No Surgery... Yet

[Boxer78]

That guy gets a million dollar salary every year from prodisc!!!! Of course he wants to use a prodisc lol

[WNB175]

I think you are doing great not rushing into a decision. Keep researching until you are as sure as you are gonna get. I don't think that you are just torturing yourself. I think you are doing your due diligence. This is a one time decision. Once you figure out what your research indicates is the best course of action, only then does it become a the leap of faith. Best......Wendy

[ian]

Drew, toss this email in the trash. I'm not saying they aren't right, I'm just saying there is too much conflict of interest with this doctor to take what they say as the final word on the subject.

If the ProDisc were the best option available the majority of doctors (outside the US) would be using it. And the fact that he's paid by the company says enough for me.

Step away from the computer, walk to the fridge, grab a beer, preferably a Guiness, sit down on the couch with your lovely wife, and start planning your trip to Spain.

Originally Posted by drewrad

Again, thanks for the responses. I appreciate them all. I am close to booking this thing, but then things like this trickle in and get me backtracking a bit. I'll just post it in its entirety.

From Dr. Bergnatoli. Actually, his go-between, Andrea:

Dear Mr. Drewrad

Prof. Dr. Bertagnoli has used multiple ADR types.

But he firmly recommends Pro Disc L in your case. All reasons that speak for this model in his judgment are esp. relevant in your case (“easy single level cases” probably work perfect with any model).

· He has co-developed the model and its tooling (not the least of importance in a manual skill like surgery).
· On top, the number of past implantations world-wide and long-term experience speak for this model. Knowing a device long and long-term is an advantage. ·
· He also does not favor unconstrained disc replacements, which have been under discussion a lot recently. Esp. not for multilevel: Having a “free core” means no guidance of movement by the ADR, which is intended. And which is close to a physiological discs, which does not have a fixed centre of rotation either. But: degenerated discs are not virgin discs. They as a rule lack the necessary external guiding structures. A natural disc IS guided in it`s movement by ligaments, annulus and facets. It`s not “wobbling freely”. Exactly those structures are involved in the degeneration process, and either are slack, or calcified and tense. In ADR implantation with a good mobilization and regain of disc height e.g. the dorsal and lateral annulus has frequently to be resected.


One should not compromise on nerve liberation to keep them unresected. And hence the additional guidance of a semiconstrained disc (like Pro Disc L or Acitve L etc.), are highly appreciated. ·


These factors are the more relevant in multi-level, where positioning can positively influence spinal alignement in semi-constrained ADRs. ·



These factors in Dr. Bertagnoli`s judgment far outweigh the lack of a “cushioning function” in ball-and-socket concepts. Cushioning in the spine is predominantly provided by the global s-shape.


I hope this was of help. Just awaiting your further data.

Dr. med. Andrea Fenk-Mayer,
Fachärztin für Orthopädie und Unfallchirurgie
Schwerpunkt Wirbelsäulenbehandlung

Pro Spine
Dr. med. univ. Rudolf Bertagnoli

94327 Bogen
Deutschland


This was preceded by this communique:

Dear Mr. Drewrad,

Permit to introduce myself: I am Dr. Andrea Fenk-Mayer, spinal surgeon and consultant with Prof. Dr. Bertagnoli.


I am responsible for preparing your medical evaluation as an international patient with him.

And due to your kind cooperation and Mr. Vicknair`s comprehensive profiling Prof. Dr. Bertagnoli could already view your medical data. I am here to pass on his surgical recommendation.

Your imaging shows moderate degeneration more or less in your whole lumbar spine to the same extent. Positively without major secondary deformity. There is no signs of rheumatoid/systemic inflammatory disease out there (still I may ask you whether CRP and HLA B27 have ever been tested due to your history and typical age group).

Surgery is of course possible, but would have to include l2-s1. Either you go for a (maximum) fusion, which fully eliminates mobile function, and disc and facet triggers. But the dorsal and ventral tissue damage can produce pain by itself, so can muscles and ligaments.


Or you go for an ADR L2-S1. Still major surgery, still certainly not reducing your pain sources to zero (a spine is more than discs).


The expectation can be pain reduction and less restrictions in an uneventful case.

This is important, because your report doesn`t give maximum non-surgical therapy so far. Degeneration is a slow process, so you do have all the time to add these:
e.g. adequate pain meds (daily basis, slow release opioids)
e.g. facet and/or peridural injections with local anesthetic and corticoid. You sure can have this locally.


e.g. light bracing for “bad spells” or major activities.

Multi-level ADR is possible and successful in very experienced hands. The more it is important to keep in mind, that it is not out there to avoid a Naproxen once in a while, if this is all that`s needed. In such a constellation the gain always would be smaller than the risk.


We are aware, that a written history can mis-judge your suffering. So I suggest you comment and//or parallelly have a non-surgical trial see above. Pro-spine`s mission is always to find the optimum treatment for the individual problem of you as our spine patient.

We thank you for your confidence into our work and are looking out for your reply.

Yours respectfully

Dr. Andrea Fenk-Mayer

And the one prior to that:

Dear Mr. Drewrad,

let me explain:


CRP and HLA B27 are screening labs to detect or exclude a group of systemic inflammatory disease (systemic spondylarthritis. The most frequent of these is Morbus Bechterew, but there are other similar). Your pain pattern and age gives hints for these. And if you have it, specific medication could change the prognosis and the pain tremendously.

So – with all humbleness because we did not see you clinically – there should be no surgery without testing at least these two lab values. Pro-spine`s mission is always to find the optimum treatment for the individual problem of you as our spine patient. And a surgeon should know and consider more than his/her tools.

For surgical technics:
no, Prof. Dr. Bertagnoli did not advice you to wait. Sorry, if we didn`t make our point.
He wanted to point out, that yours is no emergency surgery, and that decisions should not be made premature. And non-surgical treatment is ONE option, among others. (just imagine you DO have M. Bechterew, this would change everything, wouldn`t it?).


Your added info has helped a lot to come closer to a final recommendation. If it`s surgery, Prof. Dr. Bertagnoli recommends including l2-s1 (and not to confine to l4-s1). Let me lay out why: Very apparently your L23 and L34 are affected by disc degeneration as well, and not only to a “initial” degree. They do contribute to your pain. (If you wish to confirm this, one/we can do a discography. But in a very evident case Prof. Dr. Bertagnoli would not have considered this invasive test necessary. It would certainly confirm what we already know). The question is: are they bad enough to justify surgery? Prof. Dr. Bertagnoli thinks yes. Of course one must take into account, what surgery we are talking about, when answering this question. In his series 3 or 4 level ADR is not “far out” or impossible, not even rare. OR time would be around 4 h, which is what a fusion would take as well. And due to the vessel anatomy it is at least very demanding to re-enter l34 once an anterior approach to l45 was made in the past, even in very experienced hands. So for your long term future it would limit options considerably, if you confine to a l4-s1 ADR now.



These factors are the basis for Prof. Dr. Bertagnoli`s choice. Decision-making in surgery is always balancing facts, options, and expectations. With the same set of facts, there can be several solutions, even several good solutions. Other than in e.g. mechanical engineering, a choice must be made at one point by the surgeon and the patient. It is not possible to “treat the same patient with different procedures and compare the result afterwards”. So it was and is my task to explain the background of Prof. Dr. Bertagnoli`s recommendation. I hope I could.

At this time I will just wait for your answer and the lab.

Best regards

Dr. med. Andrea Fenk-Mayer,

So, it really couldn't get more strange. Is there really such a thing in re to multi-segmental lumbar patients like me of having instability issues if I go all-in on M6s?

And then, the CRP and HLA test, which I am doing. I will get them done along with the metal allergy this week.

Still going long with Dr. Pablo Clavel, but then when I get a curve ball I like to lob it at you regulars who know the backstory, esp in re to Dr. Bergnatoli. Would love your input yet again.

[Boxer78]

Couldn't agree w Ian more!!

[jss]

Good point. If the ProDisc were the cat's meow, then surgeons that weren't financially tied to it would be using it too.

[phillyjoe]

Do we know if Dr Biersedt has any financial ties to the M6 (even if not as direct as Dr B's might be to pro disc)?

[Boxer78]

Nope none. He also uses many different discs but I've never heard of him using a prodisc?

[drewrad]

So... what's the backstory then on how the Prodisc got frontloaded into the FDA's goodie wagon here in the US? Was it that it was just first in line? Who funded the FDA trial originally? Just curious why the US put its rubber stamp on it while putting its boot on the neck of most other devices. Is it because of the money to initiate a trial, that the Prodisc slicked those palms early and often?

Also, is there a similar story with the Activ L and Dr. Zeegers when compared to the Prodisc and Dr. Bergnatoli?

These are both the grandfathers of ADR, and each of them stands behind first and second gen ADR(non-polymer).

Dr. Pablo Clavel and Bierstedt are considerably younger than the two.

Is it kind of like the old grandpa shaking his fist in the street at the kids driving by in their rice mobile with the bass pumping?

I know I never used a snowboard at Squaw Valley. I always used skis and still do to this day, at 45 years old. Two skis. One on each foot. Screw the snowboard generation!

Is that kind of what I'm dealing with here in a roundabout comparison?

Or is it just strictly in Dr. Bergnatoli who, as an engineer and device maker, also holds the patents to the Prodisc and likes that royalty revenue stream coming in and wants to defend it at all costs? Licensing a product is always where the moneys at.

[drewrad]

Trying to make an informed decision and wanting to just get well is hard when you're also dealing with 1) Politics 2) Bureaucracies, including a corrupt FDA 3) Product device makers and drug companies 4) Money 6) People trying to moat in their own fiefdoms by feathering their nests.

I, like most of you, want the pain gone. That is all. We don't ask for much.

I'm thankful for the ADR, even if it does seem like it should have been designed 50 years ago and flooded the markets by now and made mainstream.

Oh, I forgot to mention. Lawyers and HMOs. Kaiser has made a calculated decision to not do ADRs anymore, end stop. I guess I'm almost Canadian at that point and SOOL, even though I don't play hockey(sorry Stonewall).

Dr. Bergnatoli has many folks who walk out of his offices feeling great, being able to sit without pain, walk without pain. The device works. I talked to a 4 level ADR Canadian a week and a half ago. He had the 4 level implantation done a year ago. He's kicking ace.

So... there's that.

But there's plenty of M6ers kicking that same kind of ace, if not more ace.

But, the ace you really want to kick is your own 25 to 30 years from now when you finally found out that the device you chose to go with, didn't have enough use to base a solid judgment on.

Just wish this stuff was more clean. Its not. I think most everyone here knows that.

What has me spooked is when Dr. Bergnatoli stresses that polymers are not good for multilevel patients due to spinal instability and that fixed socket motion are better when dealing with multiple levels. I think I'll raise that one with Dr. Clavel this Thursday.

[Stonewall_Boris]

@phillyjoe,

I can't say whether or not Dr. Bierstedt has a monetary stake in the M6. At this time it seems to be his prefered or go to disc. The M6 seems to be the preferred disc of Dr. Clavel, Dr. Ritter-Lang and Dr. Laurison (of the US) when he chooses to go overseas to do ADR with it. Are you suggesting they all have a financial stake in the M6?