Monday, July 27, 2009

Is it an Aspen or a Medical Device?

Recently, the Spine Blogger was asked by one of his readers on his opinion about the LANX Aspen Spinous Process System (ASPS). Aspen is the name of a Colorado Ski Resort Town, but the origins of the name come from the genus Populus (a tree) having leaves attached by flattened leave stalks so that they don't flutter in the wind.

But we are not talking about a device that flutters in the wind, nor does it flutter between the Spinous Process. It doesn't take a rocket scientist to see that this is a great device. The Aspen Spinous Process System is an interspinous process device that was design to address degenerative disc disease and spondylolisthesis. This is a fusion device and it is very, very slick. This product can be used in a 360 and can be inserted via a minimally invasive approach. I would assume it can also be used in a TLIF. The Spine Blogger loves the graft cylinder(that's what I call it). For those of you using the X-Stop, remember what Meatloaf sang; " Stop right there, before you go any further......., try the Aspen " I love this product, it is a winner. The SpineBlogger wants to know what our readers think.

PS: The viewing public would like to see Lanx products on their website, enough with the historical perspective on the name of towns in Colorado!

46 comments:

  1. I had the system put in in December... L4&5, and S1.... mixed results... totally eliminated lower back pain.. GREAT... but an still bothered by sciatica.... i have 3 or 4 goods days and then bam.. 2 or 3 bad days... have been on neurontin, then lyrica.. both seem to be ineffective... now i just tough out the bad days..... but i never know when they will be!! tough to plan my life!!

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  2. Pat: Eliminating back pain is one of the most difficult tasks a spine surgeon deals with. Unfortunately, medicine is more like art than accounting. This means that sometimes its not just the primary diagnosis that is affecting you pain. It could be secondary and tertiary problems. Thanks for telling our readers your story, and hopefully some of our surgeon readers can provide you with some suggestions without seeing your MRI or CAT Scan. Keep the faith!

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  3. I am in complete agreement with your opinion. I acually carried that product for a while with a very positive response from the doc's to whom it was presented. However, they do seem to drag their feet a little in adopting the technology...I wonder why they don't just jump all over it. Any thoughts? I think your blog is fascinating and a very powerful tool...keep it up.

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  4. Wil: Food for Thought. Could it possibly be that the Aspen is much more versatile in flexion and extension than the X-Stop, and the surgeons are not exhibiting as much patience in the products nuances?

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  5. Spinous process fusion plates have been around for a while (popular in Japan) and are now coming back into style as companies try to come out with something "new". This plate looks like a me too with some of the others that are out there. Is it a product looking for an indication? Or is there are diagnosis that this plate works better than cages, pedicle screws, facet screws etc....

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  6. You can get an idea of how it looks/works at:
    www.uspto.gov. Search under publication number:
    20080183211

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  7. According to Lanx "The Aspen Spinous Process System is intended for use with bone graft material, not intended for standalone use. The Aspen Spinous Process System is a posterior, non-pedicle supplemental fixation device intended for use at a single level. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion."
    http://www.lanx.com/innovations/aspen.php
    Yet others say "Placement of the Lanx Aspen in a region of the back called the spinous process involves much less surgery (than fusion) and is completely reversible."

    This means some surgeons are using it without bone graft and at multiple levels, which is not consistent with its intent.

    If it is a fusion that they are proposing, then why not go for disc replacement? It is very likely you would require additional fusions down the road, should fusion be done.

    If the intent is to only use an inter-spinous process device, without fusion, other options do exist that are less rigid, more proven, and specifically designed for this purpose. Less rigid inter-spinous devices provide control of motion without fusion. They can be used in early degeneration cases to control excess motion, or if no other intervention is possible, as in older patients or at levels where ADR is impossible.

    A careful evaluation, by surgeons with experience across all device options, using MRI and x-ray motion study (flexion/extension) should be done to determine what is best for you. A free evaluation can be obtained at StenumHospital dot com.

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  8. One may consider that the Aspen would allow a patient population to be served through an MIS procedure where they may not be able to undergo a full PLIF, thus opening up fusion options to candidates who otherwise put of having surgical treatment. Thoughts?

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  9. I hear there is a device coming out in August that is exactly like Aspen, anyone know what it is?

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  10. I have spinal stenosis and spondylolisthesis. I'm trying to decide whether to have the Aspen procedure or the standard fusion. Does anyone have any personal experience with this situation? I'm a 70yo female.

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    1. Hi. I am a 71 yo female and had the Aspen put in 2009. I was able to resume normal life soon after and my lower back pain went away as did the sciatica on right side. So, I've been a happy camper ever since UNTIL now. I seem to develop sciatica on the left side. Madding!! So painful! I plan to see nerve specialist to see what's going on. Could be totally unrelated. More later!

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  11. I had two Aspens implanted at the 2/3 and 3/4 levels as spacers. One had to be removed due to instability and the secound fractured my spinal process an also was removed. It was and still is after two years a bad experience for me...

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  12. Sounds like the Aspen device is only for lumbar spine. Is this correct? I have a failed neck surgery (actually, 3- the first two involved screw breakage or pulling out, the last ended up mal positioned resulting at Kyphosis at c3-4 and quite a problem w/occipital pain/headaches. We have been trying not to do any more surgery because of the risks. It has been 10 years and the pain is getting to be a bit too much to bear. I also have Generalized Dystonia ( a neurological movement disorder) which may have been the reason the surgeries failed.

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  13. For June 25th Annonymous: I too am a 70 yo female and did have the Aspen Spinous surgery one year ago. It was a quick recovery and pretty successful in terms of wiping away most pain. I still have some sciatica and do wonder about future stenosis.

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  14. I had the Aspen at the L5-S1 level. The spinous process fractured, went forward and down into my spine and caused severe permanent disability from my pelvis to my toes.

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  15. i'm not a fan of the aspen my surgeon used these implants on three levels supposedly to cure my pain from DDD with instability and ive been in worse pain ever since. i'm booked in for the implants removed and traditional rods screws and cages in three weeks time my back is more unstable now than before!!
    Thankyou Jim for enlightening me that the aspen was intended for use with one level it explains alot, he also used the spinology bags which ive read give no stability whatsoever for fusion patients i'm at a complete loss as to why he chose this procedure for me and what makes it more ridiculas i told him i wanted surgery so i could ride my horses without pain again my new surgeon tells me the aspen is generally used in older patients that have little activity and then the results havent been too good.

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  17. My neurosurgeon just recommended this for PLIF, at L4/L5.

    I've already had TWO microdiscectomies, and with a new 14mm herniation on the right hand side, will be needing a third.

    I'm a mechanical engineer, so I see this ASPEN device as creating a new, but sub-optimal load path: instead of carrying the weight of my entire upper torso through the disk at L4/L5, the ASPEN device, by rigidifying the connection between my spinous processes at L4 & L5, totally takes over the load carrying! So the load would go from the L4 vertebral body, through the pedicles, the lamella (one of which is already severely compromised by what will be THREE microdiscectomies!), the spinous process, across the ASPEN, and then back into the L5 vertebral body through a similar path (pretty much bypassing the softer intervertebral disk).

    Have I got this right? Anyone want to comment? Or, perhaps, just check my spelling and grammar?

    Thanks in advance,

    Steve S

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  18. I had three Aspen devices placed last March,with miserable results. All three are now loose and having more surgery in 2 weeks to have them removed and screws and rods placed. My new spine surgeon said these were not intended to be used for three levels. Wish I had knowen this before. A Lanx rep plans on being there at the surgery cause they want them back. Makes me wonder!!! Has anyone sought legal advice concerning these implants? Would love to know what you found out.

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    1. Sounds like your surgeon was more interested in making money than providing good care. Since it would seem your surgeon placed the clamps at 3 levels he was doing that on his own without any FDA approval for 3 levels (eg, off label use). You potentially could sue for that issue alone. Since you are having problems you even have a better case.

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  19. I just had the surgery on October 12th (2010). I had been in pain for over 20 years due to a car wreck and this is the first time I don't have any pain. I also have wonderful neck movement (it was installed between C6 & C7). I haven't been able to turn my head to the left for years, and now I can turn it both ways to each shoulder! So far (not long term yet) I am thrilled with it! My sister, a nurse, said that she had seen many spinal fusion patients with the standard screws and they could hardly move at all. She was amazed at my flexibility and movement that I have. I don't know the long-term effects yet, but so far, so good.

    Lorrie in Atlanta, GA, USA

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  20. I am a spine surgeon and it is my opinion that a lot of these Lanx devices are being put in with kickbacks to the docs. They are only FDA approved for one LUMBAR level and no more. The device is about $5000 each and one has to wonder about the use of these devices, especially if more than one is used, as to the motives of the surgeon. Since the company is a small company it may not fall under the Sunshine act that will be enforced this year requiring manufacturers to put on the Internet any monies paid to docs (consulting fees, royalties, etc). That would not include kickbacks from the reps which is still illegal. Be careful of this product as it has not proved itself for the duration of one's life. Also, a patient with a single level lumbar spinal canal stenosis can have a very limited lumbar laminotomy with decompression of the spinal canal with great results and a smaller incision than to put in the Lanx. The doc only makes about $600 for that procedure, but in my mind is the better choice for the patient.

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  21. My doctor is wanting me to have this new device put in on two levels. I told him I did not want to be an experiment. He sent me home to think about having it versus the old rod and screws. I need them on L4 and L5. I am a 45 year old female who is very active in working in the eduation field. I do not have time to be home in pain nor scattered brained from pain pills.

    I wear a back brace about 5 hours a day currently. Any advice?

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  22. If you only need a fusion at the L4/5 level you would only require one spinous process clamp. Pedicle screws fix the spine much better than a posterior spinous process clamp and if you have some instability (offset) at L4/5 then you would probably be better off with a interbody fusion and bilateral pedicle screws and rods at ONLY the L4/5 level. Get other opinions which are inexpensive and can be very valuable considering the alternative of having a operation that is not needed.

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  23. Thanks for your advice. I do need fusion at two levels with L4-5 being one of them. I believe L3 is another one.

    Any advice for two levels needing to be done? In reading the literature, it sounds like the Aspen device should be used only if one level is being done. Am I correct in that?

    Thanks,

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  24. Lindsay Rosenwald http://www.nytimes.com/1988/12/14/business/business-people-dh-blair-picks-doctor-as-director-of-finance.html Rosenwald, 33, specializes in finding and underwriting promising medical and biotechnology companies

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  25. Since it looks like only bad history here, I thought I would post some good news.

    I had two Aspens installed, one above and one below L4. I went from constant pain and numbness of the legs to NOTHING. I now have no pain or numbness. I'm a month into the process and going by the book. Using a Stelth back brace with no bending or twisting as yet. I'm told that that is where most failures come from not following the recovery plan. And far as I can find two devices can be installed for either the Aspen or X-Stop.

    Anyway this is great!

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  26. I had the Aspen surgery done in December 2008. It was a fairly new device and my spine surgeon thought I would be an ideal candidate for the procedure. L-4 L-5 and L5-S1 are the two levels I had done. After the surgery I was in heaven ! No more pain. No more pain pills. That lasted about 3 months. I took a spill at work and by the next day I felt the pain creeping back. My spine surgeon said to give it time and I would once again be pain free but it has been 3 years now and I am back to square one. Do your homework before any major surgery ! I wish I could say it was it was worth it but it wasn'T

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  27. Hello everyone, My name is David,I am a 43 y.o. disabled journeyman welder. In 2008 I had a L4/L5-L5/S1 spinal fusion. My neurosurgeon insisted on using the Land Aspen system for my procedure,saying it was my best option. I agreed to the procedure trusting that he knew what was best. I will agree that the recovery time was short,and that for the first months and a half things were good. 4 weeks after I was released from post-op care,I had a little problem. I was getting out of bed and felt and heard a very loud pop,fell to the floor and laid there for six hours. Once able to crawl back into bed,I called my dr. only to be told that since I had been released that I would need another referral to see the dr.
    I tried for weeks to get back in to see the dr.that did my surgery only to be told by his staffs that I needed a referral. After getting in to see my orthopedic dr.and having him make x rays,I was able to see that the L5/S1 clamp had moved. It was no longer in line with the top clamp as it was right after surgery and my orthopedic dr stated that it didn't appear to look right. He got me a referral th get back in to the neurosurgeon,albeit 3 years after the original operation. I was sent for mri's and x rays in Jan.of this year. Upon my return to the neurosurgeon he started there was nothing wrong,(he also did a C3-C6 fusion on me as well 7 mo. prior to lumbar) and that ALL I needed was a series of epi-dural injections and 3 weeks of p.t.and I would be fine.
    Well,I went to Birmingham Al.4 weeks later to get a second opinion and found outI that I had a blown disc at C6/C7 and on March 8 2012lumbar had yet ANOTHER cervical fusion. This seemed to help my neck and arm pains,but my lower back and legs still hurt like hell. I just saw this dr again on Tuesday after another series of mri's and x rays in to find out that there is a ruptured disc between L4/L5 and that is between a fused spot. Now,the x rays in also show that both clamps have moved outward from their originally placed location, and that the bottom clamp appears to have "cocked" diagonally a bit more since the Jan pics,and that I will need to have these clamps removed, the disc repaired and then RE-FUSED the correct way it should have been done to start with. Screws and rods.
    Now that I have my proof that there has been a bit of a problem since 2008 and that I have not had another cervical fusion and that the lumbar fusions are no good and will be redone,I feel that there is sufficient evidence for a major mal-practice lawsuit. And I plan to proceed with one as soon as I can locate a reputable attorney to take my case. If anyone knows a good attorney here in Alabama, please let me know. As for the Lanx Aspen system, I wouldn't recommend it for any use. And I plan to take MY two clamps to the local gold and silver shop and see how much I can get for 10,000.00 worth of Titanium. Maybe I will get some relief and use out of them after they come out. They damn sure haven't given me any in the past 4 years.

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  28. I hate spell correct and auto word insert. YES,I did have another cervical fusion at C6/C7, and it is a internal fusion device. It seems to be doing fine. As for the Lanx Aspen system in my lumbar fusions, they were not used in conjunction with any bone graphs or otherwise. My new neurosurgeon says that he has only used the aspen system in two procedures and that the results were less than expected, and had to be removed shortly after. He also stated that he,along with several of his colleagues have had to remove these devices in the recent past,and re fuse the patients with other devices and hardware. This tells me that the Lanx Aspen system is a VERY POOR device and poor choice.
    From my experience and what sounds like the experience of others on here and that I have spoken to,this fusion device should be removed from use completely, and anyone and everyone that has had them used and removed should be compensated VERY WELL financially for their pain and suffering.
    I hope that those of you that are having problems with this system find a neurosurgeon that will help you and get you back on your feet. And that will be willing to assist you in getting your life back physically and financially.

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    1. My husband had this installed two-1/2 years ago and is still in pain. His quality of life is very poor and he is quite depressed. He has been to the original surgeon who said "sorry, but there is nothing else I can do for you". Isn't that a wonderful thing for a doctor to tell a patient? He is now trying another doctor with still no relief and he doesn't know where to turn.

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  29. My husband had the Aspen device implanted in 2010. The device not only broke, but took bone with it, causes rupture of disk above and below AND causes severe nerve damage (70%) in legs. If anyone knows of a class action suit against this company. Please post. Thanks and good luck!!

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  30. My brother just had this done 15 days ago,1 level- between L4/5, and so far he's not doing too well.
    Had to go back to the hospital because he was dizzy with swelling in the area.....the Dr. gave him steroids..
    I'm starting to get a bit worried.
    How long did it generally take most folks here to start feeling better and swelling to go down?
    His Dr. didn't give him a brace to wear either, not sure why.

    Thanks

    Gary

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  31. Hi! I had the Aspen put in at L5/SI in May 2012. Leg Pain is gone. But I have back pain for the first time since my initial injury in 10/2009. I saw my surgeon last week and he said my pain might be caused by the device rubbing on the bone when I change positions (sitting to standing/rolling over in bed, getting out of bed, etc).

    Has anyone else experienced this after surgery?

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  32. Yes.please, if anyone knows of a class action against
    lanx ,let me know!
    I had THREE surgeries,and wound up having them all removed, as they slipped,broke, and caused terrible pain!
    I recently underwent a 10 hour fusion at Johns Hopkins to correct this mess..I am 6 weeks post op and doing well..after 5 years of suffering.
    I feel the obligation to get out the info to others patients,but also to join in any class action in progress.
    Ihave lost 5 years of my life due to this so called quick fix!

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  33. I've had this device since 4-2012. I've been in more pain since but never thought it'd be the device. I'm going to start a group on Facebook to generate some type of forum since I see nothing online at this time. LANX Aspen Spinous Fixation Device Forum on Facebook.

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  34. Io am a victim of the Lanx System.
    I had three operations.. all a year apart,and in each case, the appliance either moved or broke.
    Finally my surgeon refused to even speak to me, ans sent me off to pain management!
    I went for a second opinion, and was referred to Hopkins, where they did a 10 hour classic fusion..L1-T10...and now 5 months later I am pain free... I would
    love to know if there is a class action against Lanx... or whether to just sue the Doc for malpractice....I suffered needlessly for 5 years!
    The doc at Hopkins called the Lanx system junk...by the time he removed it , all three pieces were free floating in my back!

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  35. Any news on a call action suit against Lanx?

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  36. any news on a class action suit against Lanx

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  37. On April 26, 2011 I had the device put in my back at the L5 area for a less evasive surgery. BIG mistake, I ended back in the hospital for 11 days on all kinds of antibiotics and pain meds had to have a secondary surgery to remove infection and to investigate what was wrong. I now have drop foot and pernanent nerve damage incontinence in ability to function sexually. I cannot stand more than 2 minutes at a time, I'm not to sit more than 45 min., at a time twice a day. I fall all the time just trying to get from the bed to the bathroom, I live with none stop pain. I'm only 42 and I regret the day I gave up my life for a less evasive procedure

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  38. I had the Aspen device put in on July 16, 2012. The only thing it helped with is that I have reflexes again in my right leg. I had a very active life before my injury on April 1, 2012. Now I can't do anything. I've been in pain ever since my surgery.I thought I just needed time to recuperate. Its only gotten worse. I can't stand, sit, or walk for any peirod of time longer then 15 minutes. This device shouldn't even be on the market. I haven't heard 1 good thing about it. It states its not for anyone over weight, but my neurosergeon stll put it in me. I very weak now, depressed, and I don't have the quality of life I use to have. I bacically can't do anything! Now I'm going to a new neurosurgeon, in a different state. He asked me why my doctor would put this in me! He's asking me!? All I wanted to say is probably a kick back! ( But I didn't) I asked if he could take it out. He said it sounds like it needs to come out! I'm 46, and after a year 1/2 of going thru this, and not being able to do anything this whole time, I'm having to go thru this again. But my old Dr. Is living in a multi million dollar mansion on the intercoastal, not caring that he destroys peoples lives! Also never go to a Doctor that has a sign in his office that they don't carry malpractice insurance! Should have been my first sign, but guess when your in sever pain, and can hardly walk your very gullible, and trust the Doctor. When they shouldn't even be allowed to hold the title, when they don't care about destroying peoples lifes!

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  39. January 2012, My life changed forever. Due to the poor advice of a doctor, I had the aspen device applied @ L4&L5 with fusion @ L2 & L3. Almost two years later, I am in more pain than ever and my life is at a stand still. As others have spoken of, no normal activity of living much lest of breathing. I am looking for anyone who will join me in this fight against such device as the Aspen. Not only did the surgery go so wrong, they charged my insurance $39,000.00 for this device. My doctor will not see me nor anyone in his group. I finally found a doctor in Fort Worth, Texas that is trying to help me. I have nohing to loose going up against this
    lawsuit, I might even get my life back. My family has suffered along with me in this and my job; not even sure if I have one to go back too. May we all stand together in keeping the medical field accountable for the experimantal procedures to mankind.

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  40. My surgeon is excellent.I called the company Lanx, I also looked on FDA web site and saw the Aspen was approved for ONE level only, Lanx plainly stated that in spite of this it's fine to use three levels and I felt great until I tried to reenter the job market. The numbness and pain started all over again and I had a stabbing pain in the Buttox. My surgeon said without hesitation after a discgram it must have broken, I was scheduled for surgery and they were removed Jan 9th of this year. They were installed 8/1/2011 and the FDA approval wasn't until 8/2/2012 and it clearly stated ONE LEVEL as does Lanx's written advertisement say ONE LEVEL, so why do the reps insist on selling these things for multi level! I spoke with a Lanx employee yesterday and they state that it's fine for multi level. I do NOT blame my surgeon! I blame Lanx for ruining my life! Their first written word came 7/25/2011 stating one level and there was NO WAY this could have gotten to the surgeon in time, They knew they had sold this for me multi level as my name is in their data base , they should have contacted my surgeon and put a stop to it! Lanx has RUINED my life! They are plainly responsible for misrepresenting this product!!

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  41. My surgeon is excellent.I called the company Lanx, I also looked on FDA web site and saw the Aspen was approved for ONE level only, Lanx plainly stated that in spite of this it's fine to use THREE levels and I felt great until I tried to reenter the job market. The numbness and pain started all over again and I had a stabbing pain in the Buttox. My surgeon said without hesitation after a discgram it must have broken, I was scheduled for surgery and they were removed Jan 9th of this year. They were installed 8/1/2011 and the FDA approval wasn't until 8/2/2012 and it clearly stated ONE LEVEL as does Lanx's written advertisement say ONE LEVEL, so why do the reps insist on selling these things for multi level! I spoke with a Lanx employee yesterday and they state that it's fine for multi level. I do NOT blame my surgeon! I blame Lanx for ruining my life! Their first written word came 7/25/2011 stating one level and there was NO WAY this could have gotten to the surgeon in time, They knew they had sold this for me multi level as my name is in their data base , they should have contacted my surgeon and put a stop to it! Lanx has RUINED my life! They are plainly responsible for misrepresenting this product!!

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  42. Is there any news on the class action suit? please post if it's started or maybe we should start looking for reprentation

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