Notify women with dense breasts about increased cancer risk, proposes FDA

FDA proposes a policy to notify women with dense breasts about increased cancer risk and imprecise mammograms.

The U.S. Food and Drug Administration, FDA has announced important new steps to modernize breast cancer screening for the first time in more than 20 years. This will also help empower patients with more information when they are considering important decisions regarding their breast health care. The regulating agency is proposing amendments to key regulations that would help improve the quality of mammography services for millions of Americans. Key changes proposed to be implemented are-

• The Food and Drug Administration is proposing a rule that would inform women about how breast density may influence mammogram results.


• Dense breast tissue makes it harder for doctors to see cancer, meaning the tests can be less accurate.


• The agency is also proposing tightening its regulation of mammogram testing.


• 
  

  A new category — "known biopsy proven malignancy" — will be available for mammography reports so it's clear that cancers being mammographically assessed for treatment are already known and identified.

  
  


• 
  

  The FDA can contact patients and providers directly when a facility's mammography does not meet quality standards, and repeat mammography at another facility may be necessary

  
  

The agency wants doctors to ensure patients understand how dense breasts, which don’t have a lot of fatty tissue, can skew the accuracy of mammograms and present a higher risk of developing breast cancer later in life. About 12 per cent of all women are diagnosed with breast cancer at some point in their life, the FDA said. NCI estimates that, in 2018, more than 260,000 women were diagnosed with breast cancer and more than 40,920 women died of the disease. Aside from skin cancer, breast cancer is the most common cancer among women and the second leading cause of death. Additionally, mammography can be an important tool in detecting male breast cancers. According to the NCI, breast cancer may occur in men at any age, but usually occurs in men between 60-70 years of age."

"The FDA is committed to advancing efforts that improve the health of women. 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," said FDA Principal Deputy Commissioner Amy Abernethy, M.D., PhD. "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. Today's proposed amendments are part of the agency's broader commitment to supporting new innovations and methods to prevent, detect and treat cancer. We are dedicated to working across the agency and with stakeholders to provide patients with tools and information to fight breast cancer effectively."

"Breast cancer is one of the most worrisome health concerns facing women. The FDA plays a unique and meaningful role in the delivery of quality mammography to help patients get accurate screening to identify breast health problems early, when they can be effectively addressed," said FDA Commissioner Scott Gottlieb, M.D. "As part of our overall commitment to protecting the health of women, we're proposing new policies to modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting. We're committed to making sure patients have access to high-quality mammography. Today's proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field."