The Food and Drug Administration (FDA) wants to require mammogram providers to tell women if they have a common risk factor for breast cancer.
The proposal, released Wednesday, would be the FDA’s first update to mammography regulations in more than 20 years, according to a statement from the agency. Among other proposed changes, the policy would require mammography providers to inform patients who undergo the breast cancer screening test if they have dense breast tissue, which may both warp the results of a mammogram by obscuring signs of cancer, and increase the risk of developing breast cancer in the first place.
That information would be delivered in a post-screening summary letter, along with guidance for determining future medical care, the statement says. Providers in almost 40 states are required to give patients some information about breast density — though not necessarily about their own personal risk — but the FDA’s rule would codify such policies at a national level.
While the FDA called the policy part of an effort to “modernize breast cancer screening and help empower patients,” it is likely to be met with pushback from some doctors. More than half of women over 40 have dense breasts, according to the FDA, and not everyone with this common condition has the same risk of cancer, research has shown. The additional information could, in theory, lead to unnecessary testing and anxiety for some women who are not at high risk — a criticism often leveled against mammography in general, which some experts argue can lead to over-diagnosis without preventing many cancer deaths.
In its statement, however, the FDA maintained that the proposed regulations “will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication,” according to Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. The plan would also allow the FDA to notify patients if their mammography center did not meet quality standards, tighten equipment and record-keeping requirements for providers and make clearer to providers when a patient has a known cancer diagnosis.
The proposal must be open to public comment for 90 days before being finalized.
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