The U.S. Food and Drug Administration (FDA) announced Thursday that they have approved an ultrasound device for use in combination with a standard mammography in women with dense breast tissue, the first of its kind to hit the market.
The National Cancer Institute (NCI) estimates that about 40 percent of women undergoing screening mammography have dense breasts. The newly approved device will allow physicians to better diagnose patients with dense breasts, many of whom have an increased risk of breast cancer.
The specially shaped transducer of the somo-v Automated Breast Ultrasound System (ABUS) can automatically scan the entire breast in about one minute to produce several images for review. Ultrasound imaging has been shown to be capable of detecting small masses in dense breasts. During an ultrasound exam, a device called a transducer directs high-frequency sounds waves at the portion of the body being examined.
Software analyzes the differences in how the sound waves are reflected off different tissues and back to the transducer to create an image a physician can review for abnormalities. Dense breast tissue has been a concern for years as physicians continue to improve detection of breast cancer.
Mammography is a low-dose X-ray imaging method of the breast. However, mammograms of dense breasts can be difficult to interpret. Fibroglandular breast tissue and tumors both appear as solid white areas on mammograms, possibly allowing dense breast tissue to obscure smaller tumors.
Breast cancer is the second leading cause of cancer-related death among women. This year an estimated 226,870 women will be diagnosed with breast cancer, and 39,510 will die from the disease, according to FDA officials. Dense breasts have a high amount of connective and glandular tissue (fibroglandular tissue) compared with less-dense breasts, which have a high amount of fatty tissue.
As part of the approval process, the FDA reviewed results from a clinical study in which board-certified radiologists were asked to review mammograms alone or in conjunction with somo-v ABUS images for 200 women with dense breasts and negative mammograms. Biopsies were performed on masses detected with the somo-v ABUS to determine if they were cancerous. The results show a statistically significant increase in breast cancer detection when ABUS images were reviewed in conjunction with mammograms, as compared to mammograms alone, say FDA officials.
The approval comes as some doctors say they were surprised by new research showing that breast cancer patients with dense breasts are no more likely to die than other patients. A newly released study published in the Journal of the National Cancer Institute finds that women with less dense breasts were more likely to die of their breast cancers if they also were obese. Researchers say the study should serve as a reassuring finding for women with dense breasts.
As part of the approval, FDA has required that the manufacturer provide thorough training for physicians and technologists using the ABUS device, and that the manufacturer provide each facility with a manual clearly defining system tests required for initial, periodic, and yearly quality control measures.