FDA sets national mammogram standards to protect women with dense breasts


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

Supporters of the FDA’s long-awaited decision say the new standards will save lives by helping women learn more about their risks of breast density and possibly detecting cancer earlier. Providers 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 cancer death in women overall. The American Cancer Society estimates that by 2023, approximately 297,790 women will be diagnosed with invasive breast cancer and approximately 43,700 will die from the disease.

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

Thirty-eight states already require women to be informed if their mammograms reveal dense breasts, but the language varies widely and doesn’t always require providers to recommend that women seek counseling about additional testing. The FDA’s decision sets a minimum standard, while states can require even 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, an information website that aims to educate patients and healthcare professionals about dense breasts.

“That’s really not enough to raise a red flag in a woman’s brain that they should go back with a healthcare provider and have a conversation about additional screening,” said Pushkin, whose advocacy helped create the a New York law that since 2013 requires women with dense breasts to be informed of their condition and suggests talking to doctors about more testing.

The FDA first proposed in 2013 to mandate the standard language for providers of mammograms, low-dose X-rays commonly used to 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 the condition. Dense breasts may appear white on a mammogram, but so can cancer, making it difficult for radiologists to spot tumors.

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

Under the new standards information about dense breasts will be included in a “summary letter” that mammography providers must provide give to patients. A more complete report is sent to the patient’s physician.

The language also tells women that mammograms, while the best screening test for detecting breast cancer, do not always detect tumors and that other screenings may be necessary. That could be an MRI or an ultrasound.

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

That’s a familiar scenario for Pushkin, who felt a large lump in her breast in 2005 and had a mammogram done. Pushkin pushed for additional screening after being told no cancer had been found on her mammogram.

“It did five minutes later in an ultrasound,” she said.

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

“Someone should have told me,” she said of the greater difficulty in detecting cancer in people with dense breasts. “If I am denied this information, I have effectively been denied the opportunity to make a diagnosis at an early stage.”






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