The Food and Drug Administration released new standards Thursday that could potentially help more women find breast cancer earlier.
The new rules will require mammogram providers nationwide to inform women if they have dense breast tissue and recommend that they consult a doctor to see if they need additional screening.
“Today’s action represents the agency’s broadest commitment to supporting innovation to prevent, detect and treat cancer,” Dr. Hillary Marston, FDA’s chief medical officer, said in a statement.
Dr. Anne Hoyt, co-medical director of breast imaging at the University of California, Los Angeles, called it “a step in the right direction.”
“Sometimes in women who have breast cancer, the breast cancers are not seen on a mammogram because they are hidden by breast density,” she said.
The FDA’s move is significant because the risk of breast cancer is a real concern for many patients, said Dr. Harold Burstein said.
“The detection of dense breast tissue may be a marker of a slightly higher risk of getting breast cancer, and may require additional breast imaging,” said Bernstein, who called the challenge of reading mammograms “seeing through frosted glass.” compared to.
Mammogram providers will be required to implement the new standards within 18 months, according to the agency.
According to estimates by the American Cancer Society, 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 the Centers for Disease Control and Prevention, women with dense breasts are more likely to develop breast cancer. The denser your breasts, the higher your risk.
The condition is pretty common: Based on data from the CDC, about half of women 40 and older have dense breasts. Dense breasts contain more tissue and fat, so their mammograms are more challenging to read and cancer may be missed.
The only way to tell if you have dense breasts is through a mammogram, which doctors usually recommend every one or two years for women starting in their 40s or 50s. Women with dense breasts are also advised to undergo ultrasound.
In 2019, the FDA proposed new rules for breast cancer screening for the first time, requiring health care providers to give women more information about the risks associated with dense breasts. In October, the agency said it was optimistic that the final rule would be published in early 2023.
Thirty-eight states already require providers to inform women about breast density after a mammogram, but not all of them require providers to inform a woman if she herself has dense breasts.
New FDA rules issued Thursday essentially set the minimum information mammogram providers will be required to tell women.
It “provides uniform guidance,” Burstein said, because “it’s spread across the country.”
She said the FDA’s decision is expected to raise awareness of the condition and encourage more women to get mammograms to find out if they are at risk.
“Just because you have dense breast tissue doesn’t mean you have breast cancer, and it doesn’t mean you’re going to get breast cancer,” he said. “But what it may mean is that you need some additional imaging.”
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