NOW: FDA Approval of Dangerous Implants During Lame Duck Session

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http://www.now.org/press/11-06/11-17.htmlFDA Approval of Dangerous Implants During Lame Duck Session

Follows FDA Pattern of Favoring Money and Politics Over Science

November 17, 2006

Today the Food and Drug Administration (FDA) issued final approval to manufacturers Allergen Corporation (formerly Inamed) and Mentor Corp. for general marketing of silicone gel-filled breast implants to women of all ages for reconstruction purposes and women 22 and older for augmentation purposes.

" Women should be outraged by this reckless decision. Bush-appointed FDA leaders are once again endangering the public health, this time to enrich manufacturers and cosmetic surgeons, " said NOW President Kim Gandy. "

Sadly, we are not shocked that this agency is swayed more by money and politics than science and medicine. And I doubt it's a coincidence the FDA issued approval during the 'lame duck session' just before Congress is set to change leadership. The new Congress would likely have exercised more oversight, in order to limit political influence over decisions at the FDA. Without W. Bush's cronies in charge, it's much more probable that the next Congress will take a close look at the FDA's highly suspect review and approval process. But many more women will suffer until that happens. "

In recent months, more and more evidence has accumulated that manufacturers withheld critical information clearly demonstrating that silicone implants are not safe. The FDA has shown little interest in examining concerns expressed by their own scientists or the allegations of industry whistleblowers.

A recently published peer-reviewed study showed that women with implants, and their children, who are ill with autoimmune diseases and other health problems, have high levels of a toxic form of platinum, which was found in samples of their blood, tissue, hair, nail, urine and breast milk. Rather than attempting to replicate the study, FDA officials responded by dismissing it, following the lead of scientists who are paid consultants to implant makers.

Unfortunately, the FDA has not required manufacturers to study the impact of silicone implants on breast milk, breastfeeding, or the health of offspring born to women with implants. At NOW, we have heard from many women who believe that their silicone breast implants have adversely affected their children's health. In the coming weeks, NOW will be reviewing more than 1,000 questionnaires filled out by mothers with implants who detail the deformities and illnesses found in their children.

" It is impossible for women to give informed consent for implants if the information they are receiving is inaccurate or incomplete, " said Gandy. " The very real possibility that women and their children will be exposed to grave health risks is a serious matter. The FDA made an unconscionable move today. "

Gandy concluded: " The FDA has never rescinded approval for a medical device after it has been approved, but that's not going to stop NOW from trying. When the new Congress takes office we will petition our representatives to initiate an immediate review of the FDA and this dreadful, dangerous decision. "

Read NOW's recent letter sent to members of Congress

Read more about NOW's work on silicone breast implan