FDA Urged to Back Technique to Cut Down on Breast Biopsies

A powerful ultrasound can significantly reduce the number of women who undergo surgery to tell if their breast lumps are cancerous or benign, government scientists said Monday.

The scientific panel unanimously urged the Food and Drug Administration to approve the High-Definition Imaging ultrasound as a test to help doctors decide which women need a biopsy.

The FDA isn’t bound by advisory panel decisions but usually follows them.

The manufacturer, Advanced Technology Laboratories, predicts the HDI ultrasound will cut by 40% the 700,000 biopsies performed annually in America. Of those, 182,000 new cases of breast cancer are diagnosed every year, while the rest of the growths surgically examined are benign.

The FDA panel wasn’t sure how many biopsies would be prevented and emphasized that Seattle-based ATL must train doctors to use the ultrasound properly.

A mammogram is good at spotting lumps in most breasts, displaying them as blurry white spots against normal tissue. But mammograms don’t tell if the lump is cancerous or benign.

When doctors get a particularly clear mammogram, they may feel comfortable telling the woman just to get rechecked in a few months. However, most doctors to be safe order a biopsy. But doctors want to reduce the number of unnecessary biopsies. A biopsy costs about $2,500, while ultrasound costs $75 to $300, ALT said.

A weaker ultrasound now is used to tell the difference between a solid tumor and a fluid-filled cyst, which is not dangerous. ATL’s ultrasound shows a clear picture of lumps. If they have, for example, smooth edges and no irregular colors or dark shadows, they most likely are benign, explained Dr. Christopher Merritt of Tulane University, who tested the ultrasound.

When tested on 1,021 breast lumps, the ultrasound was 99% accurate in diagnosing lumps as benign, ATL said. It missed one cancer that was hidden by a cyst.