FDA and Breast Implants

The U.S. Food and Drug Administration (FDA) removed silicone breast implants in 1992 because of insufficient proof for safety presented by the implant manufacturers. However, due to the public need for implants (mainly from breast reconstruction patients), the FDA allowed some companies to continue research on the use of silicone implants for breast reconstruction and revision patients. Between 1992 and 2005, silicone breast implants were used for patients enrolled in investigational studies, reconstructive patients, and could not be marketed commercially to the general public. The United States was one of the few countries during this time period in which silicone breast implants could not be marketed commercially. Today however, silicone breast implants are back on the market.

According to an article posted by the CNN News, the FDA approved silicone implants manufactured by Inamed Aesthetics, now a part of Allergan, and Mentor for breast reconstruction and augmentation in women of all ages (http://www.cnn.com/2006/HEALTH/11/17/implants/index.html) . Apparently the as M.D.Director Daniel Schultz says, “FDA has reviewed an extensive amount of data from clinical trials of women studied for up to four years, as well as a wealth of other information to determine the benefits and risks of these products.” (http://www.consumeraffairs.com/news04/2006/11/fda_silicone.html)