DeLauro on Cancer Link to Breast Implants

Criticizes FDA medical device approval process

Washington, DC— Congresswoman Rosa DeLauro (CT-3), Ranking Member on the Labor, Health, and Human Services Appropriations Subcommittee, released the following statement today in response to a FDA review showing a possible association between saline and silicone gel-filled breast implants and a very rare type of cancer, anaplastic large cell lymphoma (ALCL).

“Today’s announcement is frightening for American consumers—not only because these implants may be dangerous, but also because it exposes the inadequacies of the process at FDA for requiring post market studies of medical devices. The FDA approves many medical devices based on short-term studies and post-market analysis to learn about long-term risks. But the companies are in control of these studies, and should they fail to complete them or lose track of patients, the FDA has no recourse and ultimately, it does not impact the approval. If these post-market studies were conducted correctly and appropriately by the companies, the FDA would be able to properly asses the dangers of medical devices and better protect the American public.”