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Medtronic Infuse Bone Graft Injury Lawsuits

Research shows the bioengineered bone growth protein, recombinant human bone morphogenetic protein (rhBMP-2)—sold under the brand name Infuse—causes male infertility. The Rottenstein Law Group compassionately advocates for those who have suffered from the harmful side effects of potentially dangerous drugs. If you received Infuse Bone Graft in surgery and believe it harmed you, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Infuse Bone Graft recalls and Infuse Bone Graft class action lawsuits. We might be the Infuse Bone Graft law firm you are looking for.

Potential Side Effects Include Male Infertility

Medtronic Infuse Bone Graft is the brand name for the naturally occurring recombinant human bone morphogenetic protein (rhBMP-2) and its accompanying Absorbable Collagen Sponge (ACS). This prescription chemical is used to help regrow damaged bone tissue by creating a scaffold to accommodate new bone mass. The U.S. Food and Drug Administration (FDA) approved Infuse for open tibial (shin bone) fractures, degenerative disc disease, and two dental bone grafting procedures. Any other use is off-label. Medtronic sold $900 million worth of Infuse product in 2010.

Since 2002, doctors have used Infuse in two spinal procedures, specifically anterior lumbar fusion (lower back) and cervical spine fusion (neck). This is quite risky as Medtronic Infuse Bone Graft can damage nearby tissue if it isn’t inserted properly or if leaks out of the ACS, which can cause spontaneous bone growth where it is not desired. Surgeons based in North Carolina determined that complications arose in 21% of the cervical fusion procedures that did not involved the Medtronic Infuse, and in 59% of the cervical infusion procedures that did involve Medtronic Infuse. Subsequently, the FDA issued a Medtronic Infuse Bone Graft warning in July 2008. Of the 280 adverse event reports submitted to the FDA, three in four were for off-label uses. Consequently, in November 2008, the Justice Department began investigating Medtronic for illegally advertising the Medtonic Infuse Bone Graft. Later, Medtronic settled two whistleblower lawsuits for $40 million.

According to a May 25, 2011 New York Times article, Stanford University surgeon Dr. Eugene J. Carragee authored a study that was published by the web site The Spine Journal. In the study, Dr. Carragee studied 240 men who underwent cervical fusion surgery. The off-label use of the Medtronic Infuse Bone Graft was involved in 69 of those procedures. Five of the six men who developed a condition called retrograde injection were Infuse recipients. When a man experiences retrograde injection, his semen goes into his bladder, making him infertile. The condition cleared itself in three of the six men. The Medtronic Infuse Bone Graft does not appear to affect women.

Dr. Carragee is not alone in his findings. Two Croatian physicians, Dr. Tommislav Smoljanovich and Dr. Ivan Bojanic, point out that Dr. Carragee’s findings are consistent reports that Medtronic itself submitted to the FDA in 2002 arguing for Infuse’s approval, though Medtronic strenuously denies this interpretation. The University of Pittsburgh’s Dr. James D. Kang notes other complications caused by off-label Infuse use in cervical fusion procedures, “[E]arly inflammatory reactions of soft-tissue swelling and sterile cyst formation … [I]t has resulted in potentially life-threatening airway complications.” These complications occurred in the 2-to-14 day period after surgery, and patients required tracheotomies, feeding tubes, anti-inflammatory medications, and additional surgery.

Several Infuse cervical fusion lawsuits have been filed against Medtronic, and at least one Medtronic Infuse Bone Graft class action lawsuit has been filed against the company by shareholders over illegal advertising.

A June 17, 2013, report in the New York Times focused on some research that indicated that the benefits of the Infuse Bone Graft were overstated. Medtronic released the data after it was accused in 2011 of overstating the efficacy and downplaying the risks of the product in company-sponsored research studies.

 

RLG’s Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Infuse Bone Graft lawsuit on your behalf if necessary. RLG will also keep you up to date on any Infuse Bone Graft class action lawsuits, FDA Infuse Bone Graft warnings, and Infuse Bone Graft FDA recall announcements.

If you received Infuse Bone Graft in surgery and believe it harmed you, contact RLG today.

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rlg Previous Comments

  1. Guest
    on September 5, 2012 at 8:53 pm

    I have had spinal fusion surgery on L4 and L5, three years ago and am still in a lot of pain. The Dr. has told me to just live with it. I also had surgery on my upper spine and am till having problems.

  2. Guest
    on August 27, 2012 at 7:01 pm

    I had my first cervical fusion surgery in July 2010 at c6c7. Nine months later I had problems swallowing. Went for my yearly check with the surgeon in July 2011. Said I needed hardware removed because my screws came loose. Had the surgery, but no other hardware was put in. Now I have more pain than since my first surgery. I live on percocet, lyrica, zanaflex, prozac, among other medications. I have nerve damage in my left arm and neck. Now I'm told my neck never was fused. I now face another surgery if I want to try to have a normal life. I'm only 48 years old. Please, it has to get better.

  3. Guest
    on August 22, 2012 at 9:52 pm

    Had a c5-6 fusion in my neck 2010. Felt better but now nerve pain is back.

  4. Guest
    on August 17, 2012 at 5:42 am

    I had my surgery March 2010. Life for myself and household has never been the same. I was not able to speak or eat when leaving the Hospital...little did I realize those were minor compared to the pain and suffering I have endured through out that time period til now.

  5. Guest
    on August 15, 2012 at 2:17 pm

    I had surgery on 4 and 5 in my lower back last January. It was good for the first month then the pain started to come back. Now its as bad if not worse that before surgery. The pain is constant and nothing helps to relieve it. The surgeon that did my surgery refuses to do another MRI just to see if anything is wrong.

  6. Guest
    on August 7, 2012 at 3:53 pm

    I had anterior intralumbar body fusion L3-4 and L4-5 with a total of 4 BONE MORPHOGENIC PROTEIN SPONGES. This was in 2009. I have had pain in my groin and recently my hips hurt badly. I am going to request an MRI because recent research reports have made me very concerned.

  7. Guest
    on August 2, 2012 at 6:41 pm

    I had my surgery in July 2004, now sometimes I can barley walk as my legs are weak. I am always in pain, have issues sleeping. I have tried to call the doctor who did the surgery to find out what he used, and I have not heard back from them. Dr.Thomas Dunn did the surgery here in Las Vegas. I also was told at the time I have Degenerative Bone Disease. Everyday it gets worse, I do not have the money to stop working so I go to work in pain all the time. At night I cannot sleep due to the pain in my back, and the pain in my legs. I wish I would have never had the surgery.

  8. Guest
    on July 31, 2012 at 9:26 pm

    I had neck infusion done in 2010. My symptoms have worsen since my surgery. I have numbness in hands. Pain in neck, shoulders and arms. I get strangled on food. Feels like my breathing is more difficult.

  9. Guest
    on July 28, 2012 at 11:44 am

    I had 2 cervical fusions. One in 2010 c3-c6 and 2011 c6-c7. After 2 surgery, airway closed twice. 2nd day and 1 week later, was rushed to the ER because I couldn't breathe. No explanation for cause. Severe nerve pain in neck and head, severe weakness left side with no known cause. On narcotics 24/7 for pain. Trouble working and daily activities. Seizures after surgeries. Unknown what was used in fusion.

  10. Guest
    on July 26, 2012 at 1:36 pm

    I Had my c6 c7 fusion with bone graft done on September 2011 and I've been on pain pills ever since. The doctor said it was normal for the pain to go to the other side... I was never told that in the beginning. I'm still in pain 24/7. Another doctor said the fusion didn't take..so I'm back to square one.

  11. Guest
    on July 22, 2012 at 5:27 pm

    I had back surgery and had barrels for a bone graft put in which was a fusion but not sure if it is the same. I do have hip and leg pain.

  12. Guest
    on July 14, 2012 at 7:04 pm

    In 2006, I had 2 level posterior anterior fusion. I have been in excruciating pain ever since. Three years later, was told I needed the simulator device by a different doctor's PA, but then he overrode her words and said I needed the Aspen device above the top level fused by my original Ortho Doc. I had the Aspen surgery. Two years later and still losing my business and my life, the Aspen device has detached from the vertebrae at top and has just been causing more pain along with placing my spine in very unstable state. I am back with my Ortho surgeon and will have surgery this Monday, July 16 to remove the Aspen device, all rods and screws and they will fuse the Aspen level starting at the bottom L5 S1 and new hardware put in up to L3/4. The only relief I've discovered has been Bupivacaine injections into low back and I get totally pain free for 24 to 30 hrs at the most.

  13. Guest
    on July 3, 2012 at 3:11 pm

    I had s1 and L5 infuse fusion two years ago, and I am still in constant pain. The pain is in both legs and in pelvic. I can't sit straight up for the pain in my pelvic for longer than 10 mins. When I had my surgery they told me it would make me feel 100% better. Boy were they wrong.

  14. Guest
    on June 28, 2012 at 1:14 pm

    I've had three bones replaced and its been about six years ago. I have recently been told that my airway was too small and not to take any sleep aides because I might not wake up. I have insomnia so bad. My arms ache and I get strangled alot for no reason. Just a few things that has been wrong. Since my surgery.

  15. Guest
    on May 17, 2012 at 5:56 am

    I had a four level fusion in 2002. I was told by the representative of that company and the doctor that I was going to be the first patient to have their device put in my cervical so they were going to video the entire procedure. Let's just say, I wish to god and any other higher power to take this out of me.

    1. Guest
      on July 6, 2012 at 12:21 am

      I had cervical fusion in 2007; continue to have neck and right & left arm pains, also numbness in fingers. I don't know what brand the neurosurgeon used.

    2. Guest
      on August 2, 2012 at 5:35 pm

      I am posting this to try and keep others from making the same mistake. I am on disability now after 31 yrs. of employment. I had my cervical spinal fusion in 2007. I have said since then to my friends and relatives that I have NEVER been the same since the surgery. I have prayed for years, before this became know to the public it was not even FDA approved. My chronic pain will always be there because of the surgery and for what? I'm in a state of depression now also. I hope someone reads this and knows they are not alone. If you haven't had it done? Take advice from me and do not!

  16. Guest
    on May 14, 2012 at 10:03 am

    I had L-5 S1 infusion and BMP10mm cage. In 2007, it hurts so bad and swelling is unbelievable. But they said that it was fibromyalgia. It's the same type of pain I was having before the infusion. Then got colon cancer in 2010. And still my back locking up and leg cramps. Would it be from this BMP?

  17. Guest
    on May 10, 2012 at 9:02 pm

    I had a 360 lumbar fusion in 2008 when I was 37 and have been in worse shape than prior. I am now on disability and suffer from so much pain that I am in bed most of the day whereas prior I ran 10 miles a day. I am also on heavy pain meds that I must get filled every month and am being pressured to have additional surgery. How can I find out what type of device was used in me. I have a cage with screws throughout my lower back and have suffered from diverticulitis since the surgery as well including contracting staph afterwards needing a PICC line inserted into my arm for 6 weeks.

  18. Guest
    on April 28, 2012 at 11:24 am

    I had a double fusion (L4 L5 and L5 S1) in 2007. Since then I still have pain in my my legs and butt area. I still swell up in the low back and have lumps in my right leg. I have had about 14 injections in my back that has not done anything. The last injection I had (about a month ago) they told me they thought I would need another fusion above the 2 I have. I have been told I have Nerve damage and that is why I have such pain. About a year ago, I started having tremors (shaking) in my head and now it is in my left arm. I to had to go on disability. I am only 39 yrs old. It is extremely hard going from being active to not even being able to vacuum without being in bed in pain. I also am not sure what they used for bone graft just know it wasn't my own bone. At the time they never said they could use my own I wish I would have known.

  19. Guest
    on April 26, 2012 at 11:33 pm

    I had an infusion on my lower back and now it hurts constantly, and I also have nerve damage.

  20. Guest
    on April 4, 2012 at 3:18 pm

    I have had three neck surgeries with several bone grafts as well as steel rods and pins in my neck, but I have had sexual dis-function at all levels since I had the last surgery four years ago. I also have had a hip replacement that has been giving me a lot of pain lately that was four years ago also.

  21. Guest
    on April 3, 2012 at 12:17 pm

    I have had a three disk fusion in my neck in 2010 which seems to be there strongest year. I do have the Infuse Bone Graft in my neck. I am messed up. I am wondering do we need to get these things taken out of our bodies before something really bad happens?

  22. Guest
    on March 20, 2012 at 9:58 pm

    In 2005, I had a posterior lumbar interbody fusion (PLIF) surgery, while at Brooks Army Medical Center in San Antonio, TX. I was a soldier who suffered from lower back pain, during the surgery they used Medtronic Infuse Bone Graft. The surgery was unsuccessful and I now receive disability, however I would like to know more if I have a case.

  23. Guest
    on February 17, 2012 at 12:27 am

    I had cervical fusion in December 2009 and Lumbar fusion L5-S1. I have been in awful pain ever since. I don't know what type they used or how to find out. I have nerve damage to the right arm, shoulder and neck. I also have terrible sciatic nerve damage to the right leg and swelling in my back all the time. This has ruined my life.

  24. Guest
    on February 9, 2012 at 4:30 pm

    In 2009, I had 3 level fusions done with both anterior and posterior approach. Never told Infuse was used, read it in the paper 3 years later. Now I have permanent nerve damage to L4&5 these levels fused with Infuse plus S1, and was told I need a Spinal Cord Stimulator implant for the nerve pain. Nothing else can be done for the daily pain. Shots have failed.

  25. Guest
    on August 13, 2011 at 11:47 am

    My daughter, Joanne, needs assistance please. In 2004, when she was only 26 years old, she was 'talked into' having a back fusion using Medtronics devices and the BMP (only approved by FDA two years prior). She was only taking Darvocet at the time which was considered just slightly stronger than aspirin. Just had failed back fusion and went into a complete depression. Prior to the surgery, she had been working for Sony after graduating from college (on the deans list). She could no longer work and was forced to take SS Disability. Her depression has lead to many problems. In March 2010, I was provided legal documents where 35 doctors were indicted for kickbacks from Medtronics from 2004-2006 and the surgeon who performed my daughters surgery testified that he did receive kickbacks from Medtronics during that time. Unfortunately, my daughter's depression as so severe that there was no time to file malpractice and we did not know about the kickbacks during the status of limitation timeframe. However, I have been told there is a 3-year limitation regarding fraud beginning from the time frame of when the patient became aware. I have the proof to show we became aware on March 2010. Could you please help my daughter? She cannot pay her medical bills, living in section 8, and is giving up hope. God Bless You RLG.

  26. Guest
    on August 12, 2011 at 10:47 pm

    I've had two infuse spinal fusion surgeries. I have worsened and new nerve problems. I have constant leg and pelvic pain. I have doctors that act like it is my head. I am 38 years old I would love to feel better. Please call me if you think I have case. Thanks.

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