On the recordSeptember 23, 1997
Breast lesions exist not only as discrete nodules but oftentimes as clusters of tiny particles known as microcalcifications. These microcalcifications appear diffuse on an X-ray; similar to the Milky Way. That's how surgeons describe it. Due to this fact, obtaining adequate amounts of tissue for biopsy is important in order to optimize accurate diagnosis, so that women don't have to go through surgery unnecessarily. This needle allows clinicians to take a larger single sampling, rather than many, painful, smaller samples that could perhaps miss the tumor tissue. That is why this product was developed. That is why it has been so supported by women and by surgeons. My colleague from Massachusetts can talk about videos that promote purposes other than this one. However, if that is the case, the FDA ought to be in there this very minute. But, they have not acted because no violation has occurred.
Source
govinfo.gov




