DeLauro, Israel, Fitzpatrick Urge FDA to Ensure Women Have Information about Breast Tissue Density

WASHINGTON, DC—Representatives Rosa DeLauro (D-CT), Steve Israel (D-N.Y.) and Michael Fitzpatrick (R-PA) today urged the Food and Drug Administration (FDA) to finalize standards that would ensure women have access to information about the density of their breast tissue. The FDA’s Mammography Quality Standards Act committee has recommended women have this information, and the representatives have introduced legislation that would codify that recommendation into law.

“While mammograms are important for the early detection of breast cancer, studies have shown that they miss half of the cancers in women with dense breasts,” the representatives wrote. “More than forty percent of all women have dense breasts and are often unaware of their risk. Currently, there is no federal requirement for the inclusion of density information in the letter women receive after their mammograms. Without the knowledge that their breasts are dense, women are unable to advocate effectively for their health. Research demonstrates that adding ultrasound to mammography in women with dense breast tissue nearly doubles the detection of small, invasive cancers. If these cancers are found early, they are often treatable, survivable, and less costly for the healthcare system to treat.”

Their letter to Acting FDA Commissioner Stephen Ostroff can be read in its entirety here.

About 200,000 women are diagnosed with breast cancer and more than 40,000 American women die from the disease annually. Catching the disease early is critical: breast cancers diagnosed at stage 0 or 1 have five-year survival rates approaching 100 percent, while that drops to 72 percent for cancers diagnosed at stage 3.

DeLauro, Israel and Fitzpatrick’s legislation, the Breast Density and Mammography Reporting Act would ensure the information women and their health care providers receive after a mammogram includes patient’s relative breast density. Studies have shown that women with dense breast tissue are at least four times more likely to develop breast cancer. They are also more likely to have an inaccurate mammogram reading.


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