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Contact a Miami Charite Artificial Spinal Disc Lawyer
Johnson & Johnson’s artificial spinal disc won U.S. FDA approval for relieving severe lower back pain in 2004. The Charite artificial spinal disc was the first to reach the U.S. market, though it had been on the European market since 1987. The only surgical solution to Degenerative Disc Disease was a procedure called spinal fusion, and the long awaited alternative was viewed as a “potential to revolutionize spine surgery.”
Despite the benefits Charite artificial spinal disc appeared to have – promising to reduce chronic back pain while, unlike typical surgery, preserving motion – the technically demanding operation has been greatly criticized as well. At the time of approval, critics of the procedure pointed out the Charite artificial spinal disc was compared to a spinal fusion technique that is not widely used today because of inconsistent results. In addition, the clinical trial results were only marginally better with Charite artificial spinal disc at one-year follow-up and equivocal at two years.
The implant was also criticized for being very risky, should they need to be removed. The FDA required J&J’s DuPuy Spine unit to conduct a post-approval study to assess the product’s long term safety and effectiveness, including its impact on other discs and on the bony structures on the back of the spine. The absence of data to assess long-term performance of the new device brought criticism as well.
Particularly vocal about the Charite artificial spinal disc has been an associate clinical professor of spine surgery at the University of California at Irvine, Charles Rosen. Rosen said, while learning about the new procedure to determine if the discs could safely reduce back pain while preserving motion, he found the Charite artificial spinal discs have regularly failed in Europe, leaving patients with life-threatening complications.
Saying it is “unbelievable,” the FDA approved the Charite artificial spinal disc. Rosen believes, “these artificial disc replacements should be recalled by the FDA to protect the American public.” According to J&J, the Charite artificial spinal disc is “the best solution for the appropriate patients,” and the company has stressed the importance of identifying appropriate patients. However, several other artificial spinal discs are in development, and should problems exist with J&J’s product, it could potentially affect the company and its competitors.
Experts have predicted the market for spinal discs could top $1 billion, but Rosen said he saw an immediate problem with J&J’s study design to win over the FDA. The company wanted to establish that the Charite artificial spinal discs worked at least as well as Bagby and Kuslich, or BAK, cages used in spinal fusions. BAK, however, is a failed operation, according to Rosen, claiming the comparison is “the worst possible operation to compare these things to.” In addition, an FDA transcript shows the agency’s own statistician portrayed the study as “strongly biased” in favor of Charite artificial spinal discs, noting important data about patients involved in the randomized clinical trials had been excluded.
A voting member of the FDA advisory panel, Brent Blumenstein, specifically complained about omitted patients during the Charite hearing, but still went on to vote for approval of the device. Rosen believes there will be thousands of people who suffer failures because the Charite artificial spinal discs, despite the positive outlook and projections of the devices all over the country.
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Contact a Miami Charite Artificial Spinal Disc Lawyer
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