Epoch HealthNew Breast Cancer Screening Requirement Takes Effect: FDA

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The US Food and Drug Administration (FDA) has implemented a new requirement for mammography facilities to inform women about their breast density. This measure, effective September 10, 2024, aims to enhance breast cancer screening by addressing the challenges dense breast tissue poses in cancer detection. The mandate highlights the importance of breast density as both a risk factor for breast cancer and a potential barrier to accurate mammogram interpretation.

Key Points:

• Approximately 50% of women over 40 in the United States have dense breast tissue.
• Dense breast tissue appears white on mammograms, similar to cancer tumors, making detection more challenging.
• The FDA mandate requires reporting breast density in four categories: entirely fatty, scattered areas of fibroglandular density, heterogeneously dense, and extremely dense.
• Women with extremely dense breasts have a 20-40% increased risk of breast cancer and the highest chance of missed cancer detection.
• Additional screening methods like ultrasound or MRI may be considered for women with dense breasts, though insurance coverage varies.
• A 2022 study showed that false positives are more prevalent than false negatives in mammograms, with a 56% chance of false positive over 10 years for annual digital mammography.
• Age remains the strongest risk factor for breast cancer, with most cases developing in women 50 or older.

“Like looking for a snowman in a snowstorm.”
— Dr. Jennifer Harvey, Clinical Radiologist and Chair of Imaging Sciences at the University of Rochester, describing detection of cancer in women with dense breast tissue.

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