FDA says biopsy needle too large for lumpectomy:
This article was originally published in Clinica
An FDA advisory panel said last week that there is no scientific evidence to suggest that two devices used for breast biopsies should also be marketed for lumpectomy. The two devices, US Surgical's ABBI and Biopsys Medical Mammotome, use larger needles than other biopsy devices, and thus take more tissue. In June, the FDA issued a warning letter to US Surgical to stop marketing its device for lumpectomy. The General and Plastic Surgery Devices panel also said the agency should restrict the product's use in breast biopsies in those cases that are difficult to diagnose.