FDA Proposes Mammography Rule Regarding Dense Breasts


August 21, 2019

FDA Proposes Mammography Rule Regarding Dense Breasts

Studies have shown that women with dense breasts have an increased risk of cancer, which could lead to missed cancer diagnoses on mammograms. In an effort to address the issue, the U.S. Food and Drug Administration (FDA) is proposing a rule that would require mammography centers to inform patients if they have dense breasts.

Dense Breast Tissue

Dense breast tissue is composed of milk glands, milk ducts and supportive tissue as well as fatty tissue. Fat, which is a nondense tissue, appears black on a mammogram, making a tumor stand out more prominently. Dense breast tissue appears solid white and is very difficult for a regular mammogram to see through. Dense breast tissue cannot be diagnosed by touch. Only a mammogram can indicate if someone has dense tissue, which is then separated into four categories. The system used to rank density is known as Breast Imaging Reporting and Data System (BI-RADS):

  • A (Almost entirely fatty): A breast that isn’t dense at all and almost entirely made of fat; this applies to about 1 in every 10 women.
  • B (Scattered areas of fibroglandular density): Mainly nondense tissue but with scattered density; about 4 in 10 women fall into this category.
  • C (Heterogeneously dense): Opposite of B, this category means that breast tissue is primarily dense but with some nondense areas; this category applies to about 4 in 10 women.
  • D (Extremely dense): Breast tissue is almost completely dense; about 1 in 10 women are categorized here.

States Already Passed Laws

At least three dozen states already require mammographers to notify women if their breasts are dense. The new rule issued by the FDA would suggest specific language that could be used throughout the country to explain breast density and why other tests may be necessary for those women. Although the FDA rule would be the minimum required in all 50 states, leeway is given for each state to require women be given additional information.

Doctor Objections

There are doctors who object to the notification as not all dense tissues have the same increased risk. Some providers are concerned that the reporting requirement could frighten women and lead to additional screening tests or biopsies that are unnecessary. Others feel that the wording in the mandated letters is too confusing and hard for the average patient to understand. Still other doctors feel that women have the right to receive information about the density of their breasts in order to make a more informed decision on their healthcare.

One Woman’s Crusade

The push for these regulations is the result of one woman’s crusade. In 2003, Nancy Cappello, a special education teacher in Connecticut, learned she had advanced breast cancer just six weeks after her mammogram returned normal results. When she asked the doctor how the mammogram missed it, the doctor told her that her dense breast tissue hid the large tumor. Cappello had to undergo a mastectomy, chemotherapy and radiation. She says she may have been able to undergo less difficult treatment had she been told about the dense breasts and that she should seek additional testing. She and her husband contacted legislators in their state and Connecticut became the first to require breast density to be reported to women.

If the rule is adopted, it will be the first change to mammography regulations in 20 years. The proposed rule is open to public comments for 90 days and may be modified before it becomes final depending on the comments received.