FDA proposes changes to mammograms to give women more info

Mammography facilities would be required to inform women with dense breasts about the risks associated with that condition and how it can impact the accuracy of their mammograms under a new proposal from the Food and Drug Administration (FDA).

Wednesday’s proposed rule is meant to modernize mammography quality standards that haven’t been changed in 20 years and comes as the FDA has confirmed that dense breasts are a risk factor for developing breast cancer.  

The FDA says the proposal is aimed at making sure patients have as much information as possible when making decisions regarding their breast health.

According to the FDA, mammograms of dense breasts — breasts with a higher proportion of fibroglandular tissue compared to fatty tissue —are not as accurate at detecting cancer.

Those mammograms “can be difficult to interpret because the dense tissue can obscure signs of breast cancer and lower the sensitivity of the image,” FDA said.

According to the National Cancer Institute, approximately 12.4 percent of women will be diagnosed with breast cancer at some point during their lifetime.

“Given that more than half of women over the age of 40 in the U.S. have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy,” FDA Principal Deputy Commissioner Amy Abernethy said in a statement.

The agency also proposed to tighten its regulation of mammography facilities, including allowing the agency to notify patients that a specific facility’s testing did not meet FDA quality standards.