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FDA proposes change to require breast density notification

New regulations on breast density put women in the driver's seat for their mammograms and their health

April 3, 2019

Alexandria, Va.—The Food and Drug Administration (FDA) last week proposed new steps to improve mammography quality standards. Among the changes is a proposed rule requiring mammography facilities to notify women with dense breasts about their breast tissue and the impact of breast density on the accuracy of their mammograms.

These mammography standards, part of the Mammography Quality Standards Act of 1992 (MQSA), have not been updated in more than 20 years. The FDA’s proposed changes will help modernize mammography standards based on the latest science and provide patients with the information they need to make important decisions about their breast health.

Because dense breast tissue and cancer both appear as white on a traditional mammogram, this can mask signs of breast cancer and lower the diagnostic accuracy. There are a variety of additional or alternative screening options beyond traditional mammograms for women with dense breasts. These include, but are not limited to, 3-D mammograms, ultrasounds and MRIs.

“When women know their breasts are dense, they are better equipped to advocate for their health and understand their options when it comes to screening,” said Carolyn Aldigé, Founder and CEO of the Prevent Cancer Foundation®. “Early detection saves lives, and when women are unaware of their risk from the limitations of traditional mammography for screening dense breasts, cancer may be detected at later stages, when it is harder to treat successfully. Knowing your breast density can make the difference between an early diagnosis and a late one.”

Nearly half of women age 40 and older who get mammograms are found to have dense breasts, so this new guidance can save many lives. The Prevent Cancer Foundation® supports regulation to improve screening standards and patient education on cancer risk factors and early detection.

References:

National Cancer Institute (ACS). (2019) “Dense Breasts: Answers to Commonly Asked Questions”

Food and Drug Administration (FDA). (2019) “FDA advances landmark policy changes to modernize mammography services and improve their quality”

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