War Breaks Out Over Medtronic's Infuse

By PAUL THACKER

Wow! Can I just say 'Wow?'

A medical journal has devoted an entire issue to problems with Infuse, a product sold by Medtronic that helps create bone and has been used on over 500,000 patients by more than 2300 surgeons. Infuse is one of Medtronic's most important products with sales of over $900 million last fiscal year.

The major takeaways from the latest issue of The Spine Journal?

• A review of the original 13 Medtronic-sponsored studies found that they reported 10 to 50 times fewer complications with Infuse than the data actually show.

• Many of the study authors had financial ties to Medtronic, with a median range of $12 to $16 million per study.

• Infuse proponents cite "less patient pain" to justify use of Infuse over traditional treatment; however, the severity of pain in this traditional treatment is overemphasized.

• Infuse can cause problems with nerves and the spinal cord.

This story is unprecedented for several reasons. Physicians tend to protect their own kind, and seldom lob bombs at their colleagues, for fear of ostracism. The main critic, Dr. Eugene Carragee of Stanford University, must know that he is not making friends with fellow surgeons by critiquing their research and pointing out the heaps of cash they are amassing from industry.

Further, as editor of a journal that is criticizing his own profession, he also takes a shot at medical journals themselves for publishing these garbage studies that downplayed risk to increase sales for Medtronic. In an accompanying editorial, he wrote:

It harms patients to have biased and corrupted research published. It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual.

Yet harm has been done. And that fact creates a basic moral obligation.

Who could disagree with that?

This story has the potential to go viral for the next few days, with coverage by The New York Times, Wall Street Journal, and the Milwaukee Journal-Sentinel, which has been leading the pack with coverage on the Infuse issue.

More importantly, this could be a critical turning point, when we see physicians finally break free from corrupt influence of industry and begin to put patients first and money second. Or maybe not.

Regardless, the war drums will not be calmed.

Last week, Senate Finance Committee Chairman Max Baucus (D-MT) and Sen. Charles Grassley (R-IA) sent a letter to Medtronic demanding a whole truckload of information on Infuse. It seems the senators have concerns that Medtronic-sponsored "science" is little more than a trojan horse designed to infiltrate the research community and plunder the federal healthcare programs.

Expect future skirmishes.

Paul Thacker is a POGO Investigator.

Image of B-52 bomber: Wikimedia Project. Trojan horse image via Wikimedia Commons.

Comments

[TERRY DANIELS]

I AGREE WITH PAUL THACKER!

[TERRY DANIELS]

I AM SO SORRY TO HEAR ABOUT ALL THE PAIN OTHERS ARE GOING THROUGH. I HAD C-6-7 ANTERIOR FUSION USING THE MEDTRONIC INFUSED GRAPH AND HAD IT AT BARNES-JEWISH SANT LOUIS, MO 2003. NO ONE TOLD ME IT WAS OFF LABEL USE. I WAS A CARDIOLOGY SALES REP, AND MARRIED TO A DOCTOR THE DOCTOR DID NOT TELL HIM IT WAS OFF LABELED. I AM IN SO MUCH PAIN, HAD TO FIGHT FOR WORKERS COMP, THEY HAVE TAKENED ME BACK TO COURT FOUR DIFFERENT TIMES, SAYING I HAVE TOO MANY PROBLEMS THEY SHOULD NOT BE RESPONSIBLE FOR. WE ALWAYS HADS TO TELL DOCTORS IF A PRODUCT WAS OFF LABEL. I HAVE LOSS SO MUCH EVEN MY KIDS DON'T UNDERSTAND THEY ARE ANGRY THEY HAVE MISSED OUT ON SO MUCH. I HAVE EVERY PROBLEM THAT EVERY ELSE HAS LISTED, NO CANCER YET! THE REALY BAD THING IS MY SISTER IS A DISABLED DESERT STORM VET AND IT WAS USED ON HER AS WELL. I ALWAYS THROUGHT IT WAS SO CRAZY WE HAD THE SAME PROBLEMS SINCE OUR SURGERIES, WHICH WERE DONE IN DIFFERENT STATES! GOD HELP US TO GET PROPER MEDICAL HELP WORKERS COMP HAS REFUSED TO TREAT ME. I KNOW AN ATTORNEY WOULD GET A LOT MORE MONEY THAN I WILL GET, I JUST WANT MEDICAL CARE. DOES ANYONE KNOW IF THE DOCTOR AND/OR THE HOSPITAL CAN BE SUED?

[Mike Bomberger]

Hi Paul,

Thank you for writing this post and helping people understand the dangers of the off-label use of the Medtronic INFUSE bone graft. We are attorneys who have helped people throughout the United States collect monetary compensation for their injuries. The cases range in severity from nerve damage and trouble breathing to paralysis and even death in the worst case scenarios.

It is truly sad that the miracles of modern medicine can be misused to fill the pockets of companies

[Chris]

Get lawyers! Keep calling!! I'm totally & permanently disabled in my 30's because of this!

[Laura Von Drehle]

I had my fusion disaster in 2006. L4/5 anterior/posterior. I wasn't advised of nor did I consent to a genetically modified anything being implanted into my body. Before my surgery, I owned a staffing service, owned a beautiful home had a active life and had optimism that I was perfectly capable to raise my son as an only parent. My son's father and paternal grandparents are no longer living and my family is too busy to help us much. My son needs me and I am often lying flat on my back trying to breathe through my pain. My depression and dispair are as chronic and agonizing as my physical pain. There's not enough money in the world to "compensate" me. I just want my life back.

[David M.]

I had spinal fusion S1 to L5 done with infuse. All this stuff i read makes me so frightened. I am scared to talk to my family about all of it. I hired a good attorney, but even at that how does all this go away. Does anyone know, can you have this stuff taken out once it has been put in? And who do you trust? i have some concerns for my family. I want to live long enough to see my grandkids and my great grandkids. I want to grow old with my wife and enjoy life. Never would have dreamed it would have come to this. if you go to a doctor and tell them you are in pain< they look at you as if you are stupid. Just totally lost in the procedure. i know we are to put our trust in God, but we as human wonder at times how can one due this to another human......
If anyone has had this removed, please inform me how well it worked out for you.
Prayers to all who suffer as I do.

[Tony LuCiano]

I received bmp infuse in a posterior lumbar fusion back in 2009. Now I will probably be killing myself within the next few years because the pain I live with is unbearable.I have severe burning pain in my lower back and legs since the surgery. The burning is severe and 24/7. I can't live like this. I was never told either that they would be using bmp infuse. This is a crime against humanity..

[kathy]

this is to Kristen in Feb, 2012 I have the same symptoms as u..all on the left side!! Its crazy. Now I am going for mri on my left leg because it is giving out..and have appt for cancer doc next week another symptom. I had cervical fusion and had to have it removed 3 years later. I too thought i was crazy. would love to chat with you through email.

[George Johnson, MD]

I also agree that some of my colleagues put money ahead of their patients. Medicine is no longer a calling, but a business. Some surgeons, through arrogance, indifference, or greed view their patients as mere machines in for repair. They probably care more for their european luxury cars than they do for John Q. Public. It's sickens me to hear that physicians break their oath to their patients and their profession. Do no harm unless you're being paid big bucks.

[George Johnson, MD]

Unfortunately, getting a medical professional association to sanction one of its own is like congress voting itself a pay cut. Now is the time for all those parasitic lawyers to come out of the woodwork and start suing Medtronic. Unfortunately, once again, they will be the only ones that will benefit. A class action will result in a few law firms making millions while the injured get a steak dinner and a pat on the back, and an "I'm sorry" from Medtronic. You will still live with the pain and the physical and psychological trauma, and no amount of money will make that better.

[kristen]

I had c5-6 cervical discectomy fusion in Nov 2009. I immediately had problems. About 4 weeks after surgery I was hospitalized for 3 days with adema from base of head to bottom of my neck. The surgeon who performed my surgery treated me like I was pain in his neck ( LOL ).
I have had chronic pain since then. I have pain and burning from the middle of my neck, shoulder, arm to fingers and pain in lower back with burning down leg to toes. Insane headaches. All on the left side. I feel like i have something lodged in my throat when I swallow. Memory and speech problems. Intermittent stabbing pain in chest. My leg gave out two weeks ago and I fell and cut open my forehead.
I have been to many doctors.I have been tested twice for MS. Basically they tell me the hardware looks fine. I have been told the disc above and below surgery are degenerating but am told that is normal with this type surgery. I have been told I have spinal stenosis and minor bulging discs in lumbar but nothing serious enough to be causing this type of pain. I am treated as a complaining patient and am given another pill to try and dismissed over and over again.
This has ruined my life. I am unable to work and in a long process trying to get disability. I am depressed and a shell of the old me.
My sister text me last night telling me of this problem with the Infuse and how it sounds exactly like what I am going through. It took me hours but I found my neurosurgeons name under Medtronics surgeon search as a surgeon who uses this device.
Can anyone advice what I should do at this point?

[Tina]

I just found out about the BMP problems. I had a fusion at lS1-L5 and discectomy at L4-L5. About 3 weeks after the surgery I began having pain in my right foot and the left calf was numb. In meetings with my surgeon, I always told him about it, but he wasn't concerned. Only after I told him that I had not had the pain and numbness before the surgery, did he become concerned and ordered a milogram which showed the fusion material had overgrown and was pressing on nerves in my spinal cord. I immediately had surgery to remove the overgrowth. The leg numbness and pain did not go away and then began to to increase. I was hoping this meant the nerve was healing, but then I start hearing about the number of people who have had several surgeries to remove bone so I have asked my surgeon to order another miliogram. I also have experienced very strange jerking & twitching which my family doctor says is a side affect of the Lyrica I take to live with the nerve pain. I also had immediately following my first surgery to "bulges" come up on my knees that even as I lost weight, they did not diminish. Can any of these other symptoms be related to the infuse?

[Bryan Rahija]

Hi Carrie, I believe this information should be in your patient records.

[Carrie]

I had a discetomy, spinal fusion, titanium plates with screws and a cadaver bone placed at C5-6 6 years ago. I know for sure that the surgeon in the same office as my surgeon used the the infuse on his patients. I am not sure if the infuse was used during my surgery or not. I am not sure how to find this information out, as my surgeon never mentioned it to me. I have been going through testing for MS including a spintal tap to diagnose me with MS due to my severe symptoms. I was then told they were not sure it was MS, but think it may be spinal cord damage due to my neck surgery and extra bone growth. The amount of meds I take daily is ridiculous. How do I find out if this infuse was used during my surgery? I know I have extra bone growth around the surgical site that was found during 2 seperate MRI's.

[Cheryl]

Please I beg you DO NOT use the BMP in your upcoming surgery Pat! My doc used the BMP without my knowledge or permisson which they are supposed to get. I had to have 4 surgeries and after 3 yrs of wheelchair bound I can now at least walk. Pain forget about it I'm stuck for life they say with 7/24 pain that unless I take meds it won't go below a ten! They use this stuff in unapproved areas, mine was used in my SI Joint. It made bones grow throughout my glute muscles destroying some of it, into my tail bone and spine and all the way across to the other side of my glute muscle! They have removed all they safely can but all the rest will remain! And if you have any type of auto immune disorder at all this stuff will cause you all types of systemic problems and worse, like bladder cancer, intestinal problems and infections, lupus to flare worse etc etc. You should check out the research like I did once I found out the truth and that BMP was used. From Germany to Sweden there were bad results and warnings!!! If only they had told me what they were planinng too use I'd have had a choice! And to those who are thinking well maybe you would have chosen to use it even if they did tell you well that's a big NO, as I've been warned for years due to my many autoimmune disorders to not take many things and I research every thing that is suggested to me to take. IF I'd been able to research it first I'd still be able to work, to work out and to dance every week like I used to! I'd be able to run with my lil grandson and be able to lie down in a bed to sleep which I have been unable to do and now sleep in a recliner due to the pressure and or nerve pain from all the bone fragments!
As for lawyers camping out to help you against Medtronic's well good luck with that one Bubbalamma because until someone of higher power steps up and stops Medtronics from sheparding their cases to a certain judge who always side with Medtronics and if you can get a lawyer that Medtronic's doesn't pay off to drag it out and not really file till after your statute of limitations runs out, well then you will be far luckier then the rest of us! My heart goes out to all who have been killed, yes CA women named Barbara is now dead due to BMP, to all who have been crippled or maimed from this stuff and who live in chronic and constant pain. You are all in my prayers. As for Medtronic's you need to MAN it up and take care of all the people you have injured! Oh right when I called you I was told I was the first to ever have had this happen, it was highly unusally you told me as I begged you and your people to help me to find a way to stop what the BMP was doing to me, to help end my agony!!! You knew how to create the monster but you didn't know how to stop it! Shame on YOU!

[Anne Guthrie]

I had a posterior fusion L5-S1 in Feb 2010, and have had major pain since...more pain than before surgery. After another MRI showing changes in vertebra and psoas muscle, my spine surgeon said "he had never seen anything like this before" and was alarmed enough to order a biopsy which showed acute inflammation. After seeing another spine surgeon and another MRI only three months later (it showed huge changes of unwanted bone growth) surgeon said "he had never seen anything like this" and ordered another biopsy which showed acute inflammation. Two more spine surgeons and finally the last one read my operative report which said bone morphogenetic protein was used in the fusion. I didn't even know BMP was used in my surgery. My surgeon didn't even tell me. This last surgeon said the BMP was probably causing the complications. I now have an appointment with Eugene Carragee at Stanford in hopes that he can 'clean up the mess'. I will be flying from the east coast to the west coast because I want a surgeon I can trust. Please, please, if you are planning to have a fusion, do not let your doctor use bone morphogenetic protein. It is not approved by FDA to use in a posterior fusion or cervical fusion. My fusion has been the biggest regret in my life.

[pat]

I am scheduled to have lumbar fusion surgery done next week with the Medtronics Infuse being utilized. After reading all the information about Infuse, I am extremely nervous. Bubbalama, how are you feeling after your 2 previous surgeries? Any complications? Any suggestions? Thanks...

[Bryan Rahija]

Thank you Bubbalama! Fixed the image credit.

[Bubbalama]

I am the recipient of 2 separate infuse fusions the latest in mid April 2011. What a frigging nightmare! Can't wait for the lawyers camped out on my lawn.
By the way the photo attributed to wiki as a Japanese bomber is actually a USAF B-52.

[Paul Thacker]

SteveB, thanks for writing in. Let me be more clear.

When a company behaves unethically in the pursuit of profit, it becomes difficult to blame them. After all, corporations have a fiduciary responsibility to their investors to make profit. Physicians, on the other hand, owe their allegiance to patients. When doctors put profit before patient, they should immediately be sanctioned by their professional societies.

[Steve B]

Nice article, but it makes one insulting assumption. As a member of the medical device sales profession, the article assumes that surgeons are the "victims" of corporate/industry corruption. I pray every day when I make sales calls on physicians that they won't drive the conversation towards "what can I do for them?" Surgeons are as guilty as anyone for the corruption that exists in the medical device industry - and to lay the blame solely at the feet of industry is an ignorant mistake.