The FDA's updated mammography regulations aim to protect people with dense breasts

The FDA's updated mammography regulations aim to protect people with dense breasts

Updated FDA regulations now require mammography providers to inform their patients about their breast density. Approximately 50% of women age 40 and older who undergo mammograms have dense breasts. Dense breasts are considered a risk factor for breast cancer; Additionally, dense breasts make mammograms difficult to read and interpret.

Mammography screening providers must inform patients if they have dense breasts and explain how dense breasts may affect the accuracy of the mammogram, the Food and Drug Administration said in a news release Thursday.

The updated regulations are intended to improve patients' access to information about what it means to have dense breasts, how dense breasts can affect breast cancer risk, and how best to develop a comprehensive breast health strategy with their health care provider.

“Today’s action represents the agency’s broader commitment to supporting innovations to prevent, detect and treat cancer,” Hilary Marston, MD, MPH, FDA chief medical officer, said in the press release.

Approximately 50% of women age 40 and older who undergo mammograms have dense breasts, which is considered a risk factor for breast cancer. Additionally, dense breasts can make mammograms difficult to read and interpret, ultimately making mammograms less sensitive and more likely to miss cancer.

The updated regulations must be rolled out nationwide within the next 18 months. Here's how the FDA's new guidance may affect your next mammogram.

What does it mean to have dense breasts?

All breasts are made up of a combination of glandular tissue, fibrous connective tissue and breast fatty tissue. Breast density refers to the amount of certain types of breast tissue relative to other types.

Dense breasts in particular have larger amounts of glandular tissue and fibrous connective tissue compared to fatty tissue.

A person's breast density can be determined using a mammogram. In fact, a system developed by the American College of Radiology called the Breast Imaging Reporting and Data System (BI-RADS) classifies breast density into four categories:

Completely fatty breast tissue: Breasts consist almost entirely of fatty tissue.Scattered fibroglandular breast tissue: Breasts are composed primarily of fatty tissue with some areas of dense glandular and fibrous connective tissue.Heterogeneously dense breast tissue: Breasts have many areas of dense glandular and fibrous connective tissue, as well as some areas of fatty tissue.Extremely dense breast tissue: Breasts consist almost entirely of dense glandular and fibrous connective tissue.

Most women fall into the middle two categories. Scattered fibroglandular breast tissue and heterogeneously dense breast tissue are found in 80% of women - each category occurs in 40% of women. About 10% of women have completely fatty breast tissue and about 10% have extremely dense breast tissue.

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How is breast density communicated to patients?

Prior to the updated regulations, mammography providers were not required to report breast density in reports to health care providers or to provide a lay summary to patients with dense breasts.

However, between 2009 and 2021, 38 states have enacted laws requiring reporting of breast density, although requirements vary from state to state.

That means some people who undergo mammograms may not notice any changes in their health care, said Sandra B. Brennan, MBBCh, BAO, FRCR, director of radiology at Memorial Sloan Kettering Westchester. "But for women in states without breast density legislation... these women will do it." [now] be informed about their breast density.”

Nationwide, breast density is classified into one of the following categories using the following language:

A: "The breasts are almost entirely fatty." B: "There are isolated areas of fibroglandular density." C: "The breasts are heterogeneously dense, which may obscure small amounts." D: "The breasts are extremely dense, which lowers the sensitivity of mammography."

Breasts are considered “non-dense” if they fall into categories A or B. In this case, the FDA directs that the summary provided to the patient should contain this statement:

"Breast tissue can be either dense or non-dense. Dense tissue makes it difficult to find breast cancer on a mammogram and also increases the risk of developing breast cancer. Your breast tissue is not dense. Talk to your doctor about breast density, breast cancer risk and your individual situation."

If a person's mammogram results fall into category C or D, their breasts are considered dense. This patient's summary should contain the following wording:

"Breast tissue can be either dense or non-dense. Dense tissue makes it more difficult to find breast cancer on a mammogram and also increases the risk of developing breast cancer. Your breast tissue is dense. For some people with dense tissue, other imaging techniques in addition to a mammogram may be helpful in detecting cancer. Talk to your doctor about breast density, breast cancer risk and your individual situation."

Breast density results must be reported to patients within 30 days of the mammogram. That number drops to just seven days if a person's mammogram shows images that could indicate breast cancer.

Risks associated with dense breasts

Dense breasts can influence a person's risk of breast cancer and impact breast cancer diagnosis.

“Dense breasts can make it difficult to detect cancer on a mammogram,” Brennan explained. “Dense tissue appears white on a mammogram and can obscure cancer.”

People with dense breasts also have a higher risk of developing breast cancer. Compared to people with fat breasts, people with dense breasts are four to five times more likely to develop breast cancer, although it's not entirely clear why.

Because of this increased risk, breast density notification can help those affected make more informed decisions about their health. The updated FDA regulations recommend that patients with dense breasts speak to their doctor; This conversation may include information about further imaging tests.

There are currently no specific additional screening recommendations for people with dense tissue, Dr. Laura Dean, a breast radiologist at the Cleveland Clinic. However, you may benefit from a number of additional screening tests in addition to mammography.

“Women with dense breasts may consider additional imaging tests such as ultrasound, contrast-enhanced mammography, or MRI [magnetic resonance imaging],” noted Brennan, adding that depending on a person's risk profile and individual situation, one type of imaging test may be preferred over another and should be discussed with a healthcare provider.

In any case, according to Dr. Dean, "The goal of screening is to detect breast cancer as early as possible, when the cancers are smaller, at a lower stage, and easier to treat."

Although additional imaging may be able to detect harder-to-find breast cancer in some people, it may come with additional risks. “Additional imaging tests can improve cancer detection, but can also lead to additional testing of even benign biopsies,” Brennan said.

Additional cancer screenings may also come at an additional cost - while mammograms are free for most breast carriers, health insurers may not cover additional tests.

However, a bill in the U.S. House of Representatives – the Find It Early Act – aims to equalize the cost of additional breast cancer screenings. The legislation would ensure that all health insurance plans cover screenings, diagnostic mammograms, breast ultrasounds and MRIs for people with dense breasts or at higher risk of breast cancer without a deductible.

As for the updated FDA regulations, experts hope they will only "strengthen the fight against breast cancer," Brennan said. “By providing patients with more information, they can make informed decisions about their breast health care.”

Breast cancer screening guidelines

Breast Cancer Prevention Guidelines:As of May 2023, the US Preventative Services Task Force (USPSTF) recommends that cisgender women and those assigned female at birth have mammograms every two years starting at age 40. This is 10 years earlier than the current guidelines. More research is needed on whether people with dense breasts should have additional screening tests and the potential benefits and risks of screening in people over 75 years of age.

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