FDA Approves The Use Of Silicone Gel Implants

I am pleased to write that after careful scientific review, the U.S. Food and Drug Administration (FDA) approved the use of silicone gel-filled breast implants on November 17, 2006. The FDA’s decision to approve these implants was based on a thorough review of each company’s clinical and preclinical studies, a review of studies by independent scientific bodies and deliberations of advisory panels of outside experts that heard public comment from hundreds of stakeholders. The FDA also conducted inspections of each company’s manufacturing facilities to determine that they comply with FDA’s Good Manufacturing Practices.

The director of FDA’s Center for Devices and Radiological Health, Daniel Schultz, M.D., stated “the silicone breast implant is one of the most extensively studied medical devices.” In the past decade, numerous independent studies have examined whether silicone gel-filled breast implants are associated with connective tissue disease or cancer. The studies, including a report by the Institute of Medicine, have concluded there is no convincing evidence that breast implants are associated with either of these diseases. Now that the products have been determined to be safe and effective, FDA will continue to monitor them by requiring each company to conduct a large post approval study following about 40,000 women for 10 years after receiving breast implants.

While this announcement only confirms what those who have been working with silicone implants have been saying for years, we are glad that it removes any lingering doubt on the subject. This is excellent news for all of my patients, as it provides those who have already undergone breast augmentation surgery or reconstructive breast surgery with silicone implants with a great deal of reassurance. For those of you who have been considering the procedure, this provides you with a large body of new research to help you make your decision, and ultimately a sound alternative to saline implants. Personally, it has been my experience that silicone gel implants provide a much more natural look and feel for my patients, enhancing their satisfaction with the results of their breast augmentation. There has never been any doubt in my mind regarding their quality or safety and I am very pleased to be able to offer them to my patients.

Sincerely,

Haven J. Barlow, Jr., M.D.