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," the FDA said. 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 offers specific wording on how breast density can affect the accuracy of mammography and recommends that patients with dense breasts talk to their health care provider about high breast density and how it relates to breast density. the risk of 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 "," suspicious "," highly suggestive of malignancy "or" incomplete: requires additional imaging assessment. " The agency would like to add two categories: "malignant tumor proven by known biopsy" and "postoperative mammography for marker placement". He would also like to add an evaluation category "Incomplete: need for pre-existing mammography 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 reflect advances "in technology and mammography processes since the publication of the current regulations". For example, 3D digital screening can provide cross-sectional images of the breast from multiple angles. The result is an "informed image" of breast tissue, which is better for some patients compared to 2D imaging.
The proposed amendments strengthen the agency's ability to revoke and suspend the activities of mammography screening centers that violate 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 cancer. According to the National Cancer Institute, in the United States, 260,000 women were diagnosed with breast cancer in 2018 and more than 40,920 women died of breast cancer that year.
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.