New FDA Rules on Mammograms

The Food and Drug Administration (FDA) updated regulations on mammograms this month. The new rules are part of the Mammography Quality Standards Act. Some of the new rules upgrade standards for certification for clinics, calling for things like referrals to healthcare providers for self-referred patients and tight standards for avoiding lost reports.

The change that is making headlines, though, is the new reporting requirement for dense breast tissue. 

Dense breasts

There has been a rule for some time requiring not only a medical report following mammograms but also a report written in ordinary language so patients can easily read and understand it. Under the new rule, this report must include information on dense breast tissue, including whether or not each patient has dense breast tissue.

In an effort to better inform patients of their risk, The Breast Center, A MANA Clinic has provided breast density information on mammogram reports since 2012. 

Understanding Dense Breast Tissue

What will the report say?

The new rule specifies the language to be used on this subject. For patients with low breast density, the report to the patient will say, “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.”

For patients with dense breasts, the report will say, “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.”

Actions to take

People with dense breasts need this information and 40% of women have dense breast tissue. First, dense breasts can be harder for mammograms to read. In addition, studies suggest that women with dense breast tissue may be at greater risk for breast cancer.  

In addition to mammograms, women with dense breasts should consider Dense Breast Ultrasound Screening. This automated breast ultrasound can find cancers that mammograms miss in dense breast tissue. This exam is painless, covered 100% by most insurance plans, and can be scheduled at the same time as your mammogram at The Breast Center in Fayetteville or Bentonville. 

All women should have annual mammograms beginning at age 40. If you have dense breast tissue, you should also consider breast ultrasound screening. Discuss your concerns with your primary care physician, or contact The Breast Center with any questions.