Medical practitioners will have to inform patients about breast density in mammograms under new FDA regulations

THE US Food and Drug Administration updated its mammography regulations, which affect physicians and medical centers across the country.

Under the new regulations, mammography facilities will have to inform patients of their breast density. About half of American women over 40 have what are called dense breasts. The presence of this type of tissue has been linked to a higher risk of developing breast cancer and can make it more difficult to diagnose the disease.

While similar laws have already been enacted in 38 states, including Colorado And Minnesotathis is the first national regulation.

The new regulations “will also strengthen FDA oversight and enforcement of facilities and help interpreting physicians better categorize and evaluate mammograms,” the agency said in a press release.

“Today’s action represents the agency’s broader commitment to supporting innovation to prevent, detect, and treat cancer,” said FDA Chief Medical Officer Dr. Hilary Marston. “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 sharp decline in the number of facilities that don’t meet quality standards. That means more women have access to consistent, quality mammography. We remain committed to advancing efforts to improve women’s health and strengthen the fight against breast cancer.”

What are dense breasts?

Dense breasts or dense breast tissue is the term used to describe the appearance of certain breasts on a mammogram. Dense breasts have less fat and more tissue, so images captured by standard mammograms may not show tumors or other masses. On mammograms, masses and tissue appear white.

mammography, breast density
These two undated photos, provided by the American College of Radiology show an extremely dense, left breast, and a less dense breast.


Dense breasts are very common, according to the National Cancer Institute, an entity of the National Institutes of Health. About half of women over 40 in the United States who have mammograms have dense breasts. The condition is often hereditary, but can also be influenced by use of menopausal hormone therapy and low body mass index, according to the institute.

Dense breasts cannot be determined by self-exams or clinical exams, only mammograms.

Having dense breasts has been linked to 1.2 to 4 times more likely to develop breast cancer. However, according to the institute, there is no link between dense breasts and death from breast cancer. According to the FDA, 1 in 8 women will get breast cancer in her lifetime.

What do the FDA changes mean?

The FDA changes are changes to regulations published under a 1992 law that gives the FDA oversight of mammography facilities, but only now has the FDA used the law to require facilities inform women if they have dense breast tissue.

The requirements are to be implemented within the next 18 months, the FDA said in a press release. The amendments provide “specific language explaining how breast density may influence mammography accuracy” and recommend that patients with dense breasts speak to health care providers about their individual situation and risk.

“While nearly all certified mammography facilities continue to meet quality standards, today’s updates, among other things, improve the FDA’s ability to communicate directly, if necessary, with patients and their providers. health care in cases where a facility has failed to meet quality standards and is not communicating adequately with patients about its shortcomings,” the FDA said in a press release. “This is intended to ensure that Important information that may affect patient care decisions, such as the potential need for further evaluation or repeat mammography, is communicated as fully as possible.”

Could ultrasounds detect breast cancer?


The FDA said the changes bring the 1992 law “into the 21st century” and use current best practices in science and mammography to improve breast cancer detections and empower patients.

The changes do not require mammography facilities to use more intensive tools to detect breast cancer. People with dense breasts can use other imaging tests, such as ultrasounds or MRIs, but the U.S. Preventive Task Force, an independent expert group that makes screening recommendations, said that It was not yet clear whether the use of these additional tests was beneficial.

The FDA continues to recommend that people get regular mammograms. The task force advises women between the ages of 50 and 74 to have a mammogram every two years. Younger women may also choose to get tested based on their individual risk factors and family history.

Leave a Comment