BRAVO BRAVO! NOW Applauds DeLauro Legislation Holding FDA Accountable on Emergency Contraception, Breast Implants

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http://www.now.org/press/09-06/09-21.html

NOW Applauds DeLauro Legislation Holding FDA Accountable on Emergency Contraception, Breast Implants

September 21, 2006

" It's obvious that the Food and Drug Administration is no longer the watchdog for public health and safety, " National Organization for Women President Kim Gandy said today, welcoming legislation proposing corrective measures for recent ill-advised FDA actions on Emergency Contraception (EC) and risky silicone gel breast implants.

Today Rep. DeLauro (D-Conn.) is introducing the FDA Scientific Fairness Act for Women, and Gandy praised the provision to establish a scientific process within six months to review the safety of EC (also known as Plan for use by women under 18 without a prescription.

" The FDA's inexcusable delay in approving this safe drug, and then denying it to young women—despite recommendations for approval by two FDA advisory panels and major medical associations—reveals the agency's failure to uphold its mandate to make scientifically sound decisions, " Gandy added.

The DeLauro bill would also halt the FDA approval process on silicone breast implants until the FDA establishes the life of silicone breast implants and implant makers can demonstrate adequate safety of their products for the established lifetime of the product. This would help women by reducing their exposure to rupture and leakage.

Another important provision calls for an independent scientific study of the effect on women and their children of toxic platinum salts from silicone gel breast implants. A recently published article in the peer-reviewed journal Analytical Chemistry reported high and hazardous levels of an oxidized form of platinum in hair, urine, blood and breast milk samples.

Gandy said, " More research is critically needed to determine what role these toxic platinum salts may play in making some women and their children very sick. " The presence of the toxic ingredient in implants was first reported at the 2003 NOW Foundation scientific symposium

examining silicone gel breast implant safety questions.

The FDA has been dismissive of these alarming findings and appears ready to approve two applications to market silicone breast implants to the general public. In fact, the FDA has already issued preliminary " approvable " letters to Inamed and Mentor corporations, the two implant makers who want to sell these dangerous types of implants. These manufacturers have spent hundreds of thousands of dollars to promote their implants and to put heavy pressure on FDA officials to approve their applications.

Silicone gel implants were withdrawn in 1992 when thousands of women reported serious illnesses and injuries after receiving the implants. Later, thousands of lawsuits were filed against a number of manufacturers by women made ill by the implants, and by the U.S. government on behalf of many hundreds of women covered under federal health care programs.

Dr. Wood, former Assistant Commissioner for Women's Health and Director of the FDA Office for Women's Health, who was honored at NOW's National Conference as a Woman of Courage, summed up the problem in her conference remarks: " What we have apparently is a small group of people with enormous influence who can overrule good science, who can overrule good health policy, who can overrule an interest in the public health of individuals around the nation. "

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