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What is Failed Back Surgery Syndrome? Linked to Infuse Bone Graft?

Submitted by on October 18, 2011 – 11:05 am23 Comments

What is Failed Back Surgery Syndrome? Linked to Infuse Bone Graft?

In September 2011, the Milwaukee Journal Sentinel profiled Tom Engel of Milwaukee and his experience with failed back surgery syndrome. Engel has undergone two spinal surgeries, one in 2002 and another in 2004, in an effort to manage his excruciating back pain. In his second surgery, the Medtronic Infuse bone graft was implanted into his spine in an off-label (non-FDA approved) use of the product. Today, Engel has what is known as Failed Back Surgery Syndrome (FBSS), and is bedridden and heavily medicated 24 hours, 7 days a week for his pain.

Engel’s experience also puts him at the intersection of two growing medical controversies – dangerous side effects from off-label use of the Infuse bone graft, and the rise of failed back surgery syndrome.

Failed Back Surgery Syndrome Defined

The International Association for the Study of Pain defines FBSS as “lumbar spinal pain of unknown origin, either persisting despite surgical intervention or appearing after surgical intervention.”

The Los Angeles Times notes in, “For back pain sufferers, surgery isn’t always the answer,” spinal surgeries in the United States are performed at double the rate of other developed nations, with no corresponding evidence that Americans are actually suffering from back pain at twice the rate of their extranational counterparts. Further, “there is a long-standing controversy among spinal specialists over how often surgery is the best option — and some say surgeons can be too quick to sharpen their scalpels.”

The St. Petersburg Times reports that about 800,000 Americans have back surgery each year, but “evidence is mounting that for many patients, surgery is no better at relieving pain” than non-surgical treatment options, and that “some patients are even worse off after surgery, leading the profession to coin the term ‘failed back surgery syndrome.’” Dr. Norman Marcus tells the Record Searchlight that “half of all patients who had a spinal fusion or laminectomy surgery say they ended up no better or worse off after the procedures.”

Why is back surgery so popular in the United States? Dr. Steven Richeimer, chief of the division of pain medicine at USC, speculates that the United States’ extraordinarily high rates of spinal surgery may be cultural – he states, “We’re in a little bit of a quick-fix society.”

Medical Device Industry Payments for Research: Example of Medtronic’s Infuse Device

Another possible reason for the rising popularity of spine surgeries is the financial entanglements of doctors with medical device companies. Some doctors who recommend surgery over other treatment options, or who promote the use of specific medical devices used in spine surgery, have received enormous amounts of money from spine device companies. In many case, these doctors failed to disclose their financial ties to the medical device companies.

Certain physicians who published early studies on the Infuse bone graft system manufactured by Medtronic earned millions of dollars in consulting payments from Medtronic. For example, the Milwaukee Journal Sentinel reported that surgeon Thomas Zdeblick received more than $22 million in royalties and other payments from Medtronic since 2002.

The early industry-sponsored studies on BMP-2 (the bone growth protein in Infuse) either failed to disclose or dramatically downplayed the side effects of BMP-2, including ectopic bone growth, unusual inflammatory cysts, osteolysis (or bone resorption) causing cage migration following spine fusion surgeries.

The nonprofit Foundation for Informed Medical Decision Making strives to help patients research treatment options and make fully informed decisions regarding surgery. Another resource for patients is the Association for Medical Ethics, founded by Charles Rosen, M.D., director of the Spine Center at UC Irvine. Dr. Rosen founded the Association for Medical Ethics (AME) in 2006 out of his concern over the rise in surgery rates. The AME calls for transparency from doctors who receive over $50,000 in consulting fees from medical device companies.

Earlier this year, Dr. Rosen sharply criticized the “marketing-disguised-as-research” that can arise from industry-sponsored research. Dr. Rosen cited Medtronic-sponsored research on the Infuse bone graft as an example of the harm that patients can suffer when new medical devices are brought to the market based on research conducted by physicians that are paid by the device manufacturers.

23 Comments »

  • 1stfrenzy says:

    How do I find out if Infuse was used in my cervical fusion?

    • admin says:

      Your operative report, the “sticker pages” in your medical records showing what medical devices were used, and/or billing records from the surgery should show whether or not Infuse (aka rhBMP-2) was used in your spinal fusion surgery.

      You can and should ask your surgeon whether the use was approved by the FDA (“on-label”) or not approved by FDA (“off-label”).

      Surgeons can freely use medical devices in an off-label manner, but medical device companies such as Medtronic are strictly prohibited by law from promoting such uses.

  • Gloria says:

    I had back surgery on September 21st. I had 1-6 lumbar, with rods and screws, and bone grafts.

    I am now having so much pain on my left side and it is worse than before my surgery. My Doctor is sending me to a pain management doctor, but not before telling me it is my sacroiliac joint and wants to fuse it.

    Pain Management said no, and I am going for injections, or maybe now as I am having problems controling my bladder. I am at a point where I don’t know what to do and the pain is unbearable.

    • Alan says:

      I am not a medical person at all, so I am talking from what I have been though. I had a SI joint fusion 1st, then back surgery afterwards. I will say the SI joint now gives me hell, that was not the problem, but now it is. I’ve had 19 surgeries so far on my back. The nerve pain is gone, but it’s pure bone pain now and some of it is SI joint. Don’t know why, but from what I have read, women have better results, good luck.
      Alan

      • Diane says:

        Women do not have better results. I had a cervical posterior fusion C2-T3 for myelopathy. After surgery, my entire body is racked with pain. I have horrible stiffness with pain throughout my entire body. I am unable to hold my head up, as my balance is off. I have to walk hunched over; if I try to hold my head up, I cannot walk well and feel that I am up very high and am going to fall.

        I cannot turn my head without turning my entire body. I get horrible headaches at the base of my skull and have terrible pain in neck, upper back, arms and hands. Since the surgery 2 years ago, I have spondylosis at every level.

        But the best part is…the quack who cut me: 1) Left me in ICU with no orders for pain medicine immediately after the brutal surgery and I had no pain medicine until the next day after the surgery; and 2) I had a CT scan done 3 months after the brutal surgery (that the quack never went over with me, and he told me, “Your neck is 100%”) …now after fighting for LTD I got my records and no, I am not fine — I have a bulging disc at the C2-C3, I have spondylosis at every level, including a deterioration of all of my thoracic region. I have severe foraminal encroachment at C6-C7 and mild foraminal encroachment at every other level, as well as spurs and vacuum phenomena (whatever that is) and much else.

        The nerve studies done after surgery show abnormality, but I have no idea what that means as the quack also did not go over that with me. I would have never had this surgery, but I was falling constantly and had been told five years previously that I needed an anterior surgery on 2 disc in the front of my neck. I did not have that done and continued to work….my neck and arm pain was so mild that I thought I would be ok without surgery. Then I fell and the nightmare began, and has never stopped.

        • lori curran says:

          I’m so terribly so for all you’ve have suffered. I happened on this blog because a friend had similar surgery the pain is chronic. I my self have suffered for years with uncontrolled RA and you feel so alone with chronic pain and the feeling you don’t want to burden people leaves you further alone. I always try and look for answer for everything probably because pain has no answer. I pray that you find something that will help. Much love lori

    • Lisa says:

      Gloria,
      I had l5-s1 surgery after having every possible shot, therapy, treatment, etc… available. It was great for about a day or two, then the rods and screws and bone graft developed a lot of scar tissue on the right side of my body, from what I was told by my new “pain mgt doc” She only does backs, she is falsely advertising that she is a pain mgt specialist. I quit my other Pain Mgt Doc because he could no longer help me. He could only prescribe me stronger and stronger drugs.
      I am scheduled to have a neuro spinal-chord simulator placed in my low back on May 16, 2012. I did the sample test for a week and was in heaven. I was able to walk for two and one half hours around the mall for the first time in 12 years. Do to pain I just didn’t do certain things. I had to pain while I had the stimulator in. I hope it works with the stimulator perminantly placed in, as to the amount of pain relief it gave me with it just partially place in. I am so bad right now I only go out of the house when absolutely necessary. I spend a lot of time in a prone position that can raise my feet, head, or both. It also has a vibration for head or feet.

      What bothers me with what I am hearing is my doctor came highly recommended and he finally said go to your family doc and see what she says. Also, the company that makes this device is Medtronic!

      Good luck to you all who suffer as I. Having you husband or mother dress you is no fun.

      Lisa

    • Michelle BIssell says:

      Hi Gloria,I haven’t had such invasive surgery as yourself, however, my fiance’, Jeff has had many surgeries over his 48 yrs.
      In Dec-2002, Jeff had a ruptured Lumbar disc. He was seen by Dr. Karl Gregorious-Neurosurgeon,in Stockton, CA. Dr. G. did a lumbar disectomy on Jeff, during Jeff’s 2-week winter semester break, while he was in his last year of school, obtaining a Master’s in Social Work. Jeff was able to return to classes right on time w/o issues. Then, in April-2006, Jeff saw Dr.Gregorious again, due to severe neck pain and also was diagnosed w/Carpal Tunnel Syndrome in both hands. Dr. G. had fused Jeff’s C-Spine @ C-5/6 & C-6/7 with great success. Then Dr. G did the Carpal Tunnel surgery 4-wks after the C-Spine Surgery (L-hand, then R-hand). Again, Dr. Gregorious was very successful with that surgery as well.
      THEN: Beginning in early 2007, Jeff began having lower back pain. It became chronic, and unbearable. After visiting w/Dr. Gregorious about it on a few occassions, Dr. G. said Jeff needed to have fusions at L-1/2 & L-4/5 and he wasn’t comfortable doing any type of fusion on Jeff. So, Dr. G. referred Jeff to Dr. Anh Le, at Alpine Orthopedic. Jeff met with Dr. Anh Le at Alpine Orthopaedic, Stockton, CA. and Dr. Le felt comfortable with fusing his Lumbar Spine at L-1/2 & L-4/5, in 2009. However, it was without a successful outcome. He’s lost his sexual drive, has EDD, has constant daily issues of feeling like he needs to urinate, but has great difficulties urinating. Now Jeff is being seen by my Pain Management Doctor, Dr. Jeff Jones-Stockton Pain Management Clinic, Stockton,CA. And the doctor is considering implanting a device called the “Precision”. It’s simular to a TENS Unit, but implanted in the body, with the wires connecting directly where the pain is located at. And the unit is about the size of a pacemaker, fit just under the skin. That is what I suggest you look at before you do ANY FURTHER FUSIONS on your spine! Good Luck TO YOU!

  • S..... says:

    I had lumbar fusion L-4,L-5,S1 in July of 2002. When I came out of surgery, I had never felt this kind of pain before — and I had 3 C-sections many years before the surgery. My surgeon had done this posterior, used the protein and cages. When he couldn’t resolve my pain, he pushed me on to another doctor to take care of me.

    At that time, I was told I had Failed Back Syndrome. My surgeon left the country, because several other people were having bad results. To this date, the pain has never gone away. As I age it gets worse. I am under 46. I have been to pain clinics, had shots, pills, and nothing takes it away. It just barely manages it. 4 yrs ago, I had an MRI done and was told I have bulges growing on top of the fusion. I do what I can on days that I call good, and otherwise not so much.

    • Alan says:

      That’s funny, after my Dr. put the cage in me, about 5 months later when I went in for my check up, he was gone, the place locked up.
      Alan

    • Diane says:

      You may have a lawsuit for this. Apparently they have been using Off Label protein cages never approved for a posterior lumbar fusion. They are Medtronic Infusion
      ….search it out on the internet.

    • tina says:

      Hi S,

      I had lumbar fusion L5/S1 in November 2010. And it has been the worst thing I’ve ever experienced in my 43 years. I thought childbirth was bad also, lol. I had a really bad staph infection after surgery that lasted more than 9 weeks when coming home from hospital. And I knew it had to be the hardware that was used. But my surgeon wouldn’t say. After sending me for X-rays, and nerve conduction test, he said I had Failed Back Sydrome also. The PAIN IS TERRIBLE, and he referred me to Pain Management and said my back was as good as it is gonna get, and discharged me. He left me like this.

      My pain management doctor is running out of pain meds because nothing is helping. I’m hurting in my pelvis, hips, BUTTOCKS with numbness and burning in legs and feet. I don’t know what to do. And I dont know what’s in me. I just know I hurt so bad it feels like it’s coming out of my bottom.

      • Kevin says:

        You very well may have Arachnoiditis in which doctors are hesitant to tell you. It will show up on a good MRI, have another pain doc or someone order you one. I had the very same thing and now have Arachnoiditis…

        • shirley says:

          Why would Drs. be hesitant to tell you that you have arachnoiditis? I have had three doctors from three different practices (one being the Mayo Clinic) confirm that I have arachnoiditis. Not sure what caused it because I had it a few years before I had my total (1-5) lumbar fusion. I suspect, and had a ortho dr tell me he couldn’t disagree, that it was caused by the numerous epidural injections I have had over the past 20 years.

      • scott says:

        I am glad I am not alone in this matter and I feel for everyone in this posting. I to had 6 back surgeries. First one, I almost bled to death and sent to recovery with Dr only saying “we’ll see when I asked him how it went. Still in terrible pain, went to another neurosurgeon and was told that I was never operated on after viewing new mri. I had to show him my scar. He said I just need simple discectomy, which he did and clipped my spinal cord. So, my back starts getting bigger and bigger from leaking CFS and surgeon is in Tahiti for 3 weeks. He gets back, I am in excuciating pain, my back looks like I have a melon growing out of it and I have to threaten to blow my head off in his lobby to get him to fix it. Yeah, he fixed it and I ended up with osteomyelitis. Took me 2 years to find a surgeon to repair it. Got fusion at L5, s1 in 04 and have been miserable ever since. Saw him today because pain in lt buttock so bad I can’t sit down. He admired his work from Mr I had and said everything looks great. THEY just DON’T GET IT!!!!!!

        • Rick says:

          Yes Scott, I agree. They just don’t get it. I had L5S1 done 2x’s in 2004. The pain still has not gotten any better and I’m doing my best as to not be on strong pain meds. I try to enjoy life as much as I can which isn’t easy.
          Wondering if you developed RE (Retrograde Ejaculation) during your surgeries? I did after my last surgery. I was told there was less than a 1/2 of a 1/2% I would get it as it was VERY rare. I was lied too as this is more common than that in men.
          I now see my family doctor every 3 months as I was told by a disability doctor that there is nothing that can be done to help fix me.
          Anyone considering L5S1, do research on it before having it done! I relied on my doctor for complete research information and I should have done it myself.

      • Christine says:

        Tina, I had two fusions. I agree with everything you say…I have pain in legs,buttocks and numbness also..I’m going to another doctor to see if anything can be done..Awful to think we just have to live like this

      • kim says:

        i am having the exact same problems. The pain in my pelvis and buttocks is relentless. I kept telling my dr. that I had pain in my hip and had that x-ray’d. Nothing unuasual. I went for an injection a few weeks ago, and for the first time, she said that she could not get to th nerve because there is BONE there. She told me that I had a bone graft along with the spinal fusion. I had no idea of this and was never told this by any doctor after all the xrays, mri’s and scan. no meds work even a bit. i am starting to loose urine when i get out of bed. i am 46 years old and newly married. i am thinking i will live the rest of my llife in agony.

  • Linda says:

    Has anybody had a good experience with surgery relieving back pain?

  • Maxine Warner says:

    I am also in excrutiating pain after numerous cervical & lumbar fusions & so many other suggested procedures for pain relief ! I also take Pradaxa for a-fib & not allowed anti-inflamatories! What in the world is possible ? Thank you for letting me vent . M. Warner

  • rae says:

    I am a 42 year old female who had a 360 lumbar fusion at levels l-3, l-4, l-5 and s-1 w/bone grafting, metal cage, and screws in November of 2008. The surgery I had required 2 surgeons as I was cut from the front and then flipped over and cut from the back all in the same surgery.

    I am in worse shape now than I EVER was before. My life is so bad that I have been stockpiling my sleeping pills for months so If and When the pain is too much, I can take myself out and end this pathetic life.

    Had any of this been explained to me by my surgeon I NEVER would have had the surgery — yes, my pain was uncomfortable prior, however, I was still able to work and use the degree I worked so hard to receive and provide for my children and more importantly, be a wife and mother.

    Now, my life consists of being in bed ALL DAY and burning my back with heating pads so much that I have scars from blisters, taking Oxycontin and Roxicodone 6 times a day, going days without showering because I have to have help and forget about any sort of life at home. I can no longer cook like I loved to do for my husband who works hard all day as I can’t stand or sit up for more than 15 min. My house is not at all how I like it to be (clean and orderly) as I cannot bend over, fold clothes, or even put away dishes without feeling something rubbing inside my back and being in pain. I even had to get help with my dog because I can no longer walk him or even take him out to a tree once a day. Finally, I am in my prime, or so ‘they’ say, and am married to a man 16 years younger to me and have been since 2005 But we live more like brother and sister since surgery because of the level of pain I am in.

    I just recently learned of the issues and similar problems of those who have had the surgery and have sent off for my records. I hope I do not learn that I was given the brand of metal cage like described here and more importantly hope I do not discover I am in the condition I am in because CEOs at a company wanted that Hawaii vacation or my surgeon wanted more money in his account than what he would have made following the oath he took!

    My advice, if told you need this surgery- research your surgeon, get a 2nd and 3rd opinion and try every other option first. If it works, great — if not, you could end up like me, waiting until you can die in peace.

    • Mike says:

      It’s not the cage that is the problem, it’s the solution of DNA. Your doctor might have been given a sample. Please don’t take no for an answer. Investigate. My Doctor’s afterwards couldn’t get through to my spinal canal either.

  • Cat says:

    Same, same and more of the same. Had two surgeries last year from l-4 to S-1. The fusion material dissapeared after the first surgery and left all the hardware “dangling” (as the surgeon described it). But, they said they found and removed a bunch of cysts that he admitted they hadn’t seen on the mri’s and would have made the pain levels I was describing make “more sense”. The next was the 360 and pain is worse now than ever. Most recently it feels like a knife has taken the place of the end of my tailbone. Of course, surgeon released me to pain mgmt doc who believes more than four 7.5/325 Narco’s a day is to much! I am struggling to continue working and have had the thought many times to just end it all because the frustration is so overwhelming. They make you feel like a junkie when you try to tell them the meds are not getting pain down to a tolerable level. If I had just wanted to be stoned on drugs I would NOT have gone through the trauma of two surgeries! Will be sending for my records and then “Hell hath no fury ….” 51 year old Granny to a beautiful and active 2 year-old has had enough!!!

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