FDA Proposes Changes to Mammography for First Time in 20 Years

In an effort to modernize and improve the quality of breast cancer screening, the U.S. Food and Drug Administration is proposing changes to mammography standards for the first time in 20 years. The changes center on best practices, patient care and patient education as well as the regulation of mammography facilities. The changes will also take into account technological advances within the field of mammography. There will be a 90-day public comment period before the changes are reviewed and finalized.

What changes are in store for mammography?

Mammography Quality Standards Act of 1992

Current mammography standards were set by the FDA in 1992 with the Mammography Quality Standards Act. In addition to setting the certification and licensing requirements for facilities, this act outlines specific procedures that facilities must follow in relation to patient care.

The changes proposed by the FDA would update these procedures and policies in order to reflect current technology in mammography. They would also take into account recent medical discoveries regarding breast cancer.

Proposed Changes to the Quality Standards Act

The most notable changes to the act involve patient education, results categorization and increased agency power. Let’s take a closer look at each:

• Patient Education - New standards would require facilities to provide women with information about breast density and how it can affect the accuracy of mammography. According to the National Cancer Institute, nearly half of all women over the age of 40 have dense breasts because density tends to increase with age. About 10% of women have extremely dense breast tissue.
• Results Categorization - The FDA would like to expand the categories used to describe findings. The current categories include: negative, benign, probably benign, suspicious, highly suggestive of malignancy and incomplete. The agency would like to add the categories “known biopsy proven malignancy” and “post procedure mammograms for marker placement.”
• Increased Agency Power - The changes would also give the FDA more power to revoke licenses and suspend operations of facilities that are not following regulations.

In addition, the proposed changes would modernize the technological aspects of the standards.

How Technology Has Improved Mammography

Mammography technology has changed in profound ways. Most recently, 3D technology is slowly being introduced to facilities across the nation. 3D imaging allows technicians to take pictures of multiple slices of the breast and join them together to get a more complete picture of the breast tissue. It is believed that 3D imaging will allow doctors to find smaller tumors and better understand their placement within the breast.

While 2D technology is still the standard and the most widely used, new 3D technology may offer better results for women with dense breast tissue. Regardless of the technology, mammography is the best method to detect breast cancer. Women are still urged to get an annual mammogram between the ages of 45 and 54 and every other year thereafter.

~ Here’s to Your Health and Wellness