In 1992 there was a moratorium on the use of silicone implants both in the United States, as well as in France. The rest of the world did not stop using them. The reason for the moratorium was due to the suspicion that silicone was associated with autoimmune diseases. These diseases are mostly seen in women and usually present in the late 20”s and early 30”s. The same age when women chose to undergo breast augmentation. There were cases of women who underwent silicone breast augmentation that subsequently developed a form of autoimmune disease. It was these cases that prompted the moratorium. The question was did the silicone implants cause the onset of these diseases. The challenge was to see if, in fact, the silicone exposure cause these women to develop autoimmune disease. To answer this question, as is done with other medical studies, the scientific method was utilized. That is, large groups of women both with silicone implants and without were evaluated as to the incidence of autoimmune disease. The findings were that women with silicone implants had the same incidence of autoimmune disease as women without silicone implants. That is, 1 in 50,000 women without silicone implants can expect to develop a form of autoimmune disease, and 1 in 50,000 women with silicone implants also can expect to develop this disease. This same statistic is extremely reliable to suggest silicone’s safety. In 1999, more than 400 scientists from around the world looked at all available data and were convinced of silicon’s safety. Between the years 1995 and 2006, hundreds of thousands of women were enrolled in studies to ascertain silicon’s safety. This 10 year study was submitted to the FDA. They concluded that silicone was safe and approved its use in 2006. Dr. Ary Krau was one of the lead investigators that began using the new cohesive silicone breast implants in Miami in 1995. He personally has not had any patients that developed any form of autoimmune disease subsequent to augmentation.
Additionally, silicone is present in many products in use, such as hair products, antiperspirants and skin products. When silicone is applied on the skin surface it is easily absorbed through the skin into the body. Thus, silicone is quite pervasive and probably exists at some level in many people that do not have breast implants.