FDA to Require Breast Density Notification Amongst Other Updates to Mammography RegulationsMarch 16, 2023
Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The MQSA was passed to ensure, among other things, that nationwide, patients have access to quality mammography services. It authorized FDA oversight over mammography facilities. This oversight encompasses facility accreditation and certification as well as annual inspections and enforcement of standards.
A type of medical imaging, mammography uses x-rays to create images (mammograms) of the internal structures of breasts. It can help detect breast cancer in its earliest, most treatable stages, when it is too small to be felt or detected by an alternative method. See ACS, “Can Breast Cancer Be Found Early?.” However, it can also be among the most difficult images to interpret. See Government Accountability Office, “GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations” (July 2006). A reader may miss a cancerous lesion if the image quality is poor, resulting in a false negative diagnosis, which could delay treatment and result in an avoidable death. Conversely, a diagnosis could be a false positive, which can occur when an otherwise normal tissue is erroneously read as abnormal. In turn, this could create unwarranted anxiety for the patient and result in additional testing (and costs).
Mammograms can also detect breast tissue density. Approximately half of women over the age of 40 in the United States have dense breast tissue. Dense breast tissue can make cancers difficult to detect on a mammogram and have been identified as a risk factor for developing breast cancer.
Most of the requirements in the mammography regulations are over 20 years old. Current regulations do not require breast density notification to be part of the healthcare provider report or the lay summary to the patient.
One key update to the regulation will require that facilities provide information to patients regarding the density of their breasts. Although thirty-eight states require notification of breast density, the requirements vary from state to state. By updating the mammography regulations, FDA sets a minimum standard that patients be informed of whether they have dense or non-dense breast issue and the significance of breast density and suggest that patients consult their doctors about the need for additional tests. The notification to patients will depend on the breast density:
- For the non-dense breast notification: “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”
- For the dense breast notification: “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast cancer is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”
The amendments also require that the written report of the mammographic examination provided to the healthcare provider include an overall assessment of breast density, classified in one of the following categories:
- “The breasts are almost entirely fatty.”
- “There are scattered areas of fibroglandular density.”
- “The breasts are heterogeneously dense, which may obscure small masses.”
- “The breasts are extremely dense, which lowers the sensitivity of mammography.”
Other updates include ensuring the availability of qualified mammography personnel and standards for mammography reports, quality assurance testing, and clinical image quality.