Increased breast density is a biological feature that affects around fifty percent of U.S. women over the age of forty. Unfortunately, it is a risk factor for developing breast cancer. According to the Memorial Sloan Kettering Cancer Center, those with the highest breast density are four to six times more likely to get the disease than those with less dense tissues.
Even so, many women remain unaware of their breast density and how it affects their risk of breast cancer and their mammography results. For this reason, the U.S. Food and Drug Administration (FDA) has recently updated its regulations under the Mammography Quality Standards Act (MQSA) of 1992, which aims to ensure quality mammography for all women in the country. The MQSA gives the FDA authority to oversee mammography facilities and enforce higher standards.
Authorities published the updated regulations on March 9, 2023. They now require mammography facilities to tell patients about their breast density after each mammogram and the increased risk of developing cancer if they have dense breasts.
The FDA has been working to ensure mammogram quality since the introduction of the MQSA over thirty years ago. The result has been a significant reduction in healthcare facilities offering patients a poor standard of care. New powers will come into force within 18 months and cover multiple areas, including facilities’ accreditation, certification, inspection, and enforcement of standards.
The FDA claims the amendments bring MQSA standards into the 21st century. Modernized regulations include various mammography best practices to enhance breast cancer detection and provide patients with more relevant information regarding their health.
Why Is Mammography Important To The FDA?
Mammography is a vital tool for the early detection and diagnosis of breast cancer, the most common cancer among women in the U.S. The American Cancer Society says there are 297,790 new cases of invasive breast cancer annually and over 43,700 deaths. Early detection of breast cancer can improve survival rates and reduce the need for more aggressive treatments.
Unfortunately, as the FDA argues, mammogram quality standards are not universal. The quality and accuracy of the diagnostic method can vary significantly depending on the equipment used, the training and experience of the staff, and the interpretation of the images by the radiologist.
More importantly, some women are at a higher risk than others, and that’s the driving force behind the new regulations. Genetics, family history, and breast density are all factors that make diagnosis more likely.
What Is Breast Density, And Why Does The FDA Consider It Important?
Breast density refers to the quantity of fibrous and glandular tissue in the breasts compared to fatty tissue. It doesn’t affect how breasts look and feel but can affect mammogram outputs. Traditional systems find it challenging to distinguish between dense breast features and signs of cancer, such as lesions or calcifications.
Primarily, this outcome has to do with how dense breasts appear. Fibrous tissue appears white or great on a mammogram, the same as breast cancer artifacts, making them harder to see in some patients.
How New Hologic Dimensions 3D Mammography Systems Improve Breast Cancer Diagnosis For Dense Breasts
Fortunately, this problem is being solved. Technology improvements are complementing the FDA’s recent regulatory updates. Hologic Dimensions 3D Mammography systems improve breast cancer diagnosis accuracy for patients with dense breasts by reducing the risk of false positives or negatives.
Hologic Dimensions 3D Mammography systems use digital breast tomosynthesis (DBT) technology to create 3D images of the breast. DBT is a technique that takes multiple low-dose X-ray images of the breast from different angles and reconstructs them into a 3D image that can be viewed as thin slices. As a result, radiologists can see features between overlapping fibrous glandular tissues to diagnose breast cancer cases more confidently and accurately.
Several clinical studies point to the effectiveness of the Dimensions 3D Mammography system, an upgrade of the older Hologic Selenia units. Research shows they offer superior performance to 2D mammography in detecting breast cancer in women with dense breasts. For instance, large-scale studies find they can increase breast cancer detection by 41 percent and reduce false-positive recalls by 15% in women with dense breasts.
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