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  • INFUSE lawsuit?

    INFUSE lawsuit???
    anyone know anything about the law suit over INFUSE bone grafting method that is reportedly causing awful problems for patients...???
    there is a list of really horrible problems the stuff can cause...it was supposedly used for anterior
    fusions, and then used off label for other fusions....
    ????

    jess

  • #2
    I've never even heard of INFUSE... Sorry, can't help you here. Maybe there's something online about it.
    Be happy!
    We don't know what tomorrow brings,
    but we are alive today!

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    • #3
      there is rohr...and all over the TV...ads to call the attorneys leading the lawsuit...
      sounds very scary...
      cannot imagine how frightening it would be to find out something placed in your
      spine could cause so many scary health problems!
      i was wondering if anyone on forum had any personal knowledge of INFUSE

      jess

      Comment


      • #4
        Originally posted by jrnyc View Post
        there is rohr...and all over the TV...ads to call the attorneys leading the lawsuit...
        sounds very scary...
        cannot imagine how frightening it would be to find out something placed in your
        spine could cause so many scary health problems!
        i was wondering if anyone on forum had any personal knowledge of INFUSE

        jess
        This is BMP2. When used in the lumbar spine, it is thought to be completely safe. The problem comes from using it off label.

        As far as I know, there is no class action suit. Did you hear something new?

        Here are two previous threads on the topic:

        http://www.scoliosis.org/forum/showt...ghlight=infuse
        http://www.scoliosis.org/forum/showt...ghlight=infuse
        Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
        ---------------------------------------------------------------------------------------------------------------------------------------------------
        Surgery 2/10/93 A/P fusion T4-L3
        Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation

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        • #5
          yes, huge ads on TV...with law company phone number, etc...
          and also, when you type the law company name into the computer,
          you can go to the part of their website that refers to medical law suits...
          definitely huge law suit in the works...
          i'll find the name of lawyers and post it...

          jess

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          • #6
            you can find the lawyers....and law suits
            go to yourlawyer.com
            then type "InFUSE" in the search and up pops all kinds of info about
            law suits concerning them....
            what i read initially was InFUSE was a problem for anterior and off
            label surgeries...but then after that it sounded like it is a problem for
            any surgeries...
            i was pretty surprised to read it...
            i am not trying to freak anybody out or say the lawsuit is true...
            just that there are lawsuits in process...

            jess

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            • #7
              the legal website lists 360 law suits....
              it says "most" of the law suits involve off label use of Infuse....
              "most"

              it also says this....

              "The latest furor over Medtronic Inc.'s Infuse bone growth product will likely lead to increased regulatory scrutiny of the spine device, as well as possible class action lawsuits, a Wall Street analyst says. According to a Forbes report, Larry Biegelsen of Wells Fargo says the fallout could lead Medtronic to sell its spine business."

              again, i am not trying to scare anyone...
              just to bring up that there are noted problems...
              i hope the problems are ALL from off label use...
              i hope no one with Infuse ever has any problems with scoli surgery

              Linda...i haven't read all 360 suits, but i did find one class action suit by shareholders....

              jess
              Last edited by jrnyc; 02-10-2012, 08:02 PM.

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              • #8
                Jess...

                I meant class action as in patients, not shareholders.

                You know how we freak out when we hear that these surgeries cost half a million dollars? Lawsuits like these are a substantial part of why medical care is so expensive. When we sue for everything that isn't perfect, we discourage future development, so I definitely hate to hear that the vultures are circling.

                Many of the doctors who have used the most BMP, and who have made the most money in Medtronic consulting fees, are some of the top doctors mentioned here in the forums. For example, I think the guys at Wash U never do a long fusion without BMP. I think the majority of us who have fusions in the lower lumbar area in the last 5+ years, have had BMP used on us. I've been aware of the controversy for about 2 years, but still chose to let my surgeons use BMP on me. Many insurance companies will not reimburse for BMP use. In many instances, at least at UCSF, the hospital is actually absorbing the cost because they still believe it's the best option in those cases.

                While the surgeons who have taken millions of dollars in consulting fees from Medtronic are and should be investigated, there are definitely questions about the assertions that have been made by the government and by the Stanford doctor (Caragee) who are behind this issue. If you want to read some of the inside information, you can sign up for a free 1-week trial of Orthopaedics This Week. I used up my free week a long time ago, but I would assume that you can do a search on INFUSE to get the details. I'm sure, when all is said and done, that it won't be as rosy as Medtronics and their consultants want us to believe, or as evil as Caragee wants us to believe.

                --Linda
                Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
                ---------------------------------------------------------------------------------------------------------------------------------------------------
                Surgery 2/10/93 A/P fusion T4-L3
                Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation

                Comment


                • #9
                  oh, i knew you meant patients....i just hadn't read all 360 law suits listed with those lawyers....
                  and that was the only law suit that involved class action that i read so far...

                  i know the most problems come from off label use...
                  i think most of the legal action will be against Medtronic...
                  the suits claim that the company did not fully disclose to the doctors how high the risks are...
                  how often problems happen....
                  what percentage of patients with Infuse had problems compared to patients
                  who did not have Infuse...

                  i hope no patient with correct use of Infuse ever has any problems from it...
                  and i have no bad intentions with this thread...
                  i just always believe knowledge is power...
                  and i think people should be aware of the risks...

                  jess
                  Last edited by jrnyc; 02-13-2012, 12:16 AM. Reason: splg

                  Comment


                  • #10
                    Osteosponge???

                    Hi -
                    I have researched everything I can find on Infuse (BMP-2) and so far it scares me and I actually am putting surgery off. Perhaps the Yale study will offer some decisive data. I am hoping another option will be available by the time I decide to have surgery. Has anyone heard of Osteosponge by Bacterin? I wonder if companies share their trial study results if asked?
                    Roxanne
                    Roxanne
                    Milwaukee Brace 2 years
                    Fused 1976
                    Fusion Repair 1979

                    Comment


                    • #11
                      hi Roxanne

                      OSTEOSPONGEosteosponge looks interesting...very interesting...
                      i started reading about it on internet..here is one study i found...



                      Bacterin Study at AAOS 2012 Annual Meeting Shows OsteoSpongeŽ Equivalence to rhBMP-2 in Spinal Fusion; Presented Specifically to Orthopaedic Surgeons
                      when i first started reading about osteosponge, it seemed to be for foot and ankle surgeries...so i was glad to see
                      it mentioned in reference to spinal surgeries...when i am less sleepy,as it is 1:40 a.m. here on east coast...i will read more about that study and others...


                      thanks for posting the info about it...

                      jess[/COLOR
                      ]

                      Comment


                      • #12
                        More on Osteosponge

                        Jess,
                        Here are twp more links:
                        http://www.bacterin.com/pdfs/OsteoSponge.pdf

                        http://www.isass.org/h/sas11_scientific_program.html (2:05pm) very small study and they used BMA (Bone Marrow Aspirate) with the Osteosponge

                        Roxanne
                        Roxanne
                        Milwaukee Brace 2 years
                        Fused 1976
                        Fusion Repair 1979

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                        • #13
                          thanks very much for that information, Roxanne....
                          i will be very interested in whatever develops with this product...

                          jess

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                          • #14
                            what is meant by off label?

                            When I had my A/P fusion surgery two years ago, BMP was used. I just recently heard about the lawsuits. So glad to find this thread. Not sure what is meant by off label??
                            Glenda
                            Age 66 Georgia (63 at time of surgery)
                            Bi-lateral laminectomy 2006
                            Kyphoscoliosis, approx 38* lumbar scoliosis, stenosis, disk herniations, lower back and hip pain, w/radiating pain, stinging and numbness in legs.
                            A/P fusion (T10-S2) 5/17/10 and 5/20/10
                            Dr Yoon, Emory Orthopaedic and Spine Hospital, Atlanta, GA
                            Pleased with outcome

                            Comment


                            • #15
                              hi Glenda
                              "off label" means using a product other than the way it was intended...
                              other than the purpose it was meant to be used for...

                              jess

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