FDA will require mammogram reports to include breast density information


Recently updated regulations from the US Food and Drug Administration will require mammography facilities to inform patients of their breast density.

Women with dense breasts are at higher risk for breast cancer, and dense tissue can make cancer harder to detect on mammograms. Yet few women recognize dense breasts as a significant risk factor for cancer.

The FDA update announced Thursday will also strengthen the agency’s oversight of mammography facilities, allowing it to communicate directly with patients if a facility is not meeting standards.

“Today’s action represents the agency’s broader commitment to supporting innovation to prevent, detect, and treat cancer,” said FDA Chief Medical Officer Dr. Hilary Marston.

About 1 in 8 women will develop breast cancer in her lifetime, according to the US Centers for Disease Control and Prevention, and mammography remains the best screening and detection tool for breast cancer.

Dense breast tissue refers to breasts made up of more fibroglandular tissue than fatty tissue. It’s usual; the FDA says it is present in about half of women having mammograms.

But it appears white on a mammogram, making the cancer — which also appears white — harder to detect, according to the American Cancer Society. Dense breasts are also associated with an up to four times higher risk of breast cancer.

Thirty-eight states require women to receive written notification of their breast density and its potential risk of breast cancer after having a mammogram; however, the language varies and does not always require providers to inform a patient of their risk.

“Even though women are usually notified in writing when they receive a report after a mammogram that says, ‘You have increased breast density’, it’s kind of just hidden at the bottom of the report. I’m not sure anyone explains to them, certainly in person or verbally, what that means,” Dr. Ruth Oratz, a breast oncologist at NYU Langone’s Perlmutter Cancer Center, told CNN earlier this year.

The new changes require facilities to provide patients with information about their breast density and to include specific language in mammogram reports to explain how breast density can influence the accuracy of a mammogram.

Additionally, the FDA requires facilities to recommend that patients with dense breasts speak to their healthcare provider about breast density, breast cancer risks, and their individual circumstances.

“The idea is to provide information that you can discuss with your supplier to make more informed decisions, including whether to consider next steps,” the FDA said in a statement.

The amendments, which amend the Mammography Quality Standards Act of 1992, must be implemented within 18 months. The FDA says these new regulations will improve inspection of mammography practices and communication with patients and providers.

“This is to ensure that important information that could affect decisions about patient care, such as the potential need for further evaluation or a repeat mammogram, is communicated as fully as possible,” the statement said. ‘agency.

The American Cancer Society has applauded the FDA’s new rule, saying it will reduce diagnostic delays.

“The final rule will improve screening by addressing new technologies, better enforcement of facility accreditation and quality standards, and improve reporting that is provided to women and their physicians,” the ACS said in a statement. communicated.

The ACS said that while the new changes can help reduce breast cancer death rates, there is still work to be done to ensure that all women have access to high-quality mammograms.

“Despite these advances, we remain concerned that the FDA has not included provisions to address variability in the quality of mammography interpretation and encourage the FDA to act immediately on this issue,” said ACS CEO Dr. Karen Knudsen in a statement.

According to the organization, “black women are more likely to have lower quality screening, which contributes to the current disparity” in breast cancer mortality among black and white women.

A study published last year found that the breast cancer death rate fell by 43% over three decades, from 1989 to 2020, translating into 460,000 fewer breast cancer deaths during that time. But when the data was analyzed by race, black women had a lower breast cancer incidence rate than white women, but the death rate was 40% higher among black women overall.

Leave a Comment