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Medtronic's "Infuse" used for spinal fusions

From: rn2006 - on 06/22/2011 3:04pm

Read a disturbing article today online in Milwaukee's Journal/Sentinal. Seems there are side effects not being reported by doctors due to high money payouts from Medtronic. I am concerned. I had my lumbar fusion (L5-S1) in March 2010. The article states that the BMP (Bone growth hormone) used with the hardware can cause severe side effects. I had an anterior approach surgery, which is the recommended way to use this system.

I also had a cervical fusion (C4-C7) in December 2004. I am now questioning if this could have been used at this time also. Surgeons were using it as an "off-label" intervention. Though I did not have the severe and immediate reactions at this time, I do have multiple bone spurs within my hardware. The article states that this BMP can cause unwanted bone growth in other areas.

I will be checking with both surgeons to see if I was exposed to the Medtronic "Infuse".

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on 06/25/2011 4:48am

I've read about Infuse also. Did your surgeon tell you he was using BMP? I had fusion of L4, L5 & S1, with BMP, which would have been off-label since it was a 2-level fusion and BMP was indicated for single fusions. I also had avascular necrosis ("death" of the bone because of lack of blood circulation) in my right hip, which developed after my fusion. I had started getting better from the fusion when my hip started hurting. I had the hip replaced in 2007. I've had continuing pain ever since. Bone scans and MRI's show that my surgecal sites look good, but I still have a lot of pain. It's hard for me to know whether my pain originates in my lower back or from the hip repacement.

How did they determine you have bone spurs? I assume you mean they are in the fusion cage? I'd like to know what they find and how they treat you for this, especially if they find that BMP caused your problems.

I now have a herniated disc L3, right above my fused discs. I'm trying to figure out what to do about it aside from taking the strong opioids I am on.

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on 06/25/2011 8:35pm

Hi rn2006,
I just posted my problems with BMP overgrowth. I had bone overgrowth removed in Dec 2010 and am now facing the possibility of another surgery for removal of additional growth that is compressing nerves.

I anticipate receiving a copy of op notes as I had 3 lumbar surgeries from Oct -Dec 2010. I am not sure which hormone was implemented during my fusion in Oct.

Yes, overgrowth is listed as a side effect but I have been unable to find much online. The Mayo Clinic is recruiting candidates for their study on this issue - alas I am not a candidate.

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on 09/21/2011 9:04pm

Hi everyone, I also have a fusion of the L-3,L-4, L-5 and the doctor used BMP-2 on me with the use of 3 bone marrow aspiritions to mix in with it to promote bone growth. I had my surgery in Jan 2011 and I am still having alot of pain and at times can't stand up straight and can't do any long free walking without bad pain in my hips. I was not told about this being used on me either. I found out from getting my medical records from the hospital were I had the surgery and the medical records from the doctor's office. I will check out Medtronic and read up about it. Thanks for the information.

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on 09/22/2011 11:27am

This has nothing to do with anything I just love your puppy Heres mine. He turned 2 on July 20th His name is Sammy. And the biggest life saver. I got him and just love him to death. Hes been great for me and the damn pain He helps me. How about you?

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on 09/22/2011 11:36am

Have you found out anything else on BMP? I would like to know I had L-5-S1 done in2007 than in 2008 they had to do L-4 also whats up with that. why couldn't it be done with the other? My PA at the pain center was to make me an appointment for hardware removel this was 1 an a 1/2 months ago I called the office to find out what was going on. They have never gotten back to me. I know I should keep on them. But when does it stop? Why do doctors do this? she has never called anyone yet. she just wants me to have the inplant done thats it. well I don't want it done right now. To me that the last resort. I'm not ready to give up. besides read others doesn't sound like it really has done much for others.

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on 09/22/2011 9:46pm

There is quite a bit of controversy about rh-BMP's "off-label" use. Keep investigating. The more I read, the more I am disillusioned with the lack of ethics of some of the medical community, i.e., doctors who failed to report serious side effects of Medtronic's Infuse (rh-BMP-2).

It is the doctor's responsibility to protect the patient from harm. How can they do this if information on the products they use is tainted?

I had scoliosis surgery in 2010 and was fused from T10-L5. Infuse was used (off-label). Now, one year later, I realize I had and have many of the complications mentioned in the recent articles. Could they by caused by the use of Infuse? Who knows and what can be done about it?

Anyone who has had a spinal fusion since 2002 should find out if Medtronic's Infuse was used. Read about the side effects and complications, then discuss it with your surgeon.

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on 09/23/2011 12:38am

When I had my AILF anterior interior lumbar fusion done Oct.2010.I know I had BMP used,could this be the reason I am not healing/becoming pain less than before???

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on 09/23/2011 2:51pm

@ Chris
Your pug is cute but I am partial to my Stanley. He is 4 and I can't even imagine a day without him. He is always there for me during my good days and the bad. Unfortunately, the bad occur more often then the good. When I am having a bad day, he knows it. He is happy to lay on the couch with me and doesn't get mad when I have to reposition repeatedly in an attempt to get comfortable. The devotion of a pug is bar none!

When I received my surgical report from the surgeon who did my L5-S1 fusion, it did state that BMP was used. Unfortunately, it does not mention MedTronic by name. Difficulty contacting the neurosurgeon who did my C4-C7 fusion because he is in alot of hot water for tax evasion. So, I am kind of stuck on what to do next.

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on 09/26/2011 9:50pm

I found this information and I thought I should post it here for those who are in need of information about this. You can go to this webpage & lookup the information it has. tessa313

AboutLawsuits.com
News and Information about Personal Injury Lawsuits

Today's Date: Monday, September 26th, 2011

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Infuse Bone Replacement Graft Lawsuit Filed Against Medtronic

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Published: January 16th, 2009

Another Medtronic Infuse lawsuit has been filed as a result of complications allegedly caused by the use of Medtronic’s bone replacement graft during a cervical fusion.

Medtronic has been accused of marketing the Infuse Bone Graft off-label for use in the cervical spine, even though it is only approved for use in the lumbar spine and for some dental procedures, and reports suggest that it could cause serious and potentially life-threatening injuries.

The Infuse bone replacement graft is a man-made, liquid bone stimulator that is implanted between spinal vertebrae. It contains Bone Morphogenetic Protein (BMP), which is a bioengineered protein that encourages bone growth to replace damaged spinal disks.

In what is believed to be at least the third Medtronic Infuse Bone Replacement Graft lawsuit filed in the United States, Paul Antonelli and his wife allege that use of the product during his cervical spine fusion caused him to suffer severe swelling in the neck and throat, which impacted his ability to breath and led to the an emergency tracheotomy after surgery.

The lawsuit was filed against Medtronic, Inc. and Medtroonic Sofamor Danek USA, Inc. in the U.S. District Court for the Southern District of New York.

Use of the Medtronic Infuse Bone Replacement Graft during cervical fusion surgery has been associated with a high rate of serious complications involving compression of the airway and nerves. Given the close proximity of the cervical spine to the airway, a number of patients who received the bone stimulator have experienced difficulty breathing, speaking or swallowing between 2 to 14 hours after surgery, which could lead to respiratory arrest or death.

In December 2008, a Medtronic Infuse wrongful death lawsuit was filed on behalf of a California woman, Shirley Nisbet, who died after going into a coma caused by respiratory arrest following surgery. The Infuse bone replacement lawsuit alleged that Medtronic failed to warn about the risks associated with use of the device in the neck, and claims that Medtronic actively encouraged the off-label use which has not been approved by the FDA.

According to reports on Minnesota’s Finance and Commerce, another Medtronic lawsuit was filed earlier this month by Mary Selke, a Texas woman who claims that the use of the Infuse bone graft in her neck caused her to suffer an inability to breath and swallow, requiring emergency surgery.

The U.S. Department of Justice is currently investigating Medtronic’s promotion and marketing of the Infuse bone replacement and whether federal laws have been violated by pushing use in areas of the spine which they have not established are safe or effective.

Other Medtronic lawsuits are likely to be filed in the coming months, as Infuse bone replacement lawyers are investigating and reviewing potential cases on behalf of individuals who experienced complications after use of the bone graft in the neck.

Tags: Bone Graft, Bone Stimulator, Infuse, Medtronic, Medtronic Infuse

There Are 3 Comments So Far • (Add Your Comments)

Comment by Kenneth on 10 March 2009:

I had an Intrathecal Pain pump inserted in 2002 for “Failed Bacxk
Syndrome” Unfortunately it helped some but not enough, They have
Dilaudid constantly runninng through, and so the Dr. talked me into
trying out the Synchromed 2 Electronic Stimulator that was about
2004. which was a mistake! I’ve had 6 Revision’s (Surgeries) I was
told that this was a new technology and it would get rid of most of
my PAIN! too which so far has not happened yet and i feel i was uesd as a guenea pig and I’m still in a lot of pain I’m currently on a
lot of pain meds on top of the Pain pump and Stimulator, OxyContin
80 mg’s,Percocet 10/325 mg,s,Diazepam 10 mg,s,Soma muscle re-
laxers I’m still in a lot of pain most day’s I’m bed ridden. I don’t know
what to do anymore, I’m thinking getting well enough do to almost
dying of Sepsis because the dr’s did not tell me the more hardware
I had Medically inserted in my body the more succeptable I was
able to get an infection. So hopefully I can try Medical Marijauna, But
I’m not sure how the Medical Marijauna System work’s here in
Seattle , Wa.

I’m a 42 year old Alaskan Native I have a
Beautiful Blackfeet native wife of 25 years 3 wonderful boy’s
and a Beautiful granddaughter My boy’s are 15,17, and 28

Comment by travis on 7 October 2009:

i had the bone graft procedure and my fusion actually grew my vetebraes together!!!!!!! now i have a solid neck that dont bend and barely turns,

Comment by james on 29 June 2011:

had my lumbar vertabrae lower 3 4 5 fused i have a big lump sticking out of my back during the day it just pops out makes it difficult to walk and pain going down my legs bladder problems

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on 09/28/2011 9:33pm

in 2004 a woman had the infuse put in her neck. I have her x rays the infuse grew out from her vertabre like tree branches. she goes into spasms, cannot control her bladder,cannot walk on her own and has to have a caregiver at that time dr.Narotam did not read that there was a study done in kentucky and the doctor who did the study on how much to put in the neck ( the surgeon put the same amount in her neck that goes in the lower lumber). to find out all the side effects go to the FDA it shows the studies and the patents that are being looked at

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on 10/03/2011 7:22pm

I love your picture of your pug. He sounds just like my sammy. He lays half on me and half on the couch. He also knows when I don't feel good. Pugs are great. I just love my baby also.

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on 05/16/2013 5:56pm

I also had the infuse bone growth used in 2008 in an off-label procedure. I now have multiple bone spurs in my lumbar with extreme nerve pain. I live in an area without access to an Orthopedic Spine Specialist, I go regularly to my pain management Dr.

Does anyone have info regarding the removal of the bone spurs? I've had 5 previous surgeries and I'm concerned about having yet another, but if I thought it could help, I'd travel again to have it done. I'm wondering if the spurs would just grow back and if the infuse cage itself would need to be removed. I'm also wondering if there's a surgeon who has experience with this in particular, or if maybe it's too soon and I need to wait until more information is known about this product.

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on 10/29/2013 6:29am

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on 06/12/2014 10:15am

This may be a bit late, but, I too am a party to the class action suit against Medtronic re: Infuse. Medtronic advised their reps/salespeople to tell the doctors that it is okay to use Infuse off label. There is tons of documentation regarding this and is why only Medtronic is being sued. I love my spine surgeon and I wouldn't participate if I had to sue him. No doctors or anyone else is being sued, just Medtronic.

If you haven't already signed up to be a member of the class action case, I suggest you do so soon, time is running out.

Good luck to all.

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on 09/18/2014 2:09am

I'm getting so afraid at looking at my future! My surgeries were done in another state. My lawyers are dragging their feet and asking me to get my own records. All I want is to find out if the part was truly used. Is it hard to get your own records sent to yourself?
I have Rheumatoid Arthritis that is gaining fast on me! The first surgery I had was for a 85 degree double curve and was fused from T-3 to L-5. As most of you know it was horrible and still is. It was done in 1996 when I was 36 years old. The next year I had to have surgery because the hardware at L-5 did not fuse and the screw was lose. Then in 2005 a month before my mother died I had surgery for a pinched nerve. I believe that was the worse mistake of my life!!! This year I was trying to get another pinched nerve taken care of. Three Mylograms were performed, a CT Scan and an MRI. Didn't know they could do that now with metal implants but seems they can. When the tech let me out of the chamber she had tears in her eyes. She told me my whole spine is covered in bone. That was the reason no needles could get through to my spine!!! Haven't we all suffered enough!!!!!!!!!!!! I'm 56 and you would think I'm over 60 the way I walk and the way my hands look!! I also have a blood disorder because of all the blood I lost during the first surgery. I have to take a chemo. pill for that 2 times a day. I appreciate you all being here. Hang in there. These days I get so low that I just cry and hold my cat. Blessings sent, Dereise......

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3 min 51 sec ago

Who is best surgeon / group to deal with bmp use in cervical acdf? Now I see a comment sign in class action law suit ...thank u! Where?
Appreciate best of best.

I know about sleeping sitting up every day, not writing or typing... pain! Missing life and doc cancelling your post op Appt ... + some one mentioned waking up with useless arm and shoulder plus?! That is part of my atypical cluster of symptoms since acdf 5/6. I know the bph was used ... doc said it was better ... I totally suspect structural issues causing neuro symptoms and Pain beyond compare. .. ANY ideas and suggestions ... specific docs and / or atty...Pls advise. God bless
Surgery was 12/2012... been challenge to live since then. If any medical professional wants to help, asap, pplssssss. Literally motor skill deficits and fight for life since, , or neuro cancelled my Appt cut I had 'been to ER' ...erratic and crazy. . t Thx ,!,,,

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2 sec ago

Brattsgirl, class action lawsuit? Where did u sign up ... with who? I see now I
can respond to specific writer. =) hope u get this. I am Midwest us, thanks,

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