A new rule from the US Food and Drug Administration just went into effect last month, requiring that mammography providers notify patients about their breast density along with their mammogram results. While some experts laud the new rule for helping inform patients and promote early detection, others are concerned that this rule could lead to overuse.
In a recent article in NBC News, researchers and policy experts—including the Lown Institute’s Senior Policy Analyst Judith Garber—explained some of the potential downsides to informing women about breast density.
Read the full NBC News article and see our previous coverage of the FDA breast density rule for more on this topic!
Unnecessary supplemental screening
One issue with informing women about their breast density is the lack a national standard on how women with dense breast tissue should be screened. While supplemental screenings may catch more early-stage cancers, there’s no evidence that they save lives or decrease the rate of more advanced cancers. At the same time, these additional screenings can lead to more false positives and unnecessary biopsies.
“The FDA is saying ‘you have this breast density, you should be aware that you have an additional risk factor.’ But then there’s not really anything that people should do about it. It’s a really terrible place to be as a patient.”
Judith Garber, Lown Senior Policy Analyst, NBC News
Specialty organizations disagree on whether or not women with dense breasts should get additional types of screening like MRI or ultrasound; the American College of Radiology and National Comprehensive Cancer Network recommend supplemental screening, while the American College of Obstetricians & Gynecologists and the U.S. Preventive Services Task Force say there’s not enough evidence to recommend additional screening.
That can leave patients in a frustrating position. The FDA’s “notification language is sort of pushing people toward doing more tests, when, in fact, the tests aren’t actually recommended” universally, said Judith Garber, Lown Institute Senior Policy Analyst, in NBC News. “So the FDA is saying ‘you have this breast density, you should be aware that you have an additional risk factor.’ But then there’s not really anything that people should do about it. It’s a really terrible place to be as a patient.”
Differing definitions of density
Another downside is that definitions of breast density are variable depending on radiologists’ readings. At least 13% of women will have their breast density classification change over a two-to-three year period. So women may get a notification one year that they have dense breasts and then a different one a few years later, which can be confusing.
And lastly, cost can be a big downside to these notifications. Insurers aren’t required to cover the cost of additional screenings, so patients may be on the hook for out-of-pocket costs.
It’s possible this rule will help women start a conversation with their providers about their risk of breast cancer and the benefits and harms of screening, which would be a positive. However, without shared decision making, it’s likely these notifications will increase anxiety and potential harm from follow-up tests, without making us healthier.