When Shopping for Disc Surgery...
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| 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