Mammogram Centers Must Notify Patients of Breast Density, FDA Says

THURSDAY, March 9, 2023 (HealthDay News) -- New U.S. federal regulations will require mammography facilities to tell women if they have dense breasts. The U.S. Food and Drug Administration update amends regulations issued under the Mammography Quality Standards Act of 1992.

"Today's action represents the agency's broader commitment to support innovation to prevent, detect, and treat cancer," Hilary Marston, M.D., FDA chief medical officer, said in an agency news release. "Since 1992, the FDA has worked to ensure patients have access to quality mammography. The impact of the Mammography Quality Standards Act on public health has been significant, including a steep decrease in the number of facilities that do not meet quality standards."

The update also strengthens FDA oversight and enforcement of facilities and helps doctors better categorize and assess mammograms. The amendments include specific language explaining how breast density can affect the accuracy of mammography. They urge patients with dense breasts to talk to their health care provider about breast density, cancer risks, and their individual situation.

Promoting patient access to information about the impact that breast density and other factors can have on breast cancer risk is part of a comprehensive breast health strategy, the FDA said.

The amendments must be implemented within 18 months, the FDA said. They will enhance the agency's ability to communicate directly with patients and health care providers when a facility is not meeting quality standards and is failing to communicate adequately with patients about that.

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