L4-5 Charite ADR Stenum

[Havanna]

Hello everyone,

I've been reading here and on other forums. This is my first and last post. I've never participated and do not want to share any details about me. Kc0iet's post showing her in a wheelchair after her surgery has moved me. So many of us have known of these problems for years, but for some reason, they remain rumors that float around as subtext. They are never brought to the forefront. I had surgery at Stenum in October of 2004. My outcome was poor, but not horrible. There were others on my trip who's outcomes were unbelievable. I hope that Vikki will come and tell her story. I'm going to post a little of John's story, because he can't. I have contacted John's wife to see if this is OK and she thinks this is an excellent idea and was very supportive.

I can't tell all the details, but John and I shared xrays and a picture is worth a thousand words.

On October 7, 2005, John had a Charite ADR implanted at Stenum hospital. The ADR was off center:


The ADR was not put far enough back:


It came apart inside John:


He ultimately had a revision surgery. He had serious complications from the revision that almost killed him. 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. He died last June.

I appreciate that the technology works for so many patients, but everyone needs to understand how much is at stake here. I hope this helps someone.

H

[wilsonrob]

Wow. I am not here to criticize. This is a very risky surgery. I knew of the many poor outcomes at this clinic but not until I had my surgery. I was one of the crazy outcomes. Fortunately the ADR's were installed well. The cutting of the main iliac vein was a major catastrophe. As I have said before, I believe that there are many good outocmes at this clinic. You can read many of them on this forum. It just seems that there are also many more bad outcomes at this clinic compared to others. I do KNOW that the amount of surgeries done in a day at this clinic far outnumber other clinics. Rushing?? I do not even want to go into the details but when I was there, one man was paralyzed in his arm. No bashing just facts.

[kc0iet]

My deepest sympathy to you and yours. Thank you for sharing John’s pictures.

[New-disc]

Havanna,

Thank you for your post!

Spine surgery is a very risky surgery.

We as humans/doctors still have alot to learn.

When a new technology comes along it can also
be a bigger risk.

My hart goes out to John, his family, and his
friends.

Todd

[Justin]

Thanks for sharing John's story. I have heard both great things about Stenum as well as failures.

I hope John's family is at peace.

[Kathy]

I am so sorry to hear about John and the others who have had bad or less than favorable outcomes. Unfortunately, there is no way to know if any one surgery will work for a certain person. It is a very serious and important decision to have any surgery and should not be taken lightly. We could all have the exact same problem, same surgery, doctor, care, etc. and all end up with a very different outcomes. I think any surgeon who claims to have never have had a bad outcome, is obviously a liar. The choice of a surgeon is as important as the choice of which surgery to have. I hope that this board and others like it will help provide people in the research process with much needed information regarding all spine surgeries and help them to make an informed decision (and doing nothing at all is still a decision, it's just a decision to do nothing and can allow for more damage where one loses the option to have certain surgeries). I know nothing about Stenum, but obviously a place that does as many surgeries as they do is going to have more bad outcomes than somewhere that does less (not because they are 'bad'; but because of the success vs. failure rate). Hopefully, with all of us 'guinea pigs', spine choices in the future will be more black and white and we will understand better why some surgeries fail and some suceed.
Gonna get off the soap box now.....

[Terry Allen Blackburn]

I had the opportunity to have the Charite Disc installed inside of my spine by a local surgeon. The surgeon I have a lot of respect for but I did do research on the Charite Disc. I would never have agreed to have this disc installed in side of my spine as the design scared the hell out of me. To have a free floating core never made sense to me when we are designed to move and have range of motion preserved with this new disc technology. I also Googled the Charite Disc and got many sites for lawyers representing people in the United States that had the Charite installed in their spine. I also came upon this article that caused me to have some serious pause over having my local surgeon install this disc:
FREQUENTLY ASKED QUESTIONS:

This recent article examines 75 patients who had poor outcomes with this disc:
Complications and reoperations of the SB Charité lumbar disc prosthesis: experience in 75 patients

Charite Artificial Disc Generating Controversy - Medgadget - www.medgadget.com

And the list goes on and on.

I chose to get the Maverick discs installed in my spine and had a good outcome going through Stenum in November 2006. I had 4 discs implanted and went with the Prestige discs/cervical and Maverick discs/lumbar.

I am very sorry for your friend's loss. I can only imagine how much pain he was in prior to his death. My only hope is that they continue to research what is best for the treatment of spinal diseases. As it stands, we are the guinea pigs for the surgeons, unfortunately. I only hope his death was not in vain and that this serves as a lesson to all to research, research, and research. Even then, the decisions we all make may not be the best ones, and we are ultimately responsible for the chances we take.

Terry Newton

[mmglobal]

H, thanks for posting. I agree, these stories are long overdue.

Yes, all surgeons have many failures and many successes. Those who have worked with me know that I do not sugar coat anything and I offer to introduce my clients to failed patients, including failed patients for the doctor that they are going to. There is no getting around the fact that spine surgery is dangerous. However, there is a difference between this type of case and the type of failure that we all fear as we go into surgery. There are many reasons to fail. You can have undiagnosed pain generators so that you have the surgery, recover, yet still have your pain. You can already have permanent damage that will not get better from surgery. You can have a case that is so complex or severe so the chance of resolving the pain generators is unrealistic. You can have a configuration that is impossible to know about, that may cause damage in the surgery that cannot be avoided. (Something like tissue that is adhering to a nerve that may damage the nerve when removed, like removing tape from a wall and taking the paint with it.) There is also the general risk of surgery that will go along with any surgery. I’m sure there are many, many more issues, but you get the point.

For the most part, failures as described above are going to happen to every surgeon. I don’t believe the studies that get into the 90’s percentage for success. I believe that there is at least a 10 or 15% chance of failure for ADR surgery for reasons that cannot be avoided.

I knew John well. We’d only met after his ADR surgery and I had the pleasure of meeting him in person a few times. His ADR failure is completely different than the other types of failures that are experienced everywhere that ADR surgeries are performed. Let me shed a little light on his case.

First, notice the angulation of the Charite’ plates on the first picture. The implant is not centered well. This is causing the upper plate to ‘fall off’, lower on the left side of the image. This demonstrates one of the problems with mobile core devices. When this occurs, the core is pushed to the extreme right and stays there. That increases the angulation and increases the forces that push the core more off center in the wrong direction. This is why the Activ-L eliminated the lateral movement of the core. Every mobile core device I’ve seen will do this. Properly implanted it’s much less of an issue. I’ve had 2 clients with M6 cervical discs explanted, one for problems much like I just described, another one for serious complications that may have been exacerbated for these reasons. (Yes, they were both Stenum patients. I know of a third, but I was not involved in the case. I did get to examine the explanted disc though.)

That brings us to the second picture. Notice how far the back of the upper plate is from the back of the vertebral body. Notice how the teeth of the plate are literally on top of the anterior margin of the vertebral body. There is the appearance of more vertebra because of an anterior osteophytes. This kind of alignment increases the risk of migration by many orders of magnitude. I see these types of films presented at the conferences as if they are a device issue, but this is not a device issue. The picture of the configuration before migration is one of a disaster waiting to happen. The surgeon should know that and be focused on proper placement. The doctors at Stenum say that there are anatomical reasons that may make it impossible to get the disc further back. That is absolute BS. I have NEVER seen this type of failure from any of the other surgeons I work with because they take care to get it right. Accepting sloppy work because you are lazy, hurried or just not careful may not cause problems most of the time. However, when the stakes are soooooo very high, accepting sloppy work may doom patients that would have otherwise been successful, to lives of pain, meds, revision surgeries and more.

After I went to Stenum with MrBee, I made excuses for them, saying that they are probably doing the surgery the way they were taught to do it years ago. The reply from one of my favorite surgeons was, “If you are a bricklayer or a librarian, that may be OK. But if you are an astronaut, an airline pilot, race care driver or a surgeon, you have to be learning all the time. That is not an excuse.”

Here is a picture that I extracted from the original Stenum-and-back website. This picture stayed up there for many years until the patient community got wise to what it really showed.



I want everyone to keep in mind that this is the image of a successful surgery. The author of the website may even be in better shape than me. They point to images like this as if it’s evidence that it’s OK to do surgery this way. However, you do NOT want any ADR implanted this way. If the patient’s disc was his pain generator and they took it out, he experiences success. If he gets away with the horrible placement, that is dumb luck, not appropriate surgical technique. At the conferences they discuss the sequelae of configurations like this: increased risk of complications like migration and subsidence. In addition, there is the expectation of accelerated wear and degeneration of posterior elements, possibly adjacent levels (due to inappropriate kinematics), AND of the prosthesis itself. It’s like driving with your tires out of alignment.

Does this mean it WILL happen? Absolutely not! All it does is increase your risk. Poor surgery does not guarantee failure just as perfect surgery does not guarantee success. If anyone wants to have poor surgery because it’s OK most of the time, I would suggest that they don’t fully understand the issues.

Back to the pictures. Look at the plates in the successful surgery. Look at the plates in John’s. He was shocked when I told him this because he’d shown the films to a dozen spine surgeons and none of them had noticed it. The disc is installed upside-down. In this configuration, the upside-down disc INCREASES the sheer forces that lead to migration. My guess is that the configuration may have been able to tolerate the terrible placement. I doubt it would have migrated if it was upside-down, but properly placed. But poorly placed AND upside-down is too much. He asked for an explanation for why the disc was installed upside-down and the question was always ignored.

(continued)

[mmglobal]

(continued from previous post)

If you think that this is a Charite’ issue, you are mistaken. While the failure mode of the Charite’ seems to be worse, you avoid the failure mode by getting the surgery done properly. Poorly located or poorly sized discs are a problem no matter which disc you use. I see similar problems with other designs. You can’t put any of them in improperly and not have disasters. I will say again and again… there is a difference between the unavoidable failure that all spine surgeons experience and a failure that absolutely would not have happened if the surgery was done properly.

Here is another case that is similar. Look at the pre-migration picture for the placement of the plates. The prosthesis is right-side-up, but it’s so anteriorly located that the cleats are literally riding on the anterior ridge. Unfortunately, the post-migration xray is oblique and of poor quality, but you can see the lower plate has migrated out and rotated 90 degrees as it migrated out and like John, the core was expulsed. Do you think it is a coincidence that the plate that was hanging off the front of the body is the one that expulse.



Any experienced ADR surgeon should look at the interoperative images and see that while this MIGHT stay put, this is just as likely, a disaster waiting to happen. In every ADR surgery I’ve observed (with the exception of one), there are literally dozens of xrays taken to insure proper positioning. None of the surgeons I’ve seen doing ADR (with the exception of one), would look at an image like this and consider the job of placing the prosthesis to be done – time to close. (I’ve seen close to 200 arthroplasty procedures in more than a dozen centers, more than a dozen implants.)

This patient was told that the reason for the expulsion was because of the fusion below. I have MANY clients with similar configurations. That placement is problematic without regard to the adjacent disc. ADR adjacent to fusion is not problematic when properly placed, properly sized, etc.

I really appreciate that kc0iet and Havanna have come forward and started this discussion. This is NOT about the design of the Charite’. This is NOT about the general risk of ADR surgery. The two cases that I have written about in this post are 100% carelessness, poor implantation that should NEVER HAVE HAPPENED. Both of these patients had every reason to look for success or at least a chance of success because they were going to a surgeon with a great deal of ADR experience. Sadly, what they got was something completely different.

Please note that the patient with the fusion was done on the same day as the MrBee disaster in August 2004. That is also the same day as the Carmont disaster. One would think that they would have learned that such anterior placement is a bad idea. We have to ask, why are they still making the same avoidable mistakes in October 2005? The surgeon gets to choose when the prosthesis is appropriately placed. They look and say, "yeah, that's good", or "no, it needs to go further back." With the Charite' they have the option taking it out and starting again. (I've seen that done many times.) It is a choice they make to close the patient when they feel that it's appropriately placed. These cases are NOT, "all surgeons have problems!"

I'm sorry this is so strong. I get very agitated when I have to discuss Stenum because I've seen so many of these unnecessary, avoidable disasters that result in lives ruined. I apologize to all the happy Stenum patients who had a wonderful experience and love them. I know a lot of happy Stenum patients. Some of them are happy campers in spite of poor implantations. Some have success with good work done. But, what I've seen as the steady stream of avoidable disasters is unforgivable. As my friend said, if you are an airline pilot or a surgeon, you have to keep learning and improving. Sadly, for the complacency shown in these cases and so many others, the patients paid such a severe price.

All the best,

Mark

[New-disc]

Mark,

I'd like to take this time to thank you for helping all of us understand what went wrong.

Todd

[Kathy]

Mark,
I have a question for you.... Dr. Garcia told me that the reason I can not bend backwards was for this very reason. He said that (in theory at least) by bending backward it could push the disc out (forward, think that is anterior?). He said that until my bone grows into the implant that I should not bend backward, to thus avoid the chance of this hapening. My question is, is there any chance that any of these patients were one of the very unlucky ones that this happened to? I am in no way defending Stenum, like I said, I know absolutely nothing about them or any of the other overseas clinics; but am trying to better understand what happened? Is there one surgeon at Stenum that has more of these outcomes than others? Or is it across the board? I just can't wrap my mind around how if they are being this careless, that they are still in business and there are people who swear by them? Just trying to understand....
PS. Not trying to offend anyone, I am neutral on this issue, just trying to 'get it'

[phylly]

Havanna,
I just read you post and am deeply sorry for your loss. I am glad that there is so much discussion here about what can happen with poor surgery and bad outcomes. Even the best surgeons can have problems but this sounds like it should never have happened. I guess I have just been stunned reading these posts and realizing the chances we all take in getting ADR surgery.
Phylly

[wilsonrob]

Thanks for your excellent take on this. I will just keep praying for all that continue to struggle in pain. I will pray for wisdom and comfort. As well I will pray for the surgeons that they take care to do the best surgery possible.

[treefrog]

Yes, thanks Havanna for bringing John's story to this site. I am deeply sorry for John's family and friends, at their loss.

And Mark, thanks so much for explaining how these surgeries may have gone wrong. It really is inexcusable that a surgeon would be so careless with someone's life.

I do have a question, as I remember in one of Dr. J's posts, that showed his disc as being placed upside down by Dr. Bertagnoli. How is that different, and could Dr. J's current problems be caused by this configuration?

[mmglobal]

Cathy, go back and read the explanations on Justin's thread and this thread. See if you can get your head wrapped around the angles, forces, etc. I don't believe that being upside-down in John's case would have had this result if the prosthesis was placed appropraitely, towards the back of the disc space.

The Prodisc is very different from the Charite, with much better 'primary fixation', that is the fixation that occurs upon implantion, as opposed to secondary fixation that occurs after bony ingrowth into the coating. The keel provides much more surface area for primary and secondary fixation and since it's a press-fit, it's also very tight and resists migration. Even so, it too should be implanted towards the rear of the disc space, as shown in Justin's images.

On my last client with Dr. Zeegers, he explained why the discs will not move. It went somethin like:

Picture working on the wheel of a truck. You jack it up and place a large stone under the suspension and then lower the jack. You can try to pull out the stone but there is no way to pull it out.

In John's case, picture that you lower the jack so the suspension is resting on the very edge of the stone instead of on the middle of the stone. If you pull it in one direction it will be impossible to move it. However, if you pull it away from the side where it's resting on the edge, the forces will want to spit out the stone like a tiddley-wink or an olive pit. Putting the disc in upside-down (in this case) makes it like the truck is on a hill.


Not all implantations for ANY surgeon are all perfect. There are reasons that make some surgeries more difficult than others. However, looking at so, so many patient films, I see surgeons that have consistently excellent output and I see surgeons that have consistently mediocre output. I rarely see surgeons that have such a steady stream of cases that fall into this "should never have happened" category of complication that would have been avoided by a technically sound surgery.

All of this comes along with the appropriate "I'm not a doctor" qualifiers. However, I have observed many, many surgeries and have probably seen a wider variety and volume of spine arthroplasty cases done that 99% of the surgeon population in the world. (One of my favorite stories is the anecdote I tell just above the picture in the OR with Buetttner-Janz and Bitan in this post: http://www.ispine.org/forum/ispine/4...nz.html#post97).

When I talk about observing surgeries, what do I mean? Here are pictures from Willie Beeson's book, in the OR at Stenum (I'm the tall one!):



Again, I'm sorry that all this comes out so strongly. It's hard for me as I become emotionally vested in so many cases, to see people suffer unnecessarily. Take everything I say with a grain of salt. Do your homework and make informed decisions.

Mark

[Terry Allen Blackburn]

You do make the appropriate disclaimer Mark about not being a doctor. Stenum will never be able to come on to the forums, nor will any other competent or, even questionable surgeon, be allowed to discuss any patient care, surgery, consultations, etc. due to patient confidentiality. So the only thing that we will ever get is your personal feelings, and we will never know the other side of any of these stories. Not to discount anything that you do here but your biases are very apparent.

I do hear you loud and clear, to do as others have suggested as well, which is research, research, research.

I could never draw any conclusions from any of this posting due to a lack of much information from many sources. As it is, we will never get any of this information, so we can all speculate what went wrong and never really know.

I am very sorry for the families loss.

Terry Newton

[Maria]

Havanna,
Thank you for posting about your friend John's passing and please thank his wife for allowing you to post the information here that helped further bring this discussion out in the open and make it more of an educational experience for those considering ADR/spine surgery.

Thank you Mark for further educating us and for stating things as you do.

[Katie]

I second that sentiment.

I do have a question though that I think is relevant. We have all heard about several of these unfortunate surgeries in 04/05. Has anyone had solid evidence of anything similar happening since then, especially in the last two years?

I have heard nothing but wonderful things from at least a dozen recent patients, who had everything from one level to stem cell work done along with multi-level ADR. The results with all of these people have been nothing but amazing. I keep calling and asking them how life is going, and it's certainly better than mine.

Just asking.................

[trkdoc714]

I agree with Terry but I'm more blunt. For whatever reason, this poor man's passing from a drug related problem and what his family has had to endure has unfortunately been turned and twisted into more bashing of a truly great surgeon. This negative marketing of medical tourist companies really does interfere with people that are sincerely looking for help and advice. I doubt that they care if anyone gets commission on the surgeries or treatments as long as they find relief.

This particular thread has extremely bad timing. I had just left for Stenum for a 2 level ADR when my wife read this thread. She has been a wreck. Due to this negative marketing technique, she didn't know if I was coming home in a wheelchair or a body bag. This is an extremely irresponsible and juvenile act on his part. My wife called the hospital while I was in the recovery room. They brought a phone to me so I could talk to her and ease her worries. Dr. Ritter-Lang was at my bedside when this happened and told us both that the surgery went well.

Mark. You claim you don't use this site as a marketing tool for your medical tourist business. You most definitely do to a great extent. Why don't you disclose exactly your motivations, your medical credentials and education. You may as well also disclose your commission per patient with Dr. Bertgnoli and others as well. Let's really get to the root of all of this. I think your "noble" facade will be seen for what it truly is if you finally admit to using this site to sell, sell, sell. I wonder if you would have this vicious attitude toward Stenum had they hired you when tried to be employed here. I guess that ethics exam was a tough one, eh?

By the way, my L4/L5 and L5/S1 Mavericks are well placed and I haven't had any serious pain meds since 48 hours post surgery. The entire staff here at Stenum has been terrific and very helpful. If anyone would like first hand details, I'd be happy to answer any and all questions. Additionally, I do not get any renumeration for relaying my experience at Stenum Hospital nor do the other four patients that had the exact great experience I have had with Stenum.

One last thing. Mark, do not ever call my house again. Each time I've mentioned Stenum in a post either here or on ADR Support, you seemed it your duty to call me and try to sell me away from them. If you feel compelled to apologize for the anguish you put my wife through, do it by discontinuing this Amway marketing practice. By the way, I checked. Stenum doesn't perform ADR on dogs. Perhaps you should take yours to Dr. Bertgnoli?

Bob Threlkel at yahoo.com

[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: http://www.ispine.org/forum/surgical...ug-2003-a.html.

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

[dshobbies]

Willie,

I don't know if you remember me but while knee deep in the rocky road of spinal remedies and ready to head off to Stenum because they came up first on my google search, you took time to tell me your story, and others, and steer me to Mark. I don't even remember the forum where I first posted but you were there and began my education. I am forever grateful and thank you for sharing your story once again.

You minimized the horror of your story. Those who don't realize that your very life was at great risk also don't understand why we feel the need to warn others about Stenum's history. Your suffering lay at the hands of your trusted surgeon and he betrayed that trust. Once trust is broken, it can take a long time to rebuild it, if ever. And for those who feel we are bashing a good doctor or hospital, that trust has yet to be rebuilt. Our only understanding of someone choosing Stenum is that they don't know what we know. If you and others didn't help educate me, today I might be one of their hidden statistics, excusing my failure as a difficult case that no one else would take. If posting on this or other forums, I feel it is now my responsibility to pass on this knowledge so others can also decide for themselves with a more complete knowledge base. I'm sorry if this hurts others but knowledge is power, both good and bad.

For those successes at Stenum, I'm truly happy for you. I just don't understand why, if going all the way to Germany, anyone wouldn't put their spines in the capable hands of those surgeons considered the best in the world, Dr. Zeegers (not practicing at the moment) and Dr. Bertagnoli.

BTW, I read an article about cardiac surgeons in the paper this morning and a new success rate transparancy. It said the transparancy wasn't important for separating the great doctors from the good but for weeding out the bad.

I am not any kind of expert in anything medical. I hope Stenum has improved their surgical techniques and skill but that is something everyone must decide for themselves, with as full a knowledge base as is possible.

Thanks Willie, Dale

[Kathy]

I think we all agree that one must research and make the best choice that they can.

There is no way for us to know a dr's true statistics. Maybe that is something that we as a spine community could fight for and try to get. Real statistics from all doctors and hospitals.

[SandyW]

I believe we must allow people to tell their personal stories - good ones and absolutely the bad (If they are not able, the story can be told by someone with first-hand knowledge). I do not think we should attack people for telling these stories. I think that's what we're all about.

My first personal experience with Mark was brief. I met him in the Hotel Thereseintor before my surgery. I could not have asked for someone who was more kind, thoughtful and helpful. He gave me his cell phone number and said to call anytime if I needed help or had questions. Because he said he was in Germany with a client, I asked him about his business.

I didn't call him because that's the way I am. I wouldn't ask a lawyer, a doctor, etc. for advice if that was how they made their money. However, if there had been an emergency, I would have called since he was the only American in town.

My second experience with Mark came while reading posts on ispine. I was blown away by the enormous amount of "free" advice he gave. It was, wow, how does he have time to answer all these questions for people and still work, attend seminars, etc? My questions have received answers from many, including Mark; he answers my personal messages. No money changes hands or has ever been mentioned.

Not all of us can afford to have Mark accompany us overseas or even go with us to hospitals here. However the cost to have Mark send films etc. all over the world is not that expensive and saves you time, headaches and gives you more than one opinion. If I had the money and had known about Mark, I would hire him in a heartbeat.

I don't think it's fair to say that doctors give kickbacks or anything else that is unpleasant unless you have first-hand knowledge.

SO, to continue this saga . . . I would not be afraid to recommend Dr. B from my experience, I think he is the BEST and I say that often. There are many here who feel the same. But I think that if anyone has had a bad first-hand experience with him, you should tell your story.

NOW, my bad story . . . I did not like the treatment I received from the staff of St. Elisabeth in Straubing. I disagree about the "take care of yourself" attitude in German hospitals. When I returned to my room after surgery, I was not attached to a monitor for heart rate, BP, oxogen levels. No nurses checked in on me. When my husband notice my irregular breathing and that my hands were blue, he ran into the hall and yelled that he needed someone. Two nurses came, one thought everything was fine. The other gave my husband a questioning look. He said is she ok, she said no get doctor.

For some reason, the meds were not correct and I was having respiratory distress. I was taken to ICU, don't remember much, pieces here and there. I was not behaving well, I think too many opiates. I wanted my husband with me (he would have helped calm me), I wanted ice chips, I was seeing huge amounts of pink bubblegum clouds on the ceiling, I was afraid, crying, I wanted to sleep, they wanted me to stay awake. And they were extremely uncaring and rude. The most disturbing thought was what if my husband had stepped out of the room, went to eat??

Then after that "unfortunate incident" as they called it, I believe that I wasn't given adequate pain meds. I had to cry, beg and plead. One night after asking them to call a doctor which they wouldn't do, I went sobbing to the nurses station and told them they were treating me like a prisoner of war, they were torturing me. Needless to say, I checked out the next day. My husband thought he could take better care of me in the hotel. It worked out well since the proprietor was able to call Dr. Fenk-Mayer directly and she called me immediately. I told her about my pain and she changed my medication. What a difference, I was able to enjoy the rest of my stay, considering. I was able to shop, found a garden thingy, which hubby had to carry home , was able to sit outside in the sunshine, eat gelato . Ok that's my bad experience.

[james]

Charite’ polyethylene core 6.5 years after installation. From Complications and reoperations of the SB Charité lumbar disc prosthesis: experience in 75 patients

[mmglobal]

I just stumbled into this thread as I was updating kc0iet's thread on the surgical outcomes forum here:

http://www.ispine.org/forum/surgical...um-kc0iet.html

I'm bumping this one up for 2 reasons.... first because kc0iet's case and John's are related because they are part of the steady stream of truly unbelieveable Stenum errors.

Second, 3 years late, almost to the day, I have an anecdote related to the study posted by James, above.

In the past, when writing about the spine conferences, I have noted that there was an amazing number of papers from the same sources, that I characterized as anti-polyethylene anti-science. I coined the term anti-science to describe what Steven Kurtz and his organization were churning out. While there was likely some useful information developed in his studies, it truly seemed that Dr. Kurtz and Dr. Van Ooij received unlimited funding from medtronic to generate "polyethylene is bad" science. Much of what they reported on had to do with long-solved problems associated with early sterilization techniques and horrifically botched surgeries like the ones described above. I even asked him in the Q&A session after he presented a paper, "how is this relevant to what we are doing today" and his reply was, "it's not". (I'm paraphrasing)

IMHO, the spine societies seemed to give him a big platform in an effort to be fair, even though he got little respect. Last week, I sat next to a very prominent researcher (PhD biomechanics) and noted the absence of Dr. Kurtz. He told me about a conference in which a substantial percentage of the audience walked out as soon as Kurtz started to speak.

In any case, what I thought was amazing is that there was NO anti-polyethylene science presented (that I saw) and while Dr. Kurtz always had 5 or 6 papers to present at most of the previous conferences I attended, he was not here. Why? (IMHO) The Maverick was not FDA approved. Metal on metal joints are no longer in favor, so there is no longer any motivation for Medtronic to endlessly fund anti-poly anti-science. It seems that they were marketing pieces looking to create a competitive advantage.

It's truly amazing how the landscape changes... attending ISASS last week after missing the last 2 years... things were quite different. I'll be posting more about ISASS here:

http://www.ispine.org/forum/ispine/2...-2-2014-a.html

Mark