Medtronic Infuse Bone Graft Lawsuits

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Published: November 17th, 2011

Off-label use of the Medtronic Infuse Bone Graft in the cervical spine has been associated with a number of serious and life-threatening complications. The U.S. Department of Justice is investigating the actions of Medtronic, Inc. and their off-label promotion of this product in violation of federal law.

MEDTRONIC INFUSE LAWSUIT STATUS: Potential legal claims are being investigated and reviewed for individuals who experienced cervical spine fusion problems involving the device.

>>REVIEW A POTENTIAL MEDTRONIC INFUSE BONE STIMULATOR LAWSUIT WITH A LAWYER<<

 
MANUFACTURER: Medtronic, Inc.

OVERVIEW: The Medtronic Infuse bone graft is a man-made liquid bone graft that includes a biologically engineered protein called bone morphogenetic protein (BMP), made by Wyeth.

The bone stimulator is used to encourage bone growth and replace damaged spinal disks by filling the gaps between vertebrae. The Infuse is soaked in a sponge-like material and implanted between spinal vertebrae, enclosed in a metallic cage.

Since it was approved by the FDA in 2002, the Medtronic bone graft has been widely used during spinal fusions and has generated sales of over $3 billion.

While the Infuse bone graft is only approved for use in the lower lumber spine, it has been widely used off-label in the cervical spine which has been associated with life–threatening problems, such as:

  • Difficulty Breathing
  • Difficulty Swallowing
  • Difficulty Speaking
  • Swelling of the Neck
  • Compression of Airways
  • Nerve Damage
  • Death

MEDTRONIC INFUSE CERVICAL SPINE FUSION SIDE EFFECTS: The close proximity of the cervical spine to the airway has caused a number of serious complications associated with use of the Medtronic Infuse bone graft in the cervical spine or neck fusions.

According to recent research presented by a group of North Carolina surgeons, the Medtronic Infuse cervical spine complication rate is about 59%, compared with a complication rate of 21% for bone grafts or collagen used in conventional cervical spine fusions.

The FDA issued a warning to healthcare providers in July 2008 highlighting at least 38 reports of cervical spine fusion problems with the bone morphogenetic protein in the Medtronic Infuse. The serious and life-threatening complications caused by airway compression have required a number of patients to receive respiratory support, tracheotomies, insertion of feeding tubes anti-inflammatory medications and additional surgery.

Most of the Medtronic Infuse bone stimulator complications have occurred within 2 to 14 days after surgery as the neck swells, compressing the airway and nerves.

JUSTICE DEPARTMENT MEDTRONIC INFUSE INVESTIGATION: On November 19, 2008, Medtronic disclosed that the Justice Department is probing their Infuse bone graft marketing and promotion to doctors and actions taken by the company that encouraged off-label use that has not been approved or determined to be safe by the FDA.

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There Are 12 Comments So Far • (Add Your Comments)

  1. [...] Medtronic Infuse bone graft is a synthetic liquid spinal implant that helps bone growth. It includes a bioengineered protein [...]

  2. [...] California woman who went into respiratory arrest after a neck surgery that involved the use of the Medtronic Infuse bone graft. The lawsuit alleges that Medtronic is responsible for her death because they promoted the bone [...]

  3. [...] alleging that the company made false and misleading statements that failed to disclose their Infuse Bone Graft problems and the extent to which sales of the bone stimulator were dependent on “off-label” uses [...]

  4. [...] The Wall Street Journal reports that Medtronic, Inc. is notifying the FDA about the August death of Shirley Nisbet, whose family filed a wrongful death lawsuit against the medical device manufacturer earlier this month alleging that fatal complications following her cervical spine fusion were caused by the Medtronic Infuse Bone Graft. [...]

  5. [...] from the Cleveland Clinic have suggested that nearly 1 in 5 surgeries in which the Medtronic Infuse bone substitute is implanted involve off-label use, for which the bone graft is not approved. Off-label use of the [...]

  6. [...] Medtronic Infuse lawsuit has been filed as a result of complications allegedly caused by the use of Medtronic’s bone [...]

  7. I had my 2nd cervical spine surgery in May of 2011 and for the first 3 to my amazement after suffering with severe neck, arm and hand cramps my pain was reduced by 75%. I also have lower spine problems and have had 4 back surgeries. In the 4th month my pain started back and gradually worsened to the point that I suffer such severe hand cramps ans my fingers hanging in place that my quality of life is almost non existance. At this time my legs and feet started cramping so bad that I am lucky to get 2 hours of sleep at night I returned to the suregon he didn’t even come in . the room to see me he had his nurse to refer me back to my pain mgt. Dr. I feel useless and hopeless. I don’t know what caused this but I do think it is related reading and researching about what was used during my surgery. Although I have not had the severe breathing problems only slight and more pain than before the surgery. My pain medication doesn’t even control my pain any more. I have been unable to find a Dr. willing to see me because of all of these problems. I feel for each and every one of you. God Bless.

  8. I was refered to a nurosurgen from my va hospitial, i had lost most use of my left hand, the nurosurgen led me to beleive i had severe compression of my spinal cord. before this surgery the only pain i had was some backache every once in a while when i worked really hard around the house. now after dr. Simmonds at Roanoke memorial hospital .led me to beleive I would probably not even be walking in 5 years so I had the neck surgery he recommended, I know I should have had a second opinion, now i have 3 large bone growths coming out of my neck where i had the surgery done, He sure did not tell me about any bone growth that would be associated, with this surgery by using the medtronic cage, to be honest I don’t even think i needed surgery at all.

  9. I had my ACDF surgery on C5-C7 in Oct. of 2007.My Surgeon used PEEK spacers
    and BMP. I developed a massive Hematoma and Could Not Breath. Within 5 hrs I was back in surgery and woke up in ICU on a resperator
    for 3 days, I was given a Medtronic stimulator to wear for several hrs a day supposedly to help fusing, i still have pain and problems swallowing and hoarsness. I found out when reading my records that a Sales Rep was present during my surgery,why I don’t know because I never saw my surgeon after thisfiasco to ask hm, he never saw me in ICU or my post op visits.I saw the PA even though he was in the Hospital.What happened to HIPPA. I’m going to the ENT doctor tomorow Who knows what he’ll say..I know hw yoou all feel..

  10. I’ve had 3 spinal surgeries, one on my neck and 2 on my lower back. The disc was shattered and he told me he put a donor bone in place and fused the area, since then I have had neck pain,arm and hand pain with some numbness along with migrane headaches. My pain meds only do so much for my pain. My doctor has since left that group of doctors and will not treat me since I had already seen another doctor in the new group he works with. These spine doctors don’t know 100% about how to fix the damage and seems to go with the newest and latest products and probably get a kick back from the companies they use parts, ect. from. All I know is my life will never be the same.

  11. In 2012 I had three stints put in. Doctors put me on Plavix. Almost one year to the date later I had a brain bleed which almost killed me, The doctors had to cut into my head leaving me with a huge scare. They took me off the plavix immediatly.My age at the time of the stints was 59 and I am now 61 thank God.

  12. In Aug 2009, I had an MRI done on my neck. I was experiencing difficulties with constant tingling in both arms, and hands; and, I couldn’t feel small items, when I picked them up, which resulted in dropping them.
    It began to involve both legs, all he way to my waist.
    Then I began to stagger, lose my balance & fall. As a motorcycle rider, I began to fall when getting on & off my bike.
    My Neurologist stated that I had severe damage fro C1-C3, that a bone spur was pressing in to the spinal cord, around C3. He added that any fusion for this was risky at best, & he advised no surgery, but to be always aware of the dangers of falling.
    After I left his Office, he called my Neurosurgeon, to tell him, that I was at risk of becoming a Quadrplegic (neck down paralysis).
    May I add that I had a brain shunt placed in 2004,for Genetic Hydrocephalus, which explains the need for both types of Drs.
    My Neurosurgeon called me at 6:30 that night, and told me to be in his Office the next day. I told him that my other Dr had said ;no surgery’, & he said I was at risk for being paralyzed.
    When the Family & I saw him, he stated that I needed immediate surgery; that at best, I had 30 days before becoming a Quad; that, even with Surgery, my odds of ever walking again were only 22%….a 78% chance of failure.
    He scheduled the Surgery, a 360 cervical Fusion for 2 weeks later.
    The Surgery, done on 2 different days, with 1 day between, was supposed to be a ‘predicted’ total of 12-14 hours. The first day, to remove the bone spur, was the riskiest, the longest, and the one that would determine my ability to walk again.
    I arrived at the hospital, ‘armed’ with a large Support Team, including 2 Pastors, our Community Chaplains, & Family.
    I have Scleroderma, & placing IV’s is near impossible. One of my Pastors, Pastor Rick, Prayed over it, & within a few minutes, it was in.
    So they asked Pastor Rick, if he would Pray with the entire Surgical Team. They surrounded my bed, holding hands (beginning with me).
    The bone spur came off within minutes, & the blood circulation immediately began.
    At the end of the 2nd Surgery (the back of my neck), they had fused from C3-T2…successfully. I set a Hospital record for the most fusions done (technically) at 1 time….most of the Medical Staff kept coming to see this record breaking Patient.
    I was in only 5 days Total, due to risk of infection, & because I was able to navigate 2 steps up & down (we live in a mobile home, the avg is 2 steps).
    Recovery, as stated was the worst of any Post Ops I’d had in my life.
    But, I had a great Support Network, a husband who did EVERYTHING (I could not use neck muscles, therefore couldn’t wipe myself, tend to any personal needs. I choked on almost everything I tried to swallow, and I completely lost my voice (great news for my poor Husband). The muscle spasms were beyond imagination, as was the pain. I developed a UTI, and my Husband was every 20-30 min, placing me on my port-a-pot. But, after only 3 weeks, I was able to stop taking morphine, and scale down to Hydrocodone.
    I wore a steel/plastic brace from the chin, to below my rib cage, 24/7, for the first 5 weeks; then was able to remove it when sleeping. I had a heavy foam brace when in the shower.
    I was also fitted for a ‘Neuro-Stimulater’, which had to be worn 6 hrs a day from September ’09 till June ’10, when the battery just stopped, signaling the end of its’ need.
    My Surgeries were 09/14 & 09/16, 2009. At our Halloween Party, my best Friend held my hand while I did the Electric Slide; and on January 19 2010, I danced at our Annual Ball, with my Husband, and alone…receiving a standing ovation, & not a dry eye in the Ball Room.
    Today, I am back riding my motorcycle, a trike, not 2 wheels; I dance, do Karaoke..yes, I got my voice back, and am able to play with our 2 Great Grandchildren. We just had our 48th Anniversary, & a Party with over 70 Guests..which my Husband & I, with help from Friends, did ourselves.
    I am Blessed, and humbled that God, & the Drs have given me this miraculous gift.
    I do have the Titanium Cage, with Cadaver. But, considering the odds that I beat, I just thank God I am alive & walking..
    I have beat the odds with this….and whatever comes, will be His Will….and one I will live with.
    If any of you are faced with this Surgery: It is rough! It is a long recovery! Find the BEST NEUROSURGEON available; trust your Dr; but most of all, trust Whichever Higher Power you believe in.
    Make sure you have a STRONG SUPPORT SYSTEM, and CAREGIVER (mine refused to let me go to Rehab, & took care of my every need).
    YOU CAN DO THIS! It is better than the alternative of never walking again.
    And, if anyone needs to ask questions about my experience, I am on FB under Maggie Stalhut. Just mention this Fusion when you request to be my Friend.
    God is TRULY AN AWESOME GOD! I am here for a reason, that I do not know, as yet. But I will do His bidding, reach out to others, to touch their lives in a Positive way.
    I AM HERE FOR YOU!

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