FDA Announces Regulation Updates to Improve Early Detection of Breast Cancer

The U.S. Food and Drug Administration (FDA) announced new regulations on Thursday that would require mammogram providers to inform women over the age of 40 about the density of their breast tissue. This is in an effort to improve early detection of breast cancer, a condition about one in eight women will develop in their lifetime.[0]

The updates will require mammogram facilities to notify women if they have dense breast tissue and recommend they consult with a doctor about whether they need additional screening. These amendments must be implemented within the next 18 months.[1]

The changes will also “strengthen the FDA’s oversight and enforcement” of imaging providers while making it easier for radiologists to categorize and assess mammograms, the administration said. 

Mammograms are the best way to detect breast cancers, however, the language informs women that these screenings may not always be successful and other tests may be necessary.[2] An MRI or ultrasound may be included.[3]

It is recommended by medical professionals that women begin to receive mammograms regularly at age 50, or sooner based on certain risk factors.[4]

Dense breast tissue is a common finding on mammograms, especially in younger women, and can make it more difficult for technicians and others to spot breast cancer warning signs.[5]

“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,” said Dr. Hilary Marston, the FDA’s chief medical officer.

Armed with the right information, women with dense breast tissue may be able to talk to their doctor about whether or not they need to take additional steps to make sure breast cancer isn't missed — such as more frequent screenings or additional imaging, like an ultrasound or MRI.

The ruling from the FDA provides a baseline of requirements for around 8,700 facilities in the United States, with individual states having the ability to demand even stricter regulations.[3]

It appears that the updates will provide the FDA with increased supervision of individual mammography facilities, supposedly with the aim of enhancing patient care and communication. Prevention and screening are key to early detection, allowing women to seek consultation earlier and further testing, if necessary.

The new regulations are a step forward in fighting breast cancer and empowering women to make educated decisions about their health care.

0. “FDA to require mammogram centers to inform women of breast density” Wink News, 10 Mar. 2023, https://winknews.com/2023/03/10/fda-to-require-mammogram-centers-to-inform-women-of-breast-density/

1. “The FDA Just Set a New, Life-Saving Guideline for Breast Checks” NewBeauty Magazine, 9 Mar. 2023, https://www.newbeauty.com/fda-new-guidelines-dense-breast-checks/

2. “FDA sets national mammogram standards to protect women with dense breasts” Texarkana Gazette, 10 Mar. 2023, https://www.texarkanagazette.com/news/2023/mar/09/fda-sets-national-mammogram-standards-to-protect/

3. “FDA sets national mammogram standards to protect women with dense breasts” The Washington Post, 9 Mar. 2023, https://www.washingtonpost.com/health/2023/03/09/mammogram-standards-dense-breasts/

4. “FDA requires breast density information to be included in mammography reports” KERO 23 ABC News Bakersfield, 11 Mar. 2023, https://www.turnto23.com/news/health/fda-requires-breast-density-information-to-be-included-in-mammography-reports

5. “FDA to require breast-density notifications from mammography facilities” Radiology Business, 9 Mar. 2023, https://radiologybusiness.com/topics/healthcare-management/healthcare-policy/fda-require-mammography-notify-women-breast-density

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