First 3-D Mammogram Device is Approved by the FDA
On Friday, the first three-dimensional mammogram was approved by the U.S. Food and Drug Administration. This is big news for Breast Cancer patients because it will allow doctors to diagnose and detect breast cancer more accurately.
Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in an article on Drugs.com, "physicians can now access the unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches."
A mammogram is a diagnostic test that uses a low-dose X-ray to create images of the inner breast tissues and structures. With the two-dimensional imaging we have been using, while effective for many patients, has resulted in about 10 percent of female patients having to have more testing done due to the initial mammogram finding abnormalities that were determined, with additional testing, to be noncancerous.
The Selenia Dimensions System two-dimensional and three-dimensional images does use nearly twice the amount of radiation, but the increase in accuracy is resulting in fewer female patients having to go through additional, and sometimes painful, testing to determine if the abnormality found with a mammogram is cancerous or not. Radiation risk estimates are still uncertain, but the increase in cancer risk from having this new mammogram is not expected to be higher than about 1.5 percent as compared to the natural incidence of cancer, and less than one percent, when compared to conventional 2-D mammography risk.
The FDA examined two study's results in which board-certified radiologists compared and reviewed three-dimensional and two-dimensional images from over 300 mammograms. The FDA states in an article in Business Week, "in both studies, the radiologists viewing both the 2-D and 3-D images realized a seven percent improvement in their ability to distinguish between cancerous and non-cancerous cases, compared to viewing 2-D images alone."
This year, close to 200,000 female patients will receive a breast cancer diagnosis. At some point in life, one in eight Women will receive a breast cancer diagnosis. However, when breast cancer is detected in the early stages where it is still localized within the breast, patients have a 98 percent survival rate.
While different organizations have different opinions, most agree that women should start having regular mammograms around age 40, and from there, should have them every one to two years. Women who have a history of breast cancer or a predisposition, such as the BRCA genetic mutation, may need to begin having them at a younger age and more frequently.
In women over 50 years of age, mammograms are capable of discovering 85 to 90 percent of breast cancers. It is also capable of finding a lump as long as two years prior to it being able to be felt. "Eight randomized clinical trials found 18 percent fewer deaths from breast cancer among women in their forties who had mammography" reports Imaginis.
The new 3-D mammography technique shows promise in saving more lives through more accuracy in detecting and diagnosing breast cancer.
Feb 17, 2011