Source: US Food & Drug Administration

Yes, that is quite the attention getter.  And no, you can’t view it on your home theater system.  Mammography is generally felt to be the current best tool for early detection of breast cancer.  It is a safe, low-dose X-ray of the breast. The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.

However, with the limitations of conventional two-dimensional (2-D) imaging, both physical contortion and technological, about 10 percent of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous.

The U.S. Food and Drug Administration has approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.  The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts. The 3-D images may help physicians more accurately detect and diagnose breast cancer.

As part of the approval process, the FDA reviewed results from two studies where board-certified radiologists were asked to review 2-D and 3-D images.  In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone.  The increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence.

The Mammography Quality Standards Act requires that all health care professionals obtain eight hours of training prior to using new mammography technology on patients. The FDA also requires that the manufacturer provide each facility with a manual clearly defining the tests required for initial, periodic, and yearly quality control measures.

According to the NCI, nearly 200,000 women will be diagnosed with breast cancer this year. And 1 in 8 women will be diagnosed with breast cancer during their lifetime. There is a 98 percent survival rate when breast cancer is detected early and still localized to the breast.

The Selenia Dimensions System is marketed by Bedford, Mass.-based Hologic Inc.

Post: David M. Schwadron, Esquire