Autologous Cultured Chondrocytes: Adverse Events Reported to the United States Food and Drug Administration
- 1 March 2006
- journal article
- Published by Wolters Kluwer Health in The Journal of Bone and Joint Surgery (American)
- Vol. 88 (3), 503-507
- https://doi.org/10.2106/jbjs.e.00103
Abstract
Background: Carticel is an autologous cultured chondrocyte product that has been approved by the United States Food and Drug Administration for the repair of symptomatic cartilaginous defects of the femoral condyle that are caused by acute or repetitive trauma in patients who have been previously managed with arthroscopy or other surgical procedures. The present report describes the adverse events following Carticel implantation as reported to the Food and Drug Administration from 1996 to 2003. Methods: We reviewed adverse event reports that had been submitted to the Food and Drug Administration's MedWatch system for information on demographic characteristics, adverse events, and surgical revisions. Adverse events were categorized into sixteen non-mutually exclusive groups. Five categories were used to classify reoperations. Food and Drug Administration regulations require manufacturers to report adverse events; however, reporting by clinicians and others is voluntary. Therefore, adverse event reporting is likely to underestimate the number of event occurrences. Adverse events may be either causally or coincidentally related to the product. Results: A total of 497 adverse events among 294 patients receiving Carticel were reported. The median interval from Carticel implantation to the diagnosis of an adverse event was 240 days (range, one to 2105 days). The median age of the patients was thirty-eight years, and 63% of the patients were male. Of the 270 events for which the anatomic site was noted, 258 (96%) involved the femoral condyles. More than one adverse event was reported for 135 patients (46%). The most commonly reported events were graft failure (seventy-three patients; 25%), delamination (sixty-five patients; 22%), and tissue hypertrophy (fifty-two patients; 18%). In addition, eighteen surgical site infections were reported, including eleven joint and seven soft-tissue infections. Surgical revision subsequent to Carticel implantation was mentioned in the records for 273 patients (93%). The reasons for the 389 revision procedures included graft-related problems (187 procedures; 48.1%), periarticular soft-tissue problems (ninety-seven procedures; 24.9%), and intra-articular problems (sixty-three procedures; 16.2%). Eight patients had a total knee replacement. Based on the manufacturer's reported distribution of 7500 Carticel lots between 1995 and 2002, 285 patients (3.8%) had an adverse event that was reported to the Food and Drug Administration. Conclusions: The most common adverse events reported in association with the Carticel technique involved graft failure, delamination, and tissue hypertrophy. Level of Evidence: Therapeutic Level IV. See Instructions to Authors for a complete description of levels of evidence.Keywords
This publication has 10 references indexed in Scilit:
- Articular Cartilage Repair Using Tissue Engineering Technique—Novel Approach with Minimally Invasive ProcedureArtificial Organs, 2004
- Repair of Extensive Articular Cartilage Defects in Horses by Autologous Chondrocyte TransplantationAnnals of Biomedical Engineering, 2004
- A prospective, randomised comparison of autologous chondrocyte implantation versus mosaicplasty for osteochondral defects in the kneeThe Journal of Bone and Joint Surgery. British volume, 2003
- Subchondral Bone Reaction Associated with Chondral Defect and Attempted Cartilage Repair in GoatsCalcified Tissue International, 2003
- Adverse drug event monitoring at the food and drug administrationJournal of General Internal Medicine, 2003
- Autologous Chondrocyte Implantation of the Knee: Multicenter Experience and Minimum 3-Year Follow-UpClinical Journal of Sport Medicine, 2001
- Two- to 9-Year Outcome After Autologous Chondrocyte Transplantation of the KneeClinical Orthopaedics and Related Research, 2000
- Postmarketing Surveillance and Adverse Drug ReactionsPublished by American Medical Association (AMA) ,1999
- Incidence of deep vein thrombosis after arthroscopic knee surgery: A prospective studyArthroscopy: The Journal of Arthroscopic & Related Surgery, 1995
- Introducing MEDWatchJAMA, 1993