FDA to require mammogram providers to notify women about breast density to help detect breast cancer sooner

The Food and Drug Administration released new standards Thursday that could potentially help more women detect breast cancer earlier.

The new rules will require mammogram providers nationwide to notify women if they have dense breast tissue and recommend that they consult with a doctor about whether they need additional screening.

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

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 more dense your breasts are, the higher your risk.

The condition is very common: About half of women 40 and older have dense breasts, based on CDC statistics. Dense breasts have more tissue and fat, so reading their mammograms is more challenging and cancers can get missed.

The only way to tell if you have dense breasts is via a mammogram, which doctors generally recommend every one or two years for women starting in their 40s or 50s. Women with dense breasts are recommended to also get an ultrasound.

In 2019, the FDA first proposed new rules for breast cancer screenings that would require 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 by 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 mammogram providers will be required to tell women.

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