•Natrelle® silicone gel-filled breast implants have experienced acceptance for more than 25 years in over 60 countries. •They were approved by the Food and Drug Administration (FDA) for use in the US in November 2006. •A Gel-filled breast implant has an elastic silicone rubber shell and is filled with cohesive silicone gel. •The safety of Natrelle® silicone gel-filled breast implants meet one of the most rigorous standards of all medical devices.