He says the Chirate is unsafe and should never have been approved because a 2-year study is too short for a disc that will remain in the spine for many years with implant patients averaging 40-years old.
"There is no solid evidence that this will last for more than five or 10 years and they will not need to have another operation," Dr Rosen said.
According to Times, Dr Allyson Fried-Cain, 52, a former foot-and-ankle surgeon, has sued the device maker, saying she suffered such an increase in pain after a Charite disc implantation that she lost her practice and had to sell her home in Marina del Rey, California.
Dr Fried-Cain, a former marathon runner whose back injury resulted from a car accident, told the Times, "I couldn't do surgery anymore. I couldn't bend over,"
"This implant has destroyed my life," she said.
According to the Times, spinal surgery is becoming a very lucrative business, "with at least $3.2 billion spent last year in the U.S. on spinal fusion."
In August 2006, the FDA approved the ProDisc-L, made by Swiss medical device maker Synthes Inc, which is expected to compete against the Charite.
In its approval letter to Synthes, the FDA said patients receiving the disc should have tried at least 6 months of "conservative" treatment with other therapies such as exercise and medication.
As a condition of approval, Synthes agreed to continue studying the disc for long term safety and effectiveness in a study involving at least 286 patients. The company is also required to conduct a yearly analysis of major adverse events and report the number of devices sold and implanted each year.
The booming spine surgery industry suffered a serious financial set-back earlier this year, when the Medicare program stopped paying for the Charite disc in patients over 60, noting that the surgery costs between $30,000 and $50,000, and has not sufficiently been tested for long term affects. The CMS stated "that the evidence is not adequate to conclude that the Charite lumbar artificial disc is reasonable and necessary."
"Therefore," the CMS memo concluded, "we propose to issue a national noncoverage determination."
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