Back injury with artificial disc replacement

If you suffered from a back injury on the job, you may be presented with the option of spinal fusion or the placement of an artificial disc. Get the facts before you make the decision.

Johnson & Johnson's DePuy Spine Unit began selling Charite Artificial Spinal Discs in 2004. This product was supposed to reduce the need for spinal fusion and other serious spinal surgeries. However, the Charite artificial discs have been associated with life threatening side effects which have made many surgeons reluctant to use the product.

In a recent report issued by TheStreet.com, Charles Rosen, a university-based spine surgeon said he can't imagine using one now being promoted by Johnson & Johnson. Rosen, recently filmed by PBS performing another new procedure, likes to provide his patients with cutting-edge services.

However, when Rosen learned more about the Charite discs he became alarmed. Rosen says he found that the devices have regularly failed in Europe, leaving patients with life-threatening complications. He says he finds it "unbelievable" that the Food and Drug Administration ever approved the devices.

"Any prudent person, who does not have a financial conflict or industry tie, would reasonably conclude that their safety and effectiveness has not been proven by the FDA," says Rosen, an associate clinical professor of spine surgery at the University of California at Irvine. "These artificial disc replacements should be recalled by the FDA to protect the American public."
Not surprisingly, Johnson & Johnson calls the implants as "the best solution for the appropriate patients" while stressing that "patient selection is key." In any case, banning the implants could hurt Johnson & Johnson and its competitors, who see the market as a lucrative growth opportunity.

To win over the FDA, Johnson & Johnson set out to establish that Charite discs work at least as well as Bagby and Kuslich, or BAK, cages used in spinal fusions. But Rosen saw an immediate problem with the study design. "The stand-alone BAK is a failed operation; it hasn't been done in years," Rosen says. "So they picked the worst possible operation to compare these things to."
Sarah Colamarino, a spokeswoman for the DePuy Spine unit of Johnson & Johnson, says the BAK was "the standard treatment for single-level degenerative disc disease" at the time the study began. Regardless, Rosen claims the company still failed to prove its case. An FDA transcript shows that the agency's own statistician portrayed the study as "strongly biased" in favor of Charite. The statistician also noted that the company had excluded important data about patients involved in the randomized clinical trials.

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