By Madeline Farber
Published March 29, 2019
For the first time in two decades, the U.S. Food and Drug Administration (FDA) proposed an update to its national mammogram regulations in an effort to modernize breast cancer screenings for women -- especially for those with dense breasts.
The federal agency in a statement Wednesday proposed that mammogram providers provide information to women regarding breast density.
When a woman with dense breasts (meaning they have more connective and glandular tissue than they do fatty tissue) undergoes a mammogram, the results “can be difficult to interpret because the dense tissue can obscure signs of breast cancer and lower the sensitivity of the image,” the FDA said, adding those with dense breasts may already have an increased chance of developing breast cancer to begin with.
The FDA in its proposal said, “specific language” could help mammogram providers explain how breast density can affect the accuracy of the mammogram. The language would also recommend patients with such breasts "talk to their health care provider about high breast density and how it relates to breast cancer risk and their individual situation.”
Patients would receive the information in a summary letter following their screening.
“We believe the proposed rule would help empower patients and health care professionals by proposing improvements to the information facilities communicate to them, helping to facilitate the sometimes difficult conversations about potential risks for breast cancer,” Amy Abernethy, the principal deputy commissioner at the FDA, said in a statement. She said more than half of women over age 40 have dense breasts.
More than 35 states already require some kind of notification for dense breasts. But the FDA's proposal, if finalized, would apply to all states and set minimum standards for the information disclosed. Regulators will take public comments for three months before finalizing the proposal, a process that can take months or sometimes years.
Additionally, another proposed regulation would allow the FDA to contact patients directly if their mammography provider is not meeting quality standards or disclosing required information, while another proposed regulation would sanction mammography providers that don't adequately track patient records and information.
In 2018, according to the National Cancer Institute, more than 260,000 women were diagnosed with breast cancer. More than 40,000 died of the disease the same year.