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.
Diagnosed with stage 3C breast cancer in 2004, Cappello learned that her dense breast tissue prevented the mammography machine from detecting the cancer, despite years of undergoing annual mammograms. She then poured her energy into advocating for breast density notification, helping to pass the first state law requiring it in 2009 in her home state of Connecticut. After, she continued to pass similar forms of legislation in other states until passing away
in November from secondary myelodyspastic syndrome (MDS), a bone marrow cancer that was a complication of her prior breast cancer treatments.
“This legal mandate means the future of 40 percent of post-menopausal women have access to this important, lifesaving information,” Joseph J. Cappello told HCB News. “You can’t stop yourself from getting cancer, but finding it at its earliest stage is the key to better outcomes.”
Destounis echoes this sentiment, saying the regulation will lead to more personalized care for women and offer additional studies to those at higher risk for breast cancer. She asserts, though, that ensuring complete awareness involves more than just a nationwide law, and that access must be available to additional forms of screening such as MR and ultrasound.
“We need to encourage open communication among health care providers, radiologists and women getting a mammogram on the benefits and limitations of mammography in denser breast tissue categories,” she said. “We need education regarding other screening tests that may be appropriate for these patients; identification of the higher-risk patient for breast cancer, and commitment to educating women and their physicians on the benefits of screening; and communication with insurers to make certain these additional screening tests are reimbursed so the patient does not have the financial burden of the screening studies.”