Just last week, the first ultrasound device to improve breast cancer detection in women with dense breasts won FDA approval. The somo-v Automated Breast Ultrasound System (ABUS) is to be used as a screening tool, when indicated, to more accurately diagnose cancer in breasts that a mammogram has determined consist of a greater than average proportion of dense tissue.
Because dense breasts contain a higher amount of fibroglandular tissue, it is difficult to detect breast cancer through mammography alone in these women. Dense tissue, for example, increases the chances that a dangerous lesion will be overlooked; this is because, like cancerous tissue, dense tissue appears as a lighter shade of grey on a mammogram, thus obscuring anything cancerous.
The FDA approval of the new screening device was based on the results of a multi-center retrospective study of 200 women with dense breasts. The study was promising, in that it showed a statistically significant increase (30 percent) in breast cancer detection when ABUS was used with mammography, as compared to mammography alone.
Presumably, improved detection is a boon for women with dense breasts, who face a greater risk of developing breast cancer than even those women who have a first-degree relative with the disease. Yet previous studies on dense breasts have broadened clinical understanding of the condition, suggesting that while such women are at greater risk of developing breast cancer, they do not face a higher risk of mortality from the disease. And because over-diagnosis and subsequent over-treatment are a serious problem, it is fair to question just how beneficial the new screening device will be.
In fact, this question is just what our research intern, Roya Heydari, considers in her opinion piece on the implications of recent legislation mandating that mammogram reports include notes on dense breasts. You can read the piece in full at our website.