On the recordSeptember 23, 1997
If my colleague will yield, as I said earlier, if U.S. Surgical were promoting for uses beyond those on the label, I think the FDA would be acting on it. But let me again get to the point of why a larger needle is useful in some biopsies situations. I am not a surgeon or a doctor, but I am just sharing with my colleagues here, and my colleague from Massachusetts, why this larger needle may be needed. This Advanced Breast Biopsy device, as it is called, does remove a larger amount of tissue than a conventional biopsy needle. Why? Why does it need to do that? This difference in needle size is not related to tumor removal. Rather, it addresses clinicians' requirements for sampling different types of lesions. Why do they do that?
Source
govinfo.gov




