Modern breast augmentation began in the early 1960’s with the introduction of silicone gel breast implants. The silicone gel breast implants were constructed of one type of silicone making an outer shell and an inner formulation of silicone for the filler. This type of implant was very popular through 1992 for cosmetic breast augmentation due to its natural look and feel.
In 1991, news stories emerged attributing myriad connective tissue disease problems to silicone gel breast implants. As a result, the head of the FDA, David Kessler, banned silicone gel breast implants for use in cosmetic breast augmentation. Since that ban, silicone gel breast implants have been in constant use for breast reconstruction in women with breast cancer in the United States and have been in continual use for cosmetic augmentation around the world.
Cosmetic breast augmentation has become an ever more popular procedure for women using an implant made from a firm silicone shell filled with saline. Over 264,000 cosmetic breast augmentations were performed in 2004.
A significant body of research has been accumulated since the ban in 1992, without any direct evidence that silicone gel breast implants cause connective tissue disorders. The two manufacturers of implants in the United States have sought approval to reintroduce silicone gel breast implants back into the market in the United States.
After several years of hearings held by the FDA, an “approval with conditions” for the sale of silicone gel breast implants was issued by the FDA in the second half of 2005. Many people are anticipating the final approval and reintroduction of silicone gel breast implants in early 2006.
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