In the late 1980's and early 1990's, many women presented to their physicians with a group of diseases known as autoimmune disorders. These autoimmune disorders were otherwise known as connective tissue disorders. They were thought to, at that time, have been due to silicone gel breast implants. In 1992, silicone gel breast implants were removed from the market by the FDA for further testing.
The first study, which was completed, was done by the Mayo Clinic and published in the June 16, 1994 issue of the New England Journal of Medicine. This study did a retrospective analysis of approximately 600 women at the Mayo Clinic, who had breast implants there in the prior 10 years. Age match controls were selected randomly from the computer to determine any significant difference in the rate of autoimmune disorders among these two cohorts. In fact, there was no statistical difference between these cohorts. This study was subsequently repeated and confirmed by Harvard University and published one year later.
Other studies have collaborated this fact that there have been no significant differences between women who have silicone gel implants and those who do not. There are areas in Europe where silicone gel implants have come back on the market. There are some thoughts that silicone gel will return to the United States market, if there are any implant manufacturers still brave enough to make them.