Lawyers and Settlements
What are you looking for?
Home Page >> Hot Legal Issues >> Medtronic Infuse Bone Graft

Medtronic Infuse Bone Graft

The Medtronic Infuse Bone Graft has been linked to life-threatening complications in patients who were given Medtronic off-label. Medtronic bone graft complications include swelling of the airways, which can cause difficulty breathing, speaking and swallowing. Medtronic Infuse has also been linked to retrograde ejaculation which can lead to male sterility. A number of Medtronic lawsuits allege the manufacturer illegally promoted the Medtronic bone product for off-label uses.

FREE CASE EVALUATION

Send your Medtronic Infuse Bone Graft claim to a Lawyer who will review your claim at NO COST or obligation.Get Legal Help Now

Medtronic Bone Graft Lawsuit Update

March 28, 2013: Lawyers for plaintiffs in the Medtronic Infuse Bone Graft litigation believe that injuries received from this product, dating back to as early as 2003, may still be able to file a claim. As with all litigation, the attorneys state that such claims will likely face a vigorous statute of limitations defense but they are working with clients to help protect their potential claims, and anyone who believes they have been injured should seek the advice of competent counsel.

Medtronic Bone Graft

Medtronic VictimThe Medtronic Infuse Bone Graft is used during surgery to stimulate bone growth and replace damaged spinal disks. It was marketed and sold as one of the alternatives to harvesting a bone graft from the hip. The Medtronic Infuse Bone Graft is not approved for any other uses but it has been used off-label in cervical spine (neck) procedures.

In 2002 the FDA granted Medtronic approval for its Infuse Bone Graft, but for limited use in the lumbar spine, or lower back, and for some oral and dental procedures. Specifically, the agency approved the Infuse Bone Graft to treat degenerative disc disease and open fractures on the tibia. The FDA also approved Medtronic Infuse Bone Graft for use in sinus augmentation and localized alveolar ridge augmentation.

Medtronic, however, allegedly encouraged physicians to use its Infuse bone stimulator off-label in the cervical spine, which helped generate sales of more than $3 billion for the manufacturer. As of September of 2008, about 680,000 units of Infuse Bone Grafts had been used in the US, according to Medtronic.

The Medtronic bone graft contains recombinant human Bone Morphogenetic Protein (rhBMP), which is a genetically engineered version of a protein that is naturally released by the body. Use of the Bone Morphogenetic Protein initiates bone growth in specific areas of the spine, giving surgeons some control over where the bone re-growth occurs.

Medtronic Complications with Bone Graft Cervical Spine Use

The Medtronic Infuse bone growth stimulator in the cervical spine has been associated with many serious problems, including:
  • Difficulty Breathing, Swallowing or Speaking
  • Compression of the Airway
  • Respiratory Depression
  • Nerve Damage
  • Death
The FDA notes that most Medtronic Infuse complications occurred between two and 14 days following surgery. Complications can also include the need for respiratory support, insertion of feeding tubes, anti-inflammatory medications, tracheotomies, and additional surgery.


FDA Warning on Medtronic Off-Label Use

In the wake of at least 38 reports of complications, In July 2008, the FDA issued a warning concerning off-label Medtronic Infuse Bone Graft use, stating that risks were associated with the use of the bone graft on the cervical spine. The agency's warning stated," that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.”

The reports included patients who experienced difficulty swallowing, breathing and speaking, caused by a "compression of the airway and/or neurological structures in the neck." Many of the patients required emergency treatment, which included tracheotomies, anti-inflammatory medications, feeding tubes and second surgeries.

The Wall Street Journal (09/08/08) reported that FDA records showed approximately 200 adverse events where patients experienced serious complications after the bone graft was used off-label.

Medtronic Infuse Bone Graft Study Conflict of Interest

According to reports, some doctors who used the bone graft system or who wrote favorable reports about the product may have been paid by Medtronic. The Wall Street Journal also said that Medtronic paid approximately $800,000 over three years to a surgeon who was accused of fabricating a study that reported positive results for the Infuse Bone Graft.

The doctor involved, Timothy R. Kuklo, allegedly based the study on "falsified information" and forged the signatures of supposed co-authors. Medtronic said the payments were related to the doctor's work developing products and speaking at company events.

Meanwhile, the FDA was reportedly concerned about Medtronic off-label use of the Infuse Bone Graft before the product was even approved, according to The Wall Street Journal. At the time, Dr. Scott Boden, speaking to an FDA advisory committee, said the discussion of off-label use should not be a focus of the meeting. Dr. Boden allegedly received more than $100,000 a year from Medtronic.

Medtronic Infuse Bone Graft Investigation

In June 2011, the US Senate Finance Committee announced it is investigating surgeons who were paid consultants for Medtronic. Committee members Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) sent Medtronic a letter to demand that key financial records, communications and documents be turned over to the Committee.

The inquiry, which will look into whether those surgeons failed to report complications associated with the Medtronic Infuse Bone Graft, was announced because a soon-to-be-published study suggests that the bone graft product was linked to complications during clinical trials but those complications were not properly reported. Some of those complications reportedly include swelling in the neck and throat, abnormal bone growth and sterility.

In July 2011 The Spine Journal published a number of articles regarding the risks associated with Medtronic’s Infuse Bone Graft, including the following:
  • Medtronic’s failure to accurately report the side effects from its clinical trials;
  • Medtronic’s failure to report that many of the authors who studied and promoted its product had significant financial ties to the company;
  • that Infuse Bone Graft can cause severe problems with nerves and spinal cords;
  • and that off-label use of Infuse Bone Graft can lead to severe side effects.
In August 2011, Medtronic announced that it had agreed to have researchers from Yale University conduct an independent review of the Medtronic Infuse spinal bone graft. The review team, headed by Harlan Krumholz, MD, will look at patient data from Medtronic Infuse clinical trials and also all Infuse FDA adverse event reports (AERS) since it came on the market in 2002. The Yale independent review will reportedly cost Medtronic $2.5 million and is anticipated to take six months to complete.

Medtronic Lawsuits

At least three lawsuits were filed against Medtronic by former employees, who alleged the company gave doctors incentives to use Infuse Bone Graft and other Medtronic spine products. Two of the cases were settled without Medtronic admitting wrongdoing.

In December 2008 a Medtronic Infuse wrongful death lawsuit was filed on behalf of a California woman who went into a coma following surgery and died. The lawsuit claimed that Medtronic failed to warn about the risks associated with use of the device in the neck, and that Medtronic actively encouraged off-label uses, none of which have been approved by the FDA.

Another lawsuit claimed that the Medtronic Infuse Bone Graft was used during a cervical spine fusion, which caused the plaintiff severe swelling in the neck and throat. He underwent an emergency tracheotomy.

In July 2011 a California woman filed a lawsuit against Medtronic and Stryker Biotech, both medical device manufacturers, claiming that the companies fraudulently promoted their products for unapproved, off-label use, which was dangerous and resulted in her serious injuries. The plaintiff, 34-year-old April Cabana, was left with nerve compression and severe pain in her lower back and extremities after surgery using a Stryker product. She required a second surgery: her surgeon used Medtronic Infuse Bone Graft in order to fuse the bone, but the product had not been FDA approved for this procedure. According to the lawsuit, Medtronic illegally promoted it for a number of off-label procedures. The surgery made Ms. Cabana’s condition worse.

In September 2011, a Florida woman, Jennifer English, filed a personal injury lawsuit against Medtronic. In August 2007, English was implanted with Medtronic's Infuse Bone Graft during a posterior-approach lumbar spine surgery, which was not FDA approved. The lawsuit claims that Infuse caused her to develop ectopic, or uncontrolled, bone growth in her spine, compressing nerves and leading to chronic and ongoing severe pain. It also alleges that Medtronic fraudulently misrepresented the risks and benefits of Infuse and improperly promoted and marketed Infuse for non-FDA approved uses.

Medtronic Infuse Bone Graft Legal Help

If you or a loved one has suffered illness, or damages resulting from the use of a Medtronic Infuse Bone Graft, please click the link below to send your complaint to a lawyer to evaluate your claim at no cost or obligation.

Last updated on May-7-15

MEDTRONIC INFUSE BONE GRAFT LEGAL ARTICLES AND INTERVIEWS

Medtronic Double-Dipping?
Medtronic Double-Dipping? Kingston, GA: Scott had no idea that his difficulty swallowing could be linked to a Medtronic Infuse bone graft. He was only aware of Medtronic complications when bone began to grow outside of the graft. Ironically, Medtronic is now selling a device to help with swallowing complications! It’s hard to swallow, but could Medtronic be double-dipping [READ MORE]

Medtronic Meddling Leads to Class-Action Lawsuit
Medtronic Meddling Leads to Class-Action Lawsuit Kingston, GA: Allen, a Medtronic Infuse bone graft victim, is reading with great interest a Medtronic class-action lawsuit filed by its investors, claiming that Medtronic intentionally misled them and charging the CEO in a cover-up [READ MORE]

Medtronic Lawsuit Plaintiffs Earn Relief from Special Appeals Court
Medtronic Lawsuit Plaintiffs Earn Relief from Special Appeals Court Annapolis, MD: The plaintiffs in a Medtronic lawsuit may have faced stormy seas when a trial court dismissed various claims against the manufacturer of the Medtronic Infuse bone graft. However, when a Special Appeals Court reviewed the case within the framework of the Medical Device Amendments Act of 1976 (MDA) and the various nuances of the framework that governs whether or not state obligations are preempted by federal oversight, the plaintiffs found some relief [READ MORE]




READER COMMENTS

Posted by
Tammy Vedros
on
When will we get justice. I'm about to lose my transportation, because SSI,isn't enough to live on. When will we see justice for all the suffering and pain. Lawyers are in no hurry. Can never get any real information on the progress of the suit. I've been suffering since 2005. No doctor wants to touch the surgery, I get, there's nothing we can do.

Posted by
Anonymous
on
I had a double Spinal fusion procedure on September 4h 2008 where two monsters used an Infuse Bone graft kit--but mixed and matched parts of the Infuse Kit and created their own device--using both an anterior and posterior approcch at L-5-5 and S-1-2. This procedure was supposed to "make me as good as new" as a corrective measure to a herniated disc at L-4-5 and a very slight amount if degeneration.

I remember waking up in recovery thinking it was a miracle--as I had no pain previously associated with the herniated disc--the new and only pain initially was incision related--my stomach and my back had multiple stiches from my belly button down to my groin--But almost two weeks to the day of surgery--I set in with the most horrific pain I ever dreamed possible to bear by a human--plus severe swelling in my hips, legs and feet ! I called the surgeons and they ordered me to come in for x-rays thinking something may have moved or shifted--but that was the beginning of cover-up. The swelling and new-found pain was the beginning stages of me rejecting the Infuse compounds.

I have since found out that the two surgeons who pushed this on me were actually part of the "Ghost Writing Team" of doctors that were paid to alter--falsify and edit test subject data to assist in the FDA approval of the infuse device. Anyway--Since November of 2014 to current day 2/4/15--I have been in the hospital four times--two different hospitals and four different doctors have diagnosed me with Severe Pain Induced Hypertension--like Stroke--Heart Attack hypertension--and under closely monitored conditions--my blood pressure is too low if my pain is under control and being administered blood pressure medication. All blood pressure medication had to be discontinued as long as my pain was being controlled. Recently I have been told that there is ectopic--like way too much and unwanted bone growth going on--where my vertebrae now looks like a 2X4 in one solid piece from my hips to the middle of my shoulder blades--yes one solid block of white bone ! And I get worse every day ! Also recently I have discovered--that the two surgeons that performed my surgery--once thought they were paid NINE Million dollars by Medtronic for their research duties--to just days ago--I have found out that the two surgeons (MONSTERS) were paid 23 Million Dollars for their ghost writing and editing skills.
Also, the two surgeons just happened to own the hospital where this night mare surgery took place--and I worried about records mysteriously disappearing--August of 2014 I marched into the hospital demanding my Operation Chart Report--and Mystically one of the surgeon's names had been removed or redacted from the hospital surgical report ! But Guess What ? I have a bill from him that my insurance paid to him (over $10,000) for his assistance in my surgery ! That my suffering friends--is the kind of stuff that put Al Capone away for good ! And I would love to see much the same for these "so-called" doctors ! good luck to all of you--but there isn't much hope for me !

Posted by
Anonymous
on
I had a medtronic back fusion in 07 was told i would be 85% back to normal had 5 disc in low back 5 in neck in 2010 wasn't aware of side effects just trusted my doctor I used to be very active raced motorcycles hunted fished woke up singing every morning now I cry every morning wishing I hadn't woke up I can't get a second opinion nobody wants to touch another dr's work no hope just more pain to look forward to the rest of my life I pray to die what did they do to me? I live in ky pill abuser's have made it so bad I can't get anything strong enough to work any suggestions would be greatly appreciated before it's to late mike

Posted by
Missouri
on
Medtronic deputy plate and screw system with a cornerstone LASR graft size 8, anterior cervical diskectomy with fusion at c5-c6. Significant swelling in vocal cords and remained in ICU for 4 days. Intubated, developed pneumonia after extubation, among other problems.

Posted by
Anonymous
on
I have suffered for 7 years with infuse device in me it has disabled me and i fight the pain to no end ,between the pain meds and life i dont have much life just wish i could get it taken out screws are coming loose will it never end.I was one of the happiest people you ever met til this ,so sad to harm another.

Posted by
Illinois
on
Infuse was used on a fusion, and the bone fusion moved up and over my disc replacement making one solid fusion of 2 levels, not just the one it was intended for.

Posted by
Wisconsin
on
In 2007, I had a slip and fall accident, settled already. In September 2008, I had a fusion and surgery at L5-S1 using the Infuse bone graft. I have never been the same. I have gone through literal HELL since my surgery. I lost control of my bladder, have had never-ending pain in my leg, and serious problems with mobility. I am permanently disabled as a result and lost basically everything I owned because I could not continue at my construction job. It makes sense now that the Infuse bone graft is causing all of my problems!

Posted by
Kentucky
on
Received Infuse four times, twice in cervical, twice lumbar. Take daily pain meds. In constant pain. Also have had several corrective surgeries. Lost use of left arm, and legs, and feet are not working properly.

Posted by
Georgia
on
I am permanently disabled and suffer with severe nerve pain. Some days I can’t even walk on my feet. I had to give up my nursing career. Two screws were bent and the fusion never healed. I NEED HELP PLEASE!!!!

Posted by
South Carolina
on
Severe pain in the neck. I have to sleep sitting up. Limited movement in my neck. I cry all the time because of the pain. Injections make it worse. PLEASE HELP ME!!!! I don't know how much more I can take...

Posted by
Anonymous
on
I had back surgery in 2005 in Nov, it was supposedly to have a disk shaved. I remember waking up feeling like I was hit by a mack truck. The Dr said let me apologize it was worse than we thought, so we had to put this cage and four bolts. I was a 31 year old Army soldier I had been married about 3 years I had a daughter from my wife who was 3 years old and I also had another daughter 5 months younger than my daughter. So both my girls were born in 2001. I got married in 2002 we got pregnant again in 2004 but she miscarried. I had surgery a year later and all of a sudden my sperm is no good the dr tells me. They placed this protien in my back knowing the side effects and cost the opportunity to have a son. I never got over the pain, the cold sweats I lost my career and most of my relationships with family and friends. Pain is a terrible companion.

Posted by
Anonymous
on
Enough of the stories! We need to do something to get justice. The attornies are not in any hurry to get us justice, all they seem to care about is profit. The more claimants they get the more money they will profit. I have had a attorney for the last 4 years and Im no closer to getting justice now then I was then. Anybody got any ideas??

Posted by
Georgia
on
Severe nerve damage, severe scar tissue growth, multiple surgeries. Recommendations by 2 Medical Universities for removal of bone graft, mesh, soft tissue growth & scar tissue growth @ lumbar level. Reconstruction of 1st surgery done in March 2003 for proper healing. Mobility impaired & disabled since defined by SS Administration June 2003.

Posted by
Anonymous
on
Had cervical spine fused C3-C7 using Infuse BMP & have none-stop pain shooting up scalp & down arms, neck & back, can't look down to waist w/o pain. Having trouble breathing & swallowing, some choking issues, constant sinus infections that think may be connected, as well as needing to use a nebulizer daily, that never needed before.

Had low back fused, lumbar L3-S1 fused w/Infuse BMP by force, because of the disc replacements that were put in between L4-5 & L5-S1 shifted, causing the L5 vertebra to shatter. The lumbar fusion was done as an emergency due to fear of the bone cutting through spinal cord. None of that makes dealing w/the pain any easier, it's constant & really exhausting. Never able to sleep & tired of the pain meds constantly have to take. Never know when legs will give out when walking or on stairs, can't walk, sit or stand for very long w/o unbelievable pain. Have stomach & bowel problems that seem to be getting worse as time goes by, now afraid of trouble at incision site because of severe pain in that area to extent clothing hurts touching it.

Posted by
Texas
on
Since my BMP surgery in late Dec 2007, I had to have additional rods implanted in my neck and I am on Prednisone (5mg) daily to allow me to actually use my arms.

Posted by
Florida
on
My husband had a 360 spinal fusion in June of 2011 and he is still suffering from server pain that travels from his lower back down to his pelvis and legs all the way down to his toes. He has a lot of numbness. From what I have read the dr used it off label and nobody is helping us. We are trying for ss but no dr is willing to say he is disabled cause he is so young and could still be healing. We need some help!! All he does is lay down he has a hard time with everything including his mental health because of this!!!

Posted by
Minnesota
on
Constant bone pain starting at C-12 and going all the way to my feet. Muscles on bone fusion side have never healed properly. Several cysts in my back near fusion area. Constanst flu-type symptoms. Continually sick with infections of all kinds. Very painful. Constant headache.

Posted by
California
on
Since 2009 difficulty swallowing, permanent nerve damage
in left arm and hand. While holding anything, even paper, in my left hand it will fall to the floor without my feeling it.
Is it possible Actifuse is as bad as Infuse?

Posted by
California
on
Bone grafts did not take. Cement was used in excess. I'm missing a lot of spins procesus bones. Im told that if just one screw comes loose or cement breaks free I cannot have this procedure ever again. Lower spine and left hip, leg and foot always hurt. Excess scar tissue from four openings.

Posted by
Missouri
on
I can not sit, stand or walk for more than 10 minutes before enduring severe pain, I continue to have sleepness nights due to the pain I endure, a lot of swelling and pain in my legs,loss of bladder, I walk bent over now due to the swelling.

Posted by
Florida
on
the damages I have suffered are: difficult swallowing, talking, eating, pain, numbness and tingling entire body especially when sitting, respiratory problems, choking frequently, fungus in blood, frequent headache....etc

Posted by
California
on
Not able to perform house work, unable to work, unable to walk without aid at all.

Posted by
California
on
We were told before her surgery that this new device (the infuse bone graft) was FDA approved for her spinal neck fusion surgery and that the only side effects could be some swelling and trouble swallowing, there was NEVER any mention of LIFE THREATENING complications which could arise. On her 3rd day post-op, she complained repeatedly about having trouble breathing and was told she was just feeling like she couldnt breathe because of the swelling in her throat and that she was just fine. At one point she said to the nurse "I CAN'T BREATHE, I FEEL LIKE IM DYING" The doctor was called and relayed the same information to us that she only felt that way and he promised us she was just fine and not to worry that we could go home and get some rest. We got an emergency phone call at about 5 am that there was a little problem with my mother and they were moving her to the CCU so they could watch her more closely. When we got there the little problem turned out to be that she had stopped breathing because her throat had swollen shut and cut off her airway and we dont even know how long it took for them to discover she was suffocating!!!!! They almost could not get an airway in because of the swelling in her throat and by the time they did get her breathing again she had gone so long without oxygen that she was now in in irreversible coma with a huge anoxic brain injury. We gave her a full 5 days but it was painfully evident that she was not going to ever recover and we knew she would never want to be that way, we removed life support and she passed away after a few agonizing minutes. MY MOTHER WAS STOLEN FROM ME IF NOT MURDERED, THE DOCTOR KNEW THIS COULD HAPPEN AND NOT ONLY SAID NOTHING, HE TALKED US INTO USING THIS "GREAT NEW PRODUCT" I believe she is the first person to die from complications of this dangerous product and it needs to stop being used in "OFF LABEL" surgeries!!

ADD YOUR COMMENT ON THIS ISSUE

Fields marked * are mandatory. Please read our comment guidelines before posting.

*Name:

Note: Your name will be published with your comment.

*Email Address:

Your email will only be used if a response is needed.

*Your Comment:

Request Medtronic Infuse Bone Graft Legal Help

First name:

Last name:

Email address:

Phone number(s):

State/Prov:

Zip Code:

Describe your complaint:

Check Claim Status Advertise with us Legal Funding


Related Lawsuits

Legal Services:

Facebook



 
FAQ | TOS | Privacy | Disclaimer | About Us | Contact Us | Press | Advertise | Member Login | Jobs | Site Map | View Mobile Website |


Better Business Bureau   CAALA   Best of the Web Approved   Public Justice


This work is licensed under a Creative Commons Attribution-NoDerivs 3.0 Unported License © 2001-2015 Online Legal Media. All rights reserved.