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FDA changes mammogram policies to provide women with breast density information

Dense breast tissue has been identified as a risk factor for breast cancer. Under the new rules, women with dense breasts will receive more information on how the condition could affect their mammogram results.
ln this photo taken Wednesday Sept. 14, 2011, Dr. Karen Lindsfor, a professor of radiology and chief of breast imaging at the University of California, Davis Medical Center, examines the mammogram of a patient with heterogeneously dense breast tissue, in Sacramento, Calif. Lindfors opposes a measure approved by the state Legislature earlier this month, that would require health facilities performing mammograms to notify patients with dense tissue that they may want to receive additional screenings. Lindfors is among those doctors who say there was insufficient evidence to support the idea that additional screenings would detect cancers earlier. (AP Photo/Rich Pedroncelli)

Author: Suzanne Nuyen, TEGNA

Published: 10:30 AM EDT March 27, 2019

Updated: 10:37 AM EDT March 27, 2019

The Food and Drug Administration announced Wednesday new policies on breast cancer screening that would provide patients with more information on dense breast tissue.

The FDA wants to require providers to explain how dense breast tissue affects the accuracy of mammograms, so that patients are more informed and have the option to take additional tests to screen for cancer.

Dense breasts have less fatty tissue and more fibroglandular tissue. The dense tissue can make it hard for machines to find signs of breast cancer during a mammogram, and dense breast tissue is considered a risk factor for breast cancer.

It's the first time in more than 20 years that the FDA has proposed amendments to mammogram regulations. According to the FDA, the amendments would "improve the quality of mammography services for millions of Americans."

“Breast cancer is one of the most worrisome health concerns facing women," said FDA Commissioner Scott Gottlieb, M.D.

The National Cancer Institute says that approximately 12.4 percent of women will be diagnosed with breast cancer at some point during their lifetime. It's the second leading cause of death among women. Men can also be diagnosed with breast cancer. In men, it usually occurs between 60-70 years of age.

Other proposals from the FDA will add three additional categories to mammogram assessments, and provide patients with more detailed reports of their tests.

“The FDA is committed to advancing efforts that improve the health of women," said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. We believe the proposed rule would help empower patients and health care professionals by proposing improvements to the information facilities communicate to them, helping to facilitate the sometimes difficult conversations about potential risks for breast cancer."