Medtronic Infuse Bone Growth Problems Withheld by Researchers

According to a new report, surgeons who received millions of dollars from Medtronic allegedly failed to report serious complications and side effects that affected patients receiving the Medtronic Infuse bone graft product during clinical trials. 

The report, published in The Spine Journal, found that approximately 10% to 50% of patients who were part of clinical trials experienced Medtronic Infuse complications, such as cancer, pain, infections and sterility. However, those problems failed to appear in a number of studies published by researchers with financial ties to the manufacturer.

According to the report, 15 of the researchers who took part in the studies received $62 million from Medtronic over a 10-year period. Despite being peer-reviewed, a number of publications failed to catch what should have been obvious discrepancies, according to the study.

The findings come just days after two U.S. senators expressed concern over the allegations and wrote a letter to Medtronic seeking answers.

Senator Max Baucus, a Montana Democrat who chairs the Senate Finance Committee, and Senator Charles Grassley, an Iowa Republican who is the committee’s ranking member, are asking Medtronic to turn over all communications with medical journals, clinical investigators, the FDA and its advisory boards, and physician consultants that pertain to Infuse complications. The senators are also looking for detailed accounts of payments to researchers involved with Infuse clinical trials and a trove of other documents.

Medtronic’s new Chief Executive Officer, Omar Ishrak, has admitted that the new study was worrisome and announced that the company would investigate questions regarding researchers’ conflicts of interest. The company expects to have a report on the issue in 90 days. Medtronic offiicials noted that data Medtronic submitted to FDA on Infuse was not in question.

Medtronic Infuse is a bioengineered bone morphogenetic protein (BMP) used to encourage bone growth and replace spinal disks by filling the gaps between vertebrae. It was approved by the FDA in 2002 and generated about $900 million in sales for Medtronic in the last fiscal year.

Some health care professionals have long suspected a link between Infuse and male sterility, but in 2009 researchers sponsored by Medtronic found no link. Their findings raised questions by other medical researchers, who pointed out that Medtronic paid them millions in consulting fees. Their study, which determined that male sterility in the anterior lumbar fusion surgeries were the fault of the doctors, failed at the time to identify which patients were given Infuse. They later revealed that out of the six cases of sterility, five of the men were treated with Infuse.

Sterility is just the latest complication associated with Infuse, which already has a warning about the risk of male sterility on the label. The BMP has also been associated with serious and life-threatening complications caused by airway compression when used “off-label” in the cervical spine.

A number of patients have had to receive respiratory support tracheotomies, insertion of feeding tubes, anti-inflammatory medications and additional surgery after experiencing problems with Medtronic Infuse after a cervical spine surgery. This has often been caused by swelling of the neck and led to an FDA warning to healthcare providers in July 2008 that highlighted at least 38 reports of cervical spine fusion problems with Infuse. Most of these Medtronic Infuse problems occurred within 2 to 14 days after surgery.

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  1. K Lee Reply

    and the Repubican are trying to limit medical malpratice suits !! Wake up Amerioca!!

  2. rickylunn Reply

    i had neck surgery done by dr kevin foley in memphis i think he is very involved with medtronic the surgery made my neck worse i am now on disabilty

  3. Richard Reply

    Infuse was used in my spinal fusion surgery and now I am disabled and suffer chronic pain. Infuse caused boney growth down my S1 nerve which had to be surgically removed. I have had a total of four surgeries as a result of the problems from Infuse plus I am no longer employed. My surgeon no longer uses Infuse as a result of the problems I have had. Also, on my 4th surgery he totally removed the Infuse as it had not completely fused and replaced it with another product. This however did not eliminate the pain and problems created by Infuse.

  4. Dan Reply

    If true, those responsible for this tragedy, and all who knowingly benefitted financially or otherwise, need to be brought to justice, tried, convicted and sentenced to terms commiserate with their crimes.

    But don’t hold you breath; the business and political elites of this country of course know that today they can buy their way out of most any charges, and even if charged and convicted will rarely suffer anything more than a mild public rebuke and/or a financial slap on the hand.

  5. joseph Reply

    Always considered a great company, Medtronic now joins the sleazy.

    How did they think they could get away with this?

  6. mike Reply

    after having this product installed in my back i had bad enough problems to be put into a nursing home. after 6 days i had a complete spinal block requiring a second surgery. my problems included spine infection, having to self-cath for 6 weeks, sexual disfunction, extreme pain. i could not take care of myself was ordered bed bound for three months with a nurse coming to see me each day. i have not worked in 6 years having seen numerous m.d.’s no one is willing to try to fix it.i was gait trained as i had to learn to walk again i want revenge.

  7. mike Reply

    i found out that two of the doctors that performed trials in which they alledge that there were no major complications in 800 surgerys also were listed as HOLDERS OF THE PATENT! KENNITH BURKUS OF THE HUGHSTON CLINIC IN COLUMBUS,GA BEING ONE.

  8. Ray Reply

    I had a multilevel fusion using BMP in 2006 and I have been in miserable pain and have had limited mobility since. I would really like to be pain free.

  9. robbie Reply

    I. Have also had to have 3 back surgerys(2 of them fusions-7 pieces of hardware), with the last one using Infuse .The infuse has now wrapped itself around & near the spinal cord ,forming a small bone growth. To remove is to be a very risky, not to mention very bloody procedure. I\’m in constant pain, extremities getting numb, & are tired of living on medications. Quality of life down the drain, only to find out more herniations! Makes you wonder how the FDA can pass such \”safe\” drugs, or what pocket is getting filled at our expence?

  10. Dave Reply

    I had my back surgery in 2007, have had a problem with infection were it would drain from the surgery site, the suegerons didn’t want to know anythig so my GP sent me to a infection doctor who walk into the room wrote a scrip an walk with out even looking at my back then he call my GP and yelled at him said theirs nothing wrong with back because of the caliber of surgeons that work on CT an MRI show extra bone growth, my implant was off lable use if the doctor mention the side effects I wouldn’t never have had the surgery with BMP.

  11. Tina Reply

    Had back fusion surgery in april 2010 and after finally convincing my surgeon something was wrong that the numbness and pain in my leg and foot were not there prior to surgery, he ordered a ct scan which showed overgrowth of the material used to fuse. He said he had never had it happen before. He went in and scraped out the overgrowth and instead of improvement I slowly got worse. I just heard of the BMP problem and sure enough found out it was used in my back. I go for another CT in 3 weeks to see if re-growth has occurred. In any event, I know my life is never going to be what it was and it means a lifetime of people thinking I’m “milking it” and leaving on horrible medications just to get through a day! I will never ride my motorcycle again or have any kind of a life. Don’t know if it was off label usage or not, just know it ruined my life.

  12. Jenny Reply

    Had cervical spine fusion in June 2010. All I was told was that the surgeon (a “top 100 doc”) from a respected ATlanta facilitym used an “injection” of protein at the fusion site to make it heal faster. I have been in worsening pain since. Same issues as TIna. Surgeon disregarded me when I told him was worse after 6 months, etc. etc.
    Am at a point where my entire back is in spasms, and can’t use arms without shoulder pain that drops me. Used to be a teacher, now trying to get disability, and of course no help from surgeon.
    Went and got my records, and on top was an electronically signed document stating I had been advised to get a LUMBAR fusion using BMP, and had been informed of issues and still consented. However, my surgery was a CERVICAL fusion. Who knows what “protein” he injected. I don’t see it listed in the op report. Clearly, someone was instructed to put these Histories in everyone’s folder no matter what surgery they got. Now, still trying to get help for worse problems lower, in constant pain. THESE SURGEONS clearly have no consience, and nothing can undo the pain, and give back lives.

  13. michael Reply

    cervical spine surgery ive had in dec

  14. Jeff R Reply

    I had L-4 L-5 fused with Infuse in Aug of 2010 the doctor told me it was a off market use even though it was an anterior procedure the 1st 2 months I felt great then the pain started coming back and has continued to get worse. I have had ok weeks when the pain goes down to a 6 or 7 but it very often is a 10 its no use going to the doctors none of the pills help anymore nobody will tell me anything or they say this looks ok or that scan looks ok. Really try dealing with pain daily. Before I started using a walking stick and my dog as a service dog people must of thought I was drunk the way I walked. Bear can counter my loosing my balance thank God I have him. I looked at my last MRI and it looks very bad but the radioligist says its fine. is it more than just one doctor or set of doctors covering this up. I will take my MRI scan out of state and have it looked at and try to find the truth, I hope someday all the people who lied about this stuff meet there maker and have to explain what they have done to people.the burning stabbing pain the numbness its all maddening

  15. Mark Reply

    I had lumbar fusion in Nov. ’07 using off label infuse and my life has been ruined forever. I was 36 y/o at the time and a Respiratory Therapist, and now I’m totally disabled. I experienced bone over growth that severed a nerve. After telling the Louisville, Ky Dr. that my pain had come back 2 months after my surgery he just kept telling me I was OK. I made 13 trips over a 3 month period trying to get him to do something. He finally done surgery just to prove me wrong. When I awoke after surgery he came in and said “it’s bad”. The bone over growth had severed the nerve and there was nothing he could do but shave the extra bone off. Now almost 5 years later since my first surgery I’m in constant pain, my right leg is numb all the time, I take pain meds around the clock and wear pain patches, I’ve had a neuro-stimulator placed in my spine by another Dr. and still get no relief. My Dr. tried his best to down play my situation and keep it quite. He told me that I was the first person in his 400 cases to have any complications. Eventually I had to switch Dr.’s and the neuro-stimulator was his only answer to my problem. My life has been taken away from me as well as my family that has to deal with my problems. I suffer from severe depression as well and sexual side effects. I sought advice from attorneys when it first happened but they said I had nothing against the Dr. but someone should have to be responsible. I was never told that these kind of complications could happen. Why must everyone like me have to go through life like this and Medtronics and these doctors just keep making their millions!

  16. JoleanP Reply

    I am looking for a surgeon who will possibly explore fusion site that bmp was used off label to look for overgrowth. My husband had ALIF surgery at L5S1 in 2007 with bmp and peek cage. Never been out of pain. Been to several doctors and they say they can’t find why he is still in pain at surgery site but suspect nerve damage.

  17. Joseph Reply

    4 weeks ago I fell out of my chair when I saw the commercial for Infuse bone graft lawsuits. I had a Multi level fusion in my c4 thru c6 so in july of 2006, three days later my airway shut down do to swelling closing off my trachi and had to be intubated and put on life support…airflighted back to St. Louis for emergency surgery. I looked in my Operative reports and its clearly states that an “off Label” use of a instrumentation with bmp Soaked Collogen sponge was used in my fusion process. ever since 2006 I havehad trouble brathing, choking when I eat and very poor swallowing, tingling in my left arm with little to no feeling, I’m still deathly frigtened to go to sleep in fear of not being abe to breath because I still wake up gasping or air….Ithe operative report doesn’t say “Metronic” but could it be with all that had happened to me….seems too coincidental not to be related some how, I remember several doctors since telling me that if I wasn’t with family at the time I surely would have died from afixiation..lose of Oxygen. Do I need a Lawyer?

  18. rew Reply

    I’ve had 4 spinal surgeries. The first was L4-5. I developed such a bone over-growth that it grew up into a huge spiral. I had bone growth over sensitive nerves, special instruments had to be used to removed this “creepy” over-growth. So cage was removed, but disc 3 was pulled out and hit nerve head. Had to have another fusion by fusing L-3 onto fused L4-5. Also have fusion of C,5,6,7. I have a very hard time swallowing or talking. N/R was hesitant to give x-ray of neck. Last surgery of the L’s was Jan. 10, will see if bone over-growth happens.
    Face it, back surgeries are killers, and the dr.’s lie about their own surgery. N/R friendly during 1st surgery, after that he turned on me like I did something wrong. I expect surgery the rest of my life to remove the bony over-growth. N/R is an asshole as the expense of my life. In fact, this has taken years off my life. The dr.’s are so far above reproach that it’s serious. I feel for anyone who has surgery. And friends/family can’t see anything wrong with you so it makes it even worse. This is a traumatic nightmare as far as I’m concerned. Since 2008, I’ve only had surgeries and P.T. and a rotten dr. who won’t face up to the fact that things went wrong. My hears goes out to everyone that has even dealt with “wrongful” surgery. I know how it feels. You also lose friends over this and become isolated. I do know that a 2 vwertabrae surgery can go right and last a lifetime. I’m not one of those as I will always have to be “cleaned out” of bone and scar tissue. It limits all my activities and leaves me suicidal, depressed, hopeless and with a half of life. No one understands unless it happens to you. I have nightmares about my body going into the pain mode again, I just can’t live with horrible 24/7 pain. I would rather be dead. And the next surgery will be worse.

  19. CCSPINE Reply

    Do any of you have a lawyer about infuse? If you do who is it? Thanks

  20. Jill Reply

    Soooo Scared. Had 3 surgeries so far, had an MRI on Friday. since I had my 1st fusion surgery, followed by revision, then followed by hardware removal, at L5/S1, the pain continues, and additional symptom sights have increased. Where do we who suffer from all this shit go from here. I can’t imagine another human being selling a product that can cause so much damage and long term suffering to another individual. Many times the tears run down my face as there is physical and emotional pain. People understand up to a point and then they get tired of hearing about it as there is nothing they can do for you. Can someone please tell me ‘WHERE DO WE GO FROM HERE?”

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