The FDA proposes mammogram changes to guidance for the first time in decades

A radiologist uses a magnifying glass to check mammograms for breast cancer. (AP)

For the first time in two decades, the U.S. Food and Drug Administration (FDA) a proposal for an update of the national mammogram regulations in an effort to the modernization of breast cancer screening for women, particularly for those with dense breasts.

The federal agency, in a statement on Wednesday it was suggested that mammogram providers to provide information to women regarding breast density.

When a woman with thick breasts (which means they have more connective and glandular tissue than fatty tissue) undergo a mammogram, the results “can be difficult to interpret because of the dense tissue can obscure signs of breast cancer and lower the sensitivity of the image,” the FDA said, adding that with dense breasts can all increase the risk of developing breast cancer to begin with.


The FDA in its proposal said: “specific language” could help mammogram providers to explain how the density of the breast can affect the accuracy of the mammogram. The language would also advise patients with such breasts “talk with their healthcare provider about the high density of the breast and how it relates to the risk of breast cancer and their individual situation.”

Patients would receive the information in a summary letter after the screening.

“We believe that the proposed rule would help empowerment of patients and professionals in health care, by proposing improvements to the information, facilities to communicate with them, to help promote the sometimes difficult conversations about the possible risks for breast cancer,” Amy Abernethy, the principal deputy commissioner at the FDA, said in a statement. She said more than half of the women over the age of 40 have dense breasts.


More than 35 countries requires a notification for dense breasts. But the FDA’s proposal, if finalized, would apply to all member states and the minimum standards for the information provided. Regulators will take comments from the public for three months prior to the completion of the proposal, a process that can take months or sometimes years.

In addition, another proposed regulation would give the FDA to contact patients directly if their mammography provider who does not meet the quality standards or the disclosure of the requested information, while a different proposal for a regulation would sanction mammography providers who do not adequately keep track of patient records and information.

In 2018, according to the National Cancer Institute, more than 260,000 women were diagnosed with breast cancer. More than 40,000 died from the disease the same year.

The Associated Press contributed to this report.

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