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The Food and Drug Administration (FDA) removed silicone-filled breast implants from the market in 1992. This left only saline-filled implants available to the public. Lawsuits against the manufacturers of silicone breast implants in the early 1990s caused a closer inspection of the safety of silicone implants.
In November 2006 the FDA lifted restrictions, and approved the use of silicone breast implants for women who are at least 22 years old. According to the American Society for Aesthetic Plastic Surgery, surveys in 2005 showed that 83.4 percent of respondents used saline and 16.6 percent used the silicone implant.
From 1992 to 2005 investigators involved in clinical studies ? who were evaluating the use of silicone implants for reconstructive and revision surgery ? were the only ones allowed to use silicone breast implants.
Silicone gel-filled breast implants were first introduced in 1962. In 1976, the Medical Device Amendments were enacted, giving the FDA authority to regulate medical devices such as breast implants. In 1988, the FDA announced that all breast implants would be labeled as class III devices, meaning they are to be considered as medical breakthrough, new technology devices, and devices with poorly established or questionable safety and effectiveness. In addition, the FDA called for implant manufacturers to submit PMAs in which data showing the safety and effectiveness of these devices would have to be approved before the device could be placed on the market. Breast implants were now under careful scrutiny of the FDA. [1] In early 1992, the FDA placed a moratorium on silicone gel breast implants provided to the mainstream market for cosmetic purposes after many women who had received implants complained of pain and illness as a result of the implants leaking. The FDA concluded there was "inadequate information to demonstrate that breast implants were safe and effective." Access to silicone gel-filled breast implants continued to be allowed under controlled clinical studies for reconstruction after mastectomy, correction of congenital deformities, or replacement of ruptured silicone gel-filled implants due to medical or surgical reasons. Implant manufacturers were required to collect clinical trial data and were allowed distribution of the implants to a limited number of augmentation patients for these studies.
In mid-1992, the FDA approved an adjunct study protocol for silicone gel-filled breast implants for reconstruction and revision patients. That same year, silicone and breast implant manufacturer, Dow Corning, announced that it would no longer make five implant grades of silicone, but that it would continue to manufacture 45 other medical grades of silicone materials. Just three years later, in 1995, Dow Corning Corp., once the major manufacturer of silicone breast and other implants, faced 19,000 lawsuits, pushing it into bankruptcy.
Original source: http://plasticsmatch.wordpress.com/?p=39
