The History And Current State Of Silicone Implants FDA Approval
Breast augmentation and reconstructive surgery has become more popular and affordable than ever before. Since their conception in the early 1960s, silicone breast implants have been highly debated because of their possible health risks. Has technology or time played the most important role in silicone implants FDA approval finally?
It wasn't until several years after silicone implants were being used that the FDA made the decision to regulate their use and evaluate the health risks. The FDA decided that they needed documentation proving or disproving the existence of health risks to women who had received silicone breast implants. The manufacturers of the implants could not provide acceptable data, so there were restrictions placed pending silicone implants FDA approval.
In 1992, silicone implants FDA approval was still pending, but some women were allowed to undergo breast reconstructive surgery and receive silicone breast implants. These women had to meet certain criteria, and women seeking breast augmentation for cosmetic reasons did not qualify. Also, the women had to participate in clinical studies sponsored by the breast implant manufacturers and overseen by the FDA. The data gathered from these studies would help make the decision for or against silicone implants FDA approval.
The silicone implants FDA approval for mainstream use came in late 2006. After over a decade of clinical studies, the FDA deemed the silicone implants safe for use. Very little has changed in the way the implants are manufactured, though. The silicone implants manufactured in the 1970s had a thinner shell, but this proved to cause a higher percentage of ruptures. In the 1980s, the shells were coated with elastomer and the silicone filling was thicker. This helped reduce ruptures and silicone migration in the body. The latest progression in silicone breast implants consists of a thick inner filling that is referred to as "gummy bear" implants because of the viscosity of the silicone gel. So far, this advancement has proved to impose fewer ruptures and incidents of capsular contracture, but studies are still underway because the implants are relatively new to the market. Capsular contracture occurs when the scar tissue tightens around the implant making the implant hard and sometimes painful. The "gummy bear" silicone implants FDA approval is active, but future study results could affect the silicone implants FDA approval. The silicone implants FDA approval means that the Food and Drug Administration of the United States has found the implants to be safe, but that does not mean that risks do not exist. There are many risks involved with breast implants of any kind but more so with silicone breast implants. Before getting breast augmentation or reconstruction surgery, be sure to talk to a certified plastic surgeon about the benefits and risks of breast implants. Also, make sure you understand the procedure and recovery of the surgery. Breast implant surgery involves risks that you need to be aware of whether silicone implants FDA approval is active or not. Don't rely completely on the FDA to determine whether silicone implants are safe for you.
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