The Truth About Disc Replacement: Help!

[D.LYNN]

Hello,

I'm posting today for two reasons: First, for those considering artificial disc replacement, I'll tell you what I've learned (it took me months of sifting through medical journals to locate this, so trust me when I say you won't find this much info. condensed into one document elsewhere!). Second, I want to know if in spite of some big red flags it might still be worth the surgery (if you were doing it). The reason why this last question is important is because I'm scheduled to receive the Charité artificial disc THIS THURSDAY, and I need the opinion of people who are IN PAIN to know if they would take this approach to TREAT pain, even in view of the risks. Finally, if anyone who has already had the Charite disc replacement reads this, may I ask if you would do it all over again?

Thanks!


CONCERNS

• My surgeon says I will get 30 years out of the disc replacement and 90 percent pain reduction. All other sources I've read indicate that the same materials when placed in hip and knee replacements have an average life of 10-15 years. Every doctor I've talked to or contacted by email, including an engineer who was quoted in the New York Times on this topic, doubts that it will last more than 10 years on average. Even other doctor's who perform this particular operation are not so optimistic about its ability to last more than 15 years. Meanwhile, the clinical trial that resulted in FDA approval reports a post-implant satisfaction rate of roughly 75 percent, BUT the caveat is that a successful outcome has been defined as little as 25 percent improvement in the patient's pain scores.

• Unlike hip or knee replacement, doctors agree that the Charite disc is NOT easily re-accessible without putting the patient at risk for massive blood loss during what the medical literature calls a "salvage" operation. (This because disc replacement surgery is done through the abdomen, which frequently, in turn, produces scar tissue that entangles nerves, ureters and the Aerortic artery, which the surgeon must nevertheless attempt to "part" in order to reach the spine.) In Europe it has been possible in some cases to replace a damaged or worn out artificial disc with a new disc but only if there is little scar tissue from the original operation. More often than not, though, if a revision operation is necessary fusion involving front AND back incisions is the only solution for an artificial disc gone bad (the orthopedic equivalent of open-heart surgery). Moreover, because of the life-threatening nature of re-operation for ANY reason, the artificial disc oftentimes CANNOT be removed even if it breaks or wears out, so doctors have no choice but to implant fusion hardware around it.

• Up until recently, I figured that because this disc prosthesis had been used in Europe since the mid 1980s, it must be safe with plenty of study to back it up prior to migrating the Atlantic to the U.S. Now, though, I have learned that one reason the major insurance companies are not covering disc replacement surgery is because there are too little data to support it as anything other than "experimental". Additionally, an engineer I contacted who has evaluated Charite discs that have failed in patients in Europe pointed me toward one of the few long-term studies that does exist out of Europe — a 17-year retrospective involving X-rays and MRI examinations of patients who had the Charite for an average of 17 years — and the results were less than ideal. The group that had great X-ray images and MRIs, which would seem to indicate that the prosthesis was functioning as designed, were largely UNHAPPY with the outcome. Out of the group that reported less pain and disability, the researchers found that there was evidence of spontaneous fusion (bony overgrowth). The implication was that the motion that everyone touts in artificial disc replacement is temporary, and that the body in response to the presence of an artificial disc tends to ossify (this was true in 60 percent of the patients followed up and has also been noted by researchers investigating competing disc prosthesis, such as Medtronic’s Maverick). The concern here, which anyone who has an arthritic spine condition such as ankylosing spondylodesis can vouch for, is that the process of ossification can be painful in and of itself when in proximity to so many spinal nerve endings. To make matters worse, what artificial disc replacement claims to preserve insofar as reduced wear-and-tear to adjacent discs it seems to make up for by increasing loads on the facet joints, which when they become degenerative (arthritic) also produce back pain and inflammation. So just as fusion is criticized for placing too much load on adjacent discs, so too it would seem artificial discs may be increasingly criticized for increasing adjacent facet joint degeneration.

• In the U.S., testing on the Charité disc shows promising short-term (2-year) results, but only when patients are in the hands of a small minority of top-notch spinal surgeons who have mastered the technique. (There is a steep learning curve involved with selecting and implanting the right size of disc, in the right position and to avoid abnormally loading the adjacent facet joints, etc.) Most people to receive this disc remain improved at 2-5 years, but the European studies seem to show that time is the enemy in disc replacement. Another thing that you find out when you read the research is that here in the U.S. doctors don't believe that the plastic in the artificial disc can cause inflammation of the spinal tissues in its own right. They also claim that the literature out of Europe shows that these plastic/metal discs are NOT subject to breakage. But this assumption is not correct according to Dr. André van Ooij, practicing in the Netherlands. He has treated patients who, in as little as 5 years post-disc replacement, are in worse shape than he has seen ANY back pain sufferer in 24 years of practice. (See: [url]www.BurtonReport.com[/url].) He has documented inflammation, lesions, cysts and other cell changes in the spine associated with the plastic particulates sloughing off as the disc prosthesis ages, as well.


QUESTION

My doctor agreed that the European findings were "curious" and stated that ultimately the answers to the long-term effectiveness and safety of the Charite prosthesis are unknown. I am in my mid 30s and expected initially to get a lifetime out of this — or at least 30 years “as advertised” — rather than a temporary fix that I will one day have to trade in for more pain than I probably experience on average now (not to mention the prospect of a salvage operation that may be as risky as open-heart surgery). If you were faced with this information and this choice, would you go through with surgery or make the best of what you have — despite the pain — until you have nothing left to lose?

[TINCAN]

D.LYNN,
I am sorry you have to go thru this. I know this is a bummer I have been suffering for 15 years. But on to your question about the artificial disk. All I can tell you is that I asked my ortho spine specialist about the art. disk and he said that when he went to a conference about it he told them his opinion and it is this; That sooner or later you will need a fusion because it will wear out too. There are too many things that go on in the back to make this thing fool proof. And it seems you have the documentation to prove what he said is the truth. But when you are in that much pain you will do anything for relief. I do hope this helped but the final ok has to come from you. I hop you have a blessed day. TINCAN
LAMINECTOMY L5-S1
DISCTECTOMY L5-S1
FUSION L5-S1 WITH HARDWARE
BONE SPURS
MEGA SCAR TISSUE
DDD UP TO THORASIC AREA
STENOSIS
SPONDYLIOSIS
DISK BULGE L4-S1

[motmcd]

Do you know where the FDA is regarding approval for artificial cervical discs?

[IUfan]

D. Lynn,
Do I ever need to speak with you ASAP!! I can empathize with your position. I have the Charite implants, multi-level @ L4-5 and L5-S1. I am impressed at the amount of information you have in your post and would like to learn from you where you went to get it all. I had my surgery on 4/1/05. Prior to the surgery I didn't have access to the internet to do my own research and had to rely on a good friend of mine to get information for me. She was only able to get information from certain places as she did all this at her work site.
I cannot vouch for problems that may be encountered post-op with single level implants. I can tell you that I was cleared to return to work on 6/13/05 and did not do well even on light duty. Before Christmas I began having pain in my low back again, worse than it was prior to the surgery. I worked the 15th and 16th and then we were off for 2 weeks for Christmas. I thought I had just strained a muscle or something and would use the time off to take it easy and recover. During the time of the syptoms got worse. I started having the tingling/numbness in my legs all the way to my toes. And I could tell that something just wasn't right. I returned to work on 1/3/06 and went home within the hour on the "go home list", an opportunity given because my section was overstaffed. I went back to work the following day and the pain grew so intense that I called my primary care phys. during a break to get worked in. I worked the remaining 45mins and in that time the pain reached an excruciating level!! I was barely able to drive myself to the Dr's ofc. He prescribed for me some pain meds and I had the previous day set up an appt. with the surgeon who did the procedure for that upcoming Friday. I have since had a Myelogram and CAT scan, had a couple of more visits with the surgeon with the last one on 2/3/06 where the surgeon told me that the Myelogram and CAT scan showed no impingement on the nerves and it was a "mistery" to him as to the cause of my pain. The only thing he could figure was that the facet joints were the cause. (I had facet joint tears prior to the surgery that were never addressed.) I was referred to a pain mgmt specialist who said that he thought it was the discs causing the pain based on the symptoms given. I was given a Caudal injection on 2/10/06 and have not gotten any relief from it. The most I got was a sore tailbone.
I have been on the internet for the past few days and nights trying to find some answers somewhere. In the recent xrays and films from the Myelogram and CAT scan as well as some images the pain mgmt Dr took while I was under the fluoroscope shows clearly that the discs are not aligned properly. More prominently at L5-S1. I have been advised from a local law grp that there is a nationwide class action suit being sought against Johnson and Johnson, the parent co. of Depuy who manufactures the discs, for specific information that was withheld from surgeons here in the US concerning the Charite implants. Johnson and Johnson purportedly "rushed" the FDA approval in some manner (you know how Capital Hill works) and some of the discs released for use did not have a polymer coating required to prevent slippage. Johnson and Johnson did not disclose to the surgeons that there was less than 1mm margin of error in placeing the endplates on the vertebrae. It was stated that "it would be extremely difficult for the best surgeon on his/her best day to place the discs properly". Those are the top two reasons for the suit. I was not informed as to the particulars of the rest, though I would have no trouble gaining that information.
At any rate, here I am after having close to six months back on my job, having very little problems am now back off from work with no definitive answer as to what is causing my pain. I am no Dr. or Radiologist but I can see perfectly. I have looked at the CAT scan films and in fact did see what appeared to be boney overgrowth on the anterior side of the L5-S1 disc, and the start of the same on the L4-5 disc. I am searching for answers and getting nowhere and I am so glad that I read your post. I have had to become an extremely educated patient and am not happy about it at all. I have to remind you that my experience is mine and is from dual level ADR (Artificial Disc Replacement) with the Charite implants and cannot vouch for or verify the results of those who have had only single level implants.
I can't tell you how valuable your information is to me and would certainly like to discuss with you the source(s) of your information so that I may present it to the appropriate people and be able to substantiate that information beyond mere "hear-say".
Thanks again and I look forward to hearing from you or reading any reply here.

PS. I did get a reply from a spokesperson at [url]www.getadr.com[/url] for the Stenum Hospital in Germany as to their having to perform posterior flexible stabilization ([url]http://www.getadr.com/dynesys.htm[/url]) on patients who had post op problems from the dual level implantation.

[charliecat31]

D.Lynn and Chucktone:
I want to thank you both for all the information you've given! I have 3 level DDD, so I am not a candidate for ADR. I was hopeful that in years to come that the science of this would be perfected and advanced that 3 levels would be possible. I now realize that this is not something I would consider. I realize everyone is different and I'm sure there are positive outcomes from this surgery, but I live in a great deal of pain on a daily basis, I'm not taking the chance of increasing it. I had a two level IDET a few years ago - 60% chance of a positive outcome. I was not in that bracket - I was in the 40% that it made worse. Once around the block of making me worse is all I'm up for.

Again, thank you for the huge amount of information and the amount of time you've both spent putting this all together. Good luck to both of you! I hope you each find some relief to your pain SOON!