[Artificial Disc Replacement / Lumbar] "A Grave Error" with Prodisc Implantation in Germany

[KBear]

I think revision is definitely extremely dangerous and risky and should not be taken lightly. Too many people go into ADR surgery thinking "If this doesn't work, then I'll just have a revision and fusion." They don't realize that the fusion success rate is much lower when it is being done as a revision. This is why it is so important to get multiple opinions from surgeons, ask questions, research and make an informed thought out decision.

Unfortunately, I think as ADR becomes more popular and more insurance companies pay for it, we will see more failures (everybody wants on the latest greatest bandwagon and everybody is not a candidate). As this happens, we will see more advances in revision; but I don't believe it will ever be as successful as if one had just had the fusion in the first place. Fusion has a really bad name and it's not warranted, there are many who have their lives back as a result of fusion.

[Susanna]

I am so thankful for this forum. If it wasn't for this forum, I would have gotten an ADR in my L5/S1 area. It was because of this forum that I did more research and found that a fusion was better for me at that level. I also have a great doctor that does EVERY kind of surgery and is great at all of them. So I had a choice of many things. He also helped me in my decision making. But sometimes like Kbear said, we want the latest, greatest thing and get our minds set on that. I believe that the FDA needs to put more restrictions on Doctors and require them to put warnings on their websites about how revisions can do damage. Just like cigarettes are dangerous. Of course those are bad comparisons. But what I'm saying is that an ADR is not for everyone, and to think that it is a simple surgery that can be undone, is like thinking that a fusion can be undone. That thought process needs to be changed. There should not be that option even available. ADR should be approached like a fusion. I believe that is the reason that so many insurance companies aren't jumping on the band wagon. It needs to be approached much differently. This is our spine we are talking about. Not our knee or shoulder. This is the area that holds the life center to our whole body. People need to take that much more seriously. I also think people need to look at fusions much more seriously too. Fusions have a bad name for themselves because there are doctors out there that aren't good at them and do them and screw them up. And because there are people who have jumped into fusions before doing other surgery's that might have been better for them. The internet is filled with horror stories of fusions gone bad. I feel that there is a reason for that. People just trust the doctor that they go to, and don't get second opinions or investigate the doctor that they are seeing. It's really scary stuff. My own cousin is a fusion mess. His fusions have been done by army doctors. I really don't think they are the best at the surgery's. I hear of so many Solders that have had bad fusions. So it's not just the ADR's that need to be revisited but also the Fusions. People need to take a step back and really look at what they are doing. That is why this page is so good.

All of you are a great source of knowledge, comfort, and encouragement. I wish we could reach more people some how!

[Job13]

Thanks KBear, Susanna

I probably made my question a bit too simplistic but I was simply interested about general public's view on revisions...

Anyways, about the vein barrier - I cant find much info on it. I have heard that it is a protective 'device' (or anti-adhesive membrane) that supposed to make the second abdominal approach for ADR revision safer by protecting one's veins from scarring over the implanted segment.

Does anyone have links to the articles, med. literature, conference papers, statistics, i.e. factual data on the usage of anti-adhesive membrane in ADRs and the real benefit in revision-wise?

I believe, such studies (% of doctors using it vs not using it), if exist, will be enormously appreciated by people who have chosen to go for ADR replacements and who might read such factual statistics about it... perhaps, it might safe someone's life in a future...
Of course the question still remains: Does the protective vein barrier make the ADR revision safe?

Justin, perhaps you have more info on it: is there any data that can be found about doctors' usage of it? I mean, are there any articles, studies, that can point out to some facts that show how many ADR doctors are using a protective vein barrier now.
Are there some statistical data that shows the number of ADR doctors using it vs the number of ADR doctor not using it and what they think about it?

Thanks to everyone

[ajj1001]

I believe, such studies (% of doctors using it vs not using it), if exist, will be enormously appreciated by people who have chosen to go for ADR replacements and who might read such factual statistics about it... perhaps, it might safe someone's life in a future...
Of course the question still remains: Does the protective vein barrier make the ADR revision safe?

I think I have seen a study/article but goodness knows where it was! I'll have a mooch and see if I can find it. Obviously I read everything I can find on revisions.

[Justin]

Justin, perhaps you have more info on it: is their any data that can be found about doctors' usage of it? I mean, are there any articles, studies, that can point out to some facts that show how many ADR doctors are using a protective vein barrier now.
Are there some statistical data that shows the number of ADR doctors using it vs the number of ADR doctor not using it and what they think about it?

I'll have to get back to you on this one...

[KBear]

Hmmmm, no idea on the research, but I have a couple of them in me, you can see them on the x-ray. I asked my surgeon before hand and he said he uses it for all ADR patients.

[Job13]

I have been searching for any statistical data about how many doctors are using a protective vein barrier vs how many are not using it. So far, I couldnt find anything.
I guess the best bet on it: if one decides to go for ADR, they should demand that the 'protective vein barrier' would be used in their surgery. 'Will it help?' - who knows. Someone pointed me to the below post just a few days ago: Liz's Prodisc revision story made me dazed pain wise...note that she DID have a 'protective vein barrier'. Well, after reading her post, it doesnt seem to me that having a barrier between one's veins and ADR is going to make any revision 'safe'...
L4-L5 Prodisc ADR removed and revised to XLIF and PLIF

Also, I have been in a communication with a woman who has 2 Prodiscs (done in USA) several years ago…she is holding off the revision which seems to be inevitable...Most surgeons would rather fuse Prodiscs in-situ (even if discs are crooked) as the revision is too risky. And I am not even talking about the fact that not everyone has extra $50K-$100K (+/-).

I also talked with another woman, with 2 Prodiscs implanted in Straubing some time ago, who is in need of a revision.

Of course I also see "jamie5136" on this forum, who had 3 Prodiscs implanted in Straubing and seems in a need of a revision. Not sure on her status but apparently its not easy to find anyone who would be willing to deal with it either.

Of course Liz's post (above link) speaks for itself...and I see some other people here searching for revision possibilities....

It seems to me that it is still pretty hard to find anyone who would want even to deal with revisions...or who is competent/experienced enough that you can actually trust. Most of surgeons dont want even to talk about taking it out. They want to fuse it in. BUT...
Dr. Andre Van Ooij, from the Netherlands, had reported about revision of 27 patients. Dr. Peloza's review: No patient benefited from the usual posterior instrumented fusion as a salvage situation and all did poorly in terms of their pain. This implies that the implant will need to be removed from an anterior approach, which as a revision will be potentially life threatening in every case because the blood vessels in front of the spine will be difficult to expose."

How safe or how life threatening the ADR revision might be - everyone can decide for themselves.

III. ProSpine web page (Myth Buster Section)
"Myth. ADR revision surgery is life threatening.
Reality. This is true in 40% of the cases, if the surgeon did not sew in a barrier between the spine and the major arteries. However, Dr. Bertagnoli does sew in this barrier."

From my surgery reports and discussions with the surgeon, Dr. B did not put a barrier in me ... and as far as I know, some other Prodisc recipients are not aware of one in them.

The above web page says that 40% of revision surgeries are life threatening. That's pretty scary!!! Its like playing Russian Roulette with a 5 bullet pistol, pulling the trigger twice. But, this also says, that the 40% life-threatening does not apply if you put the barrier in. So, somewhere, there must be some technical study, where they counted the number of revision surgeries that were life threatening with and without a barrier implanted. In the data without a barrier, they are saying 40 out of 100 revision cases were life-threatening. In the data with a barrier, this statement implies none were life threatening. If that is not true, then they are misleading, by not telling the rate of 'life threatening with a barrier in'. It reminds me of the Synthes page, that says you can avoid the Hip-Bone surgery for a fusion, if you have a Prodisc. It implies that everyone has iliac-crest bone removal for a fusion - which probably scares a lot of people into not even looking at fusion (clever). Of course, these days, you have allograft and/or rh-BMP2 (which has a near 100% fusion rate).

So, correct me if my English is failing me, but does it imply that ADR revision is not life threatening, if the barrier is used?

It would be very useful to see the factual statistical data of what % of surgeons are using the barrier. So far, we havent seen any published statistical research/analyzes/literature on it anywhere. If anyone can point me out to it, it would be very useful. You will also be doing a service to 100,000's of people, who may read those comments, and take them for gospel - without an iota of proof.

Medical Community about ADR revisions:

AAOS. Sep. 2007. By Dennis P. McGowan, MSc, MD, and Vijay K. Goel, PhD
“Removal of an infected or dislocated TDR is a life-threatening procedure, and several deaths have already occurred in the United States. Any reoperation places the great vessels at risk.”

eSpine. Truth in Spine Surgery. Robert Pashman MD “…Current lumber artificial disc replacement at L5-S1 is rarely indicated for the following reasons. There is no significant functional motion at L5-S1... Failure of lumbar disc herniation and need for revision can be life threatening…. Lumber artificial disc replacement will be subjected to a much steeper learning curve, the short and long-term outcomes may be marginal, and the revision for failed implants will be difficult and at times life-threatening”
http://www.espine.com/artificial-disc.htm

"Dr. Kurtz, who has consulted for Medtronic and other medical-device makers, says many younger patients who are getting artificial disks may need a life-threatening operation to remove a worn disk in 10 years or less." http://www.ethicalspinesurgeon.com/articles/WSJRosen.htm

Dr Van Ooij : "revision is dangerous and sometimes impossible."

Jens FRANÇOIS et al 'Early removal of a Maverick disc prosthesis: surgical findings and morphological changes'
“Revision surgery with explantation of a lumbar TDR carries great risk to the major anterior vessels and is a potentially life-threatening procedure…"

espine.com, May 5, 2010 "If there is any type of complication from the lumbar disc, the revision surgery is always life threatening."

John H. Peloza, M.D Texas. "There are multiple European studies that show success rates for the JNJ DePuy Charite between 63% and 79%. However, revisions were necessary in close to 25% of patients in one study due to continued pain. Dr. Andre Van Ooij, from the Netherlands, has revised 50 patients (10% of the patients at one study site) at an average of 4 1/2 years after surgery. The patients had incapacitating low back and/or leg pain. The diagnoses were subsidence, polyethylene failure or dislocation, metal loosening, degeneration of the facet joints at the same level, degeneration of adjacent level and bone formation around the implant. No patient benefited from the usual posterior instrumented fusion as a salvage situation and all did poorly in terms of their pain. This implies that the implant will need to be removed from an anterior approach, which as a revision will be potentially life threatening in every case because the blood vessels in front of the spine will be difficult to expose."

I.Lieberman,The Cleveland Clinic Foundation, OH
“The longevity of artificial discs is yet known… Revision disc replacement surgery will be a life-threatening operation.”

Nader M. Hebela, Paul C. McAfee et.al. ‘Revision of Lumbar Total Disc Arthroplasty and Other Anterior Instrumentation, March 2008’ “ ...careful preoperative and intraoperative planning may minimize the life-threatening risks posed by reoperation”.
http://www.semspinesurg.com/article/S1040-7383%2807%2900131-1/abstract#

Santos EG et al. ‘Disc arthroplasty: lessons learned from total joint arthroplasty’ Spine J 2004;4:182S-189S: "…Revision surgery for a failed disc arthroplasty is life threatening. Dealing with the scarring around the great vessels is the main challenge...”

Jeon, Sang Hyeop MD et al. ‘Anterior Revision of a Dislocated ProDisc Prosthesis at the L4-5 Level’:
The article highlights “the difficulties and risks associated with the use of a repeat anterior approach for the revision of a ProDisc that has failed at the L4-5 level.”

TheBurton Report: “..Removal of such dislocated artificial discs is life threatening…”
http://www.burtonreport.com/infspine/SurgArtificialDiscs.htm

Kevin Daly, E.Raymond S.Ross et.al 'Vascular complications of prosthetic inter-vertebral discs' 2006
“…Five consecutive cases of prosthetic inter-vertebral disc displacement with severe vascular complications on revisional surgery are described. The objective of this case report is to warn spinal surgeons that major vascular complications are likely with anterior displacement of inter-vertebral discs…”

Wyoming Spine & Neurosurgery: "Although some patients who have undergone spinal fusion surgeries need revision surgeries, they are generally less problematic than those after artificial disc surgery…..and the [revision] surgery can be life-threatening due to the potential for blood loss and other complications"
http://www.wyospine.com/artificialdiscs.asp

Also, the article 'Complications and strategies for revision surgery in total disc replacement'
R. Bertagnoli, Zigler J, Karg A, Voigt S. Orthop Clin North Am. 2005 Jul;36(3):389-95 advises that for safer revisions a protective vein barrier should be used: "..Another strategy to make vascular dissection easier and safer is to use an anti-adhesive membrane (eg, Gore-Tex, W. L. Gore & Associates, Inc., Newark, Delaware).."
Note that this article is from 2005 July.
My surgery was done in the end of 2006. I had no protective barrier, as far as my knowledge goes. I know another person, 2 level, the same facility. No protective barrier either....

[KBear]

It's interesting that their are doctors saying don't do an ADR on L5/S1, yet so many still do it. I personally completely agree and would fuse that level in a heartbeat if I had an issue with it. IMHO, it is just too risky to put an ADR there. On the longevity of the discs, that was the reason my insurance denied me, saying there was no long term data and I was young (28 at the time of trying to get benefits). I thought about this too, but my reasoning is that by the time this goes bad, if it does, then there will be newer technology to deal with it. With a fusion, I probably would have needed adjacent levels done down the road, so it was a gamble either way. It's definitely a scary thought to think about revision risks. Thanks for the information!

[Job13]

... On the longevity of the discs, that was the reason my insurance denied me, saying there was no long term data and I was young (28 at the time of trying to get benefits)... With a fusion, I probably would have needed adjacent levels done down the road, so it was a gamble either way...

You definitely touched a very debated and sensitive part of ADR upriseside: adjacent segment degeneration - ASD.

Below, I collected quite a few comments from studies and surgeons, which throws a lot of doubt on this claim. When you read it, or anything, always ask yourself if the author is financially biased. Its no secret now that most of the surgeons in the Prodisc FDA trials were secretly invested. In my opinion, all that data is suspect. Think also, what is the real reason for ASD? How much of it would occur regardless of ADR, Fusion or natural degeneration? What is the rate in young/old, heavy and thin people, smokers/non-smokers? Ask: If a person is aware of ASD, and is careful not to put stresses on adjacent segments, will it still occur? What about the hyperdynamics of the ProdiscL for example? It is shown repeatedly that the ProdiscL allows much greater rotation and angular bending than a natural disc. Some surgeons suggest this hyperdynamics can put unnatural stresses on adjacent segments.

There are many many unanswered questions. The major problem is: to have access for a general public to studies, publications, trial data and design specs of those ADR devices. This information is pretty much available only to the "elite", i.e surgeons who use them. We patients, who pay not only with our money but also our blood, tears and lives at times, do not have any rights in this issue. How outrageous.

Hopefully technology will find an improvement somewhere between solid fusions and hyperdynamic ball-in-joint devices. I took a brief look at M6, for example, and it does look promising and impressive. There is no sheer sliding, no 360 rotation, there is no plastic ball that in motion looks like an awkward toy (someone on this forum, I think, mentioned it already)... I would imagine that one might benefit from such a device more than from a "1st/2nd generation" of ADRs as it does look more like a normal disc...

Anyways, below are quite a few comments from studies and surgeons about adjacent level degeneration.

ProSpine web page: “The Artificial Disc Replacement(ADR) was developed to overcome the shortcomings of older fusion technology, which is associated with reduced flexibility, poor success rates, high re-operation rates and adjacent segment syndrome.”
ProSpine web page: “Also, any degenerative process will likely continue, therefore problems in other areas of the spine may appear at a later time.”

The above sounds to me like a contradiction to each other...even though written by the same source confusing.

MEDICAL COMMUNITY FINDINGS

PubMed, Denoziere G, Ku DN, Georgia Institute of Technology, Atlanta: A three-dimensional model of a two-level ligamentous lumbar segment was created and simulated through static analyses with the finite-element method (FEM) software ABAQUS. The model was validated by comparing mobility, pressure on the facets, force in the ligaments, maximum stresses, disc bulge, and endplate deflection with measured data given in the literature. The FEM analysis predicted that the mobility of the model after arthrodesis on the upper level was reduced in all rotational degrees of freedom by an average of approximately 44%, relative to healthy normal discs. Conversely, the mobility of the model after TDR on the upper level was increased in all rotational degrees of freedom by an average of approximately 52% [relative to healthy normal discs]. The level implanted with the artificial disc showed excessive ligament tensions (greater than 500 N), high facet pressures (greater than 3 MPa), and a high risk of instability. The mobility and the stresses in the level adjacent to the arthroplasty were also increased. In conclusion,the model for an implanted movable artificial disc illustrated complications common to spinal arthroplasty and showed greater risk of instability and further degeneration than predicted for the fused model. This modeling technique provides an accurate means for assessing potential biomechanical risks and can be used to improve the design of future artificial intervertebral discs. Biomechanical comparison between fusion of two ver... [J Biomech. 2006] - PubMed result

"Fans of the device say that it preserves motion and, in turn, reduces wear on nearby parts of the spine. But McAfee confessed that he"cannot find a single study on any motion-preserving device" that proves this theory." http://www.ethicalspinesurgeon.com/a...etBacklash.htm

Chan Shik Shim, Lee Sang-Ho et al. Department of Neurosurgery, Seoul ‘CHARITÉ vs Prodisc: A comparative study of a minimum 3-year follow-up’ “Degradation of disc degeneration at the adjacent level above the index level was seen in 19.4% in the CHARITE and 28.6% in the ProDisc. Conclusions. While clinical outcomes of both CHARITE and ProDisc groups were fairly good, the facet joint of the index level and the disc at the adjacent level showed an aggravation of the degenerative process in a significant number of patients, regardless of the device used, raising concerns of possible late consequences of total disc replacement, especially regarding facet arthrosis and adjacent segment disease CHARITÉ versus prodisc : A comparative study of a minimum 3-year follow-up

Columbusregional.com
Does artificial disc replacement prevent the development of adjacent segment disease? “The long-term potential benefit of maintaining spinal motion with artificial disc replacement is believed to be less degeneration and problems with the surrounding discs. However, this is only a theoretical benefit, as no good long-term medical studies have been done (these procedures and devices are too newly available). Only after a longer follow-up time and additional medical studies will we know if this believed benefit is real.”
Which is better, artificial disc replacement or spinal fusion? “The potential benefits of artificial disc replacement, including retained mobility and limiting stress on the adjacent discs, must be weighed against the potential for wearing out of the implant over time and the unknown future of the mobile facet joints and other possibilities.”http://www.columbusregional.com/medi...%20surgery.pdf

Robert Pashman MD, eSpine. Truth in Spine Surgery.
“…Advocates of the lumbar artificial disc argue that spinal fusion has two significant drawbacks. The first argument is that stabilization of the spine inherently reduces the functional capacity of the individual because of decreased spinal motion. Secondly, a transfer of forces to the adjacent segments of a spinal fusion accelerates therefore creating the potential for degeneration and the possibility of future reconstructive surgery. According to their theory, motion preservation technologies for spinal disorders would obviate these two negative consequences of spinal fusion…
…Current literature suggests that lumber artificial disc replacement when compared to spinal fusion does little to improve overall functional spine motion. Moreover, the current studies indicate when lumber artificial disc replacement is observed for a long period of time, the failure rate is high, and there appears to be little benefit to protecting the adjacent segment as with standard fusion.This leads to a situation where the short-term benefit of the theoretical advantages of lumber artificial disc replacement for motion preservation may lead to significant long-term problems…”

"Adjacent segment degeneration has been shown to be equal between disc replacement and fusion at L5-S1. Lumber artificial disc replacement will be subjected to a much steeper learning curve, the short and long-term outcomes may be marginal, and the revision for failed implants will be difficult and at times life-threatening” Lumbar Artificial Disc

European Spine Journal. M. de Kleuver, F. Oner and W. Jacobs. "Total disc replacement for chronic low back pain: background and a systematic review of the literature" "The search yielded no controlled trials and nine case series with a total of 564 arthroplasties in 411 patients. The devices used were SB Charité in eight and Acroflex in one study. The percentage results classified as "good" or "excellent" in the studies varied from 50 to 81%. Complications were observed in 3-50% of the patients... Despite the fact that these devices have been implanted for almost 15 years, on the basis of this literature survey there are currently insufficient data to assess the performance of total disc replacement adequately. There is no evidence that disc replacement reliably, reproducibly, and over longer periods of time fulfills the three primary aims of clinical efficacy, continued motion, and few adjacent segment degenerative problems. Total disc replacement seems to be associated with a high rate of re-operations, and the potential problems that may occur with longer follow-up have not been addressed. Therefore, total disc replacements should be considered experimental procedures and should only be used in strict clinical trials."SpringerLink - European Spine Journal, Volume 12, Number 2

[Justin]

ProSpine web page: “The Artificial Disc Replacement(ADR) was developed to overcome the shortcomings of older fusion technology, which is associated with reduced flexibility, poor success rates, high re-operation rates and adjacent segment syndrome.”
ProSpine web page: “Also, any degenerative process will likely continue, therefore problems in other areas of the spine may appear at a later time.”

The above sounds to me like a contradiction to each other...even though written by the same source confusing.

The statements above are true statements. I'm not sure why they are confusing.

Artificial Disc Replacement surgery was created to preserve motion of the spine, as a significant number of spinal fusions* require additional surgery due to undue stress at adjacent levels. The theory of motion preservation is based on spine interventions of the past--in theory: preserving motion = reducing adjacent segment syndrome. Of course, like anything in medicine, this theory is still being investigated and interventions are continually being refined. (*Note: this is not to say that fusion is a "bad" procedure.)

Any degenerative process within the human body will proceed uninterrupted. We can "slow" some of these processes and treat associated symptoms, but the underlying pathophysiology will ultimately prevail.