FDA Says Mammography Reports Should Provide More Information on Breast Density

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The U.S. Food and Drug Administration (FDA) has proposed changes to current regulations that would require mammography centers to provide more information on breast density, as well as how density affects both breast cancer risk and the accuracy of mammograms.

The proposed changes were announced in an FDA media release on March 27, 2019. Read the FDA press announcement.

What is breast density and how is it measured?

Dense breasts have less fatty tissue and more non-fatty tissue compared to breasts that aren't dense.

One way to measure breast density is the thickness of tissue on a mammogram. The BI-RADS (Breast Imaging Reporting and Database System), which reports the findings of mammograms, also includes information on breast density. BI-RADS classifies breast density into one of four groups:

  • mostly fatty
  • scattered areas of density
  • consistently dense
  • extremely dense

Still, no one method of measuring breast density has been agreed upon by doctors. Breast density is not based on how your breasts feel during your self-exam or your doctor's physical exam. Dense breasts have more gland tissue that makes and drains milk and supportive tissue (also called stroma) that surrounds the gland. Breast density can be inherited, so if your mother has dense breasts, it's likely you will, too.

Research has shown that dense breasts:

  • can be twice as likely to develop cancer as nondense breasts
  • can make it harder for mammograms to detect breast cancer; breast cancers (which look white like breast gland tissue) are easier to see on a mammogram when they're surrounded by fatty tissue (which looks dark)

Nearly half of women age 40 and older in the United States are classified as having dense breasts.

As of December 2018, more than 70% of states have passed laws requiring that women be notified of their breast density with mammography results. Still, these notifications are not required nationwide, which is why the FDA has proposed changes to the regulations governing mammography services.

Proposed FDA changes

According to the FDA, the proposed changes have the goals of modernizing mammography quality standards established in the Mammography Quality Standards Act of 1992 and better positioning the FDA to enforce the regulations. These are the first changes proposed in 20 years to the FDA’s mammography regulations.

The proposed changes include:

  • Adding breast density information to the mammography summary letter sent to anyone who has a mammogram, as well as to the medical report sent to the referring healthcare professional. The FDA is proposing specific language that would explain how breast density can affect the accuracy of a mammogram and would recommend people with dense breasts talk to their healthcare provider about breast density and how it relates to their personal risk of breast cancer.
  • Adding three categories for mammogram interpretation, including a “known biopsy proven malignancy” category, which would tell healthcare professionals that breast cancer has already been identified and is being evaluated for treatment.
  • Adding more detailed information about the mammography center in reports sent to both doctors and patients.
  • Allowing the FDA to contact patients and their doctors directly if a mammography center doesn’t meet quality standards and the center is unwilling or unable to do so.
  • Requiring mammography centers to use only FDA-approved digital equipment that is specifically designed for mammography.
  • Strengthening record-keeping requirements to limit information loss and improve access to and transfer of mammography records.

“We believe the proposed rule would help empower patients and health care professionals by proposing improvements to the information facilities communicate to them, helping to facilitate the sometimes difficult conversations about potential risks for breast cancer,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D. “Given that more than half of women over the age of 40 in the U.S. have dense breasts, helping to ensure patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy.”

“Once finalized, these proposed amendments will enhance our oversight of mammography facilities, including in the key area of enforcement and patient communication,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “While the majority of certified mammography facilities are dedicated to providing high levels of patient care, today’s proposed regulations would enhance the FDA’s ability to communicate directly, if needed, with patients and their health care professionals in cases where facilities did not meet our quality standards and are not adequately communicating with patients about…facilities’ deficiencies. This is intended to help ensure important information that could affect decisions about patient care — such as the potential need for further evaluation or a repeat of a mammogram — is communicated as quickly as possible.”

What this means for you

The proposed changes will not take effect immediately. The changes are open for public comment for 90 days and could be revised before becoming final.

If you live in one of the states that currently requires mammography centers to provide patients information on breast density and have your mammograms done at an FDA-accredited mammography center, you probably won’t experience too many changes in your annual mammogram.

If you live elsewhere and the proposed changes are enacted, you may receive information on your breast density in the letter summarizing your mammogram results. If you learn that you have dense breasts and are unsure what that means, contact a member of your healthcare team to learn how your breast density affects your personal risk of breast cancer.

If you know that you have dense breasts, there are lifestyle choices you can make to keep your risk of breast cancer as low as it can be, including:

  • maintaining a healthy weight
  • exercising every day
  • limiting or avoiding alcohol
  • eating a healthy diet full of fresh, whole foods and avoiding processed foods with a lot of added sugar and salt
  • never smoking (or quitting if you do smoke)
  • breastfeeding, if you have the option to do so

Along with lifestyle options, many doctors recommend additional screening for women with dense breasts. This might include MRI and ultrasound.

For more information on steps you can take to keep your breast cancer risk as low as it can be if you have dense breasts, visit the Dense Breasts page in the Breastcancer.org Lower Your Risk section.

Written by: Jamie DePolo, senior editor

Reviewed by: Brian Wojciechowski, M.D., medical adviser


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