FDA Proposes Changes To Mammography Standards For First Time In More Than 20 Years

The US Food and Drug Administration (FDA) for the first time in over 20 years prosed changes to mammography standards today. 

The changes are being made to improve quality in mammography screening  aiming at improving quality and modernizing breast cancer screening according to FDA Commissioner Dr. Scott Gottlieb.  He says that mammography is the foremost tool in determining whether a woman may have breast cancer or not. 

The most major change is basically being made to the form letters received by mammography patients giving them more information about breast density and more specific areas pertaining to the screening results.  Grater breast density is more difficult to read and therefore more difficult to interpret because the higher density can obscure signs of breast cancer and lower the sensitivity of the image.

More categories used to classify mammography findings will be added to the mammogram screening which will improve communication between the patient and her doctor and to providers.  

The new changes will also update the advances that have been made in mammography technology and processes such as 3D digital screening which can provide cross-sectional images from multiple angeles as compared to 2D imaging.

The proposed changes being made by the FDA to mammography standards will also strengthen the agency’s position to revoke or suspend the operations at mammography screening facilities that may be violating regulations to protect the consumer reported Dr. Jeff Shuren, who is the director of the FDA’s Center for Devices and Radiological Health.   

According to the FDA, the second most common cancer among US women is breast cancer while skin cancer is first and breast cancer is the second leading cause of cancer deaths after lung cancer.  More than 260,00 women in the United States were diagnosed with breast cancer in 2018 according to the 

National Cancer Instituteand deaths from breast cancer in women were over 40,920.

Recommendationsby the American Cancer Society (ACS) for mammograms are every year when a woman is between the ages of 45 and 54 and following 54 it recommends a mammogram every other year for women who are in good health and expecting to live for another 10 years. Women younger than 45  should be able to choose whether they want to start yearly mammograms or not the ACS says.

The proposed changes have a waiting time period of 90 days for public comment. Then the proposal will be written to include any more changes which will then be followed by another review before the changes will become final.

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