The FDA’s rule change requiring providers to inform women about breast density could lead to a flurry of questions
The U.S. Food and Drug Administration finalized a regulation in early March 2023 that updates mammography reporting requirements. The new regulation goes into effect on Sept. 10, 2024, and will require that all women receive information about breast density following a mammogram. It will also require they be told in their mammogram report that dense breast tissue can mask cancer and make cancer more difficult to detect.
The Conversation asked Dr. Wendie A. Berg, professor of radiology at the University of Pittsburgh School of Medicine, to explain how the rule change could affect screening recommendations as well as the way people interpret their results.
All breasts are made up of a mix of fat, milk glands and ducts. The glands are supported by fibrous tissue and ligaments, collectively called “fibroglandular tissue.” The more fibroglandular tissue a woman has, the “denser” her breast tissue.
When a woman has a mammogram, the radiologist reviewing it will describe her breast density using one of four categories: A) fatty, B) scattered tissue, C) heterogeneously dense or D) extremely dense. Categories C and D are considered “dense” whereas categories A and B are “not dense.”
Dense breasts are normal and common. Over 50% of women have dense breasts before menopause, as do about 40% of women in their 50s and 30% of women in their 60s. Breasts can become less dense after menopause, but a woman with extremely dense breasts will likely continue to have dense breasts all her life.
Breast density matters for two reasons. Most importantly, dense breast tissue can hide cancer on a mammogram. About 40% of breast cancers will go unseen on mammography in the densest breasts, labeled “extremely dense breasts,” and about 25% will go undetected in heterogeneously dense breasts.
Secondly, dense tissue also increases the risk of developing breast cancer, with about fourfold the risk of breast cancer in extremely dense breasts compared with fatty breasts, and about twofold the risk compared to breasts with scattered tissue.
Until now, 38 states plus Washington, D.C., have had varying laws about what to tell women about breast density. This has resulted in inconsistent levels of information being provided to U.S. women depending on where they live.
Beginning in September 2024, the FDA’s final rule creates a uniform national standard requiring that all women be informed in the mammogram results letter that their breasts are either “dense” or “not dense.” They will be told that dense tissue can hide cancer on a mammogram and that it also raises the risk of developing breast cancer.
The new regulations require that the specific density category be included in all mammography reports that go to the referring health care provider. Some states require the specific density category also be included in the patient results letter, and this information can be included, but must be separate from the language required by the FDA. The FDA notification cannot be altered in any way.
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