FDA’s new mammography proposal to help enhance diagnosis accuracy

The FDA (Food & Drug Administration) has reportedly proposed a new rule that would require mammography providers to inform female patients with dense breast tissue about the fact that the condition may impact the accuracy of their mammograms. The proposed regulation, apparently, will help women ponder over whether they need to consult their doctors regarding additional tests for checking on breast cancer.

The issue has turned out to be immensely critical in the wake of recent findings highlighting that dense breast tissue is a major cause behind the incline in the chances of breast cancer development. Sources with the knowledge of the matter revealed that the growth of the dense breast tissue makes it quite difficult to discover malignancies on the mammograms. Reports state that around three dozen states already have several laws concerning breast density notifications, however, FDA’s latest proposal aims to establish a standard that is applicable throughout the nation. 

The proposal is expected to upgrade the regulations mentioned under the Mammography Quality Standards Act, 1992, which helped bring around 8,000 mammography facilities in the United States under federal supervision. The rules, for the record, involve annual inspections, authorization of the facilities and enforcement of effective mammography rules.

According to The Washington Post, the NCI (National Cancer Institute) has reported that dense breasts contain rather high amounts of fibrous connective tissue and glandular tissue, while having low amount of fatty tissue. Nowadays, women at the age of 40 and older get diagnosed with dense breasts through their mammograms, and since such tissue seems white on the mammogram, resembling cancer, it tends to cover the malignancies. However, the dense breasts enhance the risk of developing breast cancer, confirmed the NCI.

Reportedly, the latest proposal is likely to incorporate advances including 3-D digital screening tools, into mammography services. It would help the agency notify patients, along with their healthcare providers, if a mammography provider fails to meet the quality standard and the need for a repeat test arises.