FDA issues new mammogram regulations aimed at further breast cancer prevention
Mammogram facilities will need to follow some new rules soon.
The U.S. Food and Drug Administration (FDA) on Thursday released updated regulations that require mammogram providers to notify patients about the density of their breast tissue.
The updates apparently will give the FDA more oversight as well over individual mammography facilities — with the purported goal of improving patient care and communications.
During a screening mammogram, a radiologic technologist uses a special X-ray machine to detect any abnormalities that could indicate a risk of breast cancer. The images show whether a woman has dense breast tissue, which can make it more difficult to spot cancer warning signs.
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Women with dense breast tissue are also at a higher risk of developing the disease.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, M.D., M.P.H., chief medical officer of the FDA in Silver Spring, Maryland, in a press release announcing the new regulations.
“Since 1992, the FDA has worked to ensure patients have access to quality mammography.”
“The impact of the Mammography Quality Standards Act on public health has been significant, including a steep decrease in the number of facilities that do not meet quality standards,” she continued.
Mammography facilities will have 18 months to comply with the new regulations.
“This means that more women have access to consistent, quality mammography. We remain committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”
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Anne Peled, M.D., a breast cancer surgeon and co-director of the Breast Care Center of Excellence at Sutter Health California Pacific Medical Center in San Francisco, said she recognizes the importance of the FDA’s new guidance.
“As a patient, knowing you have denser breast tissue allows you to talk to your health care team about whether additional breast cancer screening would be helpful and come up with a plan tailored for you,” she told Fox News Digital in an email.
“Having oversight of consistency in reporting on density and making sure people with denser breasts have access to technology like 3D mammograms is essential for improving equity in breast cancer screening.”
Roughly half of U.S. women over age 40 have dense breast tissue, the FDA noted.
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Jennifer Hartman, an Indiana-based nurse practitioner specializing in surgical breast oncology, said she believes requiring notification of dense breast tissue is a step in the right direction.
She said she also believes it’s important to provide women with affordable access to additional screening — such as breast ultrasounds or MRIs — if they do have dense breast tissue.
Since 1990, mammograms have helped reduce breast cancer deaths by nearly 40%.
“While understanding and being educated on breast density provides value, it will be even more life-saving if we could provide additional actionable measures based on that knowledge,” she told Fox News Digital in an email.
Regarding the FDA updates, mammography facilities will have 18 months to comply with the new regulations.
Dr. Jenn Simmons, a functional medicine physician and integrative oncologist at Real Health MD in King of Prussia, Pennsylvania, said she does not share many of her colleagues’ enthusiasm about the new FDA guidelines.
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“I do not believe that making women aware of their breast density will have any impact on health or long-term survival,” she told Fox News Digital in an email. “In fact, I am concerned about the anxiety that the personal knowledge of breast density will provoke.”
Dr. Simmons believes these guidelines will “provoke anxiety and lead to more patient-driven imaging, which ultimately will lead to more breast cancers due to radiation over one’s lifetime.”
“If we had recommendations for women about how to lower their risk of breast cancer if they have dense breasts, it would be something – but we don’t,” she continued. “We are simply identifying a problem for these women without offering any solution.”
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Each year in the U.S., about 264,000 cases of breast cancer are diagnosed in women and around 42,000 women die of the disease, according to the CDC.
The U.S. Preventive Services Task Force recommends that women 50 years or older should get mammograms every other year.
For those with a family history of the disease, the recommendation is to begin mammograms at 40 years old.
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Since 1990, mammogram screenings have helped to reduce breast cancer deaths by nearly 40%, according to the American College of Radiology.