FDA To Require Disclose of Dense Breast Tissue Presence To Reduce Cancer Risk

The United States Food and Drug Administration (FDA) is set to issue new mammogram regulations guidelines requiring clinics to disclose dense breast tissue presence to reduce cancer risk among patients.

The new updates will give the agency more oversight over individual mammography facilities. The decision aims to improve patient care and communications. A technician uses a special X-ray machine during a screening mammogram to detect abnormalities that could indicate a risk of breast cancer.

New Mammography Guidelines

The images can show whether or not a woman has dense breast tissue, making it more difficult for health experts to detect cancer warning signs. These women with dense breast tissue are also at a higher risk of developing the deadly illness than others.

In a statement, the chief medical official of the FDA in Silver Spring, Maryland, Hilary Marston, said during a press release that the agency's actions represent its broader commitment to supporting the innovation of technology that would prevent, detect, and treat cancer, as per Fox News.

She added that since 1992, the FDA has continued to work to ensure patients can access quality mammography. Marston noted that the impact of the Mammography Quality Standards Act on public health has been crucial. This includes a steep reduction in facilities that do not meet quality standards.

The chief medical official noted that this meant more women gained access to consistent, quality mammography. Marston said that the agency continues to commit to advancing efforts that would help improve women's health and strengthen the fight against breast cancer.

A breast cancer surgeon and co-director of the Breast Care Center of Excellence at Sutter Health California Pacific Medical Center in San Francisco, Anne Peled, M.D., said she also recognized the importance of the agency's new guidance on breast cancer detection.

Recognizing the Threat of Breast Cancer

Breast imagers divide density into four levels, designated A, B, C, and D, and range from almost entirely fatty to highly dense breasts. Currently, only about 10% of women in level D have extremely dense breasts, which are at increased risk, according to the New York Times.

The FDA's updated regulations will require that patients be notified that their breasts are either dense or not. This means that levels A and B are "not dense," and levels C and D are "dense."

The agency will evaluate facilities to determine whether or not to award a certificate that would verify compliance with the updated regulations. This would mean that if a woman does not see a facility's certificate, she has the right to ask for it or check the FDA's website.

The FDA's new guidance was first proposed in 2019, and the recent approval would give healthcare providers 18 months to comply with the changes. The decision comes as some states already require that women be given information about their breast density, said Fox8.

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