FDA sets national mammography standards to protect women with dense breasts


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

Proponents of the long-awaited FDA decision say the new standards save lives by helping women know their breast density risks and potentially detect cancer earlier. Suppliers must implement the new regulations within 18 months, the agency said.

Breast cancer is the most common cancer in women, after skin cancer, and the second leading cause of death from cancer in 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 from it.

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

Thirty-eight states already require women to be told if their mammograms reveal dense breasts, but the language varies widely and doesn’t always require providers to recommend women seek advice about further testing. The FDA decision sets a minimum standard, while states can still require even more in-depth language.

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

“It’s really not enough to signal to a woman’s brain that she needs to come back to a medical professional and have a conversation about further screening,” said Pushkin, whose advocacy helped establish law. from New York which, since 2013, has required women with dense breasts to be told about their condition and suggests talking with doctors about further testing.

In 2013, the FDA first proposed requiring standard language for providers of mammograms, low-dose x-rays widely used to help detect breast cancer.

Dense breasts have relatively less fatty tissue and higher amounts of glandular and fibrous connective tissue. Nearly half of all women age 40 and older have it. Dense breasts can appear white on a mammogram, but so can cancer, making it difficult for radiologists to detect tumors.

Women with dense breasts also have a higher risk of breast cancer, according to the National Cancer Institute.

According to the new standards, information about dense breasts will be included in a “summary letter” mammography providers should give to the sick. A more complete report will be sent to the patient’s doctor.

The language also tells women that mammograms, although the best screening test for detecting breast cancers, do not always detect tumors and that further screening may be needed. These may include an MRI or ultrasound.

“Talk to your health care provider about breast density, breast cancer risk, and your personal situation,” the new standard language reads.

It’s a familiar scenario for Pushkin, who in 2005 felt a big lump in her chest and went for a mammogram. Pushkin pushed for further screening after being told no cancer had been found on her mammogram.

“It happened five minutes later during an ultrasound,” she said.

Pushkin, 63, believes her cancer could have been detected years earlier if she had been aware of dense breasts during her previous annual mammograms. She underwent eight surgeries, eight cycles of chemotherapy and 30 cycles of radiation therapy for her cancer.

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

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