The Nationwide Density Standard for Breast Cancer

The FDA plans to amend the Mammography Quality Standards Act (MQSA) to ensure that female patients receive the information they need when making decisions about caring for the health of their breasts.

FDA Proposes to Amend the MQSA to Include Requirements Related to Dense Breasts

Since women with dense breasts are twice as likely to develop breast cancer, this MQSA amendment will require that each screening include more information about the patient’s breast density. Dense breasts can be described as breasts that consist of more ‘non-fatty tissue’ than of ‘less-fatty tissue.’ Nearly 50 percent of the women in the United States who are 40 years of age and older are classified as having dense breasts. This amendment should ensure that these women are identified and closely monitored for breast cancer.

Measuring Breast Density:

• A breast’s density cannot be determined by how a woman’s breast feels during a physical exam; however, a mammogram can measure the thickness of the breast’s tissue to determine its density.
• The Breast Imaging Reporting and Database System (BI-RADS) reports mammogram findings, including information related to breast density.

This database classifies a patient’s breast density into one of the following groups:

• Consistently dense.
• Mostly fatty.
• Extremely dense.
• Scattered areas of density.

Regardless, physicians have not agreed upon a single method for measuring the density of the breasts.

Research indicates that dense breasts:

• Substantially increase the likelihood of a woman developing breast cancer.
• May make the detection of breast cancer with a mammogram more difficult. Breast cancers on a mammogram image look white; therefore, when the cancer is surrounded by fatty tissue, it is easier to see because the fatty tissue looks darker. Since dense breasts have less fat and more gland tissue, and stroma, which do not appear darker on a mammogram, detecting breast cancer via a mammogram when a woman has dense breasts may be more difficult.

Differences in Existing State Laws

Currently, 38 states require density notifications of some kind; however, once this new amendment takes effect, density notifications will be a reporting standard for all breast cancer screenings performed in the U.S. The differences in these state laws is just one of the issues that the new MQSA amendment will address.

The existing state laws pertaining to reporting breast density differ greatly in their scope and their complexity:

• Some states only require that patients receive a general notification regarding breast density without any information concerning the patient’s own breast density. New Jersey, Connecticut and New York have these ‘inform laws.’ New York’s law is the only one of these three requiring the patient be informed as to whether her breasts are dense.
• Just 15 of the 38 states with existing laws mention supplemental screening; however, some of these laws neglect to mention that breast density is an independent risk factor for breast cancer development.

Once MQSA implements a single, nationwide reporting minimum, breast cancer screening information will be standardized for all women receiving their screenings in the U.S.

The FDA’s Mammography Quality Standards Act Amendment

With this new amendment, the breast density results must be reported to the referring physician or healthcare provider as well as to the patient.

Proposed changes to the MQSA include:

• Adding three mammogram interpretation categories, including one that tells healthcare professionals breast cancer has been identified and evaluation for treatment is underway (i.e., known biopsy proven malignancy).
• Adding information related to breast density to the patient’s mammography summary letter, as well as to her medical report that is sent to the referring healthcare provider.
• Recommending the adoption of specific language to explain how dense breasts may affect mammograms. In addition, the patient’s summary letter would advise the patient to speak with her healthcare provider about breast density so she could find out her potential risk for developing breast cancer.
• Requiring the use of FDA-approved digital equipment designed specifically for mammography.
• Including more specific information on the patient and doctor reports related to the center where the mammogram was performed.
• Increasing the requirements for record keeping so as to improve the access and transfer of mammography records as well as to limit information loss.
• Allowing direct contact between the FDA, patients and their doctors if the mammography center neglects to meet the standards set forth by the FDA or are unable, or unwilling to do so.