The Food and Drug Administration released new standards Thursday that could potentially help more women detect breast cancer earlier.
The new rules will require mammography providers nationwide to notify women if they have dense breast tissue and recommend they consult a doctor about whether they need further screening.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Dr. Hilary Marston, the FDA’s Chief Medical Officer, in a statement.
Dr. Anne Hoyt, the co-medical director of breast imaging at the University of California, Los Angeles, called it “a step in the right direction.”
“Sometimes women who have breast cancer that is present, these breast cancers are not seen on mammograms because they are hidden by breast density,” she said.
The FDA’s move is important because the risk of breast cancer is a real concern for many patients, said Dr. Harold Burstein, a medical oncologist at the Dana-Farber Cancer Institute in Boston and a professor at Harvard Medical School.
“The identification of dense breast tissue may be a marker of slightly higher risk of getting breast cancer, and that may need additional breast imaging,” said Burstein, who likened the challenge of reading mammograms to “looking through frosted glass.”
Mammogram providers will be required to implement the new standards within 18 months, according to the agency.
More than 297,700 women will be diagnosed with invasive breast cancer this year, and about 43,700 will die from the disease, according to estimates from the American Cancer Society.
Women with dense breasts have a higher chance of getting breast cancer, according to the Centers for Disease Control and Prevention. The denser your breasts are, the higher the risk.
The condition is very common: About half of women age 40 and older have dense breasts, based on CDC statistics. Dense breasts have more tissue and fat, so it’s more challenging to read their mammogram, and cancer can be missed.
The only way to tell if you have dense breasts is through a mammogram, which doctors generally recommend every one or two years for women starting in their 40s or 50s. Women with dense breasts are also recommended to have an ultrasound.
In 2019, the FDA first proposed new regulations for breast cancer screenings that would require health care providers to provide women with more information about the risks associated with dense breasts. In October, the agency said it was optimistic the final rule would be published in 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.
The FDA’s new rules released Thursday essentially set a minimum amount of information that mammogram providers will be required to tell women.
It “provides uniform guidance,” Burstein said, because “it spans the entire country.”
The FDA’s decision will hopefully raise awareness of the condition and encourage even more women to get a mammogram to find out if they are at risk, he said.
“Just because you have dense breast tissue does not mean you have breast cancer, and it does not mean you will get breast cancer,” he said. “But that might mean you need some extra imaging.”
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