FDA Passes Rule to Enhance Cancer Detection in Women With Dense Breast Tissue

FDA Passes Rule to Enhance Cancer Detection in Women With Dense Breast Tissue
A woman gets a mammogram at the University of Michigan Cancer Center in Ann Arbor, Mich., on May 22, 2015. (Detroit Free Press via AP, File/Kimberly P. Mitchell)
Naveen Athrappully
3/10/2023
Updated:
3/16/2023
0:00

The U.S. Food and Drug Administration (FDA) has passed a new rule mandating mammography facilities to notify women in case of dense breast tissue—an update expected to help in the early detection of breast cancers.

Around half of American women above the age of 40 are estimated to have dense breast tissue. The U.S. Centers for Disease Control and Prevention estimates that around one in eight women will develop breast cancer during the course of their lives. Mammography is the best tool to detect and screen breast cancer.

However, dense breast tissue can make cancer detection more difficult during a routine test. “Additionally, dense breasts have been identified as a risk factor for developing breast cancer,” said the FDA in a March 9 press release.

On a mammogram, dense breast tissue appears white—similar to cancer—leading to complications. This leads to complexity in proper diagnosing as malignant tumors could blend in with the dense tissue.

In addition to notifying women with dense breast tissue, the new FDA rules require mammogram services to recommend such women consult a doctor and determine whether they require additional screening.

The facilities also have to provide women with information about how breast density can influence the accuracy of mammograms.

“While nearly all certified mammography facilities continue to meet quality standards, today’s updates, among other things, enhance the FDA’s ability to communicate directly, if needed, with patients and their health care providers in cases where a facility did not meet quality standards and is not adequately communicating with patients about its deficiencies,” according to FDA.

Breast Cancer Among US Women

After skin cancer, breast cancer tops the list of the most common cancer among women in the United States, accounting for around 30 percent of new female cancers every year.

An estimate from the American Cancer Society predicts that 297,790 new cases of invasive breast cancer will be diagnosed among American women in 2023. In addition, 43,700 women are also expected to die from breast cancer this year.

Breast cancer usually occurs among women who are middle-aged and older. Half the women who develop breast cancer are 62 years of age or younger at the time of diagnosis. Only a small number of women under 45 are diagnosed with breast cancer.

The new FDA rule amends regulations issued under the Mammography Quality Standards Act, a law passed in 1992 aimed at ensuring quality mammography. The changes are to be implemented within 18 months.

Mammography Risks, Alternatives

Though mammography is a widely used technique to identify breast cancers, it comes with risks like radiation. Mammography uses a type of ionizing radiation that is far stronger than those emitted by natural sources.

If exposed to ionizing radiation at high levels, it can harm organs and tissues, leading to cancer. A dose of radiation that a person is exposed to during mammography is equivalent to the radiation they are subjected to in their natural surroundings for three months, according to the American Cancer Society.

Overdiagnosis is another risk of mammography. This happens because mammograms can detect abnormalities that are not cancers or cancers that would have automatically regressed on their own. As a result, many women might end up subjecting themselves to unnecessary radiation therapy, chemotherapy, or surgery.

Thermography is a low-risk early detection alternative for breast cancer. It uses infrared cameras for cancer detection. Unlike mammography, thermography is noninvasive and does not involve the use of radiation. Individuals can take as many thermography tests as they require without any perceived dangers.

On the flip side, thermography cannot exactly tell if a person has cancer. It can only be used as an early prevention tool to create a baseline and track changes in breast tissues over time so that any abnormality can be identified.

Naveen Athrappully is a news reporter covering business and world events at The Epoch Times.
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