The FDA Proposed New Guidelines To Help Detect Breast Cancer Earlier — Here's What To Know

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The U.S. Food and Drug Administration (FDA) is potentially revamping its education guidelines about breast cancer prevention, according to a recent press release from the organization. For the first time in 20 years, the FDA is proposing updating mammogram guidelines in order to help improve the effectiveness of breast cancer prevention services. The proposed FDA regulations mean that clinics providing mammograms must also update their educational materials, so that patients and medical providers can make more informed decisions about their health.

Breast cancer is one of the most worrisome health concerns facing women,” said FDA Commissioner Scott Gottlieb, M.D in the press release. “The FDA plays a unique and meaningful role in the delivery of quality mammography to help patients get accurate screening to identify breast health problems early, when they can be effectively addressed. As part of our overall commitment to protecting the health of women, we’re proposing new policies to modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting. We’re committed to making sure patients have access to high quality mammography. Today’s proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field.”

The major changes to mammography education standards would include information about breast density, Debra Goldschmidt wrote for CNN. Mammograms of breasts with dense tissue can be more difficult to read, Goldschmidt wrote, so detecting cancer in dense breasts can be challenging for doctors. Moving forward, providers will be required to distribute educational materials about dense breasts when returning screening results.

According to Ashley May writing for USA Today, women with dense breasts will be informed that, since tumors can hide behind dense tissue and go undetected, their chances for breast cancer may be higher, as mammograms aren’t always as effective for them. While some states already require that this information be distributed at mammography clinics, the FDA’s proposed regulations would mean that the new educational standards will be enforced nationwide. The new FDA guidelines would encourage women to talk to their doctors about their screening results, and consider additional imaging tests in some cases.


“The FDA is committed to advancing efforts that improve the health of women,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD. “We believe the proposed rule would help empower patients and health care professionals by proposing improvements to the information facilities communicate to them, helping to facilitate the sometimes difficult conversations about potential risks for breast cancer.”

The FDA’s new guidelines update regulations established under the Mammography Quality Standards Act (MQSA), according to the press release, which was passed to promote early breast cancer detection in 1992. The MQSA empowers the FDA to oversee mammography clinics, ensuring that accreditation and standards of care are enforced. The new FDA guidelines are also updated in light of recent advances in mammography technology, Goldschmidt wrote for CNN. New 3D digital imaging can provide images of breast tissue from multiple angles, which may provide more accurate screening results for some patients.

“Once finalized, these proposed amendments will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health said in the press release.

The American Cancer Society recommends mammograms annually for women between the ages of 45 and 54, and every other year after that for healthy women, Goldschmidt wrote for CNN. Younger women should also be given the option for regular mammograms if they want them, the American Cancer Society says. If you have any concerns about your breast health, or aren’t sure if you have dense breasts and would like more information, have a talk with your doctor as soon as you can.