FDA Approves Plan to Alert Heart-Valve Patients:...
From Times Staff and Wire Reports
FDA Approves Plan to Alert Heart-Valve Patients: The government approved Shiley Inc.’s plan to warn about 23,000 North Americans that artificial heart valves implanted in their chests are potentially defective. The Irvine-based firm, a subsidiary of Pfizer Inc. of New York, decided to notify all patients with Bjork-Shiley “convexo-concave” heart valves in response to concerns raised by the Food and Drug Administration and Public Citizen Health Research Group. The valve was voluntarily withdrawn from the market in November, 1986. As of July, 395 of the valves had fractured, resulting in 252 deaths.
