& 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.
After years of research and development, Johnson & Johnson (J&J) was the first company to market an artificial spinal disk in the U.S. that would alleviate persistent back pain and permit natural body movement. Since marketing of the device know as Charite ¢ began, surgeons have been lining up at J&J’s training center in Cincinnati to learn the implantation procedure. It is estimated that by 2010, the annual market for artificial disks could reach $1.7 billion. This particular device costs $11,500 with an additional $50,000 or more added on for the implantation surgery.
At this point, the last thing that J&J needed was a debate about the durability of the device. Unfortunately for J&J, that is precisely what it has on its hands. There are now surgeons who are predicting that, over the next 10 to 15 ears, there will be a wave of patients who will suffer applications and require surgical removal of the device. The surgeons consider this to be quite problematic because the removal procedure can be more dangerous than the surgery needed to repair a spinal fusion that has gone wrong.
Critics of the device have offered several reasons why they believe the rush to acceptance of the device is premature at best. These reasons include:
The 2-year trial used to win approval is far too short for a device that is expected to remain in the spine indefinitely without becoming displaced or causing other problems.
- The 304 patient trial group was too small.
- In the trial, the device was compared with a standard fusion surgery which is now outdated.
- Even when compared to that outdated version of spinal fusion, the device worked no better in relieving pain after 2 years.
- Some insurance companies are refusing to cover the implantation procedure.
- There has been no showing by J&J that the device will avoid the risks the company claims are inherent in fusion surgery.
- The device is difficult to fix.
- This device may not even be as good as others which are currently in clinical testing.
- If this device is a failure it will give spinal arthroplasty a bad reputation.
- The device is really an alternative to spinal fusion rather than the superior procedure J&J claims it to be.
- Experts who have studied cases involving complications with the device found many cases where everything was done right yet problems occurred.
- The device promotes bad motion in the spine.
- An analysis of several devices that were removed revealed wear that was similar to that in artificial hips and knees that generally last up to 10 years. While this might be acceptable in older patients, it is not for younger ones who would require additional life-threatening surgery to remove the device when it wears out.
The spinal column consists of 33 vertebrae that protect the spinal cord and provide stability to the torso. Between each vertebrae is a fibrous bundle of tissue called an intervertebral disc. This disc serves as a cushion to the spinal column by absorbing shock and pressure.
An intervertebral disc consists of two distinct regions:
- Outer region, or the annulus fibrosus – this retains the shape of the intervertebral disc.
- Inner region, or the nucleus pulposus – this is soft, spongy tissue that gives the disc shock absorbing properties.
As we age, the intervertebral discs degenerate and lose their ability to absorb shock. When water is lost in the disc, an injury or strain can cause the disc to tear or bulge. As the discs lose size and shock absorption abilities, the vertebrae come closer together and may compress spinal nerves. This often causes many types of disc pain that patients report such as pain, tingling and numbness.
The Charité disc was intended for patients with degenerative discs between the lombar vertebrae L4 and L5 or between L5 and S1 (sacrum).
On October 20, 2005, the Bagolie Friedman law firm announced the formation of the “International Charite Artificial Disc Practice Group,” based on a belief that numerous people in the US and abroad, “suffer Charite artificial disc failure,” and that “Johnson and Johnson is responsible for manufacturing a medical device they knew or should have known was unreasonably dangerous in an attempt to capture some of the lucrative multi billion dollar back surgery market.”
“We will be reviewing potential cases from the United States, Australia and Europe,” said Mr Bagolie.
In 2003, DePuy Spine, a division of Johnson & Johnson, acquired the Link Spine Group, and gained exclusive worldwide rights to the Charite.
In the paper, “Total Disc Replacement for Chronic Low Back Pain: Background and a Systematic Review of the Literature,” by M de Kleuver, F Oner, W Jacobs in the European Spine Journal Volume 12, Number 2, April 2003, the authors determined that despite the fact that these devices have been implanted for almost 15 years, on the basis of this literature survey there are currently insufficient data to assess the performance of total disc replacement adequately.
There is no evidence, the paper said, that disc replacement reliably, reproducibly, and over longer periods of time fulfils the three primary aims of clinical efficacy, continued motion, and few adjacent segment degenerative problems.
Total disc replacement, they said, seems to be associated with a high rate of re-operations, and the potential problems that may occur with longer follow-up have not been addressed. Therefore, the authors advised, total disc replacements should be considered experimental procedures and should only be used in strict clinical trials. J&J beat out competitors Stryker and Medtronic by securing approval of the Charite, but many surgeons have criticized the FDA for approving the device and ignoring over 17 years of evidence related to its use Europe, including a study showing that more than half of recipients had fair or poor results.
The FDA approved the Charite based on the results of a single two-year clinical trial, that was designed to merely establish that the Charite disc worked at least as well as the Bagby and Kuslich cages (BAK) used in spinal fusions. The trial was conducted at the Texas Back Institute in Plano, Texas, on 304 patients, and was led by a team of surgeons that included Dr Scott Blumenthal, Dr Barton Sachs, and Dr Stephen Hochschuler, who are considered to be among the best spine surgeons in the field.
Dr Blumenthal presented the results of the trial at a hearing before an FDA advisory panel. A transcript of the June 2, 2004, hearing, reveals the agency’s own reviewer found the study to be biased in favor of Charite, and that important data about patients had been excluded. A voting member of the panel, Brent Blumenstein, complained about omitted patients during the hearing, but went on to vote for approval anyway.
Adverse events in the study, he explained, were categorized as typical or unusual, severe or life threatening, device related or not device related, severe and device related occurring within two days of surgery and by date of onset. A Danish surgeon, Dr Andre van Ooij, also testified at the hearing, and advised the panel about the known complications associated with the Charite, and provided the members with visual slides showing the adverse events that occurred in a number of patients.
Dr van Ooij tracked hundreds of surgeries in Europe and in eight years, he treated 49 Charite patients, 28 women and 28 men, with some their surgeries performed as early as 1989. All of these patients, he noted, suffered terrible leg and back pain after the device was implanted and many were unable to undergo a surgical revision of the disc due to the dangers involved in spinal surgery.
Dr van Ooij also advised that some men implanted with the device suffered retrograde ejaculation and erectile dysfunction, and others patients suffered leg complications and joint degeneration. “One big issue that was not spoken about today,” he pointed out, “is breakage of the metal wire.”
“If you look good at the x-rays,” he advised the panel while showing a slide, “you can see the breakage and the flattening of the polyethylene core and probably also some wear debris.” Overall, more than half of the patients in Europe ended up with fair or poor results after the disc was implanted.
Orthopedic and spine surgeon, John Peloza, also testified at the hearing and told the panel that first and foremost, the Charite disc had to last the lifetime of the patient and that the average age of a person that would be a candidate for the procedure is about the mid-40s. “I think it is critical that these implants last for the life of the patients,” he said, “because revision surgery to remove the implant particular from an anterior approach will be potentially life threatening in every case.” “And at present,” he advised, “there is no consistently successful strategy to deal with a failed implant.” “I don’t think the polyethylene as they have in this implant will last anywhere near 40 years or the lifetime of the patient,” he advised. In addition, he said the fixation of the disc to the bone was compromised.
“The metal base is secured with a press fit with little spikes,” he explained. “This is not adequate and will predictably fail,” he added. There are published studies, he told the panel, that show significant re-operation rates between 5 and 20 percent with complication rates reported greater than 10 percent. As for results in regard to pain relief, the clinical studies in Europe and Australia, he said, essentially report results equivalent to fusion in regard to pain relief
The Charite does not absorb shock like a healthy disc or mimic natural motion, Dr Rosen told USA Today on July 25, 2006, and a dislocation or fracture of the disc can also cause problems, he said. In May 2006, Medicare decided to stop paying for the device in patients over 60, noting that the $30,000 to $50,000 surgery had not been sufficiently tested for long-term affects. Blue Cross and Blue Shield also determined that more research was needed over a longer period of time, although insurance plans in each state determine coverage decisions individually, according to USA Today.
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