Charité (J&J) Spinal Discs
The Charité spinal disc by Johnson & Johnson (J&J) is the only U.S. approved synthetic spinal disc and was designed to lower the need for spinal fusion. Prior to its 2004 approval, the manufacturer trials only wanted to prove that it worked as well as the Bagby and Kuslich (BAK) cage or AcroFlex disc used in spinal fusions. Both of those products are not used by many surgeons anymore because of a high rate of failure. In addition, the J&J trials did not include in the success criteria relief of pain. These success criteria also left out the ability of the disk to restore or preserve natural motion. The trials indicated that only 57% of patients that received Charité disc surgery in the trials had even modest success.
In May 2005 the University of California-Irvine Spine Center’s Charles Rosen questioned the approval method because he believed the results were weak and additional surgeries that were life-threatening were required when the discs failed, and asked the FDA to withdraw the discs in order to protect the public. The FDA has received more than 130 reports of medical trauma or significant adverse effects associated with the disc surgery. There have been a number of Charité spinal disc lawsuits filed against J&J.
Charité Spinal Disc Side Effects:
- No reduction in pain levels
- Increased pain levels
- Little if any motion improvement
- Life-threatening surgeries to remove the implant
- Allergic reaction to implant
- Incision problems
- Implants move, bend, loosen, or break
- Anesthesia side effects
- Bladder problems
- Intestinal movement slows down
- Leakage of spinal fluid
- Nerve or spinal cord damage
- Tears of the tissue that covers the spinal cord (dura)
- Blood vessel problems
Pulaski Law Firm has settled all of its clients’ claims with the manufacturer for a cash award.
– See more at: https://www.1800baddrug.com/_medical-device-claims/charite-artificial-disc.php#sthash.4GadJsHI.dpuf