The New York Times (3/27, Grady) reports that “centers that provide mammograms to screen for breast cancer will have to tell women whether they have dense breast tissue, which can increase the risk of cancer and mask tumors, the Food and Drug Administration announced in a proposed rule” yesterday.
These “new F.D.A. rules propose specific language that would be used nationwide to explain breast density, note that some women may need more imaging tests and recommend that patients talk to their doctors about their results.” The Times adds, “The F.D.A. language would be the minimum required, but states would be free to require more information, Jeff Shuren, M.D., director of the F.D.A.’s Center for Devices and Radiological Health, said in a news briefing.”
These are the first changes to the regulation of mammography screening in more than 20 years, aimed at improving quality and modernizing breast cancer screening, FDA Commissioner Dr. Scott Gottlieb said.