New info on breast density required with mammograms
WASHINGTON — All U.S. women getting mammograms soon will receive information about their breast density, which can sometimes make cancer harder to spot.
The new requirements, finalized Thursday by the Food and Drug Administration, are aimed at standardizing the information given to millions of women following scans to detect breast cancer. Regulators first proposed the changes in 2019 and health care providers will have 18 months to comply with the policy.
Some states already require that women receive information on breast density.
About half of women over age 40 have dense breasts, with less fatty tissue and more connective and glandular tissue. That tissue appears white on Xrays, the same color as growths in the breast, making mammograms harder to read. Dense breast tissue is one of the factors that can increase a woman’s chances of developing cancer.
Under the new rules, women with dense breasts will receive a written memo alerting them that their status “makes it harder to find breast cancer.” Those patients will also be directed to speak with their doctor about their results.
Professional guidelines don’t specify next steps for women identified with dense breasts, but some physicians may recommend additional forms of scanning, including ultrasound or MRI.
Breast imagers divide density into four levels, designated A, B, C and D, ranging from almost entirely fatty breasts to extremely dense breasts. Only the 10 percent of women in level D, with extremely dense breasts, are at increased risk. Those in level C are at average risk for cancer, based on density alone.
The updated regulations require that patients simply be told that their breasts are dense or not dense; levels A and B would be “not dense,” while C and D are “dense.”
The FDA will evaluate facilities to determine whether to award a certificate that verifies compliance with the new agency requirements, Dr. Hilary Marston, the agency’s chief medical officer, said.
But the situation with dense breasts and screening are not so straightforward, said Dr. Christoph Lee, a breast imager at Fred Hutchinson Cancer Center and director of the Northwest Screening and Cancer Outcomes Research Enterprise at the University of Washington. He fears the information women get about their breast density may be misleading.
Only a small minority of women with dense breasts are at increased risk for cancer based on breast density alone, Lee said, adding that “of all the clinical risk factors, breast density is only a moderate one.” Of much greater importance, he said, are risk factors such as family history and previous breast cancer.
The FDA’s hope is that the information — dense or not dense — will lead to a formal assessment by a doctor that can advise women if they are at overall higher risk.