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FDA Urged to Investigate Hidden Information About Silicone Breast Implants

Consumer activist organization Public Citizen called for a Food and Drug Administration investigation of silicone gel breast implants maker Mentor Corporation after a former employee reported that Mentor was aware of dangerous side effects of the implants, but hid them from the FDA. The former employee was a scientist with Mentor for 15 years, and believes he was let go earlier this year because of his protests against the company’s refusal to send proper test results to the FDA, Washington Post reports.

Throughout testing, scientists found that larger silicone molecules were breaking down into smaller ones, causing them to occasionally leak out of the implant bag. “The bottom line is that somebody needed to look at this,” said the scientist, who is choosing to remain anonymous, to the Washington Post. Dr. Sidney Wolfe, director of Public Citizen’s Health Research group, wrote to the FDA: “This new evidence that information has been illegally withheld from the FDA should prompt a new criminal investigation bearing on the safety of silicone gel implants,” reports Our Bodies, Our Blog.

The National Organization for Women (NOW) has long advocated against the use of silicone gel implants. Members of Congress have supported NOW’s position, and in September, Rep. Rosa DeLauro (D-Conn) introduced a bill that would stop approval for breast implants until producers of the implants can prove safety, with no breaking or leakage into a woman’s body, according to NOW’s website.

Sources:

Washington Post 10/13/06; Our Bodies, Our Blogs 10/19/06; NOW 9/27/06