L4-5 Charite ADR Stenum

[Cindylou]

trkdoc714, I am so happy for you that your surgery went so well. Bottom line, that's what we all want to hear. Results. Successful results. I will pray that pain free days surround you, in the days and months ahead, while you heal from your surgery. Of course, we all want to make the "right" decision as to where we go and who we pick for a surgeon. Who knowingly wants to pick the wrong surgeon, or the surgeon with a very high failure rate? Obviously, no one. This is the tricky business for we spine sufferers, who on top of being miserably in pain, have to buck up and do endless hours of research so that we can make an informed decision. I can even understand your lashing out at Mark, because who else is speaking so strongly against Stenum? And he has the platform, this community, right? But here's where I have to differ, so please hear me out. When Mark flew out for the observation of my most recent surgery, I did not pay him one dime. Fact. He flew out on a wing and a prayer, because he really wanted to see what this Dr. Stark had up his sleeve, in regards to SI Joint Fusion, and the future this might hold for numerous failed back syndrome folks like myself and so many others who are not living the pain free life they are so desperately seeking. Fact. This community was born of love and compassion for our fellow man. My belief and conclusion. Now, here's the kicker we all need to pay attention to: does Mark need to make a living, like everyone else?? You betcha. After speaking with Mark in person, I can testify that this is how Global Patient Network was born. So he could attempt to carve out a living, doing what he does best, helping fellow spine patients find relief from their pain. Is Mark rich from this new career? Hardly. At best, he is breaking even. If I were Mark I would be very offended that you would accuse him of taking kick backs from Dr. Bertagnoli. Outrageous accusation. Absolutely not true. If Mark is guilty of anything, it is caring too much and having seen too much from all the surgeries he has had the good fortune to observe. Yes, he is merely speaking from his experience and observations. Just remember, HE HAS SEEN ALOT. I believe he sees it as a moral duty to comment on what he has seen take place at Stenum. So now he is guilty of having a conscience. Could Stenum have turned around over these past 4-5 years in their practice? Absolutely. That's why it is up to us, in the final hour, to make the best, informed decisions we can for our care. Happy healing to you, trkdoc714. May the force be with you!!

[wilsonrob]

I spent 6 weeks at Stenum. Probably more than anyone on this forum. I can certanly vouch for the wonderful people working at Stenum. As well it is a wonderful place. There certainly seems to be some major improvements at Stenum in the last few years borne out by the improved results.

I also know Mark very well. He is very passionate in his work. I can safely say that money is not the all consuming factor for Mark. He sincerely cares and wants to know more and more about spines. He can only go by what he has seen and his past experiences.

We are just thankful that you had a successful surgery. I can tell you that I have prayed specifically for Stenum and its surgeons that they slow down and do it right. It seems they are making great progress. Congratulations.

[Katie]

I can't speak for Bob, but I think he may have the same issues as I have with all this Stenum bashing. If no one has any evidence of poor surgical practice in the past four years, why is this continuing?

If there were bad choices made, I believe that they must have learned from them and moved on. I know in the year and a half I have been waiting to raise funds to go there, they have changed several practices to improve the patients' outcomes.

I have personally spoken to over a dozen of their patients from the past two years, and all have had wonderful results. If someone else can come forth with legitimate issues, then fair enough. If not, let's drop it. We can find all sorts of mistakes from other surgeons. I would like to make an educated decision as much as anybody, but I cannot when this is so one-sided. Give me the stats on the others too, please. They are out there.

[dshobbies]

Bob,

I understand your anger and am very sorry the timing of Mark's post scared your wife. I don't think I would have reacted differently. But, and it's a big one, you are reading Mark very wrong.

Though Mark has to make a living, he doesn't do what he does for the money. There isn't enough time in the day for him to hold down a 'normal' job and still be the patient advocate he has become. He helps people because he wants to but altruism does not pay the bills. The fees he charges are quite reasonable and affordable by most. Choices to use and/or which services to use are completely up to any individual. I have often posted that Mark was my best investment into my back and he made my journey so much easier. I had spent two years walking in circles until I found him and then, voila, my surgery was scheduled. If you want to go it alone, you still have his support as well as those on this and other forums.

In a recent phone conversation I had with Mark, I asked how to educate 'newbies' about Stenum's history. This post may (or not) be a result of that conversation.

This is a right to know issue. Stenum rang their own bell too many times, however in the past, to ignore this history. If any individual feels corrective measures have been in place for four or more years, they also have the right to choose this hospital for their ONE shot at getting better. As posted often, it's your body and you have the final word. BUT you also have the right to know all the facts and make that determination for yourself. One scenario goes as follows;

You go to Stenum for back surgery which ultimately is unsuccessful. This happens even with the best surgeon and care. You come to discover their history and the first thing that comes to your mind is, 'Why didn't anyone tell me'. Well for anyone currently posting or reading this forum, he told them and showed them, nothing more, nothing less. Just as you have a right to your opinion, so does he. I understand because of what he’s done, how much of it and for how long, his opinion will generally carry more weight. This does not minimize your opinion and/or choice.

History is hard to live down and you have to prove yourself over and over again. It's the price you must pay for doing something wrong in the first place. Once a child lies, their truthfulness is always doubted.
Bob, you made your choice, you’re happy with it and your surgery went well. I couldn’t be happier for you. In fact, even though we don’t know each other, I’m thrilled that your suffering days are over. A life of pain is no way to live. I wish you and your wife nothing but the best life possible but Mark is one of the good guys. He has no agenda to push other than don’t waste your one chance. Educate yourself.

Dale

[New-disc]

Hello,

Now you know my only motive.

To help others by showing them my true life story.

My gift to others!!!

Todd

[trkdoc714]

I appreciate the loyalty shown by all of Mark's friends. He obviously has earned it. I also appreciate your defences of his points of view.

I did not want to alienate my new online brothers and sisters. I was and still am quite concerned about the increases in Stenum bashing when it is not due. In my work I deal with fact. Verifiable fact. Most if not all of the stories bandied about regarding Stenum and namely Dr. Ritter-Lang may have a morsel of fact but they also have truckloads of urban legend built in. I found this especially true in this thread. Ask yourselves these questions:

Why would this person (first and last post) bring this up now?

What would motivate her to even find this forum to post this information?

How did she get her hands on someone else's XRay/ MRI films?

How do we know these XRay/ MRIs aren't just "stock films" from a Charite class action web site?

Why did the unfortunate death as the result of drugs (Addiction? Overdose?) get twisted into placing the blame on Dr. Ritter-Lang?

Why wasn't the several class action suits against DuPuy (Charite) given the blame as that disc has had multiple failures including several identical as this case?

As my daughter-in-law works for DuPuy, she had given me technical literature on the Charite when I first became aware of ADR. The top and bottom plates are designed to be used in either top or bottom position. The technical explanation for this is the either vertabral surface may be more accommodating to one particular plate. Why is a non-medical professional, non-engineer claiming that this was a factor in the core slipping out? If it was a factor, criticism should be directed on DuPuy not Stenum or Dr. Ritter-Lang.

CindyLou and Dale, I have prayed for you both to finally find the end of your pains. I hope this was the last surgery for CL and I hope Dale finds her "fix" soon as well. I hope I don't offend either of you.

The fact remains however that the leaders of this forum must stop this unethical bashing of Stenum and of Dr. Ritter-Lang in particular. I've held my tongue (typing fingers) a long time but with my wife in tears on the phone with me a few thousand miles away just out of surgery, I was compelled to let it out finally. Mark probably does have his good points. However, once he hurt my wife, I refuse stand by and let it go any longer. The irresponsibility and lack of ethics is inexcusable.

I hope you all still will communicate with me and not think poorly of me. I want to help others on this forum in the same way I've been helped. It feels great to be alive again and I have a lot of you to thank for helping me get here!

Bob

[kc0iet]

trkdoc714,

First, let me say that I am very happy for you. I too would have likely written a similar response my first few months post op. I have never had a bad word to say for the staff or accommodations in the new American ward at Stenum Hospital.

BUT, how dare you insinuate that my post was not based in fact! I came to this board because I wanted to share my story and because I am again facing surgery. I had a 2 level ADR at Stenum in 2004 and a fusion in 2006. I have been in a wheelchair and homebound spending an average of 20 hours a day in bed ever since. The reason I came to this site now, is because my pain has increased to an uncontrollable level, now AND I have emailed and written Stenem several times with absolutely no reply or response in any way.

I too am a person that bases everything on fact. I posted my story as honestly and truthfully as I possibly could. Had Stenum made any effort to contact me, that information would have been included in my story, but they have not. Now I am looking at a two or three level 360 fusion, the very thing that cost me everything to avoid. I do not have the funds to see the only doctor in the country that might be able to save me from this destiny.

The one thing I can agree with is that I have not seen or heard about the poor results since Stenum changed to the Maverick Disc, but that does not change what happened to me, John, Mr. B, and all the others.

I am sincerely happy for you and wish for you nothing but the best and a continued pain free life. I have no doubt that you will leave Stenum (as did I) feeling hopeful, happy and grateful. You have as much right to post your opinion as anyone but I do take it personally when someone states that my story is not based in fact. I would never post anything but the facts.

[Kathy]

I think the key word is RESEARCH! You must do research, form your own opinions and make your own choice. I wanted to know that, regardless of my surgery outcome, that I had made the best choice for me. To have absolutely no regrets and I don't.
Some people, my family included, thinks I am crazy for being in a clinical trial (guinea pig). After having surgery out of state, I can not fathom having been out of the country (I am a social butterfly and hated not having more of my family near). While others prefer the out of state or out of country experience (definitely did cut out unwanted visitors ) Others believe the old saying that 'the farther away a specialist is, the better they are'. Some don't understand why the dr down the street wouldn't do. I have heard, on these boards, people bragging that the surgeon they chose would be doing their 1st surgery ever on them! (that was something else I thought crazy) Others, don't mind being the 50th patient or the 150th. While others want at least 1,000 before them. Some want to be the first in on a new technology or first one for a new device. Others prefer that a device be tried and true before getting it.
Bottom line: Different people have different preferences. And that is ok, it is good. Aren't we here to seek different opinions? If we wanted the pretty picture, we could just believe the first thing we heard and go with it. But each and every one of us came here looking for more.
Last, I do feel that the surgeons (who I have absolutely no opinion on) should be able to defend themselves; but as mentioned can not due to privacy.

[trkdoc714]

I'm very sorry for your suffering and continued pain. However, the beginning of this thread is not factual. I'm sure there many failed surgeries. Try to remember, this is elective surgery. There are risks. We're made aware of these risks. There will be failures, there's no way around that. Each of us has taken that chance in the hopes we'll be healed.

As far as the beginning of this thread goes, just go back and look at one thing. The story begins with the surgery being performed in October of 2005. Why does the film of the explanted disc have a date of July 2005 stamped on it?

I truly hope and pray you find a pathway to recovery. Living in pain is horrible.

Bob

[Kathy]

Originally Posted by trkdoc714

The story begins with the surgery being performed in October of 2005. Why does the film of the explanted disc have a date of July 2005 stamped on it?

Wow, you are observant! I completely missed that and I looked and looked at those films!

I would like to know the answer to this as well?

Anyone know?

[mmglobal]

John's surgery was in October of 2004 as Havanna stated in her original post. It looks like the 2005 date is a simple typo.

Why now? Because kc0iet recently sought me out and I suggested that others could benefit from her experiences. Havanna's post is self explanatory. How does she have his films? Because patients email xrays and compare. I also have John's films. Willie's got 'em. So do Vikki, Carmen, Fred and probably many, many others. How do you know they are not some random films taken from the Charite' lawsuit? I knew John personally. They are his films. You may choose to believe or not believe whatever you think appropriate.

I'm sorry that some find this unpleasant. This is not good for the industry, not good for the site. It's great for the patients that it helps. It's not great for the patients that it hurts. I'm sorry that this caused such anxiety for Bob and his wife. There is no way for me to time what other people post and there is no good time. It is what it is and we all have to be adult and understand that internet information is a mixed bag.

People who remember all the way back to my original ADR forum that was the predecessor of this forum and adr support... back pain support group had a thread about Fred's subluxated core. Stenum's representative did come and explain. You'll see that he said:

Originally Posted by ADR-Jim on September 23, 2004

Please don't believe everything you hear, Fred's core did not "pop out", the lower plate failed to adhear to his previously fused vertebrea. A risk they knew of prior, he will have fusion at that level and ADR above in Oct. Also it is my implant on getadr.com and I am now 18 months with no pain, skiing, tennis, soccer, lifting up to 80lbs, no problems.

A risk that they knew of prior? One would think that if they were concerned about such a complication, they might have implanted the disc with the front teeth actually having some purchase in the vertebral body instead of hanging off the edge. Positioning is discussed more, below. (Here is the original thread from back in 2004) Back Pain Support Group: Charite core popping out???? Note that the thread was started by ADRJen who is a successful Stenum patient. She was the first person I called when I resurrected the surgical outcomes posts that I had started at BPSG. Here is her update: ADRJen Charite L5S1 Aug.2003.

Yes, I called Cindy when she posted that she was going to have a total hip replacement, but I remembered her positive SI injection. I suggested that she get evaluated by someone who has a 'bigger picture'. Based on her response, I offered to connect her to someone who specialized in SI joint dysfunction. She has now canceled her hip replacement surgery and has had a much smaller surgery that seems to have resolved her pain. She chose her path with a small assist from me and we have no idea what the future holds. Had I not called her, she would have endured a total hip replacement, and presumably the pain that was resolved by the SI surgery would still be there. I think I have 100 of her dollars.

Yes, I called Bob to convey what I know about Stenum. If anyone thinks that there is a difference between the call to Cindy and the call to Bob, that's fine... I can live with that. Some people may call this marketing. I'm either blessed or cursed with this mission and have never made a profit at this. I have not been paid by the doctors. (Bob, you should not post things that aren't true and you should question the motivation of those who are telling you things that are not true.) I have only worked for the patients.

I don't know why anyone would suggest that the death was "twisted into placing the blame on Dr. Ritter-Lang." What was posted was, Unfortunately, remaining in chronic pain and the stress of the ordeal took it's toll on John and his pain problem turned into a drug problem. The drugs took him from us.

Regarding positioning of the disc: from the Charite' installation manual (2004):
> page 13, step "confirm positioning": The Centre of the artificial disc should be 2mm dorsal of the sagittal midline. (this 2mm posterior positioning is restated on page 14 also)

> page 14, step "endplate insertion" - Load the selected endplate into the endplate insertion tips placing the more angled of the two endplates inferiorly.

> page 17, step "final positioning" - Verify the final position of the Charite' Artificial disc using flouroscopy. It is important that the prosthesis is in the correct position in the AP and Sagittal planes. If necessary, the position of the prosthesis can be altered by slightly using the appropriately sized Grooved Driver. In the event of a gross malposition, the entire prosthesis can be removed and reimplanted, by reversing the previous insertion steps.

There are three grossly malpositioned discs pictured on this page. One of them resulted in a successful outcome. Two of them resulted in disastrous outcomes. I wish I could say that the steady flow of these types of failures from Stenum has stopped, but it hasn't. I have clients with similar problems with Mavericks and M6 discs too.

Regarding the angled plates. The side of the plates with the teeth that provide the bone / metal interface are identical on the angled and flat versions of the plates. Endplate shape, density, etc are not relevant issues with regard the angled plate being up or down. It is about bringing the plates parallel to each other and perpendicular to the load that will be placed on them. Bob, would you share the documentation that says the plates may be reversed? The design of the Charite' has changed somewhat. Perhaps a different device has different technique. In any case, I'd love to see what you have. I'll be happy to share the 2004 installation manual if anyone likes.

When you stand on a chair, do you put your foot in the middle of the chair of all the way on the very edge? Would you rather the chair be on level ground or on a hill. What if you stand on the downhill edge of a chair on a hill? Don't take my word for any of this... ask an engineer.

I know a lot of happy Stenum patients and I look forward to hearing about the success of both Bob and his wife. They have every reason to look forward to success. As I've always maintained... properly implanted in a properly selected patients, all of the designs will be fine.

Sorry for the disjointed ramble... I have tried to address all the questions raised. It's been a long night. I hope this helps to clarify some things. I have more to say, but have to go.

Mark

[mrbee]

Wow! What a series of posts. What perspectives on the history of Stenum. For those here who don't know me I am MrBee (Willie). I rarely post anymore here or anywhere. Mark once told me that when a spiney resumes living again that he/she stops posting. He is right.

My friend Mark was to meet me last Thursday, he called me at 6am to tell me he could not make our breakfast meeting, he had just booked flights to Germany in two days! This was so he could have a very scary cervical mulit level ADR. Hard for me to believe. I posted to him once I read his post surgical report, then I found this thread. Whoa am I in pain, not physical (I do have those intense memories) my heart is in tears for Stenum failures.

I knew Fred, Carmen, Rina, John, Rob, Charlie and others. All of us passed through Stenum. Some names of folks here who have all had revision surgeries. There are others who through my ordeal have contacted me directly. I have kept those folks confidential.I know of others who have had surgeries with surgeons here in the US that have had revsions. It happens in this highly risky world of man's attempts to artificially alter the human anatomy.

I wish to make known that indeed during my time at Stenum, and subsequent to that I knew of failures. During that era, all reports, articles etc referred to the single digit percentage of failures using the Charite device. Remember in 2004 the device was not yet approved in the US. So it was difficult to obtain much info on it. I found Mark who incredibly had had this same surgery. After speaking to him I felt OK to seek this German made technology. There was no iSpine or GPN then, just Mark a real passionate human who was helping others. By the way who here would like to help those like us who even after putting all our hopes into our seemingly only choice of radical surgery that can end horribly be there for us after? Mark does this with compassion. I found the Stenum webpage, contacted the success stories and spoke to the Director and based my decision on this, plus never ending pain!

As to my story, I am not a medical theroist. I am really bad on all these highly technical aspects of implantation, translation, lateral movement, etc. I am a simple man, who underwent a most incredible journey. I personally witnessed several immediate failures in my window of time at Stenum. Those days of old of countless hours or days spent on the computer or phone talking to so many people who had been to Stenum and were still suffering. I sought like others for an end to my horror, post my fifth surgery to be wheelchair and bed bound. On 240 plus mg of morphine daily (no typo) along with a boxful of other high powered meds.

To witness the trail of those who contacted me for solace or venting was and still is a watermark in my life. I have nothing to compare it too. Yet it happened. All of it. Why? Was it surgeon error? The device? Greed? (packing 10 to 15 Americans in a week when the German/others count was far less). Or something more than this?

It was surreal. I have prayed for Stenum for Dr. Ritter-Lang, for Dr. Zechel to stop whatever was happening. I am not like Mark, he had devoted his life to helping those like all of us to find the best choice for our surgerical decisions. I did not use or pay Mark to help me choose Stenum. He thought I was OK to make my own choice. Once my world was shattered with a failed outcome (surgery #4) I asked Mark to come with me to Stenum for my revision. He was amazed that I would invite him (I had paid for my neurosurgeon to come to my ADR surgery in August, he backed out at the last moment).

Mark and I discussed the thousand questions to ask Stenum about my upcoming rare if not unprecendented revision surgery. I was glad to have Mark with me. I value those people who have such real insights/intellect whom can help me through my life or business decisions. Mark was a beacon of light to me when all was dark. During our flight over, Mark shared his life and new passion with me. I suggested to him that he should do this. Accompany people like me to Germany and advocate for them in a foreign country in a foreign hospital environment. Only after my horror that was days away did Mark experience firsthand that epihany to stand up and tell the world about these experiences.

I do not have all the answers. For the fellow who had his surgery at Stenum (trker I think) I am thankful for you and your family that you are doing well. I pray that Stenum has a zero failure outcome. I wish there was actually zero failures in any of these horrid surgeries anywhere. It is a tough road to hoe to experience pain and suffering. I have gone through what few have. John was one. Rob another. Fred is still alive and lives on massive drugs. He has been throuh detox twice, what an insidious cycle.

I have not nor choose to stay up on the ongoings of the ADR world and Stenum. It is like a bitter time for me to reflect. However, it is part of my life. My life today is based on this experience. I do not know of any one who has my same story. From deaths door to a miracle. I can only live like you each day in wonder. My body is healed, pain free, drug free. Like surgery never happened. It is sureal.

My heart goes out to Havanna. You are a dear to recall John. I remember when Carmen flew to help John in a dark time. Folks there are many stories of compassion thoughout this world of spine surgery and life. John was like us. He made a decision that led to his ulitimate death. I know of others who have never posted anywhere, that went that way too. I was ready too, only God intervened.

This is a long post but important, not to bash Stenum, but to shed some light on the history of the events in 04. Has Stenum changed, yes. Are they free of failures? No. Is the percentage of failures like 04? I do not know. Who would know? My view looking back is this, I would hope that either with these horror's I witnessed personally and my pressure on Stenum through De Puy made Stenum "correct" the internal problems.

Does a forum like this with a thread like this help? Absolutely. Does it polarize us with opinion of course. Pro and con. I love some of the folks at Stenum. The Backenkohler is the best memory. The countryside of Stenum is outstanding. The other side though is troubling or was. Or could still be. I can only hope that for anyone reading my post that you consider carefully wherever you have surgery. Know the risks, ask questions, assume nothing, ask about failures. Ask for cetificates or credentials. This is your life in a surgeons hands, he or she will not or should not be offended. If they are, then run from that one.

Lastly, I appreciate that Mark had allowed this important thread to stay up. Other forums have closed threads like this. Is it only the Stenum aspect? Or is it a man who has helped in a world of hurting humans. Where it is easy to vent and post our intimate feelings/emotions, especially when we are in pain. My did I recluse in that world of misery. I could not even watch TV and see normal happy people doing the things I would never be able to do. I hope that did not strike to hard of a nail with some of you in that exact place. I lived it. I know it. I am thankful to God for His gift to me and my family. I am thankful for Mark as he really stands alone in helping us to wade through this world of hard choices.

I pray for Mark to recover and resume his place on the forum. I pray that this forum continues to thrive.

Willie
MrBee

[New-disc]

Mr. Bee,

Thanks for your story, it's very well written.

Todd