The FDA requires disclosure of dense breasts in mammography clinics
In a long-awaited decision, the Food and Drug Administration recommended Thursday that all mammography centers must notify women if they have dense breasts, which could put them at increased risk of breast cancer.
The density of breast tissue—whether it’s mostly fatty or glandular—varies from woman to woman and has nothing to do with the size, shape, or feel of a woman’s breasts. The only way for a woman to know if she has dense breasts, and if so how dense they are, is to have a mammogram; She can’t tell by looking or feeling her breasts.
Dense breast tissue can mask cancer risks because small tumors can be harder to detect on a mammogram.
Breast imagers classify density into four levels, labeled A, B, C, and D, ranging from almost completely oily breasts to extremely dense breasts. Only the 10 percent of women in Stage D with extremely dense breasts are at increased risk. Those in Stage C have an average risk of cancer based on density alone.
The updated regulations require patients to simply be told whether their breasts are tight or not; Levels A and B would be “not dense”, while C and D are “dense”.
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The FDA will evaluate the facilities to determine whether to issue a certificate confirming compliance with the new regulatory requirements. If a woman doesn’t see a facility’s certificate, she can ask for it or visit the FDA’s website, said Dr. Hilary Marston, the agency’s chief medical officer.
JoAnn Pushkin, the executive director of DenseBreast-info, Inc., an education group, praised the agency’s update. Although 38 states have laws requiring mammography facilities to tell women whether their breasts are full, those rules vary in how much information they must get from women. Because the new rules standardize what needs to be disclosed, they will “result in earlier detection of breast cancer.”
But the situation with dense breasts and screening isn’t that simple, said Dr. Christoph Lee, a breast imager at the Fred Hutchinson Cancer Center and director of the Northwest Screening and Cancer Outcomes Research Enterprise at the University of Washington. He worries that the information women receive about their breast density could be misleading.
Only a small minority of women with dense breasts have an increased risk of cancer based on breast density alone, said Dr. Lee, adding that “of all clinical risk factors, breast density is only a moderate one.” Of much greater importance are risk factors such as family history and previous breast cancer.
dr The FDA’s Marston said many doctors are already receiving the more detailed information because many states require it to be reported. “Clinicians need to make decisions about the patient’s situation in terms of risk factors,” she said.
“The big question is: What are women doing with the information?” asked Dr. Lee. When a woman is told her breasts are “dense,” what does that mean? Many women have heard – repeatedly – that if they have “dense” breasts they need more frequent screenings or additional ultrasound or MRI scans, will they follow this guide?
The FDA hopes the information — dense or not — will lead to a formal assessment by a doctor who can actually advise women if they are at an overall higher risk.
dr Lee cautioned, however, that an initial breast density reading should not automatically lead to further testing.
“It can be confusing for women to know what the next step should be,” he added. “There is some evidence from Europe that women in the top 10 percent of the population density might benefit from additional MRI screening.” But, he added, there isn’t much evidence that women outside the extremely dense category would benefit from additional one screening would benefit.
And even when women want such screening, insurers often don’t cover it when a woman’s lifetime risk is less than 20 percent, according to standard risk calculators used by doctors.
The new regulations, said Dr. Lee, “are a step towards informing women, but it’s not clear where they will lead.”
