SB Charité Artificial Disc and ProDisc: The Future of Disc Repair

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Topic Title: SB Charité Artificial Disc and ProDisc: The Future of Disc Repair
Created On: 10/17/2003 08:55 PM

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 10/12/2005 09:36 AM

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mrbee1957

Posts: 11

It has been many months since my last post here. I believe it to be warranted to share my story since my revision surgery at Stenum hospital. For many of you, you know my story, for those who don't I will make it brief (laugh away those who know me).In Dec 03 I suffered a major rupture fragmentation to my L4-L5 disc. I subsequently went through three (3) immediate hemi-laminectomy surgeries to remove the awful mess. This all occurred in a two week period.After this my L4-L5 disc was completely removed, well the annulus was left. I continued down the path of hellious discovery of not having a functioning spine and of course pain. In April 04' I began investigating the world of ADR. This path led through the clinical trials and the world of Pro Disc, Charite and a number of other devices. After seeing three ADR surgeons and getting denied access by my insurance for the Charite trial. I like others using the internet researched the many posts on the subject. I also found Stenum hospital. After exhausting all stateside avenues, I made the decision to go to Stenum. Some of you now may remember. In August of 04, after getting the approval from my surgeon to withstand another surgery and seeing the results from other Americans going to Stenum, I traveled to Germany with hopeful expectations. Upon arrival all was as explained and our accommodations and arrangements were wonderful. Meeting our group of other Americans undergoing the ADR surgery was informative and helpful to my wife and me.So after a physical and prep work I was readied for the surgery. During this the decision was made for a two level. So I was to have the L3-L4 and the L4-L5 replaced. Made sense to me to get two while you’re in there. All though I never had a disco-gram only a physical exam by the Stenum doctor. On to the surgery, 2 hours later and in recovery I was feeling great. Really! No more leg pain and I was taking no morphine and amazingly felt better then the previous surgeries. Was I pumped and happy!So it was with some reluctance to find I was hurting in the abdomen and swollen and my back locked up at times. Not knowing what this was and then getting the first x-ray and looking at it with some puzzlement why one plate was sinking into the vertebra? In asking I was told this is irrelevant. I said OK. But the stomach issue? Also common and no problem. After flying home I was hospitalized with a large seroma and build up of fluids abdominally. However, after all I was home and ready to recover and a short hospital stay was like OK. However, new x-rays revealed the L3 plate had sunk further and this was now serious. I visited my doctors here and one of the chief Charite investigators. I now had major pain again in the back and daily lock ups. This was due to a major degree of subsidence from the plate shifting into the cancellous soft tissue of the vertebral body. “Wow, just fix it doc” I said.Well this meant another surgery which couldn’t be done in the USA. So after many calls to Stenum and Depuy Spine, Stenum re-looked at my new films and agreed it had to be revised. What a struggle.In October 04 on the 10th month to the day of my first surgery I had surgery #5. A revision to explant the L3-L4 Charite and implant a larger size. Oh did I say that the reason was that too small of an implant was used. I forgot. But that is what I was told. A technical error. Happens. On to the surgery, well this one was longer like 4 to 5 hours and this time in recovery I was in PAIN. But I soon asked for the morphine to be stopped as I couldn’t feel my left leg, the leg that took all the original nerve damage from the ruptured L4-L5. Soon the nurse followed my request after getting doctors approval and then it happened. My left leg was ice cold.In record time I was in an ambulance headed to the Red Cross for testing. This revealed a major closure of the left iliac artery, an occlusion. My companion was told this was over 6 cm long. My blood flow was reduced over 50% to this leg and the odds of me keeping the leg was maybe 25%. Much speculation was made as to how or when this happened. Anyway, long story shortened, after 2 agonizing weeks of pain and horrible thoughts and a failed angioplasty to open the blocked artery, I came home. After which I spent two weeks in the hospital for pain management. Then home taking daily 240mg of morphine, 2100 mg of lidocaine patches and a litany of other drugs. I was wheel chair bound, when I could tolerate sitting and in bed-rest awaiting another angio or a bypass surgery. After three months I underwent the second angiogram which was again a failure. So then I was scheduled for bypass surgery yup, #6. This would entail a risky abdominal approach through the mass of scar tissue, open my chest to get to the aorta and place a plastic graft from there to the femoral artery on the left side. If this failed I would have my left leg amputated. Or die from infection, lung collapse you know standard stuff after six surgeries. So was I frightened! Out of my mind. Why did this happen to me? Well God knows.In mid May, 2005, I showed up at UCLA medical center for my pre surgery exam. In walks my surgeon, “Whoa, Mr. Beeson, what has happened? You look great!” I said yes. He asked again and then said if you look this good and your leg is good, then we can postpone surgery”. I said excellent, and then I told him what happened. I was prayed for on Palm Sunday at a new church near my home. Some things happened. Then in early April, I was hospitalized with a near fatal bacterial infection. “Go on he said”. Then in late April I was in bed and had a vision and God told me I was healed and would be healthy and strong. When I awoke and got out of bed, I had no more pain anywhere and my leg felt OK and I stopped all meds with no withdrawals. He exclaimed “This is a miracle; so let’s examine you and find out what the leg is doing”.So a new ABI test was conducted and my left leg went from .5 to .82. He said this is a miracle that an artery has either opened on its own or you have created new major collateral arteries. He said go enjoy and I’ll see you in 4 months. But there will be some pain in certain activities. I said no problem there doctor. It is incredible and a miracle. Is this for real?Explain then stopping all those meds, with no withdrawals. According to every doctor I should have had a cardiac arrest. 240mg of morphine to zero not happened before they say. Am I crazy or blessed? I prayed for the latter. I pray that everyone who has reached the point I was of little or no hope is so healed. Why me? Only God knows. Why did I share such a personal experience? To shed light on the way, the awesome way I was healed. This wasn’t through medicine or doctors or surgeries. In fact I should right now be either one legged, dead or if I survived the sixth surgery and recovered to have normal blood flow, I would still be in terrible pain and on morphine or something.Again, I haven’t been on this forum during all these months and I felt compelled to share this awesome story. I also wanted to inform all of you who read this that I am not a Stenum success (the new L3-L4 implant is improperly placed). I wish I was an ADR success, I know many who are; I also know those who are failures. I believe my story will help those searching for their own back pain relief to search carefully. To avoid by my story, all true, yet a fabulous ending through prayer and faith, making quick decisions based on marketing efforts of hospitals or manufacturers. You must make the right decision whether for Stenum or not or for ADR or not. I hope this will provide that bit of information that helps you make that right decision.I sincerely pray for each of you for relief from the pain and lifestyle altering result of debilitating back pain. I also pray for those involved in this forum and the medical field for the continued success in performing this work. As many in these fields perform exceptionally well and we should remember them in our thanksgivings.God bless you all,Willie Beeson
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 04/24/2005 03:17 PM

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steugirl

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Carmont, Thank you once again. Willie has already recommended Mark and I'm waiting for his reply as I write this. I can't begin to express my appreciation to you and everyone else who has taken the time to answer not only my inquiries, but those of anyone else finding themselves in a similar situation. The information I've received this past week has been invaluable, regardless of where it leads. I feel better in knowing that my decisions can be based on more than guessing and hoping, even though forever present. I'll let you know what Mark thinks. Dale Steuer
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 04/24/2005 12:56 AM

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Carmont

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I hope you will not rule Germany and Dr. Bertagnoli out completely. Please contact hime with your records and at least get an opinion from him. You have a complicated case that seems unlikely to be resolved with anything other than a 360 degree fusion in the US. Its worth at least the exploration for his opinion, as he is probably the best ADR surgeon in the world. He and Dr. Zeegers. There is a man, Mark Mintzer at www.gpn.com, I think, ( Global Pateint Network ) who personally knows all of the top ADR surgeons here in the US and in Europe, and could steer you in the right direction if you want some guidance. He has helped many patients with difficult cases and helped me when I had my tilted vertebra. He got opinions from three other top surgeons in Europe and the US in a few days time to help me make my decision about surgery. If you can't find him online, I'll get you his phone number. We know you are facing difficult decisions and are dealing with so much right now. You are in our thoughts and prayers. Carmont
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 04/23/2005 01:52 PM

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steugirl

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Carmont, Thank you for your reply. I'm now getting a much better understanding of both the good and the bad, but the bad is more than nervewracking. It is also doubtful, after reading about some of the failures, etc., that my husband will agree to go to Germany, which until this week was a definite option. If anything doesn't go exactly as planned and we're forced to spend additional time there, it might prove disastrous. I do though, have more information than I did one week ago and am beginning explore other options, though the direction I'll take is still quite uncertain. It's all beginning to look like a maze that has too many paths to an end result. Dale Steuer
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 04/21/2005 08:34 PM

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Carmont

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To Steugirl, Its hard to read of your disc problems and the need for correction at four levels. First and foremost, please do not consider surgery at Stenum. They have had several poor outcomes recently and I personally know many of them. Four patients who had bad outcomes were with me having surgery in August of last year. I am hearing that Stenum is admitting to only one poor outcome, Willie Beeson. This is serious underreporting of botched surgeries. Secondly, as a recipient of a Dynesys system, I believe that the device is not to be used as a replacement for ADR. Instead, it is intended for stability, and for other reasons. Stenum installed my Dynesys, because my ADR discs were not placed properly and one of my vertebra fell over laterally and needed to be righted. Revision of the discs was dangerous and the Dynesys was the least invasive surgery to correct my problem they could offer me. Dynesys was not a magic bullet and I still have pain and burning. I've read that Dr. Bertagnoli is the doctor to see when there are four or five levels that need to be addressed. He may be the only surgeon who has done five level ADR surgeries. Please send your information/films to him before you make a decision. I have heard wonderful things about him! You can get a lot of information about him and other great surgeons on www.adrsupport.com. Please check this site out, because there are many knowledgeable people who post regularly there and they are a wonderful, supportive and helpful and kind community. I wish they were around before my surgeries.... I do understand what you are going through with your pain and frustration, as many of us have been where you are now. Its tough. I'm glad to hear you are willing to travel, because even though I had a bad outcome at Stenum, the nursing care there was excellent. And in fairness, I do believe that Dr. Zechel is a caring person, but he only assists Dr. Ritter-Lang with the ADR surgeries. I've heard from a man who watched a surgery there that Stenum doesn't use flouroscopy during the procedure(which is the Charite technique in their manual) and they "eyeball" placement, which isn't good enough. It seems as if the staff's hearts are in the right place. So, I would think that other facilities provide a wonderful level of care in Germany as well. I've read that in other's posts. My best to you. Keep posting with information about your progress and plans. Carmont
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 04/21/2005 05:53 PM

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steugirl

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Dear Willie and others, After 2 previous discectomies, my final discgram revealed 4 bad levels, S1-L2 and I have been advised to get a 4 level adr, though to date, none have been preformed in the US. I am working with Dr. Delamarter in Santa Monica, CA and St. John's hospital also in Santa Monica who utilizes the Prodisc, which I just read hasn't been approved by the FDA???. I contacted Dr. Bray from Cedars and was told they are only doing 1 level. The FDA was petitioned in November, 2004 but we have heard nothing yet and I don't foresee any quick response either. I read with dismay, what you experienced as I was considering the Stenum hospital who has offered to do 2 levels and 2 dynesis???(sorry for the spelling). At this point I am not considering fusion. Since I ruptured in the past, I am quite fearful of doing so again, and am in flexion distraction therapy in efforts of keeping me stable (it is the only thing I've found that even remotely works). I can hardly move anymore and my life is limited to almost nothing. When something important pops up, I increase my therapy for a short time but it is far too expensive otherwise. I am open to all recommendations and am willing to travel though would naturally prefer to stay in the Los Angeles area. Does anyone have any advise? Please!!!!
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 04/03/2005 11:40 PM

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Carmont

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Also, in regards to MrBee's posting in March. Other than myself, I would like to hear from one other Stenum patient who has actually met and spoken to Dr Ritter-Lang, the primary surgeon doing ADR surgeries at Stenum Hospital in Germany. I was told that Dr. Ritter-Lang is not comfortable with his English and he prefers not to communicate with his patients. I thought his English was far superior to 90% of the staff at Stenum Hospital. Very educated in English. Why is the responsibility of communicating with the patients left to Dr. Zechel, when Dr. Ritter-Lang is the primary surgeon and Dr. Zechel is the assistant?
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 03/12/2005 11:57 AM

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mrbee1957

Posts: 11

Another update to Back1.com regarding my complications arising from the revision surgery performed at Stenum Hospital late last year. After this surgery to replace my L3 Charite end plate that was sinking into my cancellous bone of the vertebrae, my left leg was cold and had zero pulse. As I stated in prior posts, the trauma received from this surgery at Stenum Hospital caused or completed a complete closure to my left iliac artery. I am now approaching 4 months post op from Stenum Hospital and the revision surgery. My condition has declined to now I cannot walk 300 ft or sit too long. I stay in bed rest everyday. A week ago I visited Dr. Quinones (Vascular Surgeon) at UCLA for his opinion on this serious injury. He exclaimed that I have been fortunate to still have my leg! This was a shock due to the doctors at Stenum Hospital and the vascular surgeon I was taken too claimed this was not emergent. However, Dr. Quinones differed and indeed his observation was that I should have had an immediate bypass surgery to insert a plastic tube graft from my aorta to my left femoral artery to restore the blood flow to my leg. Dr. Quinones was quite shocked at the poor advice I have received. The most overwhelming being the time elapsed due to the series of doctors telling me to wait. His reason for immediate action is due to the prior abdominal surgeries have created in these 4 months now a massive amount of scar tissue which will be difficult and complex to pass through to access my left common iliac artery without causing other serious complications. So for those of you considering ADR surgery, please do not hesitate to ask who is your vascular surgeon? What are his/her credentials or certifications? How many ADR approach surgeries have they completed? For those of you looking at Stenum Hospital we were told that Dr. Ritter-Lang was the certified vascular surgeon. We were never shown his credentials and it is interesting that he also performs the ADR surgery. German medical certifications must be different than ours here in the USA. Again, if you are reading this post and are considering ADR surgery where ever you go, please ask this. For those of you who have found this and have seen GetADR.com webpage please ask why it shows for Stenum Hospital zero revision surgery and zero vascular injury. Granted my occlusion to my left iliac artery was deemed to be caused by my massive L4-L5 disc rupture, however, I didn't have leg ischemia until after this last surgery. Please beware of this and I hope this helps someone planning ADR surgery to ask the right questions about how your vascular artery's will be addressed, a spine surgeon is not a vascular surgeon, unless he completed both disciplines. For a very informed site on ADR and access to ADR surgeons and ADR seminars go to www.globalpatientnetwork.com. Soon I will be under going my sixth surgery for my original back injury. This one is without a doubt the most serious. I hope no one else will follow me on this path, if I can be a Daniel Boone in post ADR it is this page which will, I hope, help others in their search. Sincerely, Willie Beeson Email: [email protected]
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 01/15/2005 02:15 AM

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mrbee1957

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Hi Katie, ADR works very well for DDD, however, stenosis can be a problem. Again, an MRI will reveal this to a skilled ADR surgeon. I know Dr. John Regan at Cedars Sinai in Los Angeles and he is probably the foremost ADR surgeon in the USA. He also does fusions, microdiscectomy, etc, he is a spine surgeon. If you wish to contact him his office number is 866-56-SPINE or 310-423-9900. If you are too far from LA, then maybe he or his assistants can direct you to an ADR surgeon near you. Mention my name as they all know me well, unfortunately. You mentioned loss of muscle, are you deconditioned from the back pain? You said you are working as an RN this is demanding so I presume you are in decent shape. So ADR is a good fit if you are. Fusions take more time, early on and more pain meds then ADR,to heal. However, the results show at 2 years the pain level is the same for both! With ADR you will have more mobility, if this is important than go that way if you can. Keep me posted or ask more questions anytime. Sincerely, Willie
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 01/14/2005 02:14 PM

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chris10246

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thanks for your input. i haven't had a discgram but have had several mri's and a myelogram. compounding the disc problem is the fact that i have spinal stenosis at those levels. i've had 2 surgeries--L5S1 discectomies right and left but that level is collapsed at this point. this has been going on since 1990. is ADR appropriate with stenosis and DDD? I'm losing fuction(dorsiflexion) and atrophy of muscle is beginning. i've been waiting as long as possible as fusion is such a huge surgery and i fear losing my job(rn). so it goes. thanks,katie
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 01/13/2005 10:12 PM

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mrbee1957

Posts: 11

Hi Katie, How was this verified through x-rays or mri? If with mri are they confirming using a discgram? These are very important steps when you are told you need a 3 level fusion or ADR. The Charite has ben approved for single level by the FDA. I know through that you can go to a back surgeon who is doing the Charite implants and ask for a compassionate approval appliacation to the FDA. I met a friend over the weekend who 11 weeks ago had a 3 level performed in San Francisco. Of course that was using the Pro Disc, which since the Charite has been approved no one is doing the Pro disc since it hasn't been FDA approved. Go to DePuy Spine web page as they own the Charite and can direct you to the nearest participating surgeon. Use caution ask of their total number done. How many have they had to redo? Infections? Can you speak to one of their patients, could be a privacy issue there, especially how many 3 levels have they done. Since this was just approved in Oct 04, I doubt many have done 3 levels. In fact I bet there aren't more then one hundred in the world. You are in select company. Waiting is your best bet now for the new surgeons to catch up. If the surgeon you meet was in the clincal trial, then he/she will have greater experience. Keep me posted. Willie
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 01/13/2005 02:46 PM

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chris10246

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i don't have the answer you seek but wonder if you find anything out you could reply to my posting. i have been told by 4 docs that i need total lumbar fusion and have stenosis at 3 levels so wonder too if this artificial disc could be used. i would appreciate it if you could pass on any info. thanks,katie
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 12/05/2004 10:05 AM

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mrbee1957

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To readers of this Forum, In August I posted my early experience with my 2 level Charite SB III surgery. I was just 2 weeks post op and I was very excited with the terrific improvement. Well a lot has happened since then I feel it is important to post my continued progress. Beginning with my 6 day post op x-rays my L3/4 level; the top plate had sunk into the vertebral body. My surgeon indicated this was no problem. At 6 weeks it had sunk significantly further. This movement is called subsidence. The new position was so severe, the implant was malfunctioning causing a new pain and my spine would lock up. After many emails and phone calls, Stenum hospital agreed to redo this at their expense. On Oct 23rd I underwent the revision surgery. After 4 plus hours, I awoke in recovery to find both legs numb (a condition caused by the spine block anesthesia) once I came to I asked for the morphine reduced as I wanted to see what the pain was like. My companion (a friend and ADR expert) noticed my left foot was cold. The doctors could not feel a pulse in my groin, knee or foot. They decided to send me to a regional hospital for testing. After a CT scan, my iliac artery was found to be occluded. This was seriously reducing the blood flow to my leg. The medical team now including the vascular surgeon felt I needed to recover from the back surgery before an angiogram could be performed. We waited one week. During this week I had incredible breakaway pain in that leg and foot. The hospital had a very difficult time in managing this level of pain. Unfortunately we found my tolerance to Oxycontin after I overdosed one night. Thankfully I received the care to survive that scary night. Then back to the other hospital for the angiogram. They tried to open the occlusion using a balloon and stint, they were unsuccessful. Note, I would from this experience advice no one to have an angiogram performed one week post op back surgery. I thought I was going to go mad with the extreme back pain and I was not allowed to move for 20 hours, from this procedure. I don't know how I made it through that hellious experience. However, I was approved to come home which we did (my wife flew over to be with me due to these extraordinary problems). Once home I was rushed to the hospital for pain management. After one week and testing of my leg which has an ankle brachial index of .54, I was seen by a vascular surgeon, the outcome is I now must have a femoral to femoral bypass surgery using a plastic prosthesis tube. However, the medical team will not schedule this until I am off the major narcotics I am on for the nerve pain. Oh I forgot, the L4 nerve has been severely damaged when the new implant was installed and the distraction of the vertebrae was made to set in the larger implant to prevent subsidence. Which now at 6 weeks post op this was successful. For those of you here considering ADR, please do your homework, select a surgeon who has performed more then 100, has a low failure rate and understands subsidence issues. My surgeon has performed over 900 ADR and 3500 ventral approach. However, there is that risk with all of a failure in placement, size, injury to a major vessel, infection and etc. Albeit these typically are low percentage, however, we all think it won't happen to me. Carefully consider your options. I had no choice well I could have opted for a fusion, but I preferred the ADR as I am young (47) and very active, well I was. So this is my update for anyone seeing this and I welcome questions. Sincerely, Willie [email protected]
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 08/13/2004 09:13 PM

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mrbee1957

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Hello! I am in Germany right now. I just had a 2 level Charite ADR surgery performed on Aug 7 at Stenum Hospital. I am in Bremen right now at the Hilton Hotel. I had a most amazing recovery. I am not the typical patient. I walked right after the surgery and went to toilet immediately. I also did not take any morphine. I have had 3 previous back surgeries already all this year in Jan, so I guess you could say I know pain. In Dec 1, 03 I exploded the L4-L5 disc past 24 mm. This required immediate surgery and it reruptured. Then I formed a blood clot in the spinal canal on the nerve. Not fun, but I survived. Symptoms were in left leg no feeling at all. Except for pain, sensory was gone, thigh to toes. After surgery with the disc removed I had great pain in low back hard to move without grinding bone on bone. After 3 opinions all ADR in USA doctors. I came here to Stenum. I now have little pain in the back from stretched ligaments and muscles post ADR (Dr. Zeechel did L3-L4 due to leg symptom post other surgerys) I have FEELING in my leg. Post op I walked immediately, most folks take 2 days. I walked 3 miles on day 3. I wanted this so badly my addrenalin was high. I am on vioxx in Hotel and they come to give massages. Bremen is a great city we take walks several times a day. And terrific shopping. I must take a nap everyday due to post surgery pain and healing needs. Mine has been so far a good success, each person is different, please investigate for your situation. I had no choice. I was told I would not be walking in 6 months and would have to wait for 1 to 2 year for the FDA. Call Stenum, talk to Malte Petersen, he will give you the straight and honest info. except for language issues the care was most excellent. And with other Americans with you or form your country it is very helpful. Stenum is in a beautiful part of Germany and very peaceful. Even with my good success I plan for a one year recovery to step by step get my health back. If you wish email me @ [email protected] Willie Beeson
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 07/07/2004 01:23 PM

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flubey

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Here is an awesome Hospital in Germany. I wish I could afford $20,000 for the surgery which includes pre and post care at the hospital and 7 days at the Hilton. Check out all pages of the website. Worth the read. http://www.getadr.com/stenum_hospital.htm
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 07/07/2004 09:48 AM

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EBL123

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I would appreciate any information about European doctors who perform Total Disc Replacement surgery. Is Dr. Marnay still practicing or Dr. Bertagnoli? Any contact information would be appreciated. Thanks.
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 06/24/2004 10:14 AM

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flubey

Posts: 3

They did not approve the Charite artificial disc the FDA approved to go forward with the approval process. My Neurosurgeon said that it could still be another year before it finally gets approved here in the U.S. even though they have had great success with its use in Europe for the past ten years. Then it could be longer than that for insurance companies to pay for the new procedure. Looks like I might be getting the fusion after all!!!
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 06/14/2004 01:57 AM

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dinah007

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The FDA unamamously approved the Charite disc. See article on www.depuyspine.com/about/about.press.060204.asp
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 06/02/2004 10:03 AM

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flubey

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I am also in desperate need of more info of when the FDA is supposed to conclude the research and approve or disapprove the artificial disc replacement clinical studies. Does anyone have any clue?
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 02/26/2004 02:00 PM

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bsutton

Posts: 1

I would also like to know any info on artifical discs. If you learn anything please forward it to me. I have had a lamonectomy at L4L5 and now have instability and a degenterative disc. Thanks, Brian
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