FDA Updates Regulations on Mammography

Interviewer: Lauri R. Graham; Interviewee: David D. Lee, MD


June 14, 2019

Editorial Collaboration

Medscape &

Breast Density

How do these proposed amendments address breast density?

The proposed rule would require mammography facilities to inform patients and their healthcare providers about breast density, creating four categories for communicating breast tissue density in the report provided to the healthcare provider, and two broader groups for the report summary provided to patients. However, breast density is actually a continuum. Breasts with mostly fatty tissue or scattered fibroglandular tissue would be categorized as "low density," whereas breasts with a higher proportion of fibroglandular tissue would be categorized as "high density." The lay language summary, written in easy-to-understand terms, would describe the woman's breast density as either high or low. Those with high-density breasts would be encouraged to speak with their healthcare provider. It will be very interpretable for patients.

Why wasn't the reporting of breast tissue density required in the previous regulations, and why is it being added now?

The understanding of breast density and the role of additional breast imaging for women with dense breasts have evolved over the past 20 years. While it has been recognized for some time that dense breast tissue can make it more difficult to detect breast cancers on mammograms, we now know that dense breast tissue itself is an independent risk factor for developing breast cancer. The FDA has been engaging with stakeholders, the National Mammography Quality Assurance Advisory Committee, and the public to ensure that all appropriate factors were considered prior to proposing a federal breast density reporting requirement.

How does dense breast tissue compare with other known risk factors for breast cancer, such as family history or genetics?

It is very difficult to compare higher breast density to other risk factors for breast cancer, given the potential range of increased risk that can be associated with combinations of risk factors or even a single risk factor. The overall goal of this proposed change to the regulations is to give women and their healthcare providers more information to use as a tool to better evaluate an individual patient's own unique situation.

The majority of young women will have dense breasts. Has concern been voiced that providing this information may lead to more anxiety on the part of women?

There is an open docket to receive public comment on the proposed regulations. It is possible that there may be comments related to the language or even the practice of reporting breast density to patients. However, our intention is to provide more information to women and their healthcare providers for use as tools to help inform their healthcare decisions.