FDA proposes changes to mammography standards for the first time in more than 20 years

(CNN) – The US Food and Drug Administration announced Wednesday proposed changes to mammography standards.

These are the first changes in the regulation of mammography screening for more than 20 years, aimed at improving the quality and modernizing breast cancer screening, said Dr. Scott Gottlieb, Commissioner of the FDA.

The main changes are to provide patients with breast density information in the form of a letter with the results of the screening.

Mammograms of dense breasts are more difficult to read and interpret. "The dense tissue can mask the signs of breast cancer and reduce the sensitivity of the image," according to the FDA. Dense breasts are also known to be a risk factor for breast cancer. More than half of women over age 40 have dense breasts, according to the FDA.

"The FDA provides specific wording on how breast density can affect the accuracy of mammograms and recommends that patients with dense breasts talk to their health care provider about high breast density and their relationship to breast cancer risk. breast cancer and their individual situation. "

This is a means by which proposed changes attempt to improve communication with patients. For the same purpose and to improve communication with providers, the agency also proposed to expand the categories used to classify mammography results, currently labeled as "negative", "benign", "probably benign "Suspect", "very suggestive of malignancy" or "Incomplete: requires additional imaging assessment". The agency would add two categories: "malignant tumor proven by known biopsy" and "postoperative mammograms for placement of markers". She also wants to add an evaluation category of "incomplete: need prior mammograms for comparison."

This should help screening facilities "More accurately categorize" the results and help patients and caregivers make more informed decisions after receiving the results of the mammogram.

The amendments also take into account "advances in technology and mammography processes since the publication of the regulations in force". For example, 3D digital screening can provide cross-sectional images of the breast from different angles. The result is an "informed image" of breast tissue, which is better for some patients compared to 2D imaging.

Since 1992, the FDA has been responsible for the quality of care in facilities that perform mammograms, including standards for accreditation, certification, inspection and enforcement.

The proposed amendments strengthen the organization's ability to revoke and suspend the activities of mammography screening centers that violate the regulations. This "allows the agency to better enforce and act," said Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health.

"Mammography is the best tool to determine if a woman has breast cancer, "said Gottlieb. Breast cancer is the second most important cancer in American women, after skin cancer, and the second leading cause of cancer deaths after lung cancer. According to the National Cancer Institute, in the United States, more than 260,000 women were diagnosed with breast cancer in 2018 and more than 40,920 women died from breast cancer that year.

The American Cancer Society recommends mammograms every year between ages 45 and 54, then every two years, as long as a woman is in good health and should live another 10 years. Women under 45 should have the choice to start an annual mammogram, according to the cancer society.

There is a 90-day public comment period for the proposed amendments, which will be followed by changes based on observations. Then it will be examined before it becomes definitive.