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Charite Spinal Discs

Charite Spinal Discs Side Effects Lawsuits | Side Effects: Increased Pain, Life-Threatening Revisions, No Pain Improvement, Surgeries | Disappointing Test Results, Low Success Rate

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Charite Spinal Discs Side Effects May Result In Revision Surgery Lawsuits

Charite Spinal Discs | Lawsuits, Lawyers | Side Effects: Increased Pain, Revision Surgery, No Pain Improvement, Surgeries | Disappointing Test Results

Many patients with degenerative disc disease who chose to have a Johnson & Johnson Charité spinal disc implanted are now finding that they have increased pain or similar pain levels as compared to before the operation and little improvement in their motion abilities.  Some patients are being required to have life-threatening revision surgeries.

About Charité Spinal Discs

Johnson & Johnson’s (DePuy Spine) Charité spinal disc is the only artificial disc approved in the United States.  Before its approval in 2004, the manufacturer’s trial sought to prove only that the disc worked as well as its AcroFlex disc and the Bagby and Kuslich (BAK) cage used in spinal fusions, both of which have been abandoned by many surgeons due to high failure rates.  Furthermore, Johnson & Johnson did not include pain relief as a measure of the success of Charité in the trial.  The disc’s ability to preserve or restore natural motion was also not included in the study’s definition of “success. The trial only showed that 57% of patients who had the Charité disc surgery met modest success measures.  Despite the disappointing results, Johnson & Johnson markets the Charité disc with slogans such as “Natural motion is back.”TM and “An alternative to lumbar spinal fusion surgery.” An FDA transcript shows that an agency statistician portrayed the pre-approval study as biased in favor of Charité and as omitting important data from randomized clinical trials.

Charité Disc Criticism

Charles Rosen of the University of California-Irvine Spine Center has expressed concern and asked that the FDA withdraw the discs from the market. He discussed his concerns in an article on TheStreet.com in May of 2005. Rosen questioned how Charité was approved due to its weak results and frequent life-threatening revision surgeries.  Rosen has spoken publicly about the discouraging of scientific debate on Charité at the annual meeting of the North American Spine Society.

Free Charité Disc Case Evaluation

Patients who had the Charité spinal disc operation and who continue to suffer are encouraged to contact Parker & Waichman, LLP for a free case consultation.  Please fill out the form at the right or call 1-800-YOURLAWYER (1-800-968-7529) today.

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J&J unit DePuy loses suit dismissal bid

Apr 13, 2007 | UPI
U.S. Johnson & Johnson unit DePuy Spine has lost a bid to quash suits claiming its spinal device has defects, plaintiffs' counsel said. A Massachusetts state court earlier this week refused to dismiss four lawsuits filed against DePuy alleging the company's Charite Artificial Disc used to replace diseased or damaged spinal discs as an alternative to spinal fusion -- doesn't work for its intended purpose. The plaintiffs in the four cases alleged the spinal device failed, causing serious...

Artificial Disc Recipients Take Legal Steps

Aug 4, 2006 | Los Angeles Times
Since the moment a decade ago when Dane Titsworth picked up a box and a disc in his spine burst, he has been in ever-worsening pain. So it was with great hope that the Bakersfield building maintenance manager agreed last year to a new procedure. It meant replacing the deteriorating disc in his lower back with a Charite-brand artificial one the first artificial replacement disc approved in the U.S. "The artificial disc was going to restore my full motion and relieve all my pain," he...

A Government-Approved Artificial Disc Brings Onlu Mixed Results for People Suffering From Lower-Back Pain

Oct 11, 2005 | Newsday
Hratch Vranian's lower-back pain landed him in a study designed to test an artificial disc that his surgeon promised would be the cure he was searching for.Before the experimental surgery, he rated his pain as three on a 10-point scale. Today, three years after the surgery to place the Charité artificial disc into the lumbar part of his spine, Vranian's pain scores have almost reached 10. The 49-year-old California man can no longer work, and lives on daily doses of morphine to alleviate...

J&J Discs Face Backlash

May 13, 2005 | www.thestreet.com
Normally, Charles Rosen embraces scientific advances in back surgery. But the university-based spine surgeon can't imagine using one now being promoted by Johnson & Johnson (JNJ:NYSE).The company's Charite artificial discs last year became the first to hit the American market, offering a long-awaited alternative to complex spinal fusion surgery. Rosen, recently filmed by PBS performing another new procedure, likes to provide his patients with cutting-edge services.So he set out to learn about...

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