FRIDAY, Nov. 17 (HealthDay News) -- The U.S. Food and Drug Administration announced on Friday that it will allow two companies to market silicone gel-filled breast implants for use in women 22 and older who are undergoing breast augmentation or reconstruction. The companies must perform large, post-approval studies following about 40,000 women for 10 years after implant surgery.
The two companies are Mentor Corp., in Santa Barbara, Calif., and Allergan Corp., formerly Inamed Corp., in Irvine, Calif. As part of the approval process, the companies' manufacturing facilities were inspected to ensure their compliance with Good Manufacturing Practices. Among other measures, the companies will be required to track each implant so that healthcare professionals and patients can be notified of new information regarding the implants.
The implant labeling recommends regular MRI screening over the patient's lifetime to detect a possible rupture. The first MRI should take place three years after the initial surgery and then every two years.
"At the end of the day, the scientific data supported approval of the breast implants but the approval is not just a blank ticket," said Donna-Bea Tillman, Ph.D., director of the Office of Device Evaluation at the FDA. "We are requiring that each company conducts a large, ten-year study on approximately 40,000 women who receive the implants."
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