FDA to Offer New Mammogram Standards Supporting People With Dense Breast Tissue
Women with dense breasts have a higher risk of developing breast cancer—and mammograms are more likely to miss small tumors in dense breasts. That’s why it’s so important to at least be aware if you have dense breasts.
Now, the Food and Drugs Administration (FDA) is poised to introduce new regulations that would require healthcare providers to inform patients about their breast density. That’s the takeaway from a letter sent to Rep. Rosa DeLauro from Katherine Klimczak, the acting legislative director for the FDA.
In the letter, Klimczak said that the FDA wants to “modernize” its breast cancer screenings by requiring healthcare providers to “identify whether the patient has one of two categories of density.” Those categories would be low or high density, along with a paragraph on the significance of breast density, Klimczak said.
Klimczak also wrote that the FDA is “optimistic” that the new regulation will go into effect before the end of this year or early next year.
The regulation is a big deal because many women have no clue about their breast density and what it can mean for their overall health. But given that breast density isn’t discussed often, you probably have some questions. Here’s what you need to know.
What are dense breasts, exactly?
To understand what dense breasts are, it’s important to first go over what makes up breasts in the first place. Breasts are composed of three kinds of tissue: Fibrous tissue that holds the breast in place; glandular tissue that makes milk (lobes) and the tubes (aka ducts) that carry milk to the nipple; and fatty tissue that fills the space between the fibrous tissue, lobes, and ducts, and gives breasts their size and shape, according to the Centers for Disease Control and Prevention (CDC).
Breast density is the amount of fibrous and glandular tissue in a woman’s breasts compared with the amount of fatty tissue in the breasts, the CDC explains.
Breast density is usually broken down into four categories on a mammogram, per the CDC. Those include:
The breasts are almost entirely fatty (about 10% of women)
A few areas of dense tissue are scattered through the breasts (about 40% of women)
The breasts are evenly dense throughout (about 40% of women)
The breasts are extremely dense (about 10% of women)
If your breasts are almost entirely fatty or have a few areas of dense tissue, they’ll be categorized as low-density. If they’re evenly dense or extremely dense, they’re considered high density, the CDC says. Overall, “having dense breasts is pretty common,” says women’s health expert Jennifer Wider, M.D.
How to tell if you have dense breasts
Unfortunately, this isn’t just something you can figure out on your own. You can’t feel or see if you have dense breasts during a breast self-exam or clinical exam by your doctor, according to the National Cancer Institute (NCI). There's also nothing about the size, shape, or perkiness of your breasts that would indicate if they're dense, says Jeff Hawley, M.D., associate professor and division head in the Section of Breast Imaging at The Ohio State University Wexner Medical Center. Instead, he says, you’d need to have a mammogram to tell if you have dense breasts. “Most women wouldn’t know that they have dense breasts unless they were told after a screening,” Dr. Wider says.
Ultimately, “radiologists—doctors who interpret mammograms—determine whether a woman has dense or non-dense breasts based on the mammogram appearance,” says Dana Ataya, M.D., a breast radiologist at Moffitt Cancer Center.
However, the CDC says that there are certain risk factors for having dense breasts. Those include:
Being younger
Being pregnant or breastfeeding
Taking hormone replacement therapy
Having a lower body weight
In general, though, breast density is inherited, the NCI says.
What is the importance of breast density?
While breast cancer is a complex disease, the more dense your breasts are, the higher your risk of breast cancer, the CDC says. “It’s because there’s more glandular tissue—that’s where breast cancer occurs,” says Richard Reitherman, M.D., Ph.D., a radiologist and medical director of breast imaging at MemorialCareBreast Center at Orange Coast Medical Center in Fountain Valley, Calif.
Dense breast tissue can also hide cancers on a mammogram. “Dense tissue looks white on a mammogram. Breast cancers can also look white on a mammogram. So having more dense tissue can potentially hide a breast cancer on a mammogram,” Dr. Ataya says.
Women with dense breasts may also be called for follow-up testing more than women with fatty breasts, the NCI says.
What to do if you have dense breasts
"There’s no reason to be anxious about this,” Dr. Hawley says. “It’s fairly common and a normal finding on a mammogram.” Just because you have dense breasts doesn’t mean you’ll get breast cancer—the CDC stresses that there are many factors that go into a person’s risk of developing breast cancer. “It just means you need to be aware that there could be masking [of a tumor] and increased risk of cancer,” Dr. Reitherman says. “It doesn't mean you’re going to have breast cancer.”
But the CDC recommends talking to your doctor about your personal risk of breast cancer if you have dense breasts. And, if you have an abnormal finding on your mammogram, your doctor may recommend that you get follow-up testing like a breast ultrasound or MRI of your breasts, just to be sure that you’re getting an accurate reading. “Women with dense breasts have a higher risk of cancer, so it’s imperative to receive proper detection methods on annual appointments,” Dr. Wider says.
Keep in mind, too, that your breasts can change. “Breast density can change and become less dense over time,” Dr. Reitherman says.
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