Biopsys fields FDA biopsy inquiry

Breast biopsy device developer Biopsys Medical of Irvine, CA,is responding to requests from the Food and Drug Administrationto clarify the labeling of its Mammotome biopsy system. The FDAis concerned that marketing materials for Mammotome might containinformation implying that the system can be used for therapeuticapplications, such as complete removal of suspicious breast lesions.

The inquiry is related to a broader FDA review of breast biopsydevices that was prompted by a labeling dispute between the agencyand U.S. Surgical over its ABBI device (SCAN 6/19/96), accordingto Ellen Preston, Biopsys vice president of marketing. As partof the inquiry, officials from the FDA's Reviewing Division askedthat Biopsys submit a stand-alone 510(k) for use of Mammotomein breast biopsy applications. Mammotome's existing 510(k) coversall soft-tissue biopsy.

Biopsys was in the process of complying with the Reviewing Division'srequest when it was hit with a warning letter from another FDAunit, the Office of Compliance, concerning Mammotome's promotionand labeling. Biopsys is working to comply with the concerns ofboth units by filing the new 510(k) and by reviewing Mammotome'smarketing materials to remove any references that might implya therapeutic use of the device, Preston said.

The FDA's actions are not expected to affect the company's operations,and the firm continues to sell Mammotome devices, according toPreston. The safety or efficacy of the device is not in questioneither, she said. The news had a minor effect on the company'sstock, which fell $1.25 to close at $27, a drop of 4%, on Feb.11, the day the news was announced.