The Food and Drug Administration is cautioning doctors that it has "serious concerns" with the processing and handling of heart valves distributed by CryoLife, an Atlanta-based human tissue bank. The FDA said patients who receive the valves may be at increased risk of infection; however, because no satisfactory alternatives exist, the heart valves were not included in the agency's recall last week of human cadavar tissue processed by CryoLife. The benefits of the valves -- essential for correcting certain congenital defects in children and infants -- outweigh the risks associated with manufacturing deficiencies at the company, the FDA said. The FDA recall affected all soft tissue processed by CryoLife since Oct. 3, one month before a Minnesota man who underwent a knee operation died because of infected tissue. This week, the Securities and Exchange Commission said it is investigating whether federal securities laws were violated in connection with the matter. -- by Cinda Becker
FDA warns about heart valves but issues no recall
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