 |
| Photo: FDA |
Total disc replacement is still a relatively new surgery. The goal is to take out all the disc material in between two vertebrae and put a moveable device in its place. The artificial disc addresses one of the problems with spinal fusion - the limitation of movement at the place where the surgery is done, which may, in turn, cause problems in spinal joints above and below the surgical area, later.
So the artificial disk replacement sounds like a good idea, perhaps? After all, it will allow you to move your spine and it is supposed to take away the pain immediately. If you are considering a disc replacement surgery, slow down. Studies on the artificial disc are sketchy, in more ways than one.
First of all, be sure you are a good candidate for this new type of surgery. The American Association of Orthopedic Surgeons says if you are an ideal candidate for an artificial disc replacement you will have the following characteristics:
- Your doctor thinks your back pain is caused mostly from one or two disks in your low back.
- You don't have facet joint problems. (The disc replacement surgery sometimes causes facet joint problems.)
- There aren't any bones pressing on your nerves.
- You are not obese or grossly overweight.
- You've never had a major spine surgery before.
- You do not have scoliosis, or other spinal deformity.
Next, recognize that because this surgery is still quite new, not all the questions have been answered. There are few, if any long term studies that have looked to see if the pain stays away beyond the two year mark. Also, device failures do happen. And, surgeons need to be trained in the technique before they can perform it well.
Before an artificial disk can go on the market and be used in surgeries, it is the subject of a clinical trial done to assess its safety and effectiveness. Medtronic's Prestige Cervical Disc, for example, was approved in July of 2007, after a 2 year trial involving 541 patients altogether. Two hundred seventy six of them had a disc replacement - the others served as a control group, for comparison purposes. Based on the results of the study, the FDA approved the device. But most people would want to know that a neck surgery will relieve their pain for much longer than two years. So the company is now required by the FDA to conduct post market research for 7 more years. This is true for all artificial disc manufacturers in the US.
This leads me to mention another problem -- the potential loss of objectivity in the original research process. Researchers from the clinical trial for ProDisc, a device made by Synthes, are now under scrutiny by the FDA for not having disclosed their financial ties to the manufacturer. The New York Times has the full story on that one. What this might mean to you is that if you are considering a disk replacement upon the recommendation of your doctor, the safety indicated by the very test that gave the green light for the product in the first place may indeed not really be there, as the researchers have an invested interest to see the ProDisc device succeed.
Is it at a future for people that have had
Fusion and lamenectamy to get this operation and even above re lumbar? Is that at all a future option?
Hi, Josh,
Technically, no. It is not recommended that a disk replacement surgery be done on patients who have already had back surgery. But doctors do it, anyway. If you have had a back surgery and are considering a disk replacement, please be sure to research all your options and ask a lot of hard “what if” questions of your doctor before deciding.
I had Microdicectomy performed about 2 yrs ago and I’m still in a lot of pain. I’ve been going to a “Pain Management” Dr. Since the surgery but, manageing the pain consists of Pain Medication every month and that’s all! The meds don’t even eliminate the pain but, do make sure I have a HARD time functioning normally on a daily basis because of the drugs. Would the disc replacement be a good fit for me?
had S1-L5 fused in 2000,L5-L4 & L4-L3 fused in 2001.things have been great(virtually pain free)since then, until may 08, had an “episode”, took 2 months to work that out, now another “episode” (spasm,pain,low back.right top hip) 12/25/08.ortho says level above fusions starting to deteriorate, some facet arthritis..before this goes too far..( I see the handwriting on the wall),can they put an artificial above my fusions ? I would like to break the cycle of degeneration.
thank you
I am presently considering disc replacement…had the IDET last summer…pain was Ok for a couple of months, now pain worse than before the IDET…Lower back pain, spasms in my lower/upper back…sciatica in right leg, now transferring to left leg..seeing Chiropractor…seeing pain management Dr..taking oxicotin, after being on vicodin for almost 4 years…Yes, 4 years, Dr switched to oxicotin almost 3 months ago, worried about my liver…I’m scared to have the surgery…but I need a relief…taking entirely too much time off work. Stopped the oxicotin a few days ago, scared of the effects…they were making feel crazy. PLEASE HELP…Any advice is appreciated
I had the Charite ADR in 2002 and it has been the worst decision I have ever made. I have had 3 additional major surgeries to try and fix it. I finally had to quit working totally and take tons of meds but I am still in constant pain. I have found out through my research that the Doctor who implanted me had a large financial interest in getting this device FDA approved. I wish I had just had fusion I am confident my life would be a hole lot better. The disc is more complex than a knee or hip and this device is far from acceptable. Due you research there is tons more out there than when I had to make my decision and make sure your Doctor is not connected to the device maker in any way.
Jim,
Wow, that is quite a story. Thank you so much for sharing your experience here, and hopefully helping others to make informed decisions about their health care. I am so very sorry you have to live in pain. I couldn’t agree more about doing research before consenting to surgery. So many unscrupulous practitioners push patients into treatments they don’t need, just to make money or get status, or even practice doing the technique so they can be seen as competent.
The guidelines clearly state that to do a disk replacement, it should be the patient’s 1st surgery and should be limited to one level only, but I have read numerous reports of surgeons who do multi-level revisions on previous operations. It’s just not right.
In this article about back surgery I talk about research that strongly suggests surgery is over prescribed in the US.
My husband has a herniated S1-L5. He had surgery that scraped something to relieve the pressure to eliminate the pain, but didn’t do anything to repair the disk. The doctor now says the disk is all but gone and is recommending disk replacement. You say this isn’t a good idea, so what should he do instead?
Annette,
Sorry to hear about your husband’s surgery complication. I am not necessarily saying don’t do it, I am just trying to expose the things that eager surgeons probably won’t tell you when you go in for the consultation. Unfortunately, I don’t know what the best solution to your husband’s problem would be, and I know that’s an unsatisfying answer. Just please do your research and ask a lot of questions! It may be that a good physical therapist can get you onto a pain management program and help you avoid a 2nd surgery. Just ask a lot of questions of a lot of people, and decide from an informed perspective.
Best,
Anne
can anyone tell me should i do a fusion on my lower back i have herniated disc central and degenerated disc diasease with mild stenoises of spine im on insulin and take 7 pills a day 4 for diabeatisis and 3 for lower back pain i have 2 lower disc thats bad L-4 and L-5 with a torn nerve what should i do im 44 and feel like a cripple i did file for disability but that can take 3 years maybe sad. im also getting a lot of neck pain and numbness down my legs what do you guys think i should do.
I had Microdiscectomy (sp) in Dec2004 and was back six days later with leaking Spinal Fluid. Another surgery to correct that. I have never experienced pain like that in my life. Still in pain. I am very healthy and wonder if I would be a candidate for Disc Replacement. Oh, and I have good insurance! Any information would be great! Thanks, Paul Kansas City, MO
I had a cervical fusion c3-6 (3 levels)5 years ago that went bad. The bottom fusion didn’t take and from what I have been told the bar in my neck is too long and has destroyed a disc above and at least 3 or 4 below my surgical site. I saw a surgeon last month who feels he can do several disc replacements in conjunction with a patch job on the lowest fusion. I live in Denver, Colorado and my understanding is no one has cracked the insurance code here. The surgeon I consulted with is in Flagstaff, AZ. Can you please suggest someone I can see for a second opinion? Thanks, Lisa
Hi, Lisa,
I don’t have the name of anyone who does these surgeries. But I want to caution you because all the documents I’ve read from the FDA, and from medical associations etc. say that someone like you should not be having disc replacement surgery. They recommend that if you have more than one level or if you’ve every had any back surgery before for that matter, you should not have a disc replacement. There’s really not a lot of research behind this technique because it is still pretty new. If you have another surgery and for whatever reason it doesn’t work, you may be deemed inoperable after that. In that case, they would probably recommend you for pain management, but there really are no treatments for pain that’s due to a failed device in your spine. So you’ll be on your own, probably with more pain than you have now. I would be very careful.
I had constant pain from when I was 11yrs old, finally in Sept 2006 had a Cervical disc replaced in c4/5 and up to now, the time of writing 02/11/09 at the age of nearly 41 I finally can say what a fantastic operation, totally took my decades of pain away.
I had a prolapsed disc that had splintered into my spinal cord & started to paralyse both my arms.
Would recommend to anyone in pain.
I had a total disc replacement “Flexicore” back in 2003 I started having severe leg pain swelling retention and so on. It failed and it did damaged above and below in my lumbar spine and my two orthopedic surgeons did nothing but watch it cause additional problems. They’re investors in the device so why would they. They threw me under a bus. I had to go to someone else and he told me everyting that my surgeons did’nt explain to me. They don’t report to the FDA this is still a study and nothing has been said. They lie just to try to make money. The company was to help me but did nothing probably just getting my medical files together just in case I sue. Don’t be fools, I have a father who had fusion done 46 years ago and never complained and did fine with the fusion, he’s 79 and still no problems. You have to watch who you go to investors don’t care about you they care about the $$$$’s. My previous orthopedics tried to make me look bad to cover up there mistakes, one even said to me it’s a business. Wow that blew me away. Now I’m stuck with this disc because it is too dangerous to remove and have to go back into surgery to fuse it and rods and screws so it does’nt move. I wish I could tell you these doctors names they were to be so repitable, but the truth about them are they are snakes not doctors.
Wow, I am sorry to hear about your pain, Donna. Thanks for sharing your experience with others.
Anne
I had disc replacement last year and it worked out well. I think it is imperative that you research and ask a lot of questions of any doctor you go to for surgery.
Whether it is fusion or disc replacement.
I had the ProDisc which completes it’s FDA post approval studies in January, 2010.
This technology is not that new, with the first ProDisc done in 2001. In Europe, disc replacement is fairly common place. The use of disc replacement in the US has been held back because of reimbursement by the insurance companies.
I know more people who have had problems with fusion than disc replacement. Both surgeries take a while to heal from. However, disc replacement is not for everyone. People with significant facet joint arthritis and osteoporosis are not candidates. Like anything, the surgery won’t work if you have facet joint arthritis (hypertrophy) and bone loss. There are also other things that do not make you a candidate as it is not for stenosis or when one vertebrae shifts over another.
There are a lot of people with double disc replacements as there are a lot of Americans going to Germany and India for disc replacement surgery.
Double disc replacements are also done in the US. Workers comp companies often pay for double disc replacements if that is what is needed.
You still need to go through six months of conservative treatment before surgery. I went through epidural and facet injections before surgery was considered.
It comes down to a bad surgeon who doesn’t know what he/she is doing can mess up any surgery. Disc replacement is major surgery and a lot of thought should be put into having surgery. I was in severe, unremitting pain and could not work before surgery.
I ruptured a disc in my neck between the c6 c7 vertebre. I had a very healthy neck until this happened at work last July. Blue cross and Medicade will not cover this and I am waiting for my workers comp to go to trial. My surgeon says that I am a excellent candidate for replacement but I can’t get it covered. I am getting to the point where my left arm is going numb more frequently and I am getting migranes more too. Does anyone have any suggestions or advice. The constant pain and headaches have me wore down to the breaking point. I am begging here.
I am 4 days out from disc replacement surgery V5/V6. I am not entirely sure which device was used but it was described to me as a ball bearing like device between titanium plates secured to the vertebra by rails. It was not a fusion operation nor was the device screwed to the vertebra. It describes the device shown on your page.
After 4 hours of surgery I had a couple of rough nights in hospital but apart from massive bruising and swelling around the incision I’m feeling better everyday. The permanent numbness down one arm has gone and I feel any remaining problems will disappear with the bruising and swelling. I’ve stopped taking pain relief during the day.
The post op physiotherapy guidelines I have just look ridiculous. For example “You should lift no more than 1kg by 6 weeks”. These seem to refer to another operation entirely.
If anything changes for the worse I’ll let you know but at the moment I’m very glad I had this operation rather than the fusion.
Good to hear, Bill! I hope it continues to go well for you.
Anne
I had a L5-S1 Disc Replacement performed in 2007. Three weeks after surgery I developed a fracture (L5). I have not been right since and cannot find a surgeon to fix it. I have been told it is very dangerous to have the disc removed. Please do your research before you have this surgery done. I am a 55 year old female, who has had a hysterectomy, and also I have osteoporosis. Unforunately, I did my research too late on this surgery. You do not put this in a person with osteopenia or osteoporosis. Now, no one wants to touch me. I trusted my surgeon… my bad
I had ADR in 2007 as well, first off if you have degeneration at all you are going to grow instantly, I gained 15/16 of an inch, which the post op was so bad that I begged the nurses to kill me. 3 years later and my pain is worse. Dr said I was the ultimate candidate for this, found out the total surgery was over $225k, so I am sure he made a chunk. Be careful, because if it does not work no one and I mean no one wants to touch you.
Its now over six months since my disc replacement. Recovery was ridiculously qiuick, I was playing golf within 3 months and have played 3 rounds in the last 2 days.
No pain and great flexibility again, neck is as good as new. I’m 56 years old.
Hello all! I am a 24 year old young woman scheduled for a double disc replacement on october 15th. After years of physical therapy, injections, and chiropractic treatment, my surgeon says that this is my last option. Im soooooo beyond nervous, does anyone have any words of wisdom and what to expect?! thanks guys!
Lisa G.
hello i am 21 years old and im in the Army (infantry) for almost 3yrs now and i hurt my back in 2008 and in iraq in 2009 and i have pain all day when i sit stand even lay down i can barly get out of bed most of the time. This is my 2nd time doing physical therapy and my therapist said i have a budging disc and i had a MRI done and my results say i have DDD at L5-S1, T12-L1, T11-12 and my army medical doctor wont do a thing about it but now hes sending me to pain management. What will happen to me and if i got back surgery would it better or no.
Hi Keith Howell and and the other folks who suffer like I do from neck disc injuries. I have not had cervical disc replacement yet, as I am trying to wait it out a bit longer for the best disc option with FDA approval and insurance payment. I have been seeing a chiropractor who is an orthogonist. Try to find an orthogonist to help your pain and headaches issues. He/she uses a percusion-like instrument which actually will move your atlas bone which misaligns when all of your muscles tense up and try to compensate to protect your neck instability. It is a painless procedure and if you are an appropriate candidate, it may alleviate some major pain. My left arm nerons were rapidly misfiring and I was in excruciating pain with three number fingers, also terrible migraine-like headaches like a vice was squeezing my head. The orthogonal work has helped me tremendously and keeps my neck problem in check most of the time. I hope the procedure keeps working for me until I can get the right surgery and have the insurance company pay for it.
Hope this is potenitally a helpful option to you Keith and other folks….Good luck to all of you !
Fran
I am having lumbar spinal fusion 2 discs being replaced & metal rod, etc), next month. I have been battling pain for a few years. I am worried about my range of motion afterwards. Does anyone have feedback on that? Thanks mucho!
Is it possible for the fluid in the disc to refill after all the fluid has leaked out? I have lost the disc at L3,L4 and L5, the V.A. in 2006 wanted to do arthroscopic surgery and remove the disc with a laser but weren’t talking about putting anything back in or fuse the vertebrae. then last year they told me that they had refilled and wanted to cut a half moon out of L5 vertebrae because they said the disc had refilled and was bulging but as i have osteoporosis I said no. So is it possible for disc to refill? they waited 20 years to treat me even though I had started to go to them right after I got out of the Army, I had a 68 lb. radio fall 3 ft. and hit me in the lower back.
I am 31 years old and I have had two surgeries and now my doctor wants to do a fusion on me. I have been having back problems for six years now. I am part-time cashier and I go to school part-time also. I can’t afford to take off work because I have bills to pay and children to take care of. I have had surgery on lumbars 4 and 5. my first surgery I had some relief for about five months then it came back again so I had another surgery and did not get any relief this time. should i go ahead with the surgery or not ? they have me on percocet and that does not help at all. I dont go out any where because of the pain.
I’m 36 years old and have degenerative dic disease in my L5 S1. Ive been in pain or the past two years. I just saw a new orthopedic surgeon who seemed very eager to push the surgery on me. I am very confused and scared of surgery. I also don’t know if my insurance company would pay for the surgery.
If you smoke stop before and after surgery. They don’t tell you that cigarette smoke interupts the healing process. It is true. Also, stress WILL WILL WILL indeed cause you back pain.
My Atlas bone slipped and hit my trigeminal nerve, causing burning pain in my face. My UCC adjusts it and it has helped, but the Atlas won’t stay where it’s supposed to. Is surgery an option for me ?
Don’t ever get an ADR by Charite. Ruined my life.
I have a torn & compressed disc in my back. I am on 30 mg of morphine twice a day and 15 mg of oxycodone up to 4 times a day. Without the morphine, within about 5-6 hours, I am in delirious almost incoherent pain. You can’t touch any part of my body without agonizing pain as a result. I’m told the damage is inoperable. Are there other options?