FDA green-lights first US device for dense breasts
green light - 194.77 Kb
The FDA has approved the somo-v Automated Breast Ultrasound System (ABUS) for use in combination with a standard mammography in women with dense breast tissue who have a negative mammogram and no symptoms of breast cancer.

“Mammography is an effective tool at finding breast cancer, but it doesn’t work equally well in everyone,” Rachel Brem, MD, director of breast imaging at the George Washington University Hospital in Washington, D.C., said in a press release. “Recently completed studies demonstrated with the addition of ABUS we find about 30 percent more cancers in women who have normal mammogram, normal physical examination and dense breasts. For the more than 40 percent of women who have dense breasts, this is a significant advancement in their breast healthcare.”  

Dense breast tissue not only increases the risk of breast cancer up to four to six times but also makes cancer more difficult to detect using mammography, according to multiple studies. One study, published Jan. 18, 2007, in New England Journal of Medicine showed 35 percent of breast cancer goes undetected by mammography in women with dense breasts, as density masks the appearance of tumors. As breast density goes up, the accuracy of mammograms goes down.

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 cancer. The results showed a statistically significant increase in breast cancer detection when ABUS images were reviewed in conjunction with mammograms, as compared to mammograms alone.

The somo-v ABUS, designed for high-volume, breast cancer screening environments, can automatically scan the entire breast in about one minute to produce images for review, according to U-Systems, which develops somo-v ABUS. Exams can be reviewed and archived on the somo•VIEWer workstation. 

The somo-v ABUS is approved for use in women who have not had previous clinical breast intervention, such as a surgery or biopsy, since this might alter the appearance of breast tissue in an ultrasound image.

As part of the approval, the FDA has required that U-Systems provide thorough training for physicians and technologists using the ABUS device, and that the Sunnyvale, Calif.-based company provide each facility with a manual clearly defining system tests required for initial, periodic and yearly quality control measures.

Several states, including Connecticut, New York, Texas, Virginia and California, have enacted breast density notification legislation, requiring providers to notify women if they have dense breast tissue.

For more about screening breast ultrasound, please read "Move Over Mammo," and "Breast Ultrasound Screening Marches into Practice," in Health Imaging.