Dense breasts

FDA dense breast guideline shouldn’t trigger ‘knee-jerk’ reactions, Mount Sinai surgeon says

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When the FDA updated the 1992 Mammography Quality Standards Act to require patients be informed directly if they have dense breasts, the move may have opened a “Pandora’s box,” Elisa Port, MD, chief of breast surgery at New York City-based Mount Sinai Health System and director of the Dubin Breast Center at Mount Sinai, told Becker’s.

Prior to the March 9 MQSA dense breast guideline update, two-thirds of states already had laws in place to require mammogram reports to include breast dense findings. However, there was no standard when it came to whether the information was to be passed to the physician who ordered the mammogram or to the patient. 

The new guideline puts in place a national requirement to inform the patient directly if a mammogram detects they have dense breasts. Mammogram facilities must include a specific paragraph about the finding in every post-mammogram radiology report.

Dr. Port said clarifying the guidelines has pros and cons. “There is some evidence that having dense breasts might increase your risk of breast cancer,” she said. “Also, we worry that the density of the breast might obscure cancer in a mammogram.” 

To those points, she said, informing patients they have dense breasts gives them the opportunity to ask more questions and discuss follow-up imaging — including ultrasound. “I believe knowledge is power, and I’m very much about empowering women to learn more about their bodies,” Dr. Port said. 

“However, there is also a downside that most women do not understand,” she added, noting that having dense breasts is not unusual. “This is an opportunity for women and their doctors to discuss their particular circumstances. This should not be a red flag that means we should be doing ultrasounds on every single 40- to 50-year-old with dense breasts.”

She said she is concerned some patients might request an ultrasound prior to a mammogram if they are led to believe ultrasounds and other imaging might be more efficacious. But mammography is still the gold standard when it comes to breast cancer diagnosis.

“Mammograms pick up about 85 to 90 percent of the cancers that are diagnosed, but they’re not perfect. No test is perfect, and mammograms are the best we have and have definitely gotten better over time — from film to 3D film to digital and now with 3D,” Dr. Port said. “This evolution has massively improved technology and the detection rate of mammograms.”

Further, she said, having an ultrasound might pick up another 1 to 2 percent of cancers beyond a mammogram. “But you have to consider that ultrasound is very ‘operator dependent,’ meaning anyone who’s had an ultrasound knows they take the probe and move it around and they can miss spots. 

“The last thing I want is for women to find out they have dense breasts and not get a mammogram thinking they will jump directly to ultrasound. Even in dense breasts, mammograms are still superior.”

Another concern Dr. Port pointed out is that physicians might view the dense breast guideline from a potentially litigious standpoint. “I do worry that, out of self protection, doctors are going to start having knee-jerk reactions. They could decide that every woman who has dense breasts needs an ultrasound. That’s not the answer either. An ultrasound will generate a much larger proportion of false negatives.”

False negatives from ultrasound could “create the need for biopsies and, if biopsies aren’t conclusively normal, that could then generate more possibly unnecessary surgery,” Dr. Port said. “There’s a whole Pandora’s box potentially opened here when it comes to recommending everyone to have more tests.”

Instead, noting a patient’s risk of breast cancer is informed by family history among other factors, Dr. Port said, “Breast density cannot be viewed in a vacuum. OB-GYNs or primary doctors have to have these detailed conversations with their patients.”

FDA Orders New Mammogram Standards for Women With Dense Breasts

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Women with dense breast tissue will be given additional information at their cancer screenings under new rules adopted by the FDA.

Providers of mammograms will have to tell women that their tests are harder to interpret and suggest they speak with their doctors about more testing, the FDA says.

This will lead to greater detection of breast cancer earlier, advocates say. 

Breast cancer is the second most common cancer in American women, after skin cancers, says the American Cancer Society. This year, about 300,000 new cases will be diagnosed, and about 43,700 women will die from breast cancer, the organization says.

“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” Hilary Marston, the FDA’s chief medical officer, said.

Most states require that women be told when their mammogram finds they have dense breasts. The FDA decision applies a minimum standard for 8,700 facilities across the country, and states can still require more explicit wording, The Washington Post reported.

“Dense breasts have relatively less fatty tissue and higher amounts of glandular and fibrous connective tissue,” The Post wrote. “Nearly half of all women 40 and over have the condition. Dense breasts can appear white on a mammogram — but so does cancer, making it difficult for radiologists to detect tumors.” Women with dense breasts also face a higher risk of developing the disease.

Mammogram providers have 18 months to comply with the standards. Information about dense breasts will be included in a letter to patients and their physicians.

Dense breasts raise breast cancer risk, but many women aren’t aware of that — here’s what to know

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The only way to tell if you have dense breasts is via a mammogram, and not all states require providers to notify women of their breast density.

A woman gets a mammogram at Mt. Sinai Hospital in Chicago

A woman gets a mammogram at Mt. Sinai Hospital in Chicago in 2012.Heather Charles / Chicago Tribune/Tribune News Service

Most women are aware that a family history of breast cancer increases their risk of the disease, but far fewer understand that extremely dense breasts can pose a greater risk.

A survey published Monday in the journal JAMA Network Open found that of nearly 1,900 women who participated, the majority saw breast density as a less consequential risk factor than family history.

But women with extremely dense breasts, which are characterized by minimal fatty tissue, face a risk of breast cancer four times higher than women with the lowest breast densities, according to the study. About 10% of women who get mammograms have this level of breast density. By comparison, having a mother, sister or daughter who’s had breast cancer is associated with double the risk of the disease.

Women who have a substantial amount of dense breast tissue but not to an extreme degree— about 40% of those who get mammograms — have a 20% higher risk of breast cancer relativeto those with average breast density, according to the study.

That’s slightly lower than the risk associated with having a glass of wine each night, according to Dr. Phoebe Freer, chief of breast imaging at the University of Utah’s Huntsman Cancer Institute, who wasn’t involved in the survey.

“Everybody has a different amount of fibroglandular tissue and a different pattern,” Freer said, referring to dense breast tissue. “It’s almost like a patient’s fingerprint.”

The only way to tell if you have dense breasts is via a mammogram, which doctors generally recommend every one or two years for women starting in their 40s or 50s.

The Food and Drug Administration proposed a rule in 2019 that would require mammography facilities to inform patients about their breast density and its significance. In October, the FDA said it was optimistic that the final rule would be published by early 2023.

Thirty-eight states already require providers to give women information about breast density after a mammogram, but not all of them require providers to notify a woman if she herself has dense breasts.

A woman leaves a mammography mobile screening bus in Anaheim, Calif.
A woman leaves a mammography mobile screening bus in Anaheim, Calif. on Oct. 17, 2016.Mindy Schauer / Digital First Media/Orange County Register

Since dense breasts are common, doctors may inadvertently downplay the risks, said Christine Gunn, a researcher at the Dartmouth Institute for Health Policy and Clinical Practice, who conducted the JAMA research.

“There are a lot of conversations with primary care doctors where they say, ‘This is normal.’ For some women, it translates to, ‘Oh, I don’t have to worry about that,'” Gunn said.

In individual interviews as part of Gunn’s survey, six out of 61 women said dense breasts contributed to breast cancer risk. 

There are two reasons dense breasts are linked to a higher risk of breast cancer.

First, the composition of the breast might predispose people to cancer. The reasons for that aren’t clear, but scientists suspect that cancer is more likely to develop in fibroglandular tissue, which is unique to the breast, as opposed to fatty tissue, which is found throughout the body.

Second, because women with extremely dense breasts have almost all fibroglandular tissue, it’s harder to detect cancerous masses or calcium deposits on a mammogram. That makes it easier for cancer to grow or spread undetected rather than being spotted and treated early.

Checking for cancer in a patient with dense breasts is like searching for a white spot on a white wall, according to Dr. Melissa Durand, an associate professor at the Yale School of Medicine Department of Radiology and Biomedical Imaging.

Durand explained that both fibroglandular tissue and cancer show up white on a mammogram, whereas fatty tissue shows up black.

“In a completely fatty breast — so lots and lots of black on the mammogram — we can be as accurate as 98%,” she said. “But our sensitivity can drop really low — in some studies, even as low as 30% — if you have an extremely, extremely dense breast.”

Radiologists said the ideal type of mammogram, especially for women with dense breasts, is a digital breast tomosynthesis, which is often better at detecting cancer than standard mammograms.

From there, doctors might recommend an ultrasound or MRI. Women with dense breasts should probably get supplemental screenings each year, radiologists said.

Ultrasounds are safe and relatively inexpensive, but Freer said they can miss cancer or show false positives, which can be confusing for patients. MRIs are the most sensitive option, but to get insurance companies to cover the cost, patients usually need to show additional risk factors, such as a genetic mutation or family history of breast cancer.

“The more often you get screened, the more likely you are to be called back for additional imaging,” Freer said. “It does create some anxiety and it definitely takes time. Most patients are willing to undergo that risk in order to get the life-saving benefit.”

Women can’t change their breast density, but it can shift with age.

“Typically, younger women will have denser breasts,” Durand said. “As we age, just like other parts of our bodies, we acquire more fat, so your breast tissue can get more fatty tissue in it.”

To lower one’s risk of breast cancer overall, doctors recommend limiting alcohol intake, exercising regularly and maintaining a healthy diet. The Breast Cancer Surveillance Consortium offers an online tool to help people gauge their breast cancer risk based on multiple factors, including breast density.