In September 2024, the US Food and Drug Administration (FDA) issued a mandate requiring mammography centers to inform over 40 million women receiving annual mammograms in the United States about their breast density. This decision aims to enhance the shared decision-making process between patients and healthcare providers regarding breast density and screening options. Approximately half of all women in the US have dense breasts, a condition that complicates breast cancer screening and diagnosis.
Women with dense breasts, who do not have other risk factors for breast cancer, should not be automatically considered at high risk for the disease. Despite the lack of randomized trials demonstrating a reduction in breast cancer deaths by adding MRI or ultrasound screenings to mammograms for asymptomatic women with dense breasts, there is ongoing research into the effectiveness of these supplemental screenings.
A comparative effectiveness analysis published in 2024 suggests that integrating MRI with digital breast tomosynthesis for women aged 40-74 with dense breasts could potentially save more lives. However, this approach also increases the likelihood of false-positive results and benign biopsies.
"would lead to more lives saved (9.5 vs 8.5 per 1000 women screened) but increased the number of false-positive results (1850 compared with 1392 per 1000 women screened) and benign biopsies (628 vs 221 per 1000 women screened)." – Authors of a comparative effectiveness analysis published in 2024
The FDA's mandate is designed to provide clarity and guidance, but it also "increases the complexity of breast cancer screening for women and their clinicians, many of whom may not be prepared to interpret and act on information about breast density," according to a paper published in JAMA Insights.
"increases the complexity of breast cancer screening for women and their clinicians, many of whom may not be prepared to interpret and act on information about breast density." – Authors of a paper published in JAMA Insights
Dr. Christoph I. Lee and Dr. Joann G. Elmore, both funded in part by the National Cancer Institute for their research on breast cancer, have offered an evidence-based summary to assist healthcare providers in discussing breast density with patients. They emphasize the accuracy of digital mammography and digital breast tomosynthesis in detecting breast cancer, even in dense breasts.
"Digital mammography and digital breast tomosynthesis have high accuracy for detecting breast cancer, even for dense breasts (digital breast tomosynthesis sensitivity is [about] 88% for all women and 77% for women with dense breasts)." – Christoph I. Lee, MD, MS, and Joann G. Elmore, MD, MPH
A population-based modeling study suggests that adding supplemental ultrasonography every other year for women aged 50-74 with dense breasts who previously had negative mammograms could be advantageous. The study indicates that this addition might lead to more lives saved but also an increase in false-positive results and benign biopsies.
Dr. Lee and Dr. Elmore's work is supported by various institutions, including personal fees from UpToDate, DeepHealth/RadNet, and editorial board work with the American College of Radiology. Dr. Lee also receives royalties from McGraw Hill, Oxford University Press, and UpToDate.
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