FDA Decides Silicone Breast Implants Are Not Proven Safe

January 9, 2004, Washington, WA - The U.S. Food and Drug Administration announced today that it will NOT lift current restrictions on the sale of silicone breast implants in the near future, rejecting the recommendation made by an FDA advisory panel in October. Instead, the agency today released a revised guidance document for breast implant makers to "provide a reasonable assurance of safety, and to allow women and physicians to make informed decisions about silicone implants."

The FDA's new recommendations are likely to delay approval for several years. They include:

* The designing of mechanical testing and other testing of implants outside the body that can predict what happens in real life, such as why, how, and how often implants break or leak.

* More clinical research on the consequences of implant breakage and leakage, based on women with breast implants inside their bodies.

"This decision sends a crystal clear message to women that silicone gel breast implants are not proven safe," said Dr. Diana Zuckerman, president of the National Center for Policy Research (CPR) for Women & Families, a think tank that has criticized the lack of research on long-term safety of medical implants. "It should be a booming wake-up call to doctors across the country -- those who put in breast implants and those who provide medical care for women with implants. I hope they will be more responsive to the patients who come in with implant problems."

Inamed's own research, submitted with its application, showed extremely high complications rates in the first two to three years that women have breast implants. For example, 46 percent of breast cancer patients and 20 percent of augmentation patients needed additional surgery to correct implantproblems.

This rejection of silicone gel breast implants comes just two months after the chairman of the advisory panel that recommended approval, Dr. Thomas Whalen of the Robert Wood John Medical School, said the panel's 9-to-6 recommendation was "misguided" and that "to approve this device poses threats to women that are clearly unknown."

"This is a triumph of science over wishful thinking," said Zuckerman. "FDA has based their decision on science -- or more accurately, the lack of scientific proof. The recommendation for approval was based on the hope that these implants would be safe, but there was no proof to back that up, and many unanswered questions."

Today's decision means that silicone gel breast implants are still available but restricted to clinical trials for unlimited numbers of women recovering from breast cancer surgery and women who need to have their silicone gel implants replaced, and fewer women who are seeking breast augmentation for the first time. The FDA estimates that 40,000-50,000 women are currently participating in implant research.

"This decision will remind implant manufacturers that they need to prove their products are safe for long term use before getting FDA approval," adds Zuckerman. "Breast implants have been sold for 40 years -- maybe they will finally get the message."

Source:National Center for Policy Research for Women & Families

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