Breast reconstructionIn the United States, implants from silicone gel were banned by the Food and Drug Administration because of growing concerns about the safety of such implants. More than one million women had availed themselves of the implants at the time of the ban, and the subsequent litigation led manufacturers to agree to a settlement of $4.25 billion. The degree of risk associated with silicone-gel breast implants is still a matter of debate within the scientific community.