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

[Hooch]

Just wanted to say I sincerely admire the courage of you and your husband Anastasia, and I wish you all the best in the future. Your website is very necessary in informing prospective patients of the potential dangers involved in disc replacement and medical tourism. There seem to be plenty of people around who do not realise that revision operations of disc replacements are dangerous and do not generally have fantastic outcomes. Particularly concerns over facet arthrosis do not seem to be well understood by many patients, and the medical literature freely indicates that indications regarding facet arthrosis are still 'developing'.

Thankyou for sharing your story.

Chris.

[Katie]

Anastasia, you are a very strong and courageous woman. I understand a little bit of the struggle that you and your husband have been through. I thought my fight was tough...but it doesn't come close to what you have been through. I am so sorry.

Please keep up your fight and let others know about the dangers of spine surgery. Far too many people who are overwhelmed with pain don't feel that they have the strength or ability to do the research. With the deceitful actions on other forums, their job is that much more impossible. Those of us that have gone before owe it to new patients to share the best way forward.

I am shocked but not really surprised at your experiences with trying to get your story out there. It would make me even more determined to succeed. If you ever need some help, feel free to ask.

I'm just waiting to make sure that my surgery is as successful as I believe it is, then plan on going to the media here in Canada to let others know they have options that for some reason seem to be hidden to the general population. I suspect that I will hit a few roadblocks like you did along the way.

[Job13]

Chris, Katie- thanks so much for kind words. Posts like yours make me actually stronger in a realization that someone reads and appreciates the effort!
Katie,I read your post at 2 months post op and it sounds that you are doing awesome. I am sure that your surgery is a successful one-no any other words for it!

Chris, I especially appreciate your observation about facets and bringing it out on the open for people to chew on. As a matter of fact, your post made me think about facet joint indications again and I decided to post a 'small debate' about it. I pulled it out of Matt's research and I hope it will be a great value for people. Please feel free to add whatever studies you found that contradict the numerous reports that facet arthrosis is an absolute contraindications. Please note, when possible, if the surgeon who is proposing that there is flexibility, is also financially invested in the device.

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I read the below "fact/myths" in one's web page and it made me uneasy...to the point that I decided to post some facts about it.
We, patients, tend to go to doctors web pages, read fascinating testimonials (never seen a single bad one on any doctor’s web page), then read statements and promises from doctors in the same page, and many of us would make decisions based on that read data. While in an “old world of medicine and doctors” that would be THE way to go (i.e. trust your doctor), the “new world of medicine” seems to be operating quiet differently nowadays. When I talked with several doctors, their answers and suggestions on what is better for me was highly correlative to their agenda, the fact of what device/technology they were invested in or who their “idol” was. Not all them can be right. Maybe even none of them. It seems that to make the best decision, the patient have to be a doctor him/herself! But we, the desperate patients, without dozens of years of training, are totally at their mercy, and have to rely on our wits to determine who is money driven, who is buddy-driven, and who is a real doctor.

Below is my observations that intend to create awareness and motivate people to do their own research and think twice if you will. I dont know if the below will create debate, but I certainly hope newbies will think about it after reading doctors' web pages (any doctor I mean).

I. ProSpine web page ('Myth Buster' section):
Myth. Facet arthrosis or facet hypertrophy is a contraindication for ADR surgery.
Reality. Only severe and untreated facet arthrosis or facet hypertrophy is a contraindication for ADR surgery..."

That's great news for all those people with facet arthrosis! You can still get a Prodisc implanted, if you go to Straubing!

Except ...
The following list is a fraction of various authoritative sources specifying the inclusion/exclusion criteria for ADR with the Synthes Spine Inc. PRODISC®. In particular, every reference states specifically that facet joint disease (degeneration, arthrosis, arthropathy, osteophytes) is a contraindication. The reasoning is patently clear: If the facet joints are arthritic (and a pain generator), then expanding the disc space and increasing mobility will significantly exacerbate the pain condition, and furthermore accelerate the facet degeneration. Furthermore, the Synthes labeling states that the remaining disc height should be 5mm or more. This prevents over-distraction damage to the nerve root, and also provides a margin of safety that there is not already significant facet Arthrosis due to a collapsed level.

1. Synthes Spine: ”Radiographic confirmation of facet joint disease or degeneration.” (note Dr.B is the main instructor for Synthes)
2. Rudolf Bertagnoli: ”Care should be used to assess patients for the presence of facet arthropathy,”
3. Rudolf Bertagnoli2006, ”Patients should be screened carefully for evidence of facet joint impingement/degeneration”
4. Rudolf Bertagnoli 2005, severe nondiscal central or severe lateral spinal canal stenosis associated with hypertrophic posterior facet joints,
5. Synthes Spine Surgical Technique: “Radiological confirmation of severe facet joint disease or degeneration”
6. FDA: ”Radiographic confirmation of facet joint disease or degeneration.”
7. Dr. Shedid: Patients with any of the following conditions should not undergo placement of this disc: infection; …; facet joint disease;
8. Spine-Health.com ”clinically significant degenerative facet disease”
9. Spine Universe: Prodisc Clinical Trials: Radiographic confirmation of facet joint disease or degeneration.
10. Dr. Kulkarni et.al: ”Facet arthropathy has been appreciated as a major contraindication”
11. Dr. Delamarter et.al.: ”severe facet degeneration were excluded from the study”
12. Dr.Zigler et.al: ”The authors identify factors leading to clinical failure, including posterior facet arthritis”
13. Dr.Tropiano et.al: ”Exclusion criteria included facet Arthrosis”
14. David Wong et.al: #1: Facet Joint Athritis
15. Dr. David Thierry: ”emphasized the importance of normal facet architecture.”
16. Spine-Health.com: Facet Technologies, Facet arthritis is currently a contraindication for any type of disc replacement.
17. Dr. Matthew Scott-Young: ”This is a failure of indication, in which the facet arthropathy is overlooked by the surgeon.”
18. Dave Levitan: OrthoSuperSite, Interview Dr. Bertagnoli: “We know that 98% of complications are surgeon-related,” he said. “What were the reasons for these problems? No. 1 was the wrong indication. As pointed out before, indication and proper patient selection is really crucial.”
19. Le Huec J.C.:”This improvement is significantly [negatively] correlated with facet arthrosis and muscle fatty degeneration.”
20. M.E. Jansen: “pathology of the posterior elements. In such cases, fusion is still the first choice for treatment,”
21. Balkan Cakir et al: “The inclusion criteria … absence of facet joint arthrosis confirmed by CT, no pain relief after facet joint infiltration,”
22. Christoph Siepe, Michael Mayer et al: “strict policy to before surgery rule out symptomatic facet joint involvement”
23. John Regan: “Posterior facets should be carefully evaluated on physical exam and on the imaging studies such as MRI and CT scans. If posterior facet disease is suspected, diagnostic injection may be used to rule out this condition as the contributing source of pain as these patients do not benefit from total disc replacement.”
24. Hochschuler, McAfee: “If .. factors (such as significant degenerative changes in the facet joint) are present, then the patient may have to undergo a revision surgery after the initial surgery
25. Zucherman et. al.: “radiographically documented evidence of facet joint disease”
26. Weishaupt ’99:. “fortgeschrittene Facettendegenerationen II.-III. Grades“

[Job13]

Well, I posted "Myth Buster" in Education section here as I think its more appropriate actually there than here but it was redirected for some reason to this thread???.
This thread should be perhaps just for the 'surgical outcome'...

Justin, shouldnt it be in Education section? I will be adding links to the actual sources and articles. It just doesnt seem that above 'Myth Buster' post belong to this thread.

[Justin]

Well, I posted "Myth Buster" in Education section here as I think its more appropriate actually there than here but it was redirected for some reason to this thread???.
This thread should be perhaps just for the 'surgical outcome'...

Justin, shouldnt it be in Education section? I will be adding links to the actual sources and articles. It just doesnt seem that above 'Myth Buster' post belong to this thread.

Your post above ties in nicely with your Surgical Outcome thread. Articles in the Education Section are typically peer-reviewed publications from Journals.

[Job13]

Oo-okey. I dont mind (I had to add a bit in the above to make it more sense as why I am posting it now).

[Greg]

I know you might have stated this before (so sorry if I am being redundant) but I cant remember at this moment...but were your issues with your facet joints brought up and talked about by your surgeon before you had your ADR? Did he do any type of tests before surgery that showed the facet issues throwing up the red flag for ADR??? Maybe a test specifically looking at the facet joints or one that happened to show issues with the facet joints?

[Gilbert P]

Hi Greg

I have mild and moderate facet issues at three levels and DR. B would do a Four level ADE replacement on me.

i think he can see an American with pre payment and will do it for the money which I would have no recourse if it goes bad.

Sorry

Gil

[KBear]

Hi Greg

I have mild and moderate facet issues at three levels and DR. B would do a Four level ADE replacement on me.

i think he can see an American with pre payment and will do it for the money which I would have no recourse if it goes bad.

Sorry

Gil

My MRI said moderate to severe facet degeneration, yet every American doctor I saw said it was not that bad and I was a perfect candidate for ADR. I think it's all relative, because seriously who doesn't have facet degeneration that has severe DDD? I even asked the surgeon following me for the trial if my facets were too bad for surgery and he said no. I saw Dr. Zigler, Dr. Hisey, Dr. Garcia (co inventor of Active L) and Dr. Blumenthal and all said my facets were not too bad for ADR surgery. Plus I had to qualify for a trial and they have strict criteria. This is why I think it's so important to get multiple opinions, because one or two surgeons may lie to you for money; but the more opinions, the easier to get the truth. I feel great now, so obviously the surgeons were right and my facets were not too bad.

[Gilbert P]

KBear

I think it depends on the device (ADR) installed and how much increase motion they create.
Your disc can replicate the natural disc while the pro disc contains more motion by 15% +- and wears the facet joint much faster

In most clinical trials facet degeneration is a contraindication for ADR surgery??

It is a crap shoot and most do very well a small percent do not.

Gil