Most likely the regulations "will publish before the end of the 2022 calendar year or early 2023."
Mammograms are crucial for the early detection of breast cancer. However, some mammograms are unable to detect cancer in women due to higher breast density. So, the US Food and Drug Administration (FDA) has decided to implement new regulations for informing patients about their breast density and screening options, reports PEOPLE.
In the US, breast cancer affects one in eight women. Dr. Sarah Friedewald, the chief of breast imagining at Northwestern Medicine told CBS News, "About 40[%] to 50% of the women in the country actually have dense breast tissue. It just makes it a little bit harder for us to find cancer on the mammogram."
According to the American Cancer Society, dense breasts have more tissue and less fat, and both tissue and tumor look white in the results. Also, it may be difficult to detect tumors because dense breast tissue has more cells that can develop into abnormal cells. In such cases, doctors often recommend additional tests such as breast magnetic resonance imaging (MRI) or breast ultrasound.
Now, according to the new regulations, FDA is planning to inform patients about their breast density and screening options. This information was part of a letter to Rep. Rosa DeLauro (D-CT) from Katherine Klimczak, the Acting Legislative Director for the FDA. The proposed amendments to the Mammography Quality Standards Act (MQSA) would need the patient's mammography report summaries to include where they have low-density or high-density breasts and information on the "significance of breast density."
So glad @DstnyRichardsTV is focusing on this. I’ve had 3 mammograms - each required me to go back because they found something “concerning.” It was just dense breast tissue. Women need more options and info up front; it would alleviate a lot of uncertainty https://t.co/wGG0LU303k— Melissa Luck ☘ (@MelissaKXLY4) October 26, 2022
The letter also states that the agency is "optimistic that the MQSA final rule will publish before the end of the 2022 calendar year or early 2023." Moreover, the radiologists have to identify the patient as one of the four breast density categories in their mammogram report.
In a press release, DeLauro, chair of the United States House of Representative Appropriations Committee said, "After three years, I am pleased that the FDA has finally communicated that they believe they will be able to roll out a rule requiring providers to notify women of whether they have dense breasts, what this means for their risk of breast cancer, and the importance of speaking with a health care provider about breast density."
October is #BreastCancerAwarenessMonth and women are encouraged to get their #mammogram. Dr. Christine Klassen, a @MayoClinic Breast Clinic physician, explains breast density and what it means if your mammogram shows you have dense breasts. https://t.co/N33d3VQ1M7 pic.twitter.com/WVeW6p8w4L— Mayo Clinic Comprehensive Cancer Center (@MayoCancerCare) October 26, 2022
However, many states already require women to be notified that they have dense breasts in their mammogram summary reports.
"The 38 states with existing inform laws provide varying levels of notification. A single national reporting standard would mean all American women receive equal information about the screening and risk implications of dense tissue and provide equal opportunity to discuss supplemental screening leading to earlier detection," JoAnn Pushkin, executive director of DenseBreast-info.org, said. "I applaud Rep. DeLauro for her persistence on behalf of American women."
What a woman is told about her breast density should *not* depend on where she lives. 38 states with laws = 38 different versions. A national standard is needed and overdue. Thank you @rosadelauro for her work to address this and to @rosadelauro people for highlighting the need. https://t.co/fw4Ge4tetB— JoAnn Pushkin (@JoAnnPushkin) October 25, 2022
Representative Cover Image Source: Getty Images | Alexey Yaremenko