CHARITÉ™ Artificial Disc

 

 

 

In October 2004, the CHARITÉ™ Artificial Disc (manufactured by DePuy Spine, Inc., a Johnson and Johnson company) was introduced to the U.S. Market for disc replacement, designed to be used by the general population of back pain patients. The operation costs associated with placement of the artificial disc are typically in the range of $25,000 to $35,000.

The CHARITÉ™ Artificial Disc is composed of two metallic endplates and a polyethylene core that moves between them. During surgery, the patient's degenerated disc is removed and a pair of endplates made of cobalt chromium are inserted in the space between the vertebrae and attached above and below the disc. A polyethylene material is then inserted between the plates to create a disc-like structure that mimics normal disc functionality by providing a normal level of separation between the vertebrae and allowing for the usual range of motion and flexibility for that segment of the spine.

We believe that the CHARITÉ™ Artificial Disc is defective and that DePuy improperly marketed and failed to adequately warn of the disc's dangers.

One of the key figures in the Charité debate is Dr. Charles Rosen of the University of California-Irvine Spine Center, who has said that the FDA should withdraw the discs from the market. His analysis was discussed back in May of 2005 and published on TheStreet.com. Dr. Rosen questioned how Charité was approved in light of the limited efficacy and high prevalence of life-threatening revision surgeries. Dr. Rosen has spoken publicly about the CHARITÉ™ Artificial Disc, including a presentation held by the North American Spine Society. Dr. Rosen also argues that the FDA review process was not robust enough in that the standard two year review is simply not long enough to determine efficacy of the CHARITÉ™ Artificial Disc.