The FDA is making updates to mammography regulations that were issued under the Mammography Quality Standards Act of 1992 and the Federal Food, Drug, and Cosmetic Act of 1938. These important improvements will help ensure that every patient is given feedback concerning their personal mammogram results, as well as additional health information. The FDA has developed two patient density paragraphs, one intended for patients with low breast density and one for patients with high density breasts. These paragraphs contain an explanation of high breast tissue density, as well as specific information for women to discuss with their healthcare providers. The information must include, at a minimum:
- The effect of high breast density in masking the presence of breast cancer on a mammogram
- The qualitative assessment of the provider who interprets the mammogram
- A reminder to patients that individuals with dense breast tissue should talk with their providers if they have any questions or concerns about their summary.
In 2012, New York State enacted a law requiring letters be sent to women with high breast density after their mammograms. Now, all women living in the United States will receive a similar letter in the mail as per federal law. The information provided will be specifically tailored to the needs of the patient, as well as any recommendations for additional follow up care. This new step will promote awareness while giving patients access to information about their own breast health.
These letters will be arriving in your mailboxes very soon- so read them carefully, take time to learn about your breast health, and advocate for yourself with your medical providers. Early detection is the key for improving survival, so make sure you schedule an annual mammogram starting at the age of 40 and perform your self-check every month.
The full Federal Law is available here: bit.ly/FDAFederalreport