Ultrasound may reduce need for breast biopsy - Food and Drug Administration approves Ultramark 9 High Definition Imaging Ultrasound System Level 3 - Brief Article

FDA Consumer, July-August, 1996

A newly approved use for an ultrasound breast imaging system may reduce the need for breast biopsies in the United States by up to 40 percent. An estimated 700,000 such procedures are now done each year.

The new application, approved by FDA last April 11, will help doctors decide whether a biopsy is needed to determine whether certain breast tumors are malignant (cancerous) or benign. It was approved for diagnostic use along with mammography and physical breast examination.

The Ultramark 9 High Definition Imaging (HDI) Ultrasound System Level 3 was cleared for marketing in 1991 for general-purpose diagnostic ultrasound, including determining whether breast lumps are cystic (fluid-filled) or solid. Cystic breast tumors are always benign, but solid tumors may be either benign or malignant. Until now, nearly solid tumors have had to be biopsied to ensure a correct diagnosis.

With high-definition imaging, however, doctors are able to judge whether a solid tumor is highly likely to be benign. Those so judged could be treated without biopsy.

FDA's Radiological Devices Panel of the Medical Devices Advisory Committee recommended approval after it met in December 1995 to review data submitted by the system's manufacturer, Advanced Technology Laboratories, of Bothell, Wash. The firm-studied 1,270 women with 1,344 breast lumps initially detected by mammography of physical exam. Of these, 431 tumors were indeterminate--that is, doctors could not be sure whether they were benign or malignant.

Using the HDI ultrasound system, doctors predicted that 176 of the 431 tumors were benign. All 1,344 tumors were biopsied for diagnosis. The biopsies confirmed that the 176 tumors were benign.

The study results showed that adding HDI examination to mammography and physical breast exam--tests routinely done on women with breast lumps--could significantly reduce the number of biopsies for lumps judged highly likely to be benign.

The HDI system is approved for use in women with breast lumps 1 centimeter in diameter (about three-eighths of an inch) or larger.