FDA's dense breast notification requirement explained

 

 Per Becker's Hospital Review, "effective Sept. 10, healthcare facilities providing breast imaging services will be required to notify patients of their breast density in mammography reports. 

Radiologists are required to send two mammography reports, one to physicians and a more simplified 'lay' report to patients. A patient's breast density has almost always been included in the report radiologists send to physicians. Whether breast density has been included in the patient report has varied by state."

 For patients, this means their report will include:

• The patient's name, and the name, address, and telephone number of the facility performing the exam.
• Depending on whether the patient's breast density is dense or not dense, as indicated by the mammography report, the patient lay summary must include one of the following notification statements:
• Not dense: "Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation." 
• Dense: "Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation."

 While full mammography reports include:

• Name and location of the facility performing the exam, (at a minimum the city, State, ZIP code, and telephone number).
• An overall final assessment of findings, classified into one of the following categories: 
• Negative
• Benign
• Probably Benign
• Suspicious
• Highly Suggestive of Malignancy
• Known-Biopsy-Proven Malignancy
• Post-Procedure Mammogram for Marker Placement. 
• In cases where no final assessment category can be assigned due to incomplete work-up, the report should indicate:  
• Incomplete: Need additional imaging evaluation
• Incomplete: Need prior mammograms for comparison.
• An overall assessment of breast density, classified in one of the following categories: 
• "The breasts are almost entirely fatty." 
• "There are scattered areas of fibroglandular density." 
• "The breasts are heterogeneously dense, which may obscure small masses." 
• "The breasts are extremely dense, which lowers the sensitivity of mammography."

 Why should patients know their breast density?

Dense breast mammograms are significantly whiter than non-dense breast mammograms. Cancer, too, typically appears white on a mammogram, meaning a radiologist is often "looking for something white in a field of white," Dr. Vincoff said. 

"But having dense breasts doesn't just make your mammogram more difficult to read, it also increases your risk for developing breast cancer," she said. 

Having dense breasts means a patient may be a good candidate for additional cancer screening. 

"It's really important information for a patient [to have] for both reasons," Dr. Vincoff said. The FDA regulation requires patients in every state to be notified not only of their breast density, but also told what that density means. Patients will learn that their density means their mammogram might be limited and they might have an increased risk for developing breast cancer.

This is an interesting website I found about breast density: https://densebreast-info.org/