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.
READER COMMENTS
Nadine
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Laurie
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I had a fusion in April 2015 to prevent the Charite Disc from moving and causing further damage. I was told it is too dangerous to remove the disc therefore I was left with 2 options. Live with the pain or have a fusion which may result in a 75% improvement.
To date I have been unable to locate an attorney interested in a potential suit against J&J.
LYNND
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I pressed the doctor, who had been involved in the clinical trial for this device, to explain my odds. I sensed hesitancy. The comment that only about 57 percent find relief, makes sense in light of the hedged response I received. Even though in 2005 it was FDA approved, it was still very new to the U.S. but not to Europe. So I contacted European researchers who had done a 17 year follow up. I have a background in journalism and I received a personal reply. Indeed, patients had developed a high rate of complications and were among the "worst" the researcher had ever seen for pain levels.
Prior to the surgical consult I had suffered many years of pain, and failed conservative care. My back pain was always at least a "7" on a 10-point scale. It woke me up in the morning. It kept me from being able to use the first part of the day. But several times a year the pain would escalate to the point where taking in a breath of air hurt. The spastic condition of my back was such that during these periods, which typically lasted three days, I was unable to use a toilet and was confined to the use of a bedpan because I could not get out of bed. I have been in the level of pain where I could not even turn in bed without assistance. I keep on hand a commode and a walker, not just a cane. I have been in so much pain during these acute episodes that I have become clammy, nauseated and light-headed, to the point where I think I am entering the initial stages of shock. This pain has been so utterly off the charts at times over the past 17 years that it is hard not to consider back surgery as an option. However, it is all too common that whatever the procedure is, it is followed by still more procedures. Whether it's Artificial Disc Replacement or traditional fusion, adjacent segments typically degenerate in the years to come leading to more pain and more surgery. Eventually, it is possible to become permanently bedridden. Psychologically, I know I can't endure the thought of having off-the-charts pain of the variety that will not subside in a few days but is produced by failed back surgeries. Therefore, instead, I have opted to severely limi my lifestyle — including giving up my job. I typically manage if I don't sit, stand, remain on bedrest or do any one activity for prolonged periods. But there have been consequences among friends and family for not pursuing the surgical option. They think I'm a coward. Even my in-laws have been particularly cruel given that they are retired medical (GP/RN). They have implied that I can simply go back to work. I've shown them my medical reports and during the last severe incidence of pain I was actually at their home when it occurred. They are aware that my husband (their son) had to obtain a lower bed frame for me. That he missed almost two weeks of work. And that I had been given a bedside commode by the emergency room doctor.
Now let me say that of all the people, the medical community is the cruelest. They are so used to seeing people suffering that after awhile they are skeptical of how bad it can really be. I have been accused of drug-seeking when I have been brought to the ER by family and/or my husband. I have literally put an end to my life, at 43 without a job and without children, all so I can AVOID being hooked on heavy duty drugs. I have a family member who visits a pain clinic for such drugs. And she works full time. I do not have any high-dose pain killers and I am allergic to all NSAIDs. So the result is, when my pain is out of control I have no choice but to be brought into the ER by wheelchair. Despite this, I have been forced to wait hours upon hours.
I despise the fact that doctors in the U.S. are inadequately trained to recognize chronic pain for the life-sapping affliction it is. Just the same, I would caution anyone reading this that whether it is the Charite or some other procedure that involves a medical device implant, it is of vital importance to 1) ask the surgeon how many operations he/she has performed of this identical type, and 2) learn whether the surgeon is on the receiving end of benefits or perks from the device manufacturer.
What made up my own mind against the Charite ADR was this: I asked the surgeon, who had participated in the clinical trial for the device, if the manufacturer offered any incentives. He was honest with me, indicating that "Yes" there were incentives to use (recommend) this particular solution to my pain. His answer gave rise to a potential conflict of interest. Sure enough, some four years later I read a news article in which the Department of Justice was investigating the manufacturer of several medical implants, including the Charite ADR, for offering doctors what amounted to kickbacks.
As to the overall safety question, I would add this: It's not just the fact that ADR revision surgeries are particularly high-risk for life-threatening complications. That's a given that anyone investigating ADR ought to appreciate. However, prospective patients also need to know that the more spinal surgeries one undergoes, the less effective the outcomes tend to be. So should you have surgery or not? If you're down the road, attempting to correct failed back syndrome, you probably have little choice. But if you haven't yet had your first spinal surgery and you are still able to work OR are lucky enough to have a family member or spouse who is willing to support you — and if in controlling your lifestyle, activity and stress level you can fend off taking mega doses of pain meds day-to-day, my advice is NOT to seek out spinal surgery.
Even when a spinal surgery is a success, it too often amounts to a temporary solution. Many doctors do not recommend patients undergo spinal surgery — even though the pain is chronic and debilitating. Oftentimes this can feel as if the doctor lacks compassion or is doubting how bad the pain really is. But what's really at stake is not your credibility but your chances of success with ANY form of spinal surgery. Spinal surgery for degenerative discs, in particular, is notoriously tricky. Disc decompression for sciatica may be successful but disc replacement or fusion for degenerative changes is rarely a long-term solution. Sure it isn't easy to totally give up the lifestyle you expected (or had). But when you consider that the pain you experience is not likely to go away 100 percent or that it will eventually rebound, you may stand to lose more from going down the surgical path than you gain.
Michael Thomas
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Sally
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David L Rodgers
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That's three major surgeries and counting..
The worst pain imaginable...I feel for everyone and anyone who has experienced what the Charite disc has done to their lives.
I'm at the point now where I'm investigating the possibility of removing the Charite disc. To remove it, doctors are required to create an incision elsewhere, and the risks increase dramatically. Sadly, it appears to be my only option left..other than living out the rest of my life in unspeakable discomfort.
I welcome any knowledge of orthopedists who have history with this procedure.
Best wishes for all..
Jim
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Jennifer BeLieu
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Leah
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Guisel
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I do not recommend this surgery.
The charite disc has RUINED life too.
SCott Lindsey
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Shannon
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When I received my Charite artificial disc at L4-L5, I was a 38-year-old former athlete and non-smoker, in otherwise good medical condition, who presented with degenerative disc disease and herniated disc as well as four years of unremitting pain as the result of an automobile accident. I was a non-smoker and within the desired weight range for my height.
I received my disc right after the FDA approval, and the operation was performed by one of the neurosurgeons who'd studied the procedure in Ohio during the FDA trial. When I woke up from my procedure, I, too, was almost screaming in pain. The procedure we'd been assured would only take a couple of hours had stretched on for eight. However, the pain was brought under control quickly by the nursing staff and I went home 2 1/2 days after the operation.
Within a week, I was experiencing excruciating pain--not in my back, but in my foot. At first, incompetent ER doctors in my hometown tried to tell me I had gout or some other silly thing despite the fact that I had just had significant surgery on my spine. When I saw my surgeon again, he ran some tests and then said off-handedly that he'd probably nicked a nerve sheath and the pain would resolve. Five months later, despite continued pain and difficulty rehabilitating, he released me from his care. He sent me to no physical therapy sessions--my rehab was walking. He cleared me to return to work. In fact, his office never called me again to follow up, and never returned my calls when I tried to schedule appointments. (I now know why; more on that later). I added to my rehab efforts with flexibility and light strength training and swimming. Within half a year, however, that rehab screeched to a halt. It was all I could do to work one day because I'd literally be laid up for two afterwards--all before the first anniversary of my procedure.
Over the next five years, my condition continued to deteriorate. Within a few months of being released from the surgeon's care, I was back on pain medications. I began to limp noticeably. My ankles and lower legs started to show weakening and deterioration, sometimes sending me to the floor in a heap when my legs would suddenly give way. Radiologists, pain management specialists and my personal family doctor could detect nothing on my films to explain these worsening conditions. I, too, started to be treated like a drug-addicted hypochondriac--to the degree where I refused to go to the emergency room for severe bouts of pain. MRIs and CAT scans showed an 'artifact' over the disc and only limited signs of damage at adjacent levels. I packed on over seventy-five pounds in a year because I could no longer work, clean house, work out, walk without fear or even drive--thereby exacerbating the vicious cycle of pain and worsening conditions. Finally, my doctor sent me to a new spine surgeon who took a look at my films and said, "We need an x-ray." I had one that day in his office. He came in, looked at the films and said, "This artificial disc is severely misaligned. You're going to need another surgery to rectify this." I left his office and went directly to the hospital where the artificial disc operation had taken place and got all my medical records.
Apparently, the prosthetic was visibly misaligned at my six weeks' x-ray, with a surgical screw already protruding. Upon a closer look at my surgical records, I discovered that my two hour procedure had turned into an eight hour procedure because initially the wrong size disc had been inserted and consequently had to be removed and replaced--none of which I was informed of by the original surgeon.
A L4-L5 spinal fusion and laminectomy was scheduled. I was informed that despite the misalignment of the prosthesis, the artificial disc could not be removed due to the dangerous placement without running severe risks of injury or death. The surgeon placed me on extreme restrictions until the operation--I could not lift more than five pounds, ride in a car longer than thirty minutes, sit longer than an hour. My life and activity level dwindled to nothing. And then, the day BEFORE the operation, my insurance denied the fusion, calling it 'medically unnecessary' due to the contraindications of MRI films and 'experimental' due to putting a fusion over an artificial disc. While I appealed the decision, another seven months passed--under the same restrictions. I packed on MORE weight and was literally almost afraid to do anything. The danger of paralysis or internal bleeding if that disc moved any further was emphasized to me, and scared me into doing exactly what the surgeon wanted which was nothing.
Now, in the past month, I was hospitalized at a major university hospital with worsening symptoms (sudden shift of radicular pain from the right to the left, extreme numbness and loss of feeling in both legs, low grade fever and severe pain)and a suspected infection at the artificial disc level. The diagnosis of the denied surgery was confirmed by my new surgeon, who has now scheduled me for a complete decompression of the totally impinged L-5 nerve root (and I have an L-6 as well, which complicates matters) as well as a fusion above, over and below the artificial disc. This surgeon has confirmed that the initial prosthetic NEVER fused, and in fact the misalignment of the disc is visible, obvious and progressive. This diagnosis has been confirmed by multiple orthopedic surgeons through consultation, and hopefully my insurance won't appeal this procedure.
So the Charite disc that was touted as giving me a full range of motion, a device supposed to last for thirty or more years, a device supposed to halt further spinal degeneration, to remove all pain and to give me back my life? Well, it did the direct opposite. Best case scenario for me after this upcoming surgery is 50% pain reduction--ever. Best case--and the ability to not move fully, to not regain my full strength and fullness of life. But, I'll be able to pick up a baby or clean my house--slowly--and walk and hopefully swim again for exercise and weight control within 6-8 months. I will always be on medications, most likely, and am now likely to suffer all the negative consequences of spinal fusion surgeries that I'd hoped to avoid.
BUT, 50% is a hell of a lot better than 0%. At least that will give me the chance to create some kind of quality of life--something that the Charite' disc completely took away from me for the past six years. A nightmare--plain and simple.
Leah
on
I woke up from surgery into A LIVING NIGHTMARE. I immediately started screaming at the top of my lungs, barely able to comprehend the amount of pain I was in. I thought I was still having surgery and woke during the procedure. I have had 4 children and thought childbirth was the most pain I had experienced. I felt as if my spine was on fire...as if a million saw blades were cutting me open...there are no words to TRULY convey the horrific excruciating hell I woke up in. I was a wild woman....begging my husband to smother me with a pillow. I would have killed myself if I had been able to. I was on the max. amount of hospital grade morphine and was literally sobbing so hard, my pillow was soaked with tears of pain and fear......not being able to get ANY relief from feeling like you are being burned alive...SCARED ME TO DEATH. The Dr. looked stunned and scared as well and I begged him to please knock me out..I could not take it. I was put into a twilight sleep for 3 days....and was maxed out on a combination of opiates for an additional 5 days. I was still uncomfortable, but able to cope somehow.
I left the hospital on a daily medication routine of: Dilaudid, percocet, valium, ambien, oxycontin and flexeril. I had never taken pain killers prior to this and had NO IDEA what a lethal combination THAT was. The Dr. just kept refilling them month after month as I slipped into a drug induced coma basically....he never talked about side effects or physical dependence. I could not walk for months and was a MESS.
As I slowly began to emerge from the drugs by lowering the doses myself...to see how much pain I could tolerate...I decided to just throw out all the meds. Well I ended up in the ER from withdrawl symptoms so severe I thought here we go again.
To sum it up.....I spent the next few years trying to live with the pain and balance daily pain medication. The Charite disc overloaded my endplate causing fissure fractures, damaged my facet joints, is so unstable that it alternates between giving me electric type shooting pains all across my back and sciatic nerve pains down my right leg. It also caused massive nerve damage and most recently was diagnosed with Spinal Adhesive Arachnoiditis, a rare incurable progressive pain disease that most sufferers describe as cancer pain without the relief of death. The progression of numbness is followed by partial paraylsis then can become complete paraylsis. There are only a handful of Dr.s that are knowledgeable of this disease and its very hard to get the right treatment/medications/therapy that I need. I have tried every single pain relief alternative therapy/medication over the past 5 years since that fateful surgery.....and NOTHING has helped in any significant way except pain medications.
I HAVE to take daily narcotics to get through my day. The stigma attached to that is another hardship: from most Dr.'s (especailly in CA..my God) I am treated like a drug seeking addict...the 3 years following the surgery, since the MRI CAT scans and x-rays did not show much and the cast from the metals in the discs obscured the view to the point that the radiologists notes would read that I suffered from "failed back syndrome" and would have to BEG the Dr.'s to give me larger doses of narcotics (after being forced to take antidepressants and a slew of other medications that NEVER touched the pain..but am required to follow orders so I dont come off as a drug seeker) because the pain is so great. I have been bullied 1st by my family to "get to rehab" to get off the meds...which I did..only to be bedridden and crying nonstop for days..weeks..unable to walk...until THEY finally figured out I was in REAL pain. Then again years later when I moved and another Dr. convinced me that pain pills CAUSE pain, which can happen, so back to detox...and again...the pain was incapacitating. I HATE taking the narcotics and rarely tell people about my condition...so I dont have to get the "Ohh....taking Oxycontin AND Percocet???Whoa!! How are you even standing???" I did not add my daily muscle relaxants to stop the horrible spasms I have. The Charite has RUINED my life and I pray to GOD that it does not get worse.
Terry
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