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

[Job13]

Hello everyone. Those who remember me from other forums, no introduction is necessary.
For those who never heard of my story, in short:

In Oct 2006, I had Prodisc implanted at L4/5 by Dr. B. in Straubing. The rest of the spine was fine. Afterwards, I found myself bedridden in severe pain with no help for a year (even though I lived only one hour drive from ProSpine's office in Germany). Dr.B, never answered any of the emails himself. Everything was done through his assistant Dr. F.M.

After a year of research; After contacting many ADR specialist surgeons, and hearing repeatedly that I was NOT a candidate for the ADR surgery by any measures; After getting official reports from some of these surgeons from several countries including Germany, basically condemning my ADR surgery: My husband flew me to LA (on a lie-flat seat, non-stop flight) for a revision. We had to spend 130K to remove the Prodisc. In Germany, it would have been covered by our insurance - except Prospine refused to admit a problem, thus effectively blocking our ability to get help. The other German surgeons who said the implantation was contraindicated, gave various reasons why they themselves could not do the revision ( some admitted that they did not know how, some did not want to take the risk when it wasnt their mess, a few experts declined, stating that they could not treat US citizens). So, in the end, we had only the choice of London or Los Angeles.

The link for my original post "One year Hell ADR in Germany (L4/5). Revision to fusion" is here (I have the post on many forums but not on this forum because it didnt exist yet):
Prodisc Hell in Germany

I was silent on the forums for a while....The revision was hellish. It left me with too many complication that I have not written online about yet. I had sympathetic damage as a result of the psoas muscle access. It took months of HBO treatments to get the sympathetic nerves under the control. I was lucky...or I would say that God answered my prayers.

IMHO-if you are in more pain after the surgery in Straubing, search for answers elsewhere. I have never seen anywhere, on any board, that anyone has ever heard of the Straubing surgeon admitting to error. While FDA trials, with top U.S. surgeons, had a 53.4% success rate (table 15), Dr. B's peers in Germany note he reports 97% success rates, but they state "prospective randomized control trials could not confirm such high success rates". Another article cites Dr. B's 98.2% success rates - and mocks how Dr. B purportedly uses a perfect set of patients to determine success criteria ( a high-school student knows you need both pass and fail conditions to find pass & fail conditions):
"...Bertagnoli and Kumar have described 98.2% good and excellent results with only 1 complication in 108 patients with different indications for TDR. However, the authors did not provide scientific evidence for their conclusion on so-called prime, good, borderline or poor indications for TDR, nor did they describe a statistical basis on how poor indications were evaluated when almost all patients treated showed excellent results. Tropiano et al reported 100% patient satisfaction rate (87% entirely satisfied, 13% satisfied, 0% not satisfied) in a series of 53 patients. FDA-supervised investigational protocol studies as well as carefully selected other studies could not confirm such high success rates..."
Hmmm, so Dr. B. is able to determine failure conditions from his perfect results? I wonder, was I a perfect result, that helped him determine failure conditions also?

"A GRAVE ERROR IN TREATMENT"

Two years later, through a German investigation from TKK, an independent 'MDK' medical doctors presented to us a report stating that the surgery that occurred in Straubing with Dr. Bertagnoli was a Grave Error on multiple factors and (translation) "for completely incomprehensible, medically not understandable reasons, it has been contravened grossly against the indication criteria for implantation of spinal disk protheses".
Of course, that was no surprise, since every other surgeon said the same thing.

Even with an official report through German medical investigation, the doctor denies there was a problem...
Of course, I got fired from my job (which I worked many years to get) and we were forced to leave Germany.. My husband lost his job too. Its hard to comprehend what we have gone through because of Straubing Prodisc but somehow, we survived it all...so far.

I have people with the Prodisc contacting me from all over the world. Heart breaking stories. Some of them are from the same surgeon. I ask myself: how many people like that are out there? But most importantly:
Why does one of the "best" do not admit errors or mistakes? How many more in the future?
If DrB claims that he puts ADRs in 90% of his fusion patients... but, if only 5-7% of those 90% are actually indicated for the ADR (according to US studies)....what kind of number of people are we talking about, who are not indicated for the surgery? No one knows their story. No one cares. Some of them tell their factual stories, and get banned from forums. I hope this forum will honor the concepts of freedom of speech. This information, along with success stories, is very critical to people having a rounded picture.

(A concise overview is below. More technical web pages are on a way.)
Artificial Disc Prodisc and my story

My best wishes to everyone and especially to those who are losing hope, who dont have any strength or desire to go on: each step - MATTERS.

[Keano16]

I've read your story on Mark's forum... And I think I also replied there.

Your story is very interesting, much like my mother's story. Unfortunately we were never been able to prove or find out if surgeon did the mistake, or complication occurred (it was traditional discectomy surgery).

I really like that all this is becoming so public that people are trying to contact you to get help with their cases. Its your obligation now to guide them trough hell that you already went trough.

p.s.
I tried to email you, but never get response. Please write a PM if you are interested in personal contact.

[Greg]

Wow! What a story. I've heard nothing but great things about Dr. B but we are all human and make mistakes. But again, we are all human and it takes a really good person to own up to it and admit you made a mistake. I cant pass judgement, nor will I, but I hope you find the answers you are looking for.

Whether it is Success or failure, I still love to hear all stories. Sugar coating pain and treatments doesnt help anyone and hearing the facts 1st hand is the best thing for all. Sorry you had to go through such a painful experience but there is good in everything that happens. For instance, maybe you have the motivation to help others who are in similar situations like you.

I went through a lot of BS and people neglecting me or shoving me away because they didnt want to do the work to find out what was really wrong. But that motivates me to want to help others in any way I can. I can see it has done the same for you. As bad as a ride it was at least there is some good coming out of it....or at least thats how I try to look at it

[linda]

Hey Job13,
I also read your story when I started my research on surgery on the UK forum I think. Also a while back someone was asking what had happened to you and another member on the ISpine or either ADR support forum because they missed you. I am so sorry for all that you have been through and when I read your story I definetely had second thoughts about the Prodisc. I enrolled in the Freedom Disc trial around Jan '09 and was given a 50/50 chance of getting the Freedom Disc or the Prodisc. I really wanted the Freedom Disc. I was going to do it but my doctor kept being given the Prodisc and had never put one of the Freedom ones in. I got to see the Prodisc in a model of a plastic spine and it moved like a toy train. The Freedom disc was all one unit. After reading your story and several more I just can't commit to it. My problem is at L5 (collapsed) and that Prodisc just seemed liked too much movement.

Anyway, I would love to hear more about your story and how you are doing now. Oh and everybody talks about that doctor like he is the best thing since sliced bread. This is THE best forum and the only one I belong to. I do read the others every once in awhile. Welcome to the site and I look forward to hearing more from you.
Take Car,
Linda

[jamie5136]

As I know personally these posts are viewed by the doctors themselves, so I am going to keep this short. I feel your pain and went through a highly unsuccessful surgery in Germany myself. I don't think this error was on purpose, but nonetheless, my three discs (2 of the 3) sank up into my vertebrae (badly) and then cemented in place... consequently I am left with massive pain in my lower back, upper back, legs, etc. I have been told I can come back for xx number of dollars for artificial facets and a fusion, which may be an option, but I would try to go to someone close or someone who has good follow-up. I get about one email every 4-6 months, have had one call and that's it. No return emails in ages. They have my 60k in a Cyprus bank account, so I am nobody now. I was told it was a 95+% success rate and later found this was not true. He has a salesperson work for him schlepping his services. I believed it would be successful, had no idea about subsidence or degenerating facets, etc. I was lied to. If I had to do this over again, I would have fused L5S1 and done an ADR at L45 and that's it. These three CANNOT be removed w/out dying on the table and I hear that fusing in place is not successful, I can't take pain meds, so I am left in daily misery. My life was turned upside down. I can't have children now, my family is left sad and angry and my fiance feels so bad for the pain I endure daily. I now know why insurance does not pay for these; they are experimental. I would not only not recommend this surgery, but I would not go over-seas; plenty of good doctors in the USA. I am sad and in pain and feel hopeless. Do your research, talk to patients and be leery of those who "work" for doctors as liaisons. Mark was the only person who helped me, but no solution was worked out as 10+ doctors had all different views on how to "fix" me... fuse in place, take out, do nothing, etc. etc. Who can I trust? Nonetheless, I am a cripple now. I get private messages all the time of people with similar stories and concerns about said doctors. They fear posting, but I get private emails; the whole thing is sad. People are given hope, robbed blind, and left in pain with no solution; very sad.

[KBear]

Your stories are heartbreaking and I am so sorry that you have had to suffer through this. Rest assured this forum is not like the others and free speech is allowed. I personally saw on other forums where posts that were negative about certain doctors being deleted and people who weren't using the 'right' doctor were harassed about it (some even calling these people's homes and scaring their family about what they were about to do). It is unreal how political some forums are. This is a true non profit and their are no financial ties to any doctor, hospital, etc. I have zero experience with overseas surgery, so have no opinion either way. I do know that all doctors have failures and it is to be expected; how they handle it afterward is the difference. I hope you both find the help and relieve you need and deserve and thank you for sharing with us.

[Greg]

Your stories are heartbreaking and I am so sorry that you have had to suffer through this. Rest assured this forum is not like the others and free speech is allowed. I personally saw on other forums where posts that were negative about certain doctors being deleted and people who weren't using the 'right' doctor were harassed about it (some even calling these people's homes and scaring their family about what they were about to do). It is unreal how political some forums are. This is a true non profit and their are no financial ties to any doctor, hospital, etc. I have zero experience with overseas surgery, so have no opinion either way. I do know that all doctors have failures and it is to be expected; how they handle it afterward is the difference. I hope you both find the help and relieve you need and deserve and thank you for sharing with us.

I agree 100% with KBear. Mistakes happen but how they are handled makes the biggest difference

I am SOOOOO sorry about your troubles and wish the best of luck to you all. Both of you have been added to my prayer list

[Susanna]

So does this mean that is you have an L5/S1 problem, you shouldn't get any kind of ADR? I have to go back an look at my records because now I can't remember if I am a L4/L5 or L5/S1. I was told that the fusion wouldn't take away my back pain. That the ADR is my best hope for this. And my doctor is not pushing this on me. He even encouraged me to get other opinions. I am in so much pain, it hurts to walk. I can't go on like this much longer. I have United Health care and have read how others have wasted so much time appealing their rejections. I don't hold out any hope that they will change their mind.

So what do I do?

Susanna

[KBear]

So does this mean that is you have an L5/S1 problem, you shouldn't get any kind of ADR? I have to go back an look at my records because now I can't remember if I am a L4/L5 or L5/S1. I was told that the fusion wouldn't take away my back pain. That the ADR is my best hope for this. And my doctor is not pushing this on me. He even encouraged me to get other opinions. I am in so much pain, it hurts to walk. I can't go on like this much longer. I have United Health care and have read how others have wasted so much time appealing their rejections. I don't hold out any hope that they will change their mind.

So what do I do?

Susanna

Susanna,
I know it is all very overwhelming trying to figure out what to do. I remember thinking I would never get it. You will, just ask questions and keep learning. If it were me, I would fuse L5/S1 in a heartbeat if it needed surgery. In my opinion that has so little movement that it's not like fusing other segments. As far as insurance paying for ADR, if you are just a 1 level patient, you could be in a clinical trial and have it paid for, that's what I did. If you want more information on this, message me and I can tell you more.

[Gilbert P]

HI Job 13

I have read your story severial times and will not go to Germany! To many levels for ADR and I would have no recourse if needed more help. Thank You for telling us your story we need to hear the good, bad, and ugly.:thumpup:

Susanna- KBear, has given you some great advise,one level with other healthy levels you may get in to a trial, fuseing L5-S1 works great Get severial options.


We all know how hard it is to find and trust your judgement to do the correct procedure.
Keep Moving Forward

All The Best

Gil