Like many women, Shama Mullen breathes a sigh of relief every time she receives good news about the results of her latest mammogram. But two years ago, Maren’s doctor sent her additional information that surprised her.
She had dense breasts.
“I had never seen a letter like that before, and I didn’t even know what dense breasts meant,” said Mullen, 38, of Andover, Massachusetts. Mullen immediately searched the internet for more information and called her doctor with questions about follow-up tests.
Under new rules from the Food and Drug Administration, women age 40 and older in all states will now receive a breast density notification along with their standard mammography test report. Massachusetts and 38 other states have already sent notices regarding breast density, which reflects the ratio of mammary glands and connective tissue to fatty tissue. FDA requirements standardize these messages.
When the tissue is dense, it becomes difficult to detect breast cancer on a mammogram. And dense breast tissue is a risk factor for cancer.
You have a thick chest. Well, what is it?
Mammogram studies show that almost half of women over the age of 40 have dense breasts.
Women with dense breasts will now be encouraged to talk to their doctors and be told that “in addition to mammography, other imaging tests may help detect cancer.”
Some health advocates say the notice oversimplifies a complex issue. They argue that without clear, evidence-based instructions, women can be left scared, confused and frustrated.
There is no national standard for tracking reports of dense breasts, said Judith Garber, senior policy analyst at the Roan Institute, a nonpartisan health policy think tank.
This means that women will receive different advice from different doctors.
Some doctors recommend that women get additional tests such as additional mammograms, ultrasounds, and MRIs, while others advise them to continue getting regular mammograms, said Dr. Mark Perlman, professor emeritus at the University of Michigan School of Medicine. That’s what it means. Written screening guidelines for the American College of Obstetricians and Gynecologists and the National Comprehensive Cancer Network.
“You can’t counsel all women with dense breasts with one policy that fits all,” Perlman says.
Whether a woman can have additional imaging tests may depend on her insurance, which doesn’t always cover her, says Robert, an epidemiologist and senior vice president for cancer screening at the American Cancer Society.・Mr. Smith stated.
Smith said it’s important for women to know whether their breast tissue is dense.
Radiologists classify breast tissue into four groups:
Very dense Almost dense Almost entirely fat Almost entirely fat.
Because breast cancer can hide behind dense tissue, “these cancers grow, get bigger, become more advanced, and eventually poke out from the corners of the dense tissue and become visible on mammograms.” ” said Smith. “Even if a diagnosis is made, it is not an early one.”
Smith added: “If the breast is completely dense, traditional techniques simply aren’t very accurate, so auxiliary image processing is required.”
Dr. Hilary Marston, the FDA’s chief medical officer, said the notice will empower women.
“We really wanted to make sure that women were given the information they needed in plain language to make good decisions for their health,” Marston said. “The most important thing is to make sure people have access to information in a clearly communicated, high-quality way.”
Benefits and risks of additional testing
Part of the confusion is that experts disagree on whether women with dense breasts need additional imaging.
The American College of Radiology and the National Comprehensive Cancer Network recommend that women and their doctors consider additional screening tests, but two other influential groups, the American College of Obstetricians and Gynecologists and the American Preventive Services Special The committee says there is not enough evidence of benefit to make a recommendation. Additional tests.
Dr. Nancy Keating, a professor of health policy at Harvard Medical School, also said that while additional tests can detect more cancers than mammograms alone, there is no evidence that additional tests save lives.
Keating said that with additional testing “we don’t know if the results would be any better.” “We don’t know if the additional image processing would do more good than harm.”
Gerber said additional imaging procedures such as ultrasound and MRI come with risks. Both tests can lead to “false alarms” in which benign tissue is marked as suspicious.
False alarms can lead to invasive biopsies that can cause pain and bleeding, as well as stressful and unnecessary follow-up tests, some of which include additional procedures that can cause side effects or allergic reactions. This includes radiation exposure and dyes.
In some cases, additional screening tests can result in women being diagnosed and treated for cancers they would not otherwise have had, a problem known as overdiagnosis or overtreatment.
A study published in 2022 estimated that 15% of mammogram-detected breast cancers in women ages 50 to 74 are overdiagnosed. Ruth Etzioni, a biostatistician at Fred Hutchinson Cancer Center and co-author of the study, points out that not all cancers are the same. Some aggressive tumors grow quickly and require immediate treatment, while others grow too slowly to harm a woman during her lifetime. Older women diagnosed with slow-growing breast tumors may die from other causes before the cancer causes problems.
Some studies have questioned the reliability of the systems used to label breasts as dense or dense. A review article in the Annals of Internal Medicine found that 13% to 19% of women had their subsequent screening mammograms reclassified into a different breast density category, from dense to non-dense, or vice versa. Ta.
Chrissy Matos said she had her first mammogram at age 40, but received her first notification of dense breasts this year at age 42. Matos, who lives in Stroudsburg, Pennsylvania, said she wonders why her breasts didn’t look dense on her first mammogram. Breasts tend to be denser in younger women.
Doctors recommended a second mammogram, this time using a new technology known as digital breast tomosynthesis (also known as 3D mammography). Matos said the ultrasound revealed that the suspicious areas on the mammogram were not a cause for concern.
The high cost of advanced imaging puts it out of reach for many patients. Women from rural and marginalized communities often lack access to modern technology.
Gerber, the Loan Institute analyst, said the FDA’s language is misleading. Although it is true that women with dense breasts are 1.5 to 2 times more likely to develop breast cancer than other women, they are no more likely to die from breast cancer.
The FDA’s notice language generally “kind of encourages people to get more tests when in fact they’re not recommended,” Gerber said. “So the FDA is saying, ‘Now that you have this breast density, you need to be aware that there are additional risk factors.'” But there’s nothing people should do about it. It’s a really terrible place to be a patient. ”
The FDA’s Marston said she hopes women and their doctors can use the concentration notifications to have informed conversations. “We certainly don’t want to hide information from women,” Marston said.
Given the uncertainty about the benefits of additional screening tests, Perlman said the “safest and probably most accurate” way to advise women with dense breasts is because “what is best practice at this time is “I don’t know for sure,” he said.
Mullen said she was relieved that an insurance-covered follow-up test found nothing suspicious. But “breast cancer is always on my mind because of my family history,” Mullen said. She knows her breasts are dense, so “I think I would have been nervous if I hadn’t had the ultrasound.”
