Implementation has begun for a federal rule requiring mammography facilities to include breast density information in reports. The regulation comes in force as women worldwide mark breast cancer awareness month this October.
Mammography reports will now have a density assessment indicating whether a breast is dense or not dense, and the level of density. The Breast Imaging Reporting and Data System (BI-RADS) is used to identify four density classifications:
BIRADS-1: Predominantly Fatty Breast
Breast is not dense and composed mostly of fat tissue
BIRADS-2: Scattered Fibroglandular Densities
Breast has scattered fibroglandular or dense tissue surrounded by a high proportion of fatty tissue
BIRADS-3: Heterogeneously Dense Breast
Breast has a combination of fatty and dense tissue, which may affect detection of abnormalities
BIRADS-4: Extremely Dense Breast
Breast is has little fatty tissue and a high proportion of dense tissue, making detection of abnormalities difficult
More than 2 million women worldwide are diagnosed with breast cancer every year, making breast cancer the most common cancer among women. Women with dense breasts are up to five times at risk of breast cancer.
According to the National Cancer Institute, dense breasts are common and nearly half of women older than 40 have dense breasts.
Dense breast tissue make mammographs more difficult to read because, unlike fatty tissue which appears black, these appear white like lumps and abnormalities. Including breast density information in reports, allows women to make better decisions about further testing such as an ultrasound, MRI, and digital breast tomosynthesis or 3D mammography, which detects more cancers than standard 2D mammograms.
Apart from dense breast tissue, other high risk factors include early onset menstruation (before 12 years), late menopause (after 55 years), age (after 40 years), and the use of birth control pills or hormone replacement therapy. Lifestyle-related factors include high alcohol consumption, being sedentary, and being obese.
Breast cancer also affects men but women are 100 times more at risk of developing it.
The new rule from the U.S. Food and Drug Administration was issued in March 2023 with an effectivity date in 18 months. It is an amendment to modernize the 1992 Mammography Quality Standards Act by addressing recent medical research, screening practices, and digital imaging technology. It also has provisions strengthening federal oversight of mammography facilities in areas of patient communication and enforcement.
Breast Cancer Awareness month is a worldwide campaign every October to raise awareness and promote early detection. According to the World Health Organization, there is a 5-year survival rate of 90% for women diagnosed at stage I, while it is 22% for those diagnosed at stage IV.
WHO's Global Breast Cancer Initiative seeks to decrease mortality rates by 2.5 percent annually by 2040. The mortality rate is 70% in low-resource areas, and there is a 60% survival difference between breast cancer patients in high-income countries and women in low- and middle-income countries.
In the United States, annual screening mammograms without cost sharing are available to anyone insured 40 years and older through the Affordable Care Act. Several states began requiring breast density reporting in mammograms prior to the FDA's rule.
The American Cancer Society recommends an annual mammogram for women between 45 to 54, while those between 40 and 44 can have this done optionally, and those 55 and older can choose to have the test done every two years.
A yearly breast MRI is recommended for women 30 and older who are at a high risk for breast cancer.
Sources:
Image 1
Caption: A 3D mammogram of the left craniocaudal shows no abnormalities. Image from the National Cancer Institute, National Institutes of Health.
Image 2
Caption: An open-access 2013 image from the National Library of Medicine shows three different levels of breast density detected using the AutoDensity segmentation process.
Article
https://www.fda.gov/news-events/press-announcements/fda-updates-mammography-regulations-require-reporting-breast-density-information-and-enhance?utm_medium=email&utm_source=govdelivery
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