Silicone gel implants were invented in 1963 for breast augmentation to replace the use of silicone injections. Silicone gel breast implants were widely marketed and used over a thirty-year period until 1992 when the FDA banned them for lack of sufficient safety and efficacy data. The number of breast implant operations in this time period is estimated to be between one and two million. Today, there is a great deal of controversy regarding certain physical characteristics of silicone gel breast implants versus what was revealed to or understood by patients as well as the medical profession. There are at least six important product information issues that should have been disclosed by the manufacturers in the package inserts accompanying the product.
Silicones have biological activity.
Contrary to popular belief amongst plastic surgeons in the beginning, silicones were and are biologically active compounds. There are published reports and internal company documents from silicone breast implant manufacturers that reveal screening and discovery of silicone compounds which exhibited pesticidal, antibiotic and hormonal activities. Injected silicones caused problems. The potential danger of silicone compounds was published widely in the scientific literature revealing adverse reactions to silicone injections when used for augmenting the human female breast. Despite much evidence, a correlation between silicone toxicity from direct injection with the possible silicone toxicity associated with gel bleed from implants was never addressed.