Charite Spinal Discs

2007-03-21

Charite Spinal Discs: Approved Despite Evidence of Complications
Heidi Turner

Los Angeles, CA: Charite Spinal Discs were designed to help people with degenerative disc disease. They were implanted in order to eliminate the disc that was causing the patient pain while at the same time maintaining motion within the patient's spine. Charite discs were considered an attractive alternative to spinal fusion because spinal fusion merely immobilized the painful disc but did not remove it.

However, criticisms have arisen that the success rate of the Charite spinal disc implantation is less than 60%. Many patients have complained that they either have more pain or at least similar pain levels to what they experienced prior to the surgery and that the disc resulted in little improvement to their mobility. In some cases, patients have to undergo serious surgery to revise problems associated with the Charite spinal disc.

The Charite Articifical Disc has a plastic core sandwiched between two chrome plates. The disc is meant to lock into the spine; however, in some cases the disc slips out of place for no obvious reason. When the disc slips out of place emergency surgery is required in order to remove the disc.

Before the Charite spinal disc was approved for use in 2004, the manufacturer ran trials but only set out to prove that the disc worked as well as the AcroFlex disc and the Bagby and Kuslich cage, both of which are no longer used by many surgeons because of their low success rates. The trial also did not include either pain relief or restoration of natural motion as measures of success.

The FDA approved Charite Artificial Discs despite over 17 years of evidence in Europe that showed patients with the discs implanted suffered serious pain including joint degeneration, leg pain, and back pain. Meanwhile an associate clinical professor of spine surgery at the University of California at Irvine is calling for an immediate recall of the discs because of the serious complications that can result from their use. He noted that some patients suffer fracturing and pulling apart of joints of the spine.

Additionally, a Blue Cross Blue Shield Association medical advisory panel found that, based on a review of the Charite disc, there was no evident advantage to using the disc. The U.S. Centers for Medicare and Medicaid Services questioned the effectiveness of the disc, noting that the two-year trial sent to the FDA showed only that the Charite disc was no worse than spinal fusion surgery rather than proving that the disc offered significant advantages over that procedure. Based on that, and the finding that more patients with a Charite disc implanted suffered severe or life-threatening events than people who had spinal fusion (15% compared to 9%), Medicare has barred coverage of the device for patients older than 60.

Charit� Spinal Disc Legal Help

If you or a loved one has suffered from increased back pain after having a Charite disc implanted, please contact a [Charit� Spinal Disc] lawyer who will evaluate your claim at no charge.

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