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Proposed bill may rescind silicone breast implant approval

Article-Proposed bill may rescind silicone breast implant approval

Washington — Rep. Rosa L. DeLauro, D-Conn., is being applauded by women’s-rights advocates for reintroducing The FDA Scientific Fairness for Women Act, reports PRNewswire-USNewswire.

Sybil Niden Goldrich, founder of Command Trust Network, and Mary McDonough, founder of In the Know and a former star of the TV series “The Waltons,” are publicly praising Rep. DeLauro for her legislative action. If passed, the FDA Scientific Fairness for Women Act would make women’s health a priority at the Food and Drug Administration by taking politics out of the agency’s decision-making.

Late last year, the FDA lifted its 14-year restriction on the sale of silicone breast implants despite independent studies showing that virtually all silicone breast implants disintegrate in the body over time. Opponents of the reinstatement claim the manufacturers’ own data show that more than half of cancer survivors and one in five cosmetic patients require additional surgery within three years of receiving silicone implants. In ordering the reinstatement, the FDA ruled that silicone implant manufacturers must conduct a study of 80,000 implant recipients over the next decade to determine the implants’ long-term safety and efficacy.

Rep. DeLauro’s bill would rescind the approval of silicone breast implants if safety has not been conclusively demonstrated for the life of the implant.

In its story, PRNewswire-USNewswire quotes Goldrich as saying, “In a decision that was clearly contrary to the interest of women’s health, the FDA placed science second to politics when it recently approved silicone breast implants. The DeLauro bill is necessary because it would mean the FDA will be required to pursue the post-market surveillance they promised at the time of implant approval.”

The story says McDonough questions why the safety-and-efficacy studies weren’t done before the FDA allowed the implants back on the market.

“We've already been down this rocky road in the 1990s with rupturing saline implants,” she told PRNewswire-USNewswire. “Why can’t we ensure proper safety protocols this time around with silicone? We commend Congresswoman DeLauro for taking the initiative to get the FDA to take women’s health in to account.”

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