After rigorous review, the FDA can offer a “reasonable assurance” that today’s silicone implants are “safe and effective,” said Donna-Bea Tillman, director of the FDA Office of Device Evaluation. Studies have found no association between silicone implants and cancer or other life-threatening diseases, although the FDA is continuing to monitor for these risks.
The FDA is also requiring each of the two manufacturers of silicone gel implants, Inamed Aesthetics and Mentor Corp., to study 40,000 women for 10 years to assess potential health problems. These studies will help answer questions on the implants’ long-term safety.
-Allan Parungao, M.D.
