Silicone breast implants were developed in the 1960s. They have been used for breast reconstruction (about 15 percent of implant procedures, as estimated by the U.S. Food and Drug Administration) and breast enhancement (about 85 percent of implant procedures, as estimated by the FDA). Dow Corning Corporation was the primary supplier of silicone breast implants. By the mid-1990s approximately two million women had received breast implants. Over time, some silicone breast implants leaked or ruptured. Thousands of implant recipients began experiencing a variety of symptoms (joint and muscle pain, hair loss, rashes, memory loss) and even serious diseases of the immune system. One such disease is systemic lupus erythematosus, a chronic inflammatory disease of the connective tissue. The FDA has since banned the use of silicone breast implants for cosmetic purposes. Saline-filled implants are still approved for breast reconstruction and enhancement.
In the early 1990s, a class action lawsuit was filed against Dow Corning and other manufacturers on behalf of women who claimed that implant leaks caused various ailments. The complaint alleged strict liability (liability without fault), negligence (lack of due care), failure to furnish adequate warnings and/or instructions, and breach of express and implied warranties (promises about the performance of a product). Dow Corning argued there was no scientific proof that silicone caused immune system diseases. Dow Corning and the other manufacturers were found liable in this landmark breast implant lawsuit. The manufacturers agreed to a $4.25 billion settlement in 1994 to compensate women for their silicone implant-related injuries. The litigation ultimately led Dow Corning to declare bankruptcy in 1995. The company is under reorganization and in 1997 made a $2.4 billion settlement offer. The other manufacturers agreed to a new settlement.