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FDA offers update on breast density notification law timeline

by John R. Fischer, Senior Reporter | October 21, 2022
Women's Health
The FDA plans to release the national breast density inform law before the end of 2022 or in early 2023.
A window for the release of the breast density notification rule is in sight, with the FDA saying that it should be published before the end of the 2022 calendar year or in early 2023.

The agency disclosed the timeline in early October in response to a request by the chair of the House Appropriations Committee U.S. Representative Rosa DeLauro (CT-D). DeLauro introduced the Breast Density and Mammography Reporting Act back in 2017 with Representative Brian Fitzpatrick (PA-R).

Senators Dianne Feinstein (D-CA) and Dean Heller (R-NV) introduced the Senate version.

The bill was signed into law on February 15, 2019 and requires mammographers to inform patients in reports if they have dense breast tissue and what risks the condition carries, so that they and their physicians can take necessary precautions to ensure they are cancer free.

“Forty percent of women over 40 have dense breasts, and their risk of breast cancer is much higher. When it comes to surviving cancer, early detection is key, as 99% of women who receive an early diagnosis survive it,” said DeLauro in a statement.

While several states have their own breast density inform laws, they differ in descriptions and the amount of information that mammographers are required to provide to patients and referring physicians. They also do not all require women to be notified of their own breast density.

“A single national reporting standard would mean all American women receive equal information about the screening and risk implications of dense tissue and provide equal opportunity to discuss supplemental screening leading to earlier detection,” Joann Pushkin, the executive director of advocacy organization, www.DenseBreast-info.org, told Diagnostic Imaging.

The new law will include reporting language developed by the FDA, and dictates that reports must include at least the effect of breast density in masking the presence of tumors, the qualitative assessment of density by the provider interpreting the mammogram, and a reminder that individuals with dense breast tissue should speak with their doctors if they have questions about their report.

In a recent video interview with Diagnostic Imaging, Dr. Wendie Berg, a radiology professor at the University of Pittsburgh, said that for women with dense breasts, “about 40 percent of their cancers will be missed on mammography, and they may benefit from adding supplemental screening with ultrasound or MR.”

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