I'm thinking of having a compressed disc replaced with a Pro Disc.
I would like to hear from anyone who has undergone the procedure as a neurosurgeon I visited in Spain has told me that the results are "spectacular".

Hi, Dave H http://www.healthboards.com/ubb/wave.gif

Welcome to the boards. http://www.healthboards.com/ubb/biggrin.gif You'll find good people here with lots of knowledge and good listeners!

I think that the prosthetic discs here in the states are still in the clinical trial stage http://www.healthboards.com/ubb/frown.gif There are several of us here on the board that are waiting for them to be approved. We'll be all over it! Understand that the trials are going real well.

Sorry this wasn't much help. Hope someone else has more information for you and, if I'm wrong about them still being in the trial stage, someone let me know ... welcome again!

Husker ............. http://www.healthboards.com/ubb/round.gif

Hi Dave
Artificial discs are being used in the UK....
I live in Exeter and am some way along the road of seeing if artificial discs can help with my problems. I have been seeing a really good ortho doc at the Royal Devon and Exeter who puts these things in called Dr Daniel Chan. He uses the SB Charite III which is the other make of these things..
Most experience with artificial discs is in Germany the best known being Dr Zeegers at the Alpha Klinic in Germany.

Best wishes
Tim


[This message has been edited by moderator2 (edited 02-19-2003).]

Hi,

I just heard on T.V. a minute ago, that the pro-disc might be approved for use more often in the USA in 2-3 years.
It was just on CSB news watch.
It is only being used for case studies at this point, at least that is what they said on the news.
Keep us informed if you have this procedure.
The woman that they interviewed, is virtually pain free after a car accident.

Take Care,
Baxter

Hi, Dave and 'Welcome to our world" http://www.healthboards.com/ubb/wave.gif

You will find good friends and some of the most knowledgable people in the world on this board. I know nothing about artificial discs so this post was an eye-opener in itself. Gook luck with your procedure, and remember this is also a good place to vent if you ever need to.

Now, to the US peeps,
Anybody know why we are so FAR behind in getting these things? http://www.healthboards.com/ubb/confused.gif

Take care, all and God's blessings go with you http://www.healthboards.com/ubb/heart.gif http://www.healthboards.com/ubb/wave.gif

Many thanks to everyone that has replied to my enquiry about Pro Discs. It's been very useful.
All the best
Dave

Hi Dave,

I had disc replacement surgery this past June. I got the SB Charite III disc, the other disc being tested in the US. I was also told that the results this far have been spectacular, but as of yet, have not been so fortunate myself.

Let me know if you want details about the surgery or recovery and I'll be happy to provide them.

http://www.healthboards.com/ubb/wave.gif

HomeChicken... Where did you have your surgery at? What doctor? I just read that the only place to get it done in the united states is at the Texas Back Institute in Plano. Experimental only so far. I would like to here about your surgery..

------------------

Sher

I am scheduled for a disc replacement myself. I am going into a program to be elgible for Prodisc. I have a 2 out of 3 chance of recieving the Prodisc. If I don't get them, I will be fused. The program is totally random. You have no control on what you will get! You just take your chances. I was told that they will probably be approved in 4 years, after they test them on us ginny pigs! HA! If you are in the pain I am in, you really don't care. Good Luck!!!

Hi SherryElaine,

I did indeed have the procedure done at the Texas Back Institute in Plano. I was told the surgery would be a breeze, and I would be back to work in 2 weeks. Well, the pain following the surgery was horrendous, and I have a pretty strong pain tolerance too. It took me almost 2 months to make it back to work, and I feel like I probably went back before my body was ready for me to. I walked with a cane for about 3 weeks. I am still in phsyical therapy, also. At this point, my pain level is worse than before the surgery. There was another woman who had her disc replacement the same day as me, and recovered much more quickly.

I last saw the Dr. Friday, and he says my continued pain may be due to a problem with my facet joints, which some people get after having the procedure done. So now I am waiting to have facet injections done, and if those help, a rhizotomy. (sp?)

From what I have heard, the surgery is great for some people...but then there are others for whom it does not work as quickly or as well. I will keep everyone posted on how mine goes though, as it looks like I'm the only one on here so far who has had it done. These boards are great for getting the info the doctors don't tell you!!

Hope you have a good day.

Oh yeah, I though I would add...the SB Charite III Disc is still in FDA trials. However, it is in the phase 2 trial. This means that the doctor gets to pick who gets the disc, and who gets the fusion; no surprises after you wake up! http://www.healthboards.com/ubb/eek.gif

Thanks for the info HomeChicken. I have been to the Texas Back Institute a few times myself for a cervial neck problem and I see Dr. Zigler and I know he did a surgery on a lady that had low back pain using the pro-disk? inplant and her surgery turned out great and she is pain free. They were even on the local news here. I am facing a cervical fusion in the future and also have low back pain, that does not require surgery yet. I wish the best to you and hope you get well soon.

------------------

Sher

Hi thehomechicken,

Hope you start to feel better real soon!

Do keep us posted as I am(and I know others here)intersted in any info on the artificial discs!

Thanks again,
Tony

I'm new to all this back crap, you are all far more informed thanI,but....... I had asked my PT about a "fake" disc as I have a ruptured L5/S1 that lost most of its fluid (I am recovering from a Micro-d). She wrinkled her nose and said that some of the press has been hyping such things, but professionally she was being told that these discs essentially are not working long term - yet. I hope these more advanced trials mean thqt they have new/better options. Be cautious. As I have learned recently, we only get one back!

Hi Dave,
I wonder if you had a disc replaced in the meantime and if yes, what your experience is, particularly if you used Prodisc.For your info, I am not affected myself but have developed some knowledge by helping introduce a fusion device which would compete against a non-fusion product like Prodisc(I am not a medical person though).
In case you have not yet done the procedure my only recomendation would be to get any information available about clinical data of the implant you will use, including pain data and it should include a sizeable number of patients. The FDA is also a good source if the product has been introduced to the US already. Prodisc of course is only at 510K level yet so you would need to get European information available.
Thanks in advance,
L.


Originally posted by Dave H:
I'm thinking of having a compressed disc replaced with a Pro Disc.
I would like to hear from anyone who has undergone the procedure as a neurosurgeon I visited in Spain has told me that the results are "spectacular".

G'day One and all.....

ADR is available here in Australia. I am having mine done on May 1st with a Charite III. At this point I am have a two level replacement but that will be dependent on the preop discogram....hopefully only L5/S1 will need to be done!

It has been accepted in Australia and unlike the USA we do not have the rigid FDA trials you have. My surgeon has followed the development of ADR for the past 30 years, however it has only been the past 15 months that he has felt they are of a standard and quality that he is confident in using. There are however only five surgeons in the entire country performing them here.

After extensive research I am confident (as is my surgeon of course!)that this is the answer to my problems. My surgeon has offered me an 80% chance of a pain free life; opposed to the advice given to me when comtemplating fusion or laminectomy..."don't do it for pain relief.......it WON'T help".

As I suffer with chronic sciatica I have been warned that I may have increased problems with this post-op but that with time it will settle. The sciatic nerve will be stretched and pulled during surgery so it is logical that the inflammation will take time to settle.

I have spoken to many people via message boards and direct contact and have been enormously encouraged in what is mostly successful outcomes and indeed all I have spoken to have had Charite implants inserted. Bottom line logic tells me that as with knee or hip replacements, disc replacements "should" work....out with the diseased, non-functioning part.....in with a brand new one!

My advice would be to certainly research every angle you can and if you are a candidate then hold out for a Charite replacement. I will certainly post my story and follow up once I have had my surgery....I have no doubt it will all be positive!
http://www.artificialdisc.com./ {Good starting point}

Cheers from Downunder!

Hi have heard a lot of good things about the disc replacements, but also some bad things. I have spoken to some on other board were the disc was but in to far towards the nerves. There is harly anything they can do once its in, due to the scar tissue build up.

Hi, everyone!
Can someone please tell me what the artificial disc is used for? Is it in place of fusion, or just for a simple herniation, or what?

Also, Homechicken - who did your surgery at Texas Back Institute? I just had laminectomy/microdiscectomy done here at the new TBI office in Phoenix, by Dr. Ali Araghi, with Dr. Stephen Hochschuler assisting. Did you run into either of them during your TBI experience?

Originally posted by thehomechicken:
Hi Dave,

I had disc replacement surgery this past June. I got the SB Charite III disc, the other disc being tested in the US. I was also told that the results this far have been spectacular, but as of yet, have not been so fortunate myself.

Let me know if you want details about the surgery or recovery and I'll be happy to provide them.

http://www.healthboards.com/ubb/wave.gif

Hi HomeChicken,

I am researching disc replacement for a friend of mine. Any information that you have on your experience with the SB Charite III would be greatly appreciated. As you know going through this process is confusing and frustrating especially when you are in pain!. If you can help us out with any info please email me at [removed].com. Thanks in advance.

------------------

[Please read and follow the board posting guidelines
as you agreed to do when you registered for membership.
Do not post your email address on the message board.]


[This message has been edited by moderator2 (edited 02-28-2003).]

I am 5 months post-op with a Pro-Disc.I first saw Dr. James Zuckerman @ St. Mary's Spine Center in San Francisco, he was already to the randomized part of the study. I was put on his list while I began jumping thru the hoops with the HMO ins & got no where because SF was "out of the area". In August I learned an orthopedic surgeon where I live in Oregon was going to start the study, I had fortunately seen him previously. I was one of the first 3 so was not randomized (2 out of 3 get the disc, the other a fusion). I can't compare it to a fusion not ever having one but it is still a very major surgery. The disc is inserted thru the abdomen & a vascular surgeon needs to open/close for the ortho or neuro surgeon. Post-op you deal with both abdominal pain & back pain (the damaged disc is removed & the artificial disc drilled/tapped in). My back pain has resolved quite a bit & I can now stand up straight but I still continue to have nerve pain in my leg. I am told it can take a year or more for a damaged nerve to recover, yikes! The nerve does not throb as bad as it did prior to surgery (but it did the first few mos after surgery). It has been a very slow process for recovery, much like a fusion. My surgeon told me to figure 6 mos to where I was feeling good & a year for a full recovery. I do have good mobility in my lower back (L5-S1), a benefit of the Pro-Disc. The only question is, they aren't sure how long the disc will last (20 yrs was mentioned to me & by then, pray for new technology!). I have not (so far) had a problem with the disc migrating, confirmed by x-rays. The disc is relatively small & cannot feel it.
If anyone wants further info on the artificial discs, post a message & I will give you websites, Drs names that I have talked with, etc. I did a lot of research prior to my surgery & felt it was the best option for my situation.

Hi everyone,
Thanks to everyone for posting.
I'm off to Munich for a double Charite disc replacement in April. Dr Zeegers is performing the op at the Alpha Klinik and by all accounts so far he's the man to see. (www.[removed].com).
Thanks Mark for your useful info. Finally, I'd like to hear from anyone who has had experience of Dr Zeegers.
I'll let everyone know how I get on in April.
Cheers for now
Dave

[Please read and follow the board posting guidelines
as you agreed to do when you registered for membership.
Doctors may be discussed by name, city and state.
Do not post their websites on the messge board. Thank you.]


[This message has been edited by moderator2 (edited 02-28-2003).]

Hi Dave, I don't know of this dr, just wanted to wish you luck in April! You'll be in my prayers that everything works out great!! Take care!

------------------
your friend, out2lunch

DaveH -
What is the name of the neurosurgeon you saw in Spain? I'd like it for future reference as I usually live there. Thanks. - di

I have tried to research a lot of products during a considerable time period now, mainly fusion (cage) products and also with an eye on artificial disc-replacement products. From a (future) competitors point of view if you want. What I have learned so far is that I should never belive in "its great, fantastic etc etc." Digging a bit deeper I found that the real success rate of most of the products is substantially below what most companies would like us make believe. Unfortunately, I would like to add. I also never understood why the aritficial disc replacments concepts (like ProDisc, Charite) have not taken off compared to fusion, despite being on the market for such a long time already. My personal explanation is that - like in fusion - this is a much more complicated procedure than one would like it to be. You face surgery in a very delicate area (like in fusion as well) where a lot of nerves pass by, you can do a lot of damage by trying to do away with damage, with the result that it is - at least from the information I could gather - a much more disappointing result than one would assume by looking at the more marketing oriented promises of the various implant-companies. A look at the shape of at least some of the implants will also ensure that you understand that this is not a minor thing that is going to happen to your back, or might even - rightfully, if you start to think what it will mean putting them in your back? - scare you right away. Sad but true and I therefore understand and can only support those remarks that advise to avoid a surgery as long as possible. There are surgeons who promote Prodisc and it is probably also a question of what is the least damaging of the various surgery procedures. I found that fusion products are also not equal at all in their outcomes. There are however also well known spine surgeons, at least in Europe, who advise against using artifical discs believing they are not ready for implant. For them the risk of migration and potential damage of the adjacent vertebrases are too high. This is in my opinion at least one argument one should investigate. I assume that the fixture of the endplates to the vertebraes must engage quite considerable force to the vertebraes and could damage them over the long term. Browsing the web it is easy to find some information which appears to me more balanced than some "hype", on e.g. http://www.neurosurgery.org/focus/aug02/13-2-10.pdf
But get me right, I do not even want to discourage using Prodisc, my only advise would be: do research research research. But also, DO NOT believe in or be satisfied with "it is fantastic". Request clinical studies and read them in detail. And then decide because afterwards it is too late.
Originally posted by Dave H:
I'm thinking of having a compressed disc replaced with a Pro Disc.
I would like to hear from anyone who has undergone the procedure as a neurosurgeon I visited in Spain has told me that the results are "spectacular".

[This message has been edited by lakezurich (edited 02-28-2003).]

[This message has been edited by lakezurich (edited 02-28-2003).]

The name of the Doctor in Spain is Dr Antonio Mostaza. He works in Leon (North of Spain ) in The Clinic Nuestra Señora de la Regla"

DaveH -
This is fantastic - I actually live in that region - Castilla y Leon, in a city not too far from Leon. I travel to Leon a lot in my work.
Is Dr. Mostazo someone who you would recommend for all aspects of back surgery, or his speciality only the pro-disc? How did you find him? My Spanish is pretty good, but does he speak English?

Hi Dave
I was wondering if you had the conversation with your Dr. about failure and if the artifical disk was not a success, would it be possible to remove the implant and do a fusion?

I am currently waiting for a replacement disk to be O.K.d by the FDA.

Thanks for all your info!

Hi surfdaddy,
I haven't really talked with Dr Zeegers much about failures. He reckons that his success rate is approx 85% but how do you rate failure?
I'm not a doctor but I think that Charite discs can be removed although I'm not certain how easily. Prodiscs are apparently more difficult or impossible? to remove as the fins top and bottom are hammered into place. PLease correct me someone if I am wrong.
regards
Daveh

DaveH -
Thanks for the information. This is very helpful. Good luck with your surgery - keep us posted!
- di

Hi Dave,

Thanks for the info. Please keep us posted on your operation and recovery.

Surfdaddy

To my knowledge, it should not be too complicated to remove an artificial disk because - unlike in a fusion - the two vertebraes are of course not fused together. In fact, I have even seen a failed fusion implant being reoperated (removed) and refused with another product. The surgeon involved however did not like to do that operation at all because because the risk of doing damage particularly to nerve roots is at the very edge of being acceptable. The most likely procedure after a removed artificial disk is likely fusion, but would appreciate any other comments. However, some surgeons feel that the anchoring of the endplates can damage the two vertrebraes and I wonder if this could not create problems. Comments appreciated. What makes me a bit nervous about the tone on this board is that I hear a lot about how great it is but no real information seems to be available. I wonder if the reality between what is "hyped" for marketing reasons and what is real might not be as big as in the fusion arena. To give an idea, I post another link here http://www.lni.wa.gov/hsa/ProvBulletins/pb-pdf/pb_01-05.pdf
Of particular interest is the requested information form at the end. Compare the information given in this form to the information that is given to prospective lumbar fusion patients by the various postings of implant producers and I believe you understand why the back-pain board is so huge.
I believe to state that artificial discs are great without being able to show clinical data for a substantial amount of patients and over at least a few years (problems usually show off later) is quite adventurous. Another thing which I would like to stress: Keep in mind that the information given in the fusion-information letter is based on American studies, e.g. all involved implants are FDA approved. I have no doubt that the FDA approval for artificial discs will be achieved within ca 2 years. That will not allow you to assume that you have an operation and achieve the result you wish, as the fusion-information letter proves. Simply because the FDA approval is based on whether the implant is safe to use, it does unfortunately not at all mean that the result for the patient must be 100 % successful. That means that you should use all information sources before you make a decision for any procedure available but never rely on hearsay or only. Luckily you will have at least 2 years to do research.
Originally posted by surfdaddy:
Hi Dave
I was wondering if you had the conversation with your Dr. about failure and if the artifical disk was not a success, would it be possible to remove the implant and do a fusion?

I am currently waiting for a replacement disk to be O.K.d by the FDA.

Thanks for all your info!

Hi: just a quick info on the procedure IF you are a foreign company/inventor developing a new implant:
You need a certain time to start developing a new implant, you need to work together with surgeons and when the trial and error period ends you have likely have spent somewhere between 2-5 years. During this time you are able to start implanting in most countries much easier than in the US and are immediately ready to introduce it to the market. It is the FDA which decides which product can be used in the US, it is however only YOUR decision when you wish to start a trial (510K) in the US, not the FDA. Because you likely wish and need to focus however, you will not consider expanding to the US during your initial years despite the US being the biggest market. However, unfortunately the FDA usually does not accept clinical data that you could present which was done outside the US which means that you have to start all over again in the US, meaning that finally it will take somewhere between 2 to 5 years longer until you as a patient or a surgeon have the choice to use it. I think here US regulations actually should be changed to allow the US to get access to new technology faster. Hopes this explains why it takes so long.
Originally posted by emeraldbee:
Hi, Dave and 'Welcome to our world" http://www.healthboards.com/ubb/wave.gif

You will find good friends and some of the most knowledgable people in the world on this board. I know nothing about artificial discs so this post was an eye-opener in itself. Gook luck with your procedure, and remember this is also a good place to vent if you ever need to.

Now, to the US peeps,
Anybody know why we are so FAR behind in getting these things? http://www.healthboards.com/ubb/confused.gif

Take care, all and God's blessings go with you http://www.healthboards.com/ubb/heart.gif http://www.healthboards.com/ubb/wave.gif

A doctor at the Chicago Institute of Neurosurgery and Neuroresearch (his last name is Geisler) is doing these trials as we speak.

I have my 1st appt. at this clinic on Thursday to finally get some answers. They seem really wonderful so far. Sent me a huge packet of info a few days ago. It had info about the clinic, my doctor, what my appt. would be like and papers for me to fill out. VERY different than my other doctors! I hope it works!

Good Luck!

------------------
Herniation at T7/8
Bulge at L4/L5
Protrusion L5/S1
Currently walking with a cane and looking for help!

[This message has been edited by calip (edited 03-02-2003).]

I had a discussion with a spine surgeon regarding a new lumbar fusion implant and during the discussion also asked him about his opinion on artificial discs, Prosdisc as well.

He has a pretty strong opinion: It does not make sense at all and he would never use them. You gain 3º which compared to a fusion is very short of nothing and simply for this reason it does not make sense to use them.

To achieve this you may face considerable difficulties (migration and potential damage to the vertebraes among the most important) which could create real problems later on. He is of the oppinion that the hype these artificial discs create are pure marketing gimmicks.

He also gave me an advice which I feel is important:
When considering a spine operation always get an opinion of a surgeon with at least 100 operations per YEAR. Also try to get an opinion of an orthopedic suregon as well, and not only of a neurosurgeon because orthopedic surgeons have a better understanding of mechanics.

Originally posted by Dave H:
I'm thinking of having a compressed disc replaced with a Pro Disc.
I would like to hear from anyone who has undergone the procedure as a neurosurgeon I visited in Spain has told me that the results are "spectacular".

Hello Dave

I had a Pro Disc implanted between L4/5 in Jan 2003. After 4 days I felt a new pain in my lower back and a new x-ray showed that the top plate had dislodged. I went back into surgery, and woke up to be told that the whole prosthesis was faulty!! Everything was removed, and I believe with great difficulty, because of scar tissue already forming. I thought that I had done a great deal of research before, consulting with higly regarded surgeons. At no stage was I told that this Pro disc surgery was still experimental, and there are quite a few neurosurgeons putting them in in South Africa. I had been told that I was a good candidate for the procedure, and opted to have it done because of the quicker recovery period. I now have nothing in this space at all, and have been told that I need a fusion sooner rather than later. This opinion was from an orthopaedic surgeon. The neurosurgeon was hoping that a natural fusion might occur, but after a lot of discussion with doctor's this diagnosis does not seem likely. Also, the conservative but sound attitude is that traditional fusions are still proven to be successful 25 yrs down the line. The fact that my "top" surgeon did not check the appliance properly before surgery, and that the Pro Disc itself was faulty are I believe reason enough for anyone to seriously reconsider having this procedure done.

Best Wishes

Hi lakezurich and Judy Lou
Thanks for posting,
The surgeon I'm going to (Dr Zeegers) says he has 10 years of experience in inserting Charite discs and has carried out over 750 so far. If this is true, and I have no reason to doubt him, then he seems to be a good bet. I've changed my mind from Prodisc to Charite because of the difficulties in removing / repositioning the plates after insertion if there are problems. Dr Zeegers doesn't think that migration of the end plates is an issue anymore but I'm sure there will be someone out there that will tell me different.

I've thought about fusion but have heard that although the area which has been fused can be fine afterwards there can be associated problems above and below as these discs then have to do more work.

It seems that having a replacement disc(s) inserted also recreates lost disc height and this has to be advantageous.

I hasten to add that I'm not a doctor, just a guy in pain who has done a fair bit of research - maybe not enough - but you have to make a decision sometime! I just hope I am making the right one!

One thing for certain is that back surgery is a very complicated topic and I'm not sure anyone knows which treatment will be right for everyone.

Speak to you soon
DaveH

Absolutely agree with you last remark. I am not at all impressed by your figures about charite though. This is 750 surgeries over 10 years, less than 75 per year. Simply by looking at these figures I am not willing to believe that this is a success story having so few operations. The ortho surgeons I know do between 100-600 opereations per YEAR, the majority between 200-400. Maybe I am a bit biased however because as I once mentioned, I am myself involved in the introduction of a new fusion implant with almost as many patients as charite but over a much shorter time span. Again, also not as a medical person but I have acquired some knowledge about fusions and of course I am also looking over the fence, i.e. artificial discs. I had a discussion with a surgeon of a large spine center yesterday on which my remarks were based and I must confess that after having had discussions with a few surgeons that are all working at centers doing well above 200 operations/surgeons, I firmly believe that artificial discs are not ready for implant. Unfortunately, because progress is very necessary, as today's fusion outcome is by no means satisfactory. I am assisting one of the parties which is trying to bring relieve, hopefully there are others. From my knowledge today, I have to assume that atifical discs are simply a jump too far, the natural step should be making fusions work. Hopefully, artificial discs will work in ten years by now, but I doubt they will before.

The problems above and below the fusion can happen, absolutely correct. However, there is absolutely no difference to artificial implants. It can happen there as well because the degree you gain is extremely small and well comparable to a fusion. In fact, I believe that artificial discs create an additional problem which fusion does not: the pressure on the vertebreas by the endplates can damage them.

Restoring original height is an issue which you have to adress, absolutely correct as well. But again, applies to both artificial discs and cages (if you use cages in a fusion which I believe is a necessity). We e.g. use different sizes for this reason. In fact, I believe that the restoring-height question is more difficult to solve with the artificial discs than with cages. There are however a wide variety of cages, and I would not want to create the impression that I believe all of them are good.

It is of course also correct that there is no solution that applies to all. Back problems are so tremendously complicated that one really has to look at it individually, but I believe there are steps to ensure a better chance of a good outcome. The most important to gather all information possible, which obviously you are doing. This is also why I attached the link to the information letter about fusions which contains very critical remarks in my last response.

But whatever your decision is, I truly hope that it is the right one for you that will enable you to have a pain free life afterwards because that is all what counts!


Originally posted by Dave H:
Hi lakezurich and Judy Lou
Thanks for posting,
The surgeon I'm going to (Dr Zeegers) says he has 10 years of experience in inserting Charite discs and has carried out over 750 so far. If this is true, and I have no reason to doubt him, then he seems to be a good bet. I've changed my mind from Prodisc to Charite because of the difficulties in removing / repositioning the plates after insertion if there are problems. Dr Zeegers doesn't think that migration of the end plates is an issue anymore but I'm sure there will be someone out there that will tell me different.

I've thought about fusion but have heard that although the area which has been fused can be fine afterwards there can be associated problems above and below as these discs then have to do more work.


It seems that having a replacement disc(s) inserted also recreates lost disc height and this has to be advantageous.

I hasten to add that I'm not a doctor, just a guy in pain who has done a fair bit of research - maybe not enough - but you have to make a decision sometime! I just hope I am making the right one!

One thing for certain is that back surgery is a very complicated topic and I'm not sure anyone knows which treatment will be right for everyone.

Speak to you soon
DaveH

I am sorry to hear about your problems despite that in a way you confirm my reservations.
I must admit that I am not able to assess why it happend, whether you are the unlucky exception or whether something was done wrong or whether your surgeon is not good, so I cannot help you in this respect and because I am not a medical person it would not be right to try.

What I feel is important however: I think you should discuss it as fast as possible with an orth surgeon of your trust. One that does at least well over 100 operations per year because if the does less he is not experienced enough and likely had not had enough "problem" cases which may help him assess your situation. Fusion is also not without risk and therefore I enclose this link again: http://www.lni.wa.gov/hsa/ProvBulletins/pb-pdf/pb_01-05.pdf
Reoperations can work and a fusion after artificial disc removal is possible but still more complicated than fusion immediately.

I have seen cases were we were unable to insert two cages because of scar tissue (but those were not artificial discs removed) which makes me feel the the only advice I can give is: get in contact with a good experienced ortho surgeon fast to have him confirm that waiting much longer will not endanger later fusion or discuss fusion fast if necessary.

Originally posted by Judy Lou:
Hello Dave

I had a Pro Disc implanted between L4/5 in Jan 2003. After 4 days I felt a new pain in my lower back and a new x-ray showed that the top plate had dislodged. I went back into surgery, and woke up to be told that the whole prosthesis was faulty!! Everything was removed, and I believe with great difficulty, because of scar tissue already forming. I thought that I had done a great deal of research before, consulting with higly regarded surgeons. At no stage was I told that this Pro disc surgery was still experimental, and there are quite a few neurosurgeons putting them in in South Africa. I had been told that I was a good candidate for the procedure, and opted to have it done because of the quicker recovery period. I now have nothing in this space at all, and have been told that I need a fusion sooner rather than later. This opinion was from an orthopaedic surgeon. The neurosurgeon was hoping that a natural fusion might occur, but after a lot of discussion with doctor's this diagnosis does not seem likely. Also, the conservative but sound attitude is that traditional fusions are still proven to be successful 25 yrs down the line. The fact that my "top" surgeon did not check the appliance properly before surgery, and that the Pro Disc itself was faulty are I believe reason enough for anyone to seriously reconsider having this procedure done.

Best Wishes

Hello Dave,
I am not sure if your operation is imminent or if you have an imminent necessity to do it. If not and if you would be able to wait for another two years why not wait until the FDA approves ProDisc? Prodisc will certainly be approved by the FDA, I have no doubt about that but I have also no doubt that you will be able to get a pretty clear assumption by their questions/wordings by that time of whether they will really regard Prodisc as an advantage or not. I think this would be helpful for you as I don't really see that much difference between either Charite or Prodisc. Actually SB Charite just lost a patent dispute to ProDisc.
Out of curiosity, do you have any knowledge about the price of a Prodisc or Charite implant?

Hi Dave

Please ask Dr Zeegers more about the 15 plus % failure rate,which I think is quite big. Rather base your questions on possible complications and where and how his previous cases are doing and how long they have been well. I realise that when we are in pain, the best case scenario is appealing!. Initially I was so " FOR " the Pro Disc, that when things went wrong I felt very cheated. I had also experienced a day with no back pain at all. (1st day up ) I could not believe that things had gone wrong as I had felt so positive prior to my op. Retrospectively, and after a lot more discussion & research, albeit too late, I truly feel that you should take a few more months if neccessary ( you have lived long enough with horrible back pain ), to consult further. I now KNOW that an Orthopaedic Surgeon is the way to go. I regard myself as a fairly well read & informed person, but it takes another setback to get another wake-up as to how much we need to constantly question the people we regard as " superior " to ourselves! I am not talking about nitpicking issues, but perhaps there are people out there who will understand what I Am talking about.
I actually cannot believe that I went ahead with this procedure knowing what I have subsequently found out! I realise that sometimes we have to be progressive in our thinking, and that is where I thought I was, but clearly this is not so with regard to these artificial discs. I am still a bit spaced out I think from the previous 6 weeks trauma, but I will happily chat in more detail to anyone if they would like to. Also, I am referring to SA doctors of International accreditation. Names will happily be given. I cannot cope with the idea of someone else having problems & pain when actually it is quite clear that there is not enough long term evidence of success in this regard.

Take Care
JL

I appreciate your emotional reply and at the same time I am happy for you that ADR obiviously worked very well for you. I think it is too complicated and too technical to reply to every single one of your comments, as it is also not possible to give advice on this board as to what is an individual patients best solution. That must be up for him to discuss with a competent medical person which I am not. I believe the only help is trying to help him/her get as much information to become a knowledgeable patient who is able to ask the right questions but also to be treated the way he/she deserves, and not at least be able to hopefully find the right surgeon. It is important because we discuss an issue which sometimes means getting a life back to normal or to be disabled for the rest of life as your own experience clearly shows.

Where I would support you is that there is a huge amount of misinformation and I also agree about your remarks re surgery techniques. In fact you will unlikely find two experienced surgeons (which I would somehow artificially call surgeons doing at least over 100 operations per year) which use the same procedure for the same product. This is no problem for an experienced surgeon because there is not only one right procedure.

Beside that we talk about a gigantic cost to the health system and also about financial interests of all parties involved trying to sell solutions, nobody disputes that. One point I think is valuable that you threw in: medication and recovery. It is extremely difficult, probably impossible to assess pain before/after operation over a large number of patients/products/time period. This information is unfortunately not gathered in a reliable comparable way and I gave up on this. Information about whether medication is still needed or could be reduced entirely and when a patient has recovered fully and/or at all, is however always available because it is needed for workers compensation etc.

I have no doubt that ADR worked excellent for you, I do however seriously doubt your conclusion that your excellent result is reason enough for other patients to go for it and will enable them to be sure they will achieve the same result. Without doubt you would also find a patient for likely any fusion product on the market with equally excellent results as you achieved luckily. It would however be equally wrong to extrapolate such an observation.

The only real infomration that would be of help is to put scientifically verifiable clinical data (long-term, at least 3 years because at that time the problems usually start to show up at the latest, for the same product) on the table that is able to show that any specific product is able to reproduce a satisfactory result in many hundreds of patients as well and can reasonably be extrapolated.

In fact I would like to see such information (not only for ADR's but for fusion as well) being presented to prospective patients or at least be available for medical persons. For fusion there is luckily much more information around, and it is not at all just wonderful information. I posted twice a link which should in fact allow you to get an idea of the real risks involved that many of todays products obviously have, but also make clear that it really is in your very own interest to get involved.

You also make the assumption that cage is cage and all are bad, an unjust simplification. I could prove you wrong with hard clinical data.

Your assumption that all surgeons misinform/do not inform because they are afraid of new things is also a generalization which I know not from hearsay but from having discussed problems with many surgeons is unfair to at least the ones I know. In fact I am talking about experienced ortho surgeons with 200+ operations/year which are well aware of the problems of fusion (or some fusion implants if you wish) and gave clear reasons for their strong negative opinion against ADR's. Statistically this is not significant but they gave me enough information to get an informed opinion and for example make me suggest that people interested in Prodisc or similar products and who are able to wait for another ca. two year period should think about waiting until they are able to read the FDA approval comments by then. (Which are a good information source anyway. Even having the FDA-approval stamp is in my personal opinion not sufficient and if you do not research that information you will not have a full understanding of shortcomings of many products.)

Another point which I raised in my last response to Dave: he mentioned one Doc with 750 or so Charite implants over a 10 year period. With all due respect: if you have a product that is supposed to be superior would you really assume that the majority of surgeons would resist start using this procedure over a now 10 year period. Indirectly you state that virtually all of the surgeons doing the ca 250’000 – 300’000 (my own rough estimate) lumbar back surgeries every year outside the U.S., are ignorant enough, afraid of the new or don’t care at all about their patients well-being. The use of ADR’s compared to all other procedures is however in fact still miniscule.

Is this assumption really realistic? Or is it a valid question to ask why there is such a miniscule proportion of ADR’s being used and so little clinical data available.

I nevertheless congratulate you on your decision to gather information and make it available because it will assist potential patients to get more information.

Hello Judy,
I think you are going the right direction and I hope you will find the solution for you that will make you pain free at last.
I also truly believe that you made the right decision to consult an othopedic surgeon but nevertheless would like to make the following comment as my earlier quotes could give the impression that I regard neurosurgeons as not competent to do lumbar spine surgery. This impression would of course be entirely wrong. Both neuro- and orthosurgeons have their role to play and often a neuro- actually works together with an ortho-surgeons which I believe is an excellent combination. The neurosurgeon is more aware of potential problems in the neuro area (nerves etc) and the orthopedic surgeon is more aware of the mechanics. Because mechanics is however of particular importance in the lumbar area, it is always advisable to consult an orthopedic surgeon, for an artificial disc anyway, because there are tremendous mechanical forces at work which need a good judgement. It is these mechanical forces which I found make orthopedic surgeons nervous particularly with regard to the fixation of the endplates and their long term impact on the vertebraes.

I nevertheless hope that you will sometime soon be able to poste a positive result and leave your shocking experience behind you forever.
Originally posted by Judy Lou:
Hi Dave

Please ask Dr Zeegers more about the 15 plus % failure rate,which I think is quite big. Rather base your questions on possible complications and where and how his previous cases are doing and how long they have been well. I realise that when we are in pain, the best case scenario is appealing!. Initially I was so " FOR " the Pro Disc, that when things went wrong I felt very cheated. I had also experienced a day with no back pain at all. (1st day up ) I could not believe that things had gone wrong as I had felt so positive prior to my op. Retrospectively, and after a lot more discussion & research, albeit too late, I truly feel that you should take a few more months if neccessary ( you have lived long enough with horrible back pain ), to consult further. I now KNOW that an Orthopaedic Surgeon is the way to go. I regard myself as a fairly well read & informed person, but it takes another setback to get another wake-up as to how much we need to constantly question the people we regard as " superior " to ourselves! I am not talking about nitpicking issues, but perhaps there are people out there who will understand what I Am talking about.
I actually cannot believe that I went ahead with this procedure knowing what I have subsequently found out! I realise that sometimes we have to be progressive in our thinking, and that is where I thought I was, but clearly this is not so with regard to these artificial discs. I am still a bit spaced out I think from the previous 6 weeks trauma, but I will happily chat in more detail to anyone if they would like to. Also, I am referring to SA doctors of International accreditation. Names will happily be given. I cannot cope with the idea of someone else having problems & pain when actually it is quite clear that there is not enough long term evidence of success in this regard.

Take Care
JL

LakeZurich:

I think you must be referring to another's post. You say that I conclude that my success implies others should go for it and that they should expect similar results. I specifically said that people should not expect a recovery like mine.

You say that I make an assumption about cages? The word cage does not appear in my post. I make no mention of the various interbody devices.

Where do I say that all surgeons misinform? I simply related my experience and suggest that all information should be challenged and verified. Don't accept generalities and rumors. Only use information that can be substantiated. Opinions are valid, but they are only opinions. Here is an exchange I had with a ProDisc surgeon.

Q: What do you know about how things are going with the Charite study?

A: I've heard that things aren't going very well.

Q: Well what have you heard.... complications, success rates... what?

A: I don't know, I've just heard that things aren't going very well.

I'm sorry but that is meaningless. Other patients from the same doctor have been scared off the Charite based on these rumors. This is from an excellent doctor who I'd be happy to have surgery with if I was doing a ProDisc in the states. It just serves as an example of a great doctor unintentionally spreading misinformation.

The idea that we'll some day be able to get "scientifically verifiable clinical data" is a pipe-dream. If that were the case, we wouldn't have so many doctors saying multi-level fusion for pain is 50-50, while others say it's 90% success and I've never made anyone worse. I'd venture a guess that the conservative doctors success rate was actually better than doc 90%... he just didn't lie about his results. In my small circle, I have found 2 patients that doc 90% "never made anyone worse", actually made worse.

Do you like the scientific FDA studies for IDET that cite one complication in 17,000 procedures? IDET must be awesome. Unfortunately, anyone who looks into the studies realizes that the numbers are seriously flawed, they are all to be taken with a grain of salt.

So, sadly the spine patient is left with few options all of them (including ADR) are fraught with potential problems. However, if one is facing fusion and is a candidate for ADR, they should look seriously at the technology and make an informed decision. The world is full of nay-sayers. Your argument that since it hasn't caught on and replaced a substantial percentage of fusions yet is amusing. The medical community is slow to change. I think your expectations about what the medical community does are way too high.

Mark

Hi LakeZurich

The cost of the Pro Disc in South Africa was Twenty Nine Thousand SA Rand. I will also continue to have the assistance of a Neuro who will work and who often does work with my Ortho Surgeon.

Best Wishes
JL

thanks a lot for this information. That is actually much more than I thought, if it is for the implant only.

Hello Mark,

Fair, you made the statement that people should not expect your experience of recovery.

It appears to me though, that after accusing all others of supplying imprecise and unclear information, you are now trying to back out of statements you yourself made. I am not going to comment on all details and am a bit confused by many of your comments anyway, but only try to veryfy my point but only for one reason: I wish you we would all supply facts or links. I stick with my opinion that you actually give misinformation because your comments – to put it diplomatically – will lead people to extrapolate and draw the wrong conclusions. I believe the most dangeous side of your remarks is that you mix your own personal experiences with generalisations and I believe this is misleading.

First, I myself am fortunately not affected by back problems myself but got into it by assisting the introduction of a new implant to the market (and in due course you will read about it in medical papers). During this ongoing process, I have however likely been able to see a sizeable amount more surgeries and complications and outcomes than you did (hands on, not hearsay) and have also been able to get quite a clear picture of how the medical spine community works. I do not have knowledge or intend to aquire knowledge about non-fusion technologies (except artificial discs because these fall into the categorie where I want to know what is best). I also have no knowledge about IDET and would not want to comment on that process. Fusion (and artificial discs) should always be the lender of the last resort however and any responsible surgeon will advise accordingly and act accordingly. Prevention is always better than intervention.

However, to start with your statement re IDET I am posting this link http://www.fda.gov/foi/warning_letters/m2548n.pdf for the reason explained later. I believe you have no knowledge at all how the FDA works and what the purpose of the FDA is. It is not the FDA’s job to do studies! It is YOUR job as an inventor/implant producer to supply studies to the FDA. This can be done during the 510K process (for which you must get approval by the FDA), the FDA may also require you – even after approval of the implant – to conduct additional studies. A body of competent medical persons will then verify your results. The FDA does not do scientific studies – another misinformation by you - they check if scientific studies delivered are scientific or require additional scientific studies. You accusation that the FDA supplies flawed information (again you don’t say this explicitly but it is exactly what you state) is very adventurous as it’s findings are exclusively based on facts delivered and presented to them by the producers. If you try to go around this process, you get –rightfully- in serious trouble as the above link shows, which I poste without having even read it but to highlight the process only. You can discuss the approval process by the FDA, rightfully or wrongfully, but your remark does not make sense at all. That means the FDA information is very well helpful to potential patients and you may now understand why I am of the firm oppinion that the FDA approval papers on artificial discs will very likely be helpful to make an informed decision.


This brings us to a second statement of yours: it is impossible to supply clinical verifiable long term data. That is now utter nonsense as this is exactly the process I am also involved in, supplying medical data for an implant to key surgeons. There is not one single patient of which there are no medical records which contain certain data for sure, I mentioned on/off medication, back to work or not etc. Try to get around workers compensation without that data. In other words: if you want to supply data you have the data. That is not double-blind, but enough to give a very clear picture of what is going on. If no data is made available, I personally always ask myself if the data may not be as excellent. Beside this, what do you think the FDA requests from you, hearsay?

Your idea to build up a databank about peoples experiences is a good thing if restricted to enable people to get hands on experience about potential outcomes, but as long as your are not supplying clinical data over a multiyear period/same implant, all patients, you will not be able to draw any conclusions that are valid. In fact, I certainly support you remark “not to accept unsubstantiated remarks”, but that is exactly what you do yourself because you do not supply unbiased verifiable information. It is great that you are doing so well, but that is not an information which is of value to evalutate artificial discs. Basically, I think it is very helpful for other people to get hands on experience of other patients. I believe however it is dangerous to loose sight of the bigger picture and the bigger picture is you but plus another 500 patients as well at least, and over an observation period of at least 3 years.

I also noted your remarks about potential pain, artificial discs can always be removed etc. Discussing this would lead me into an area which I try to avoid as I am not a medical doctor. Having discussed these issues with neuro- and ortho-surgeons I dare however say that the lightness you discuss such issues are far off reality and that your remarks are unqualified and of no help to patients who should ever get into the situation of FBS.

I may add here that you did in fact not write cage = cage = bad. Not in words, in fact that is however exactly the statement you made indirectly because the majority of fusions are of course with cages and I believe that is the way it should be. In other words I don’t think that I cited you wrongly, I simply highliged what you really said. Addditionaly, I respect your remarks about your own success although not proven long term (and hope you will keep your so far fantastic result long term!) but again dare
say that I regard your remarks about artificial discs also as unqualified based on my discussions with surgeons that are not as indifferent as you may think.

It is YOUR duty (meaning the Prodisc or Charite or XY Fusion implant or whatever producer) that must do the clinical study and if your product works, for sure as hell you will do it because we also talk about money. (Spine back related medical systems are one of the fastest growing areas). It it the only way that you are able to prove your superiority and if you are superior you will do it. If you don’t supply this information, I will ask you why.

So here we close the circle. You tell me that I have no idea how slow the medical community is to adapt and you want to tell me that after 10 years of experience the medical community is just too plain stupid to get it (again, not exactly your wording but exactly the meaning of your wording.)

Frankly, I understand your frustration after the pain you have gone through and the frustrating process you have gone through (and I know that you are unfortunately not a small minority), but this has nothing do to with reality. It is your wishful thinking.

To close: The past few years I have also developed a great respect for surgeons who tell me they will not touch a new implant that has not been in use for at least 3 years and proven succesful with clinical data.(Yes, at first I also thought they are stubborn, want to stick what the know etc.!) I was wrong and naiv and I accept now that they are the truly professional experienced surgeons and know how much can go wrong later, after what may look as a success initially.

No hard feelings however!

I stopped posting to this thread because DavidH let me know (off the forum) that the 'discussion' here made him uncomfortable as he approaches his surgery.

However, I feel that my mission to debunk ADR misinformation is an important one and I've started another thread, just for that purpose. I invite anyone who's interested to come join in a productive discussion over here:
http://www.healthboards.com/ubb/Forum14/HTML/003602.html

Mark

The CERVICAL ProDisc is entering clinical trials in the US. You can join the trial and get a 50-50 chance of receiving the artificial disc.

They only accept people with a single level problem.

I spoke with 2 people who travelled from the US to France to receive the ProDisc. Both are satisfied. One received two implants.

I wonder what peole in this forum think about the pros and cons of travelling to a foreign country to get this technology.

It seems very risky, because if something goes wrong you may not have the ability to travel again to correct it, and knowledge in the US is limited at best. What do you think?

Last September I travelled from California to Munich for a 2-level lumbar disc replacement. The cost was very low, about 1/5th of what it would have been in the US, or less. The standard of care was very high and I had the benefit of a surgeon who was much more experienced in ADR than any American surgeon. If something happens to my back again, I'll probably head back there.

There is another German surgeon who's done over 150 Bryan cervical replacement discs. Last December, he started using ProDisc-C. If I needed a cervical disc done, I'd probably go to him. After the clinical trials get to the open enrollment phase an the American surgeons have sufficient experience, I wouldn't hesitate to have it done here.

Remember that even though it looks better than fusion and is very promising, it's still scary stuff with a lot of risk.

Mark

------------------
*** L4-5 and L5-S1 Disc Replacement (SB Charite III) 9/20/02 by Dr. Zeegers, AlphaKlinik, Munich, Germany ***

2/25/00 Microdiscectomy/laminotomy L4-5, 10x15x7 mm left paracentral protrusion

9/23/00 CANCELED L4-S1 360 fusion CANCELED

9/15/01 emergency microdiscectomy L5-S1, 14x13x10 mm left paracentral protrusion

Both discectomies helped with hip/leg/foot symptoms, but left the underlying back pain. Residual left foot pain and numbness. Lost axial reflex (left ankle).

*** The AlphaKlinik was wonderful. My expectations were high, but the clinic, it's staff, and Dr. Zeegers far exceeded them!!!

*** L4-5 and L5-S1 Disc Replacement (SB Charite III) 9/20/02 by Dr. Zeegers, AlphaKlinik, Munich, Germany ***

I'm surprised that you did not opt to get the lumbar disc replacement in the US. The Texas Back institute and others I believe are doing them as they are now approved.

I guess if you needed an emergency follow up, you could have that performed in the US.

The cervical discs are so new in the US, that the doctors here might have a hard time following up on a procedure performed in Germany or France.

I sent my radiology to France, the doc there recommended a single level of fusion using a cage, and a second level of a Bryan Disc replacement. The docs here want to do 2 levels of fusion with donor bone. I figure that if I need a fusion, I may as well get it done here. Why travel so far just to get 1 prosthetic?

Glad that you are happy with your decision in any regards Mark.

-BJ

[This message has been edited by cotal (edited 03-18-2003).]

BJ, the Charite and ProDisc are not yet approved. Charite may be approved in mid 2004. ProDisc is probably a year behind.

Because the study populations are complete, they are allowed to continue procedures for single levels without randomizing into fusion/ADR groups. However, they must still follow the study guidelines for patient selection. 2-level ProDisc is still being randomized.

So for me, multiple level Charite in the US was not an option. 2-level ProDisc ran a 1/3 chance of getting a fusion instead. Even so, I would have had a surgeon who had done only a handful of procedures. Going to Munich, I got the most experienced ADR surgeon in the world, with over 800 procedures. Experience counts here!

Thanks for the good wishes,

Mark

BJ, I think the reason that cervical replacement discs are not as far along as lumbar, is because cervical fusions tend to be much more successful.

Whatever you decide, good luck. Please keep us posted.

Mark

Back pain since 1991 after car accident while 6mths pregnant
Pain on and off for 11yrs
3yrs ago had:
2 x Epidurals
2 x MRI's
1 x Facet joint injection
Oct 1st felt disc tear and had intensive physio for 6 wks because thought to have ligament trouble.
2 x Discograms (last one Dec '02)
2 weeks post op on L5-S1 after DDDwas diagnosed, Disc has been replaced with 'Prodisc'. Feeling great although some pain in right leg and numbness on left thigh. No more drugs.

Hi Dave,
I'm writing to let you know that I have had this operation done and it has been life changing. I couldn't walk or function without being on all sorts of drugs ranging from normal pain killers with Anti-inflammataries to stronger pain killers and Morphine as well as sleeping pills!

It has been a tough 4 months for me and my family, because 3 years ago I had the same trouble and was of work for nearly 3 months until I had the Discogram, which lasted for 14 months.

As I understand I am the 4th person in the UK to have this procedure done (do let me know if I'm wrong), I read an article in a medical journal recently about another male patient who had this done a few weeks ago in Birmingham. I know what pain is in the back it is debiltating and you just don't know what to do about it or with yourself. I really hope that this sorts out your problems as it has mine. Feel free to contact me if you need to ask any questions. I had a very good Surgeon and was very confident about going ahead with this procedure.

Best wishes
Tracey

Hi Tracey,
Thanks for posting and offering to provide info. I'm really pleased that your surgery has worked.
I'm off to Munich for disc replacement(s) in two weeks time.
Hope you keep improving
Best Wishes
Dave

Hi Dave,

I had the PRODISC operation on 5th March '03 and am feeling great. I had it done in this country by a great consultant in Hertfordshire, my consultant couldn't perform the op as he hadn't had the training, he assisted and was really pleased with how everything went. I'm recouparating at home for the next month but feel better each day.

What exactly is your problem, ddd? Would be great to help others understand this 'new' procedure over here and would like to get people together for support.

Tracey
Middlesex, UK

------------------
2 weeks Post 'Prodisc' Operation and feeling like I'm 25 again!

Best of luck, Dave H, as you prepare for your surgery this week. Say hi to all the beautiful women of the AlphaKlinik for me - oh yes, and Dr. Zeegers too!

Please drop me a line after your surgery!

Mark

I'm off to the Alphaklinik (Munich) tomorrow for surgery. Thanks to you all for posting over the past couple of months. I'll let you know how I get on.
All the best
DaveH

My Daughter, 22yrs old, was injured in a car accident 2years ago and has suffered with back pain ever since. She has undergone physical therapy, chiropratic care, steroid injections, IDET and numerous, myelograms, dicograms, CT. We will be seeing a new Dr. in 2 weeks who is doing phase 2 of the ProDisc study. Since she is so young and fusions will cause more problems down the road with the other disc, we will look at all options. I would rather have a cure that didn't involve either of these procedures. She also has the added complications of having only 4 lumbar disc instead of five. I have previously had a 3 level laminectomy that I remained in severe pain for 4 years, but now I am totally pain free. I wish hers could be this simple.

I am researching everything I can get my hands on regarding ADR and Fusions.

Margie

Hi Everyone,

I'm now two weeks post op after a double ADR L4/5, L5/S1 performed by Dr Zeegers at the Alphaklinik in Munich. The type of disc used was the Charite Link prosthesis.

So far, and I know its early days yet, everything has gone fantastically well. From being able to only walk 200 yards without resting I can now walk 2 miles with no pain.

In fact, it feels like I am now beginning on a new life (I'm 40 today!) and I still can't believe that all my back pain has disappeared. I hope it stays that way! I won't claim that I am completely pain free as I have quite a lot of muscle pain however I expect this to gradually disappear as each muscle gets use to working properly again.

I am not a doctor and have no medical training but I from my experience I would recommend checking out the Alphaklinik if you are considering back surgery. The doctors at this clinic and Dr Zeegers in particular have a great deal of experience in back surgery.

I was very nervous about travelling to a foreign country for major surgery but, so far, it has been one of the best decisions I have ever made.

Margie, if you have any questions please post them and I will get back to you ASAP. I'm flying back to the UK today so it might take a couple of days getting back to you.

I hope my experiences give some of you out there hope of a cure to your back problems.

Take care

Dave H

Margie,

The web address for the Alphaklinik is www.alphaklinik.com (http://www.alphaklinik.com)
It is a very informative site and there is an English version.

Dave H

David, I'm so glad to hear of your success. Thanks for posting.

Just a heads up.... don't be surprised if your link the the alphaklinik's website gets deleted. The terms of service for HealthBoards precludes members from posting such links. They are very strict about enforcing their TOS.

Talk to you soon...

Mark

I have just learned from a study coordinator that the FDA has now changed the enrollment protocol for the Pro Disc here in the states. Apparently, there is no longer a fusion are to the study. Now all patients can receive the Pro Disc, no one is placed in the fusion arm of the study.

The major difficulty I am experiencing with the procedure is getting my insurance company to pay for the prosthetic Pro Disc. My carrier is Aetna, and I have at least received permission to send a letter to the medical director to try and provide a "medical necessity" for the disc over the fusion. If anyone has any suggestions for reasons that would help me obtain medical neccesity status over a fusion, I would greatly appreciate your input.

I am 33 years old and had a micro-discectomy at age 23. I have DDD at the same site of L5-S1, with two major tears in the disc as confirmed by discogram. I have received three selective epidurals and I still have limited leg pain and high concentrations of pain in my low back.

I appreciate any suggestions on how to approach the insurance company.

Thank you.

go directly to the doctor making the recommendation. He should be able to give you a short letter indicating why its reasonable and necessary to have that surgery over the fusion. I would then write a separate letter myself indicating that the likely hood of future treatment is decreased, recovery period is much less and follow ups I would assume are less. Less x-rays for checking the status of fusion, etc.. Over long run could save insurnace company much more money as if the fusions doesn't work you could be stacking up the bills.

On the other hand, for you, it also give you I assume the chance of future fusion should the disc replacement not work. I don't know if they do fusion after replacement but figure it could be done as last resort. Anyway, it gives you a couple chances rather than just one.

BIG THING IS FUTURE CARE SHOULD BE LESS IF THE REPLACEMENT IS SUCCESSFUL, just not sure the difference in cost between the fusion and prodisc to start with.

Good Luck.

------------------
Auto Accident Aug 1988
L3-4 disectomy 1989
L3-4 now re-herniated
L4-5 DDD
L5-S1 herniated
5/14--scheduled for trial stimulator implant
Hopefully to hold on for Prodisc for all 3 discs

[This message has been edited by wbaker68 (edited 04-28-2003).]

Hi East Texas Bear

I'm 3 weeks post Op 2 level ADR using Charite link disc at the Alpha Klinik. So far with fantastic results. I can't advise about insurance as I had to pay myself (22000 euros to give you an idea) but I did ask my surgeon why he uses Charite ADR's instead of Pro Disc. He said that the Pro Disc can't be moved (or are very difficult to move) after inplantation, if the alignment is not spot on and that there is much more known about the Charite discs as they have been around longer.

The main thing to ask your surgeon is how many ADR's he or she has performed. I could have had the Op free on the UK health service BUT the surgeon had only performed 15 ADR's. Whereas Dr Zeegers at the Alpha Klinik has carried out more than 800. No contest really as you only get one chance with this type of surgery.

Finally make sure that you have plenty of physiotherapy lined up for after the operation as you will certainly need it.

Kind regards
Dave H

Yes, the single-level ProDisc population is filled, so they are into the open enrollment phase... no more 2/3 ProDisc, 1/3 fusion. However, for 2-level patients, they are still randomizing.

David is right.... for both ProDisc and Charite' experience counts. But, many US surgeons are well over 50 procedures. Some of them are truly the cream of the crop... I wouldn't hesitate to be Dr. Regan's 50th patient!

Since I needed 2 levels, I would not consider the ProDisc study in the ranomization phase... I did not want to risk fusion. I learned, like David did, that travelling to Europe is not all that expensive. So if 25 to 30 thousand is doable for you, Europe is a good way to go. Charite should be FDA approved in about a year. That will open the floodgates for multi-level procedures, but beware... there will be a whole new learning curve for the US doctors as they must then learn when they shouldn't be doing ADR - now that the study guidelines will no longer apply.

Good luck... pain-free vibes out in all directions,

Mark

East Tex Bear,
I had the L4-L5, L5-S1 ADR surgery as a participant in the Prodisc trial at a famous back institute in Plano, TX in Dec 2002 (hence my username = ADR2002). Your surgeon and his team will be able to help you get things set up with your insurance company so that they will pay for it. Mine was covered. My total out-of-pocket was less than $1500. I was told that most insurance companies considered the significant difference in the cost of 360-degree fusion and ADR (since the artificial discs were supplied free by the manufacturer) with only the "Blue" insurance companies dismissing it out of hand.

My surgery has also been miraculously successful, although like mmglobal (Hi, Mark!), I do experience some pain at times. I am doing very well, pushing the envelope on the activities that I can now do without pain. I have not had any narcotic pain killers in months. I do occasionally use NSAIDs, mainly ibuprophen and naproxen sodium.

Before deciding to participate in the trial, I did several weeks of research and agonizing over the decision. I have had a successful bi-level ACDF, but wasn't pleased with the idea of having a 360-degree lumbar with harvested bone tissue. Not knowing about the opportunities in Europe and having lots of pain, I decided to take the chance and, fortunately, I got the Prodiscs.

Knowing what I know now, I would probably take the route of getting the surgery done in Germany rather than participate in the trial, because there is still a 33% possibility of getting fusion.

My intent is to complete my 2-year obligations under the trial so that Prodisc can be proven and accepted for use in the US.

My personal experience/opinions. Take it for what it's worth.
Tony

Hey Mark -

How are you doing with your new disc? Still well? Im thinking of having my l5/s1 replaced. Im waiting for teh nonrandomization phase of the prodisc here in Central NY (Syracuse). I have to say, when I read teh net, I find a good number of folks who are thrilled with the outcome, but I also find a the uncomfortable truth of some who havent. I think Ive found 5 or so (2 here and 3 elsewhere). Im just an L5/S1 but Im not decided anymore. Well I was until all the reading I did this evening. I actually have read almost ALL the published medical resulst that have come out (as in SPINE Journal etc) from Europe. But man the failures are a fright.

Paul

A very heartfelt thank you to all who have responded to my inquiries about the Pro Disc. I am going to pursue this opportunity, and although I don't take this procedure lightly, I feel much more confident about the results of the Pro Disc vs. a fusion at this point. Again, thanks to you all for your guidance.

Hey Dave,
Are you out there? Hope all went well. Looking forward to hearing from you!

Mark

Hi Dave,
Sorry about that last message I got stuck on page one of the thread and did not read all of the new messages.

CONGRATULATIONS!!!


I would like to pick your brain but I am pressed for time right now.

Glad to have you back

Mark