FDA proposes new mammogram guidelines for women with dense breasts
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FDA proposes new mammogram guidelines for women with dense breasts
For the first time in 20 years, the Food and Drug Administration (FDA) has proposed changes to mammogram guidelines. This change would require mammogram providers to tell women with dense breast tissue that the condition could make it harder to interpret their screening tests and to recommend that they talk with their physicians about whether they should have additional tests to check for cancer. By proposing this change, the FDA is hoping to modernize standards to include better communication and technology.
Dense breasts have relatively high amounts of glandular tissue and fibrous connective tissue and relatively low amounts of fatty tissue, according to the National Cancer Institute. Nearly half of women ages 40 and older who get mammograms are found to have dense breasts. Because such tissue appears white on a mammogram – the same as a cancerous breast tumor – it can obscure malignancies, making mammograms of dense breasts more difficult to read and interpret. In addition, dense breast raise a woman’s risk of developing breast cancer.
After skin cancer, breast cancer is the most common cancer in women. About 268,000 women will receive diagnoses of invasive breast cancer in 2019, according to estimates by the American Cancer Society. More than 41,000 will die of the disease. The American Cancer Society recommends mammograms every year between the ages of 45 and 54 and every other year after that for as long as a women is in good health and expected to live another 10 years. Women younger than 45, should be given the choice to start annual mammograms, the cancer society says.
There are already 37 states which require some kind of notification for women with dense breasts, but the language varies widely. The FDA proposal would establish a minimum standard that would apply nationwide, but states could retain more stringent requirement if they wished.
These policy changes will also take into consideration advances in mammography technology and processes since the current regulations were published. For example, 3D digital screening can provide cross-sectional images of the breast from multiple angles. The result is an informed image of the breast tissue, which is preferred for some patients over traditional 2D imaging.
Some women who have dense breasts could benefit from supplemental tests such as MRIs or ultrasounds, experts say. But that opinion isn’t unanimous. The U.S. Preventive Service Task Force, an independent panel of experts who review evidence on the effectiveness of preventive services, has concluded that there isn’t enough evidence to determine whether the benefits of extra testing outweigh the potential harm.
There is a 90-day public comment period for the proposed changes, which will be followed by changes based on the comments. Then it will be reviewed before it becomes final.