FDA mammogram rule aims for better detection

Mammogram providers will be required to inform women with dense breast tissue that their cancer screenings may be difficult to interpret and suggest that they consult their doctors about the need for additional tests, the Food and Drug Administration announced Thursday.

Supporters of the FDA’S long-expected decision say the new standards will save lives by helping women learn about their breast density risks and potentially detect cancer earlier. Providers must implement the new regulations within 18 months, the agency said.

Breast cancer is the most common cancer among women, after skin cancer, and the second leading cause of cancer deaths among women overall. The American Cancer Society estimates that in 2023, about 297,790 women will be diagnosed with invasive breast cancer and some 43,700 will die of the disease.

“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 in a statement.

Thirty-eight states already require that women be informed if their mammograms reveal dense breasts, but the language varies widely and does not always require providers to recommend that women seek guidance about additional tests. The FDA’S decision sets a minimum standard for about 8,700 facilities across the United States, while states can still require more in-depth language.

Some states currently tell women they have dense breasts, but nothing more, said Joann Pushkin, executive director of New York-based Densebreast-info, a resource website that aims to teach patients and health-care professionals about dense breasts.

“That’s really not enough to raise a red flag in a woman’s brain that they need to circle back around with a health provider and have a conversation about additional screening,” said Pushkin, whose advocacy helped establish a New York law that since 2013 has required that women with dense breasts be told of their condition and suggests speaking with doctors about more testing.

The FDA in 2019 first proposed requiring the standard language for providers of mammograms, low-dose X-rays widely used to help detect breast cancer. The FDA had to review hundreds of public comments on the proposal and was delayed by the agency’s efforts during the pandemic.

“We went into this all hands-ondeck response to the pandemic,” Marston said in an interview. “Things like this took a little bit to get out of the door.”

Dense breasts have relatively less fatty tissue and higher amounts of glandular and fibrous connective tissue. 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 have a higher risk of getting breast cancer, according to the National Cancer Institute.

Pushkin, who in 2005 felt a large lump in her breast, had her own experience with the challenge of cancer detection as someone with dense breast tissue. After she got a mammogram and was told no cancer was found, she pushed for additional screening.

“It [appeared] five minutes later in an ultrasound,” she said.

Pushkin, 63, believes her cancer could have been detected years earlier had she known about dense breasts when she had earlier annual mammograms. She underwent eight surgeries, eight rounds of chemotherapy and 30 rounds of radiation treatment for her cancer.

“Someone should have told me,” she said of the greater difficulty detecting cancer in people with dense breasts. “When I’m denied this information, I have effectively been denied an opportunity for early-stage diagnosis.”

Under the new standards, information about having dense breasts will be included in a “summary letter” mammography providers must give to patients. A fuller report will be sent to the patient’s physician.

The language also tells women that mammograms, while the best screening test for detecting breast cancers, don’t always detect tumors and that other screenings might also be needed.

“Talk to your health care provider about breast density, risks for breast cancer, and your individual situation,” the new language says.

The prescribed messaging uses language that’s easy for people to understand, Marston said. “Anyone can pick up the letter and understand what it means,” she said.

While there’s no universal consensus on what other tests are the most effective for detecting cancer in women with dense breasts, MRIS and ultrasounds are among the most common.

While mammograms are free for most women, supplemental cancer screenings may not be fully or even partially covered by health insurers. Only nine states and D.C. mandate that plans cover at least part of the cost of tests beyond mammograms, said Rachel Brem, director of breast imaging and intervention at the George Washington Cancer Center.

She applauded the new regulations but cautioned that without additional measures to address insurance gaps, they “could increase health-care disparities among underserved women for essential and critical screenings.”

“It can be a daunting amount of money for many women,” said Brem, who founded the Marylandbased Brem Foundation, which helps women pay for tests after abnormal mammograms.