FDA to Implement New Mammogram Regulations to Support Women with Dense Breasts

Annual mammograms are vital for early detection of breast cancer, which affects one in eight women in the United States. However, some mammograms fail to detect the disease in women who have a higher breast density.

Dense breasts have more tissue and less fat, which makes reading mammograms more difficult as tissue and possible tumors both appear white in results, according to the American Cancer Society. The CDC also states that women with dense breasts have a higher risk of getting breast cancer.

Because of this, doctors will often suggest women with dense breasts have additional tests, such as a breast magnetic resonance imaging (MRI) or breast ultrasound.

The FDA is now planning to implement new regulations for informing patients about their breast density and screening options, according to a letter to Rep. Rosa DeLauro (D-CT) from Katherine Klimczak, the Acting Legislative Director for the Food and Drug Administration.

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The proposed amendments to the Mammography Quality Standards Act (MQSA) would require the patient's mammogram report summaries to indicate whether they have low- or high-density breasts and information on the "significance of breast density."

Radiologists would also be required to identify a patient as one of four breast density categories in their mammogram report, which will be sent to the patient's referring healthcare provider.

The FDA's letter states that the agency is "optimistic that the MQSA final rule will publish before the end of the 2022 calendar year or early 2023."

"After three years, I am pleased that the FDA has finally communicated that they believe they will be able to roll out a rule requiring providers to notify women of whether they have dense breasts, what this means for their risk of breast cancer, and the importance of speaking with a health care provider about breast density," DeLauro, chair of the United States House of Representatives Appropriations Committee, said in a release.

There are several states that already require women to be notified that they have dense breasts in their mammogram summary reports.

"The 38 states with existing inform laws provide varying levels of notification. 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, executive director of www.DenseBreast-info.org, said. "I applaud Rep. DeLauro for her persistence on behalf of American women."

According to the National Cancer Institute, early detection of breast cancer through mammograms allows patients to get a head start on treatment, and can decrease the likelihood of it spreading.

The American Cancer Society suggests that women should start thinking about getting annual mammograms when they turn 40, and that by the time they're 45 they should be getting them done yearly.

Health officials also advise women of all ages to practice "breast self-awareness," which means becoming familiar with how a person's own breasts normally look and feel, so they will be more likely to recognize anything out of the ordinary when doing a breast self-examination.