FDA requires dense breast disclosure at mammogram clinics

In a long-awaited ruling, the Food and Drug Administration recommended Thursday that all mammogram centers should tell women if they have dense breasts, which can increase the risk of breast cancer.

of breast tissue density — Whether it is mostly fatty or glandular tissue varies from woman to woman and has nothing to do with the size, shape or feel of her breasts. The only way for a woman to know if she has dense breasts is to have a mammogram. She doesn’t know when she sees or touches her breasts.

Dense breast tissue can obscure the risk of cancer because it makes it harder for mammograms to detect small tumors.

Mammograms classify density into four levels, designated A, B, C, and D, ranging from almost completely fatty to very dense breasts. Among women with level D, she is only 10% at risk with very dense breasts. A person at level C has an average risk of cancer based on density alone.

The updated regulations simply require patients to be told if their breasts are dense or not dense. Levels A and B are “not dense” and levels C and D are “dense”.

FDA will evaluate facilities to determine whether to award a certificate demonstrating compliance with new agency requirements. If a woman doesn’t see her facility’s certification, she can request it or check the FDA’s website, said FDA Chief Medical Officer Dr. Hilary Marston.

JoAnn Pushkin, executive director of advocacy group DenseBreast-info, Inc., applauded the agency’s update. Thirty-eight states have laws requiring mammography facilities to inform women if they have dense breasts, but these regulations vary in the amount of information women should receive. The new regulations will standardize what needs to be disclosed, she said, “leading to early detection of breast cancer.”

But the high-density breast and screening landscape is not so simple, says Christophe Lee, breast imaging technologist at Fred Hutchinson Cancer Center and director of the Northwest Screening and Cancer Outcomes Research Program at the University of Washington. Dr. He fears that the information women get about breast density can be misleading.

Only a small percentage of women with high breast density have an increased risk of cancer based on breast density alone, said Dr. Lee. It is nothing more than that of Far more important are risk factors such as family history and previous breast cancer.

FDA’s Dr. Marston said many physicians already have more detailed information because many states require reporting. “Clinicians need to judge a patient’s situation in terms of risk factors,” she said.

“The big question is what women do with that information,” Dr. Lee asked. What does it mean when a woman is told her breasts are ‘dense’? Many women need more frequent screening or additional screening with an ultrasound or MRI if their breasts are ‘dense’. I keep hearing that. , do they follow that guidance?

The FDA’s hope is that whether or not it’s well-informed will lead to a formal assessment by doctors so they can actually advise whether women are at higher risk overall.

However, Dr. Lee cautioned that the first finding of breast density should not reflexively lead to further testing.

“For women, knowing what the next steps should be can be confusing,” he added. There is some evidence from Europe that it can.” But he added that there isn’t much evidence that women outside the very dense category benefit from supplemental screening.

And even if a woman wants such screening, insurance companies often won’t cover it if the standard risk calculator used by doctors shows that the woman’s lifetime risk is less than 20%.

Dr. Lee said the new regulation is “a step towards informing women, but it’s not clear where it will lead.”