Many patients with degenerative disc disease who chose to have a Johnson & Johnson Charité spinal disc implanted are now finding that they have increased pain or similar pain levels as compared to before the operation and little improvement in their motion abilities.
Some patients are being required to have life-threatening revision surgeries.
About Charité Spinal Discs
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.”TM 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.
Charité Disc Criticism
Charles Rosen of the University of California-Irvine Spine Center has expressed concern and asked that
the FDA withdraw the discs from the market. He discussed his concerns in an article on TheStreet.com in May of 2005. Rosen questioned how Charité was approved due to its weak results and frequent life-threatening revision surgeries. Rosen has spoken publicly about the discouraging of scientific debate on Charité at the annual meeting of the North American Spine Society.
Need Legal Help Regarding Charite Spinal Discs?
Patients who had the Charité spinal disc operation and who continue to suffer are encouraged to contact Parker & Waichman, LLP for a free case consultation. Please fill out the form at the right or call 1-800-YOURLAWYER (1-800-968-7529) today.