Mammogram providers will be required to inform women with dense breast tissue that their cancer screenings may be difficult to interpret and recommend consulting their doctors about the need for additional tests, the Food and Drug Administration announced.
breast density risks and potentially detect cancer earlier. Providers must implement the new regulations within 18 months, the agency said.
that in 2023, about 297,790 women will be diagnosed with invasive breast cancer and some 43,700 will die of the disease.“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” Hilary Marston, the FDA’s chief medical officer, said in a statement.
Some states currently tell women they have dense breasts, but nothing more, said JoAnn Pushkin, executive director of New York-based, a resource website that aims to teach patients and health-care professionals about dense breasts. Dense breasts have relatively less fatty tissue and higher amounts of glandular and fibrous connective tissue. Nearly half of all women 40 and over have the condition. Dense breasts can appear white on a mammogram — but so does cancer, making it difficult for radiologists to detect tumors.of getting breast cancer, according to the National Cancer Institute.
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