June 22, 2011
Washington, DC— Congresswoman Rosa L. DeLauro (CT-3), Ranking Member on the Labor, Education, Health, and Human Services Appropriations Subcommittee, issued the following statement today in response to the report released and updated information by the FDA today on the safety of silicone breast implants.
Congresswoman DeLauro sent a letter to the Food and Drug Administration in February, 2011, asking for more information about how post-market studies are conducted and their impact on FDA approval, and called for a public Advisory Committee meeting to review information about the potential dangers of breast implants. The FDA research results released today showed that many of these long term post-market studies, which were part of the device approval, lost track of the majority of the enrolled patients, which is simply unacceptable.
“This report reinforces the need for a public Advisory Committee meeting this year to review the safety of breast implants and provide the public with information about the post-market studies of both saline and silicone gel implants. As most breast implants are implanted in young women intending to keep them for the rest of their lives, it is critical that women have access to as much information about the potential risks and the temporary nature of these devices.
“It is also very clear to me that post-market studies must be taken more seriously if they are to remain part of the FDA’s approval process. Post-market studies that are poorly designed, poorly conducted, or unfinished are not scientifically meaningful, and should not be considered so. When Congress gave the FDA the authority to approve devices needing post-market studies, we did so with the intent that the Agency would rely on their scientific merit for continued approval of the device. The FDA must require and enforce more rigorous post-market studies of devices, especially for long-term devices such as breast implants, to ensure their safety. I call upon the FDA to improve this process, and to fulfill their responsibility to protect American consumers.”