sometimes wrongly suggested by other parties that implants that have an FDA approval mark are mainly sold in America and that the FDA is therefore a purely American matter for products. Essential Aesthetics only uses Mentor Protheses.