In 1992, the FDA decided that silicone gel-filled breast implants 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 breast implants had been called into question after several reports of a possible association between the implants and the subsequent development of connective tissue diseases. Such reports led to general public concern fueled by popular media attention and multiple class-action lawsuits against the product's manufacturers. It was in this climate that the FDA was forced to make its decision. This article reviews current scientific evidence on the safety of silicone gel-filled breast implants. Issues pertinent to oncology are highlighted. These include the possible carcinogenic effect of silicone gel, the safety of irradiating breasts with silicone implants, and the ability to mammographically image the implanted breast.