One in Eight Women Benefit from 3-D Mammography Approval

Kathleen Blanchard's picture
FDA approves 3-D mammography
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FDA approval of the first 3-D mammography device means better surveillance of breast cancer that strikes one in eight women.

Use of 3-D mammography was found in two studies to be superior to the currently use 2-D mammograms for spotting cancerous tumors. In the review, radiologists reported a seven percent increased accuracy for detecting breast cancer, findings that mean ten percent less women will have to undergo anxiety-producing recall for additional breast cancer testing.

The device, manufactured by Selenia Dimensions System is the first 3 dimensional X-ray to provide 2-D and 3-D images of the breast, and according to the FDA is an “upgrade to Hologic’s existing FDA-approved 2-D system.”

Mammograms deliver low dose radiation to detect cancerous tumors, but have been under scrutiny as to their usefulness for detecting breast cancer early. Approximately ten percent of women will undergo additional testing with ultrasound, which in some cases leads to biopsy. Studies suggest the anxiety associated with additional testing can destroy a woman’s quality of life waiting for answers.

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Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health says, “Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches.”

The 3-D mammography device will improve breast cancer surveillance. When detected early, there is a 98 percent survival rate. Additional testing for breast cancer not only causes anxiety for women, but also results in higher out of pocket cost.

The FDA also notes the radiation risk of cancer with the new 3-D mammography is unknown, but expected to be low compared to cancer incidence and 2-D mammogram.

FDA approval of the Selenia Dimensions System means radiologists can obtain needed information to track changes in breast tissue. In the studies that influence the decision for approval, there was a 7 percent increase in accuracy of breast cancer detection. The 3-D mammography device will benefit one in 8 women who will develop breast cancer in their lifetime.

FDA Newsroom

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