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FDA guidance on dense breast tissue

This #WomensHealthMonth, let us highlight the silent risk of dense breast tissue, a factor affecting 1 in 2 women over 40. Dense breast tissue does not only make mammography difficult but also increases the risk of developing breast cancer. As per new FDA regulations, screening units must notify patients about their breast density, an essential step towards effective detection.

On March 9, 2023 the U.S. Food and Drug Administration published updates to the mammography regulations to require mammography facilities to notify patients about the density of their breasts.

With 1 in 8 women getting breast cancer in their lifetime, quality mammography, is very important for early breast cancer detection. Approximately half of women over the age of 40 in the U.S. have dense breast tissue, a description of its appearance on a mammogram. Dense breast tissue can make cancers more difficult to detect on a mammogram.  Additionally, dense breasts have been identified as a risk factor for developing breast cancer. The amendments finalized today provide specific language explaining how breast density can influence the accuracy of mammography. They recommend patients with dense breasts talk to their health care provider about breast density, risks for breast cancer and their individual situation. Helping to promote patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy.

The Breast Imaging Reporting and Data System (BI-RADS) includes four categories for breast density reporting: A) almost entirely fatty; B) scattered areas of fibroglandular density; C) heterogeneously dense, which may obscure small masses; or D) extremely dense, which lowers the sensitivity of mammography. Categories A and B are “not dense” and categories C and D are considered “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; overall about 7% of women of mammographic age have extremely dense breasts.

However, we still need improved solutions for early detection. Traditional mammography misses 25%-40% of breast cancers in women with dense breasts.

Using symptomatic clinical (interval cancer) detection as the gold standard, about 25% of breast cancers are missed on mammography in women with heterogeneously dense breasts as are about 40% in women with extremely dense breasts , even with tomosynthesis. If one includes cancers visible only on MRI, mammographic sensitivity is as low as 30-35% in women of all density categories. The risk of developing cancer associated with extremely dense breasts is 4-6 fold that of fatty breasts, or two-fold compared to scattered fibroglandular tissue. This compares to an approximately two-fold higher risk with one first-degree relative with breast cancer or two second-degree relatives on the same side of the family, depending on age at diagnosis.


Effective September 10, 2024, letters will be required to tell a woman her breasts are “dense” or “not dense,” that dense tissue makes it harder to find cancers on a mammogram, and also increases the risk of developing cancer. Women with dense breasts will also be told that other imaging tests in addition to a mammogram may help find cancers. Implementing appropriate supplemental screening should be based on patient risk for missed breast cancer on mammography; such an assessment should include consideration of breast density and other risk factors. Breast imaging centers should have a consistent approach to recommending supplemental screening and consider ways to facilitate ordering of such imaging by referring clinicians. Insurance barriers to supplemental screening and diagnostic breast imaging remain and will need to addressed through federal legislation

Introducing a breakthrough in breast cancer screening with the THERMOMIND VISION ONE thermal-sensor-based, contact-free, radiation-free screening modality.

THERMOMIND, are developing a breakthrough in breast cancer screening through VISION ONE a thermal-sensor-based, contact-free, radiation-free screening modality that is not dependent on breast density for its accuracy and epitomizes patient centric care.

Fifteen VISION ONE devices are being built to be deployed for clinical trials starting this summer in 11 hospitals in the US, Europe, Israel. Some 28,000 participants are to be screened over the next three years, through our EU funded Thermobreast project.

FDA guidance on dense breast tissue
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