Since being approved by the FDA in 2004, manufacturer Johnson and Johnson and the FDA have received reports of more than 130 instances of significant adverse events or medical trauma associated with the Charite artificial disc surgery. The U.S. Food and Drug Administration (FDA) approved the Charite spinal disc in October of 2004, after only two years of clinical trials in the United States, although the disc had been used in Europe since the 1987. The Charite spinal disc is manufactured by DePuy Spine, a subsidiary company of Johnson and Johnson. The artificial disc, the first of its kind in the United States, was manufactured and marketed to reduce the need for a more invasive and dangerous lumbar spinal fusion surgery in patients with degenerative disc disease and related conditions.
Adverse Events and Reported 57% Success Rate of Charite Artificial Spinal Disc
Because the Charite disc has only been on the market for about five years in the United States, little is known about the long-term effects of the artificial disc. However, despite a pre-FDA approval success rate of 57%, the device won approval in 2004. Potential risks associated with the Charite disc include allergic reaction to the implant materials, bladder problems , bleeding, which may require a blood transfusion, implants that bend, break, loosen or move, pain or discomfort, paralysis, potential side effects from anesthesia, slow movement of the intestines, spinal cord or nerve damage, spinal fluid leakage, the need for additional surgery, tears of the dura (a layer of tissue covering the spinal cord), problems with your blood vessels other than bleeding, incision problems, infection and death. In Europe, surgeons have noted problems with the artificial disc for more than two decades.
Charite Artificial Spinal Disc Lawsuits
Numerous patients have sued Johnson and Johnson alleging the pharmaceutical company knew or should of known about the serious complications of the artificial disc surgery. Despite criticism, the Charite spinal discs are still being used in surgery, and many patients do not learn of the problems associated with them until it is too late. Charles Rosen, an associate clinical professor of spine surgery at the University of California at Irvine, said "these artificial disc replacements should be recalled by the FDA to protect the American public." If you or a member of your family had a failed Charite artificial disc replacement surgery, you should contact an attorney handling Charite disc replacement cases for more information about your legal rights. You may be entitled to compensation from Johnson and Johnson for your medical expenses, lost earnings, additional surgeries and pain and suffering.