Abstract In 1992, the United States Food and Drug Administration (FDA) announced that breast implants filled with silicone gel would be available only through controlled clinical studies despite the fact that they had been used for mammoplasty in millions of women around the world for more than 30 years. The safety of silicone gel breast implants had come into question after several reports on a possible association between the implants and subsequent development of connective-tissue diseases. Risk assessment refers to the systematic, scientific characterization of potential adverse effects of human exposures to hazardous agents or activities. The following risk assessment is intended to review the current scientific evidence for the safety of silicone gel-filled breast implants since the FDA’s decision in 1992. There now appears ample evidence from the scientific literature for the safety of these prostheses.