Washington, DCJudging from the response of patients who have received the Charite artificial disc replacement, Charite disc complications have been an issue for quite some time—and even extend to those who participated in trials analyzing the effectiveness of the device, according to a ''Maude'' adverse reaction report on the official Web site of the US Food and Drug Administration (FDA).
According to the complaint, the patient had reported anterior migration of a Charite disc sliding core, a device that had been implanted when the patient was a participant in the initial clinical trials prior to FDA approval of the Charite system in 2004. According to the adverse reaction report, the complaint occurred two years after approval of the device, in 2006. A revision and fusing procedure was reportedly performed, with the Charite left in the disc space to act as an interbody device.
There has been some criticism with regard to the approval process of the Charite spinal disc system, which is manufactured by the DePuy division of Johnson & Johnson. Various barbs have been thrown over the two-year clinical study period many feel was too short and did not achieve a success rate worthy of approval.
Of equal concern is the need for revision surgery when a Charite fails, which not only adds to the expense of the initial procedure ($11,500 for the device and a further $50,000 for the intricate surgery required…), but also adds an element of risk should the device require removal. Akin to an attempt to remove a pacemaker lead from the heart muscle, removing a Charite spine disc can come at a greater degree of risk than the installation.
And then there are the stories of real people who have suffered through Charite disc complications.
"I'm a female in my forties that [sic] received a Charite implant a few years ago," writes one woman on healthboards.com. "I have suffered through 5 hospital stays and numerous ER visits over the past three years. I have spent a total of 48 days in the hospital; some of these in the ICU where I lost almost 1000mL of blood upon removal when a major vein was severed.
"I have had the implant put in. I was fused. I had the implant taken out. I am on a hefty amount of narcotics just to be able to get out of bed. My pain is exponentially higher than it was before electing to get the implant from my ill-advised doctor.
"My life has been ruined. I cannot work. Most days I cannot even get out of bed or do so late in the afternoon. I suffer from mid back, lower back, hip, flank, leg, perineal, clitoral, bladder and rectal numbness, neuralgia and weakness. I cannot urinate freely. I have virtually no peristalsis. I now use a cane. Worst off all, I have no children...AND (author emphasis), presently, 99.9% probability of never having the capacity to carry one.
"I have lost my job, my home, my friends, my savings, my hope, my joy of life. My time is spent in a bedroom where I lay in agony most of the time with my two wonderful cats that bring me comfort and support. There are times when I cannot get in the tub for four days at a time, I cannot comb my hair, get dressed, etc. I get out of the house maybe once or twice a month...
"If I did not have the wonderful husband that I have, I would be spending my time alone, helpless.... Thank God for him."
Little wonder there are lawsuits alleging Charite disc complications.
If you or a loved one have suffered losses in this case, please click the link below and your complaint will be sent to a defective products lawyer who may evaluate your Charité claim at no cost or obligation.