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FDA Publishes New Standards and Updated For Mammograms

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The U.S. Food and Drug Authority has issued changes to the mammography standards to more effectively screen for breast cancer.

The changes announced on Wednesday, March 27, places emphasis on giving patients more information about their risks of breast cancer and help them make decisions regarding their health. One of the proposed changes is breast cancer screening among patients with dense breasts.

Breast Cancer Screening Among Patients With Dense Breast

Mammograms, which is used to detect the early signs of breast cancer, are often difficult to interpret in patients with dense breasts. The dense breast tissue can obscure the early signs of breast cancer, therefore, making the screening process a little less effective.

According to the FDA, dense breast is also one of the risk factors for breast cancer.

The proposed new mammography standards include improved communication between the health care provider and patients. The agency wants patients to receive lay summary letters that provide vital information, including breast density and the risks that come with it.

Furthermore, the agency wants to add two more categories to classify the results of their mammography: "known biopsy-proven malignancy" and "post-procedure mammograms for marker placement." The two will be added to the current list of categories which are "negative," "benign," "probably benign," "suspicious," "highly suggestive of malignancy," and "incomplete: need additional imaging evaluation."

The changes will enable healthcare providers to classify more precisely a patient's situation and help them make informed decisions.

Modernizing Breast Cancer Screening

The new breast cancer screening standards also add advances in the mammography technology and processes from the past couple of years. This is the first time that the FDA has proposed amendments to the regulation in more than 20 years.

"As part of our overall commitment to protecting the health of women, we're proposing new policies to modernize our oversight of mammography services, by capitalizing on a number of important advances in mammography, like the increased use of 3-D digital screening tools and the need for more uniform breast density reporting," stated FDA Commissioner Scott Gottlieb.

"We're committed to making sure patients have access to high quality mammography. Today's proposed rule would help to ensure patients continue to benefit from advances in new tools and robust oversight of this field."

According to the Centers for Disease Control and Prevention, an estimated 237,000 new cases of breast cancer are diagnosed among women and about 2,100 in men. About 42,000 women and 450 men die from the disease every year in the United States.

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