FDA Says Breast Density Must Be Reported to Women During Mammograms

Posted on April 01, 2019


Women with dense breasts who get mammograms must be told of their higher risk for breast cancer under new rules proposed Wednesday by the U.S. Food and Drug Administration.

The FDA would also tighten its regulation of mammogram facilities, giving the agency the power to notify patients if problems are found at a center so that repeat mammograms can be done at another certified center.

"The steps we are announcing today are intended to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care," FDA Commissioner Dr. Scott Gottlieb said during a Wednesday morning media briefing.

Not only is dense breast tissue a risk factor for breast cancer, but mammograms can be difficult to interpret because dense tissue can obscure signs of breast cancer, Dr. Amy Abernethy, principal deputy commissioner at the FDA, explained during the briefing.

"For women with dense breasts, they should talk with their health care provider about their high breast density and how it relates to breast cancer risk and their individual situation," Abernethy said. "Given that more than half of women over the age of 40 in the United States have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy."

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