About the Charité Spinal Disc

Johnson & Johnson’s (DePuy Spine) Charité spinal disc is the only artificial disc approved in the United States. Before its approval in 2004, the manufacturer’s trial sought to prove only that the disc worked as well as its AcroFlex disc and the Bagby and Kuslich (BAK) cage used in spinal fusions, both of which have been abandoned by many surgeons due to high failure rates. Furthermore, Johnson & Johnson did not include pain relief as a measure of the success of Charité in the trial. The disc’s ability to preserve or restore natural motion was also not included in the study’s definition of ‘success.’ The trial only showed that 57% of patients who had the Charité disc surgery met modest success measures. Despite the disappointing results, Johnson & Johnson markets the Charité disc with slogans such as ‘Natural motion is back.’â„¢ and ‘An alternative to lumbar spinal fusion surgery.’ An FDA transcript shows that an agency statistician portrayed the pre-approval study as biased in favor of Charité and as omitting important data from randomized clinical trials.