FDA Approves Silicone Gel Implants for Breast Augmentation!
- INDIANAPOLIS, IN, December 09, 2006 - After a 14-year moratorium, the FDA approved the use of silicone gel implants for cosmetic breast augmentation. The American Society of Plastic Surgeons (ASPS) applauded this decision as a victory for women who are now allowed to make an informed choice about their health care. The approval is effective immediately for cosmetic breast augmentation for all women who are at least 22 years of age.
In 1992, silicone breast implants were put under the magnifying lens of the media by Connie Chung with a sensationalized report of a small group of women who claimed that they developed connective tissue disorders, such as Lupus and Rheumatoid Arthritis, after breast augmentation. Despite the absence of any scientific evidence to support these claims, this report soon erupted into a national indictment of cosmetic breast surgery as well as a cottage industry for personal injury attorneys. The FDA quickly withdrew silicone breast implants from the market and placed the burden on breast implant manufacturers and plastic surgeons to prove that these diseases were not caused by breast implants.
Over the past 14 years, multiple scientific studies have been conducted in large groups of women with and without breast implants to determine how frequently they develop these disorders. The overwhelming conclusion has been that the natural occurrence of such disorders is about the same whether or not a woman has breast implants. Even the American College of Rheumatology, a leading organization of doctors who specialize in connective tissue disorders, have concluded that there is NO cause and effect relationship between silicone breast implants and these diseases.
After being presented with large volumes of scientific data supporting the safety of silicone implants, the FDA conducted a long and thorough review process that eventually led to an FDA advisory panel hearing in April of 2005, during which they heard over 20 hours of testimony from implant manufacturers, plastic surgeons, and a variety of public advocacy groups. Months of careful review and consideration of all of the data followed, and on November 17, 2006, the FDA announced its" approval.
According to the ASPS, over 300,000 women underwent breast augmentation in 2005, a statistic in support of their conclusion that this surgery has "...been proven in numerous studies to have psychological and physical benefits for women who choose this procedure." The FDA decision comes shortly after approval of silicone breast implants in Canada, and now brings us in line with the over 60 countries in the world who have already approved silicone breast implants.
09.12.2006 - 9:22 Source: 24-7pressrelease.com | Read: 247 X
