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Published on March 28, 2023

FDA’s new rules for mammograms aren’t new for Cape CodBreast Density Guidelines

Hearing that the Food and Drug Administration (FDA) now requires mammogram providers to inform patients about breast density confused some Cape Cod Healthcare patients because they have been receiving those letters since 2015.

It’s a matter of the federal regulations catching up with us, according to Anne Morris, MD, radiologist at Cuda Women’s Health Center in Hyannis.

“This is nothing new,” she said. “Nothing will change for our patients because we currently send letters informing them about their level of breast density. Patients can also access their mammography results on MyChart if they have signed up for the patient portal, and they will still get the breast density letter.”

It is easy to understand why news about the FDA mandate around breast density reporting confused some people who questioned how this regulation differed from current practices. Until now, Massachusetts and more than 30 other states already notified mammogram patients about the density of their breast tissue. The new FDA ruling made the letters a nation-wide requirement.

New Alert to Lifetime Risk

Along with notification of their breast density, mammography patients will, beginning next month, receive a notice of their lifetime risk of breast cancer, if higher than normal, said Dr. Morris. The percentage lifetime risk will be in their report, which will be sent to their primary care physician. Lifetime risk will be calculated using the Tyrer-Cuzick risk model.

Why breast density matters

Breast density reporting laws originated with Nancy Capello, Ph.D., whose advocacy resulted in Connecticut passing the first bill in 2009.

“My dense breast tissue remained hidden in my medical records for 11 years,” Capello said in an article on her website, entitled Are You Dense? Exposing the best kept secret.

When she was diagnosed with stage 3C breast cancer, Capello was finally told that her mammograms had revealed dense breasts that put her at higher risk for cancer and made cancer more difficult to detect.

“The first thing patients need to know is that dense breasts are common and normal,” said Dr. Morris.

There are four categories of breast density:

  • Fatty
  • Scattered
  • Heterogeneously dense
  • Extremely dense

“About 50 percent of women have heterogeneously dense or extremely dense breast tissue, which makes it more difficult to find breast cancer on a standard 2-D mammogram,” she said.

According to Dr. Morris, dense breast tissue and cancer both are white on a mammogram, so breast density notifications were intended to let patients know that radiologists may not be able to see cancer due to the density of their breast tissue.

“Women with dense breasts have a higher rate of breast cancer and should discuss their breast density status, its effect on their breast cancer risk, and the potential need for further screenings with their primary care physician,” she said.

3D (Tomosynthesis) Mammography

3D mammography is extremely helpful when clinicians are dealing with dense breasts, and this advanced technology is the standard for screening mammograms at Cuda, Dr. Morris explained.

“With 3D mammography, we are already performing the test that is commonly recommended for women with dense breasts,” she said.

Like conventional 2-D screening, 3D mammography uses X-rays to produce images of breast tissue. However, unlike 2-D mammography, the 3D machine moves around the breast, taking pictures at different angles in much the same way as a CT scan. The array of pictures creates a multi-layered, in-depth view. The extra dimension makes the tomosynthesis machine better at finding cancer in women with dense breasts, said Dr. Morris.

Only patients with tremors, those who have trouble holding their breath or who are unsteady on their feet are not good candidates for 3D mammography.

Breast MRIs

Patients at high risk (women with a strong family history or greater than 25 percent lifetime risk of getting breast cancer) can receive breast MRIs, she said.

State-of-the-art FAST MRI, an abbreviated and more cost-effective version of the standard MRI, is available through our Women’s Health Centers:

Your next mammogram

You can conveniently schedule your mammogram online using MyChart. From your own phone, tablet or personal computer, log in to your patient portal and select the place and time that’s most convenient for you.

Mammograms are available at Cuda Women’s Health Center in Hyannis, Seifer Women’s Health and Imaging Center in Falmouth and Fontaine Outpatient Center in Harwich.

A screening mammogram is the best way to detect breast cancer in its earliest stages when it can be treated effectively, beginning at age 40 for women of average risk, according to the U.S. Centers for Disease Control.

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