Carticel is a cartilage implant that was first used in clinical trials in 1995. The FDA approved its use for the general public in 1997. Since that time, one major study has been published by the FDA's Center for Biologics Evaluations and Research.
At least 7500 patients have been given Carticel for defects in the knee joint cartilage. There were 294 reported cases of problems such as graft failure, infection, tissue overgrowth, or splitting of the implant into two or more layers. This represents a 3.8 percent rate of adverse events (AE).
All in all most patients had a good result. A 3.8 percent complication rate is fairly low. The AEs reported were typical of knee surgery for this type of knee problem. Carticel will continue to be used and results reported.