New Mammogram Guidelines: U.S. Food & Drug Administration Wants Better Communication for Patients by Mei Marcie

Since 1992, the U.S. Food and Drug Administration (FDA) has been responsible for the quality of care at facilities that conduct mammograms. For the first time in 20 years, the FDA has proposed updates to the national mammogram regulations issued under the Mammography Quality Standards Act of 1992. In 2018, it is estimated that more than 260,000 women were diagnosed with breast cancer and more than 40,920 women died of the disease.

One key proposed change is the reporting of breast density. The FDA wants patients be provided with information about breast density in the form of a letter with screening results. Dense breast tissue may obscure signs of breast cancer and lower image sensitivity, and dense breasts are also known to be a risk factor for breast cancer. The additional information given to patients can help the patient discuss results with their doctor and review their breast-cancer risk.mThis change is significant given that more than half of the women over 40 have dense breasts.

Another change to improve communication is the addition of three new categories in mammogram findings:

• known biopsy proven malignancy
• post-procedure mammograms for marker placement
• incomplete: need prior mammograms for comparison

The FDA is also proposing that it can directly notify patients and their doctors of mammogram facilities that do not meet quality standards, and regulate improved record-keeping requirements by the facilities.

The American Cancer Society recommends "all women should begin having yearly mammograms by age 45, and can change to having mammograms every other year beginning at age 55." Given that mammograms are a part of regular health screening, it is a significant step to communicate better the results in order to achieve what screening is all about: early detection and saving lives.

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