DeLauro: Science Ignored Again as FDA Approves Silicone Gel Implants

DeLauro: Science Ignored Again as FDA Approves Silicone Gel Implants

Congresswoman Rosa L. DeLauro (Conn.-3) today issued the following statement upon learning that the Food and Drug Administration (FDA) had approved silicon breast implants. DeLauro is the author of The FDA Scientific Fairness for Women Act, which requires manufacturers to demonstrate the safety of breast implants prior to the approval of their applications. She is also the ranking member of the House Appropriations Agriculture Subcommittee, with jurisdiction and oversight responsibilities of the FDA and its budget. In the 110th Congress, DeLauro will likely become the chairwoman of this subcommittee.

"FDA's decision to approve the use of silicone breast implants is very disturbing given the unproven safety record of these devices and recent allegations that one of the manufacturers failed to submit important safety data to the FDA. This appears to be yet another example of the FDA dismissing scientific evidence in order to appease corporate interests.

"When Congress reconvenes next session, it must examine the agency's approval process and ensure that the FDA makes decisions based on science and not on corporate and political considerations."

In 2000, FDA's own researchers found that 69 percent of women with silicone breast implants that were an average age of 17 years experienced ruptures, and 21 percent experienced leaks.

http://www.house.gov/delauro/press/2006/November/Silicone_Gel_Implants_11_17_06.html