Gynecare Promotion Is Criticized

Gynecare Inc. promoted an unapproved device in violation of federal regulations, according to the Food and Drug Administration. In a warning letter dated Feb. 5, the FDA cited the Internet home page of Menlo Park-based Gynecare Inc. and several news releases for improperly promoting the company’s uterine balloon therapy system. The device, designed to treat women who suffer from excessive menstrual bleeding, “is part of an investigational clinical trial and does not yet have approved marketing clearance,” the FDA said. The releases said the device was safe and effective, claims that the company isn’t allowed to make unless the device is approved for marketing by the FDA. Gynecare’s chief financial officer, Mack Farnsworth, said the company has responded to the FDA and has taken corrective actions. “We are in the process of rebuilding our Web site,” he said. “We’ve responded to the FDA. We’ll just move forward from here.” Gynecare shares fell 37.5 cents to close at $7.25 on the Nasdaq Stock Market.