Since 2019, Washington has had a statute (RCW 70.54.460) requiring that any woman who has a mammogram must be notified if the images show that she has dense breasts. Similar reporting requirements have been required on other states, but there has been no national standard. Just this month the FDA updated mammography reporting requirements for all mammography facilities nationwide.
The Washington law specifies the language that must be used in a report send directly to the patient as well as to the physician who referred her for the mammogram:
“Your mammogram indicates that you may have dense breast tissue. Roughly half of all women have dense breast tissue which is normal. Dense breast tissue may make it more difficult to evaluate your mammogram. We are sharing this information with you and your health care provider to help raise your awareness of breast density. We encourage you to talk with your health care provider about this and other breast cancer risk factors. Together, you can decide which screening options are right for you.”
38 states and D.C. have similar “dense breast” reporting requirements, but the language used in such reports vary from state to state. The FDA has now issued a national requirement that such notifications must be sent to women who have mammograms, as well as to the referring providers. The rule goes into effect in September, 2024. The specific language in the notices must clearly state that “your breast tissue is not dense” or “your breast tissue is dense.” The notice must also recommend that patient consult their healthcare providers about the risk of developing cancer if the patient has dense breasts.
The importance of such notice requirements is based on two facts: first, women with dense breast tissue are at greater risk of breast cancer and, second, regular mammograms are less likely to find cancer in such cases. Often, physicians order supplemental screening, including ultrasound and MRI exams. Studies reflect that cancer that is missed by a mammogram can be found with such testing.
