Silicone gel breast implants are medical device prostheses used to substitute for human breast tissue for purposes of augmentation or replacement following mastectomy.
Implants consist of a plastic envelope or shell containing a soft gelatinous mixture.
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.