Charite Artificial Spinal Disc

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Charite Artificial Spinal Disc Side Effects

When Johnson & Johnson’s Charite artificial spinal disc received FDA approval in 2004, backers said it had the potential to revolutionize spinal surgery. Roughly 65 million Americans suffer from low-back pain every year, and 12 million have a condition called Degenerative Disc Disease. In the study leading to Charite’s approval, the FDA study involved patients implanted with the artificial disc and a control group who received fusion. The study was not designed to demonstrate the superiority of one device over the other, and critics of the procedure pointed out the potential for serious Charite artificial spinal disc side effects.

During the study, J&J set out to establish that Charite discs work at least as well as Bagby and Kuslich, or BAK, cages in spinal fusions, but critics immediately pointed out the implant was being compared to a spinal fusion technique that was no longer widely used because of inconsistent results. As a result, Charles Rosen, an associate clinical professor of spine surgery at the University of California at Irvine, said, “they picked the worst possible operation to compare these things to.”

Opposition to the Charite artificial spinal disc was also voiced regarding the clinical trial results that were only marginally better with the implant at one-year follow-up and equivocal at two years. Potential Charite artificial spinal disc side effects could also be suffered, according to critics, should the implants have to be removed. There is little data available for experts to assess long-term performance and Charite artificial spinal disc side effects, and even though the FDA required J&J to conduct a post-approval study, it can be years before a device’s actual long-term safety and effectiveness is determined.

When the FDA’s advisory panel recommended the approval of the device, it came despite grave warnings from orthopedic surgeons in the field. The procedure is considered routine in Europe, where it has been used since 1987. According to a Danish surgeon who has tracked hundreds of the operations abroad, Andre van Ooij, there was evidence indicating serious Charite artificial spinal disc side effects could occur. Noting, “retrograde ejaculation and erectile dysfunction” in men, he also cited leg complications in others and pointed to joint degeneration as particularly problematic.

Van Ooij said all of the patients have “really terrible leg and back pain” and that revision surgery is dangerous and sometimes not even an option. A number of experts who participated in the FDA’s hearings at the time of approval, including the FDA’s own expert engineer, were also worried about the length of the U.S. study, saying many Charite artificial spinal disc side effects would not surface until well after the study ended.

Vocal about his feelings regarding the potential for Charite artificial spinal disc side effects, Rosen said, “I don’t know how anyone, in good conscience, could put these things in knowing the past history and potential for so many failures…It’s just money over everything else, and it’s just cruel.”

Product Liability Breaking News

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Every year, more than one million Americans are seriously injured as a result of defective medical devices, according to the Institute of Medicine. Johnson & Johnson''s Charite artificial spinal disc has added to that number, with over 130 severe a...

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