FDA Says Mammo Reports Should Provide More Info on Density

This is a good thing. Here is a little background history.

For as long as I have been a radiologist we have always had the breast density in the mammo report. If the patient was not getting that information, it was because the ordering physician was not passing it on. The report included the caveat that if the breast tissue was very dense something small may get hidden. At some point the "lay letter" to the patient was mandated by the ACR giving the results to the patient by mail re: normal vs abnormal. We were given form letters with specific wording to use and we used them. It did not include breast density.

Fast forward many years to when it became evident that not only did dense tissue hide things, there was an inherent increase in the % of developing cancer compared to fatty breasts. Makes sense. More breast tissue cells, more chances for one to develop a problem.

Several years ago some states instituted laws that made it mandatory to include breast density in the lay letters. The ACR responded with new form letters that included breast density and in accordance with the law, indicated why it was important to know and that it was important to get additional exams such as US or MRI to make sure there was nothing bad lurking in that dense tissue. The FDA now made this federal law. The problem is that insurance companies usually do not pay for patients without symptoms and with normal reports regardless of density.

Prior to this FDA announcement, some states have already written much better laws which not only mention the density and recommend the additional imaging, these states make it mandatory for insurance companies to cover the cost of the additional studies. They are required by law to pay for additional studies based on density alone in an otherwise "normal" patient with a "normal" screening mammogram. This is where the federal law needs to go as this new information will do you no good if you cannot pay for it yourself. It will only cause more anxiety. Can you imagine getting a report that says "you need more studies but you're on your own"?