Firm argues breast biopsy case with FDA

June 19, 1996

U.S. Surgical of Norwalk, CT, is in discussions with the Foodand Drug Administration regarding what the agency claims is inappropriateadvertising of the firm's Advanced Breast Biopsy Instrumentation(ABBI) system (SCAN 5/22/96). The skirmish may say more

U.S. Surgical of Norwalk, CT, is in discussions with the Foodand Drug Administration regarding what the agency claims is inappropriateadvertising of the firm's Advanced Breast Biopsy Instrumentation(ABBI) system (SCAN 5/22/96). The skirmish may say more aboutthe FDA's slow-changing internal organization than any marketingmalfeasance.

According to the FDA's June 3 warning letter to U.S. Surgical,ABBI, originally called the Auto Suture Biopsy Device, was given510(k) clearance as a gastroenterology-urology biopsy instrument.The problem is that the company is promoting the system for breastbiopsy applications, said Marcia Meyer, FDA public affairs specialist.

That is not the case, countered Steve Rose, director of mediarelations for U.S. Surgical. The company submitted an applicationfor a biopsy device, which was then routed to the GI and urinarydivision because that is the only FDA group that handles biopsyequipment marketing applications.

The company's 510(k) clearance document makes several referencesto mammography and breasts, he said. It also mentions the Loradtable used with ABBI, which is designed for breast applications.Finally, the predicate core-needle biopsy system mentioned inthe 510(k) process was used in breast applications.

"We went to the FDA with a biopsy device and they said`You need to submit this to our GI and urinary division.' Thereis no division that evaluates breast biopsy (devices)."