The Hill News

Congresswoman Rosa DeLauro (D-Conn.), Ranking Member on the Labor, Health, and Human Services Appropriations Subcommittee, sent the following letter to Jeffrey E. Shuren, M.D., Director of the Center for Devices and Radiological Health at the Food and Drug Administration.

The text of the letter is below.

Dear Dr. Shuren:
      
I am writing to strongly urge the Center for Devices and Radiological Health (CDRH) to hold a public Advisory Committee meeting this year that would release all available information about the 10-year post-market study results for saline breast implants, and also make available all results for the post-market Core studies and large long-term study of silicone gel implants. The Food and Drug Administration’s recent announcement about the rare form of lymphoma that may be associated with breast implants serves as a stark reminder that post-market studies are especially important for all implanted device! s that are intended to remain in the body for many years.

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