Firm Is Sent FDA Warning on Breast Surgery Device: U.S. Surgical Corp. is improperly peddling a new device for taking tissue samples as a breast cancer surgery instrument that would minimize pain and scarring, government regulators have charged. The Food and Drug Administration sent a warning letter to the company this week, ordering it to stop advertising the device as the Advanced Breast Biopsy Instrumentation system, or ABBI. U.S. Surgical, based in Norwalk, Conn., said it disagrees with the FDA position and hopes to meet with regulators to work out the dispute. The ABBI system includes a sophisticated X-ray machine to find diseased tissue and a needle that is inserted into the body to collect biopsies, or tissue samples.
Times Staff and Wire Reports