Originally Published MX March/April 2005
BUSINESS NEWS
FDA in ReverseIn February, FDA reversed its earlier decision by approving the Vagus Nerve Stimulation (VNS) therapy system by Cyberonics (Houston) for the treatment of severe depression. The agency's approval permits the company to market the VNS system as a "long-term adjunctive treatment for patients over the age of 18 with chronic or recurrent treatment-resistant depression . . . that has not responded to at least four adequate antidepressant treatments."
FDA's general and plastic surgery advisory panel will meet April 11—13 to consider revised premarket approval (PMA) applications from Inamed Corp. and Mentor Corp. (both in Santa Barbara, CA), two leading manufacturers of silicone gel breast implants. Both firms' PMAs were denied in 2004, when the agency revised its manufacturer guidance on silicone breast implants.
Les Weinstein, ombudsman for FDA's Center for Devices and Radiological Health, recently released his annual report forcalendar year 2004, citing a total of 125 complaints and disputes—a 4% decrease as compared with 2003. The overwhelming majority of complaints (90%) came from industry, with 7% from consumers, and 3% from healthcare providers. The office most often cited in complaints or disputes was the Office of Device Evaluation.
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