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John R. Fischer, Senior Reporter | February 21, 2019
A new federal regulation requires
mammographers to specify if a patient
has dense breast tissue in
their reports
All U.S. mammography reports will now be required to include up-to-date information on the density of a patient’s breast tissue, following the passage of a federal funding bill this month.
Signed into law on February 15, the legislation includes a regulation requiring mammographers to include if a patient has dense breast tissue and what risks the condition carries, so that they and their physicians can take necessary precautions to ensure they are cancer free.
“The legal mandate is meant to educate women regarding dense breasts and explain that mammography is less sensitive in the denser breast categories. The denser the breast tissue, the more difficult it is to identify a small mass that may be cancerous, as it may hide in the dense background,” Dr. Stamatia Destounis, a clinical professor and managing partner at the Elizabeth Wende Breast Care center, told HCB News. “It is also meant to inform the health care providers that will get questions regarding this topic from their patients.”
Thirty-six states have currently passed breast density inform laws to raise awareness about the challenges and risks of dense breast tissue in cancer diagnostics. These laws, however, differ in their descriptions and the amount of information they relay to patients and doctors, and not all require women to be notified of their own breast density.
In accordance with the mandate, the FDA will develop reporting language on the topic through its regulatory process and take steps to ensure mammography reports and summaries include necessary information about breast density when sent to patients and their providers.
According to DenseBreast-Info.org, this information at the very least must include:
• The effect of breast density in masking the presence of breast cancer on a mammogram
• The qualitative assessment of [breast density by] the provider who interprets the mammogram
• A reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary.
The passing of the bill has been lauded by breast density advocates, including Joseph J. Cappello, who was
brought on board this month as new executive director of Are You Dense Inc. and Are You Dense Advocacy Inc., two nonprofits founded by his late wife, Nancy Cappello.