Tuesday, July 17, 2012

Spineology: Good Times, Bad Times

If there ever was a product that was slick before slick was a popular word in spine, it had to be the OptiMesh developed and marketed by Spineology. TSB remembers the first time Spineology presented its technology seeking an infusion of investment capital. The year was 2003.  Since then, the company has gone through an up and down evolution.  The OptiMesh was a deployable pouch inserted via a cannulated tube into stable vertebral defects.  The objective was to contain grafting material in place.  The material that this pouch was manufactured out of is PET which has since been used in the Dynesys System Cord.  Unfortunately for Spineology things have changed.

On July 5th, a complaint was filed for damages and demand for jury trial in the United States District Court of Indiana against Spineology.  The plaintiffs are Debra and Thomas Day and their civil action is brought on behalf of the the plaintiffs for personal injury and damages sustained as a direct result of negligent and otherwise wrongful conduct by the defendant, Spineology, Incorporated in connection with its design, development, manufacturing, testing, packaging, promotion, marketing, distribution, labeling and sale of OptiMesh what was implanted in the plaintiff.

The facts surrounding the case do not bode well for Spineology.  Based on the law, "any person who seeks to introduce a medical device into interstate commerce must prove that it is safe and efficacious for its intended use or that it is substantially equivalent." The challenge that the Spineology legal team will have will be proving that its product was not used off label rendering it adulterer and misbranded, since manufacturing adulterating or misbranding a product into interstate commerce is prohibited under the law 21 U.S.C. Sec. 331 (9-c), (g), (2003).

The Medical Device Amendment to the Food, Drug, and Cosmetic Act of 1938 require medical manufacturers to undergo premarket approval by the FDA, mandating that manufacturers must design and implement a clinical investigation.  As many of you know, the only way a device may by pass the PMA process is if there is a "substantially equivalent product," or predicated device in interstate commerce prior to May 12, 1976.  As this complaint unfolds the contentions bring to light the many challenges that companies have in properly adhering to FDA requirements. Spineology sought to market OptiMesh without conducting trials and obtained approval via a 510(K). Their submission asserted that they intended to market the product to maintain the relative position of bone grafting material and that it did not impact the stability of the vertebral body and did not include the end plates.

Spineology was warned in November of 2003 by the Office of Device Evaluation that there were reasonable concerns that the device would be used for an intended use not identified in the proposed labeling, and such use could hold harm.  Based on Spineology's labeling, the company did just that by indicating contradicted use of the OptiMesh. In August of 2007 Spineology received another warning letter for promoting OptiMesh for use in Kypho and Vertebroplasty. The complaint stated that since Spineology promoted and introduced OptiMesh into interstate commerce for uncleared indications the product was rendered adulterer under section 501(f)(1)(B) of the FDA.  It was also misbranded because Spineology did not notify the FDA of its intent to introduce the device into commercial distribution.

From June 9, 2010 thru June 30, 2010 the FDA conducted an investigation at one of Spineology's clinical investigation sites.  This investigation was performed to ensure the the Spineology data and information would be accurate and valid scientifically.  On 9/22/10 a warning letter was sent to Spineology which revealed serious violations.  The letter informed Spineology that its clinical investigator was not adhering to the study's protocol.  Despite these warnings, it is alleged that Spineology conceded this information from its physician surgeons as well as the plaintiff.

The plaintiff was treated in December of 2009 with an XLIF for instability at L4-L5 presenting with right leg pain which was resolved with the surgical procedure.  Nearly one year later, the plaintiff presented with left leg symptoms similar to her right leg pain.  The surgeon treated her conservatively unexpectedly developing a L5-S1 asymptomatic disc herniation.  On January 21, 2011, the plaintiff underwent  a surgical revision which included the partial removal of her right posterior instrumentation and a TLIF using the OptiMesh, since and XLIF procedure was not amenable to implantation at L5-S1. After 4-6 weeks the plaintiff began experiencing right buttock pain and leg pain.  A lumber CT verified extrusion of the bone graft into the right lateral recess with right nerve root compression at S1.  On 4/26/11 the plaintiff underwent exploration of the epidural space.  During the exploration it was determined that the OptiMesh had a tear posteriorly in the pouch.  The surgeon notified Spineology.  On 4/26/11 the plaintiff's pain returned. A subsequent CT on 6/7/11 demonstrated complete extrusion into the epidural space, with implant removal on 6/13/11.

There are many questions that need to be answered in order to determine whether or not Spineology acted accordingly in how they presented and marketed their product. Unfortunately, based on their track record with the FDA, Spineology may be swimming against the current. Corporations are no longer viewed as ethical or acting with integrity by juries, especially when it comes to adjudicating a product liability case involving loss of consortium. No one really knows why these events occur to some patients. Is it a quality issue? Is it a training issue? Is it an off-label issue? Is it surgical technique? But then it does raise our  defense of the importance of having a properly trained sales rep in the room. These questions will be difficult to prove because the attorneys nor the jury were in the operating room at the time of the event. Yet, off-label use is a no brainer especially when there are issues concerning structural support. The plaintiffs attorneys have a substantial amount of negative facts as to how Spineology has managed its day to day business, it will be interesting to see where everyone lands at the end.   In these types of cases no one wins, the patient suffers and the company loses credibility.  TSB wants to know what our readers think?  OptiMesh or OptiMess?  

"Good Times, Bad Times......you know I had my share"

78 comments:

  1. putting the pre-market process aside for the moment, it's a travesty that these product classes, REGARDLESS of pre-market pathways, aren't bound by condition-of-approval post-marketing studies. FDA has had its head up its ass for a good part of the last 20 years. their guidance over these matters is nebulous at best, and industry is awfully confused because of it. i'd love to place full blame on industry in these cases, but as in most issues, the blame lies somewhere in the middle.

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  2. At the end of the day, the doc is free to use the device however he wants - the company just can't MARKET it unapproved ways. People seem to forget this. If the surgeon decided that this was the best course of treatment, then he takes the responsibility.

    Bone grafts and cages extrude all the time due to multiple factors. Is Optimesh more dangerous than those standard treatments? - probably not. Unless they can prove that Optimesh is more dangerous than alternative procedures, the plaintiff is going to have an uphill battle.

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    1. The alternative devices are load-bearing constructs with the potential for stability given good carpentry, not a plastic mesh bag packed with bone graft. Violation of the laws of physics are required to enable stability.

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    2. Peek cages retropulse. Compared to the number of cages implanted-----insignificant number.

      Optimesh cages retropulse. Compared to the number of cages implanted---significant number.

      10:15 - That is why the FDA requires testing and studies. Using the 510K predicate loophole to get around that is reckless and only serves the interest of the manufacturer's bottom line.

      This is a case of profit ahead of patient safety by the manufacturer.

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    3. 4:27 On what data do you base your second statement?

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    4. The manufacturer should be tracking data--- in controlled studies.
      I work with a doctor down in Fla that tried Optimesh. He has revised numerous cases now because the balloon bag migrated out the disc space. I have instrumented cases with him for 3 years and never seen this many revisions with standard peek cages.

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  3. Hope the good doctor got a signed consent that he was using Optimesh off label.

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    1. I hope the doctor goes to jail too.

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    2. Neither the law nor the professional societies require discloser (in a physician's consent form) of off label use of a product by a physician --the FDA doesn't practice medicine nor regulate it. thank god for that.

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    3. Informed consent has nothing to do with the FDA. It has to do with full disclosure to the patient.

      Most states have legislation or legal cases that determine the required standard for informed consent including off label disclosure for surgical procedures.

      You are mistaken.

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    4. show us one state law that requires a doctor to mention the regulatory status, indications for use, or off-label use of an implant in a consent. good luck finding that.

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    5. I thought Optimesh was currently under an IDE study and an experimental device not approved? If it is an investigational device informed consent must be obtained.

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  4. TSB, it helps credibility to be exact: May 28, not 12. Perez-Cruet did what many spine surgeons have done in studies, only Spineology was not as sophisticated as Medtronic in making sure his tracks were covered. And the court case sounds more like an inept surgeon than a product malfunction.

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    1. 10:43 Did you read the complaint?

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  5. This logic only makes me question how smart our industry is. Go ahead and look in the mirror the next time your surgeon uses your non approved screws instead of the approved hooks during the next posterior cervical case. The fact is doctors are allowed to use things off label and should, at least until the FDA does a better job of giving indications that are more realistic.

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  6. The lawsuit is not about a doctor using off label (legal). It is about a manufacturer promoting for off label for an unapproved use.(illegal)

    Big difference.

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  7. Do surgeons have to alert the patient if they are using off-label?

    The more I think about it, I think the surgeon is more at fault.

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  8. When a surgeon uses an implant, the standard of care is that he is an expert on that implant. The indications for a device are not a secret. It's all on the FDA website, the product website, and the package insert. A surgeon absolutely cannot claim ignorance to the labeled indications for a device he is implanting, despite what some rep might have said.

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  9. This is not about the surgeon or standard of care. This is about a manufacturer that ignored the warnings from the FDA and continued to promote off label. The surgeon is not named as a party to the lawsuit.

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  10. The VP of sales is another douchebag from the Recupero coaching tree...with a waistline expanding to match his ego

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  11. Does this blog ever discuss anything positive occuring in spine or is it just a forum to vent frustrations and bith & complain about all that is unfair or unjust in this industry? Or, perhaps, the sad reality is that there simply isn't anything positive to discuss any more w/ regards to spine. Such a sad state of affairs,,

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    1. I think that if there were something positive about the spine industry it would be discussed here. If you want to read happy stuff from happy patients go to a patient website and read about all the Americans who went outside the US and got their botched surgeries fixed or got the NeoDisk and the M6.

      How about you AnonymousJuly 17, 2012 12:43 PM tell us of all the wonderful things the industry has done on behalf of patients. Tell us all about how wonderful and innovative XILF is. LOL!

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  12. Dude, did you read the same thing I did? Your processor is not working. It's obvious OTW and its bastard step child OSN never report anything except what's in their best interest. It's new get over it, or don't read the blog.

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  13. 12:43 Please let us know about your positive day in spine I just can't wait.

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  14. Indiana is another area where Spineology has non spine surgeons implanting...Interventional docs doing outpatient OptiMesh procedures. I hope this isn't another NJ- "Dr Kaul" situation with a lawsuit based on a bad outcome....imagine that story.

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    1. Dr Robert Sloan-Neurosurgeon did surgery. Not claiming malpractice against him.

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    2. Would be interesting to know if spineo is pushing interventionalists to use instrumentation. Was't Kaul using mesh in his interbodies?

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    3. Kaul's insurance carrier is not covering the malpractice cases because he was not licensed to practice spine surgery. The lawyers will figure it out and go after the only place they can get the money. The manufacturers.....they better be clean in this.

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    4. The manufacturers better not have any financial ties to Kaul or it is going to get nasty!

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    5. globus is late to the party but just wait until there new expandable endoscopic tlif cage is getting thrown in by every tom, dick kaul, and harry

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    6. Endoscopic discectomy has been around for a long time and has not been adopted. This could be an interesting product but the market will be tiny. There are already endoscopic cages out and no one uses them.

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    7. More doctors breaking the law and not going to jail.

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  15. 10:43 Regardless of your opinion, both the surgeon and the company are accountable, now either go to law school or go back to selling, JD

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    1. The doctors and the industry has been breaking the law for decades. Nobody is held accountable. Did any of the 100 doctors who took bribes in the Infuse scandal get arrested or even fined? Did any of the crooks at Medtronic go to jail?

      You need to learn what accountable means.

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  16. The sad reality is that there isn't a "code" as to who can or can't use instrumentation. There are plenty of surgeons, both ortho & neuro, who haven't been fellowshipped trained but instead just decide at some point in their careers that they can or want to instrument. As long as the letters MD or DO reside after their names, who really governs how, when, why or what these physicians use? As for indications, surgeons have the latitude to use what they want as they see fit due to the loophole of "clinical neccesity". The fundemental problem in this industry is when some scab sales rep pushes or pursuades someone to try or use something which is outside the surgeon's comfort zone, level of training or experience. After all, it's all about the revenue at the end of the day isn't it? Sadly, no one seems to talk much about patient safety anymore.

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    1. You have to be kidding me right now? You just pointed the finger at a salesperson because a surgeon, who is not qualified to do spinal procedures, was "persuaded to try or use something outside the surgeon's comfort zone." That is ridiculous. What, did he have a gun to the poor doctor's head?

      You are an idiot.

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    2. 3:58 - obviously you suck at sales.

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  17. @3:58 Yes, indeed I did. My years of experience in this industry have taught me that someone will try to sell to even the least capable customer if it helps provide an opportunity to generate revenue. So, yes, all to often surgeons are targeted and pursued if asales rep feels/ thinks that they can somehow convince a surgeon to use their product.

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    1. It's ridiculous to think that a sales rep of any kind could convince a surgeon to use any product implanted in a patient. A jury has never found this to be the case nor would they. Any good defense attorney would go-to-town if a surgeon was on the stand claiming he/she was duped.. Has there ever been a case with a surgeon on the stand claiming this? Certainly not a surgeon as a defense witness.

      This is a civil case and I imagine Spineology would call the surgeon as a witness. I'm not sure but the surgeon would probably take the 5th.
      It's eye-opening to me when I read people in this industry so quick to blame the companies in our industry or sales people. Product use is surgeon driven and surgeon responsibility. I would hope any rep who deviated from his/her product labeling or making false claims about a product use would quickly be shown the door or exposed by the surgeon. However, responding to a surgeon's question and providing input to the best of a rep's knowledge is a whole other matter; what are other surgeons doing? How are other surgeons using the product?, etc.

      Infuse is/was the the largest, fastest growing product in our industry. 90% or more was used off-label and we are all aware of the complications that have been associated with the product. Was the use soley driven by the sales people? No, decisions to use the product were made by the surgeon as he/she saw fit.

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    2. @8:07 Are you freaking kidding me? Did I read your comment correctly? I quote "It's ridiculous to think that a sales rep of any kind could convince a surgeon to use any product impanted in a patient"???

      You HAVE to be kidding, right? Convincing or persuading a surgeon to use a given product is the VERY nature of the sales rep's job responsibility? Why is it that so many reps in this industry have close ties to a surgeon or that is it of such significance that relationships carry so much weight in the industry? Answer: BECAUSE OF THE REP'S ABILITY IN INFLUENCE THE CUSTOMER.

      WOW,, the comments on this board never cease to amaze.

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    3. A rep's job should be to sell his/her products based on what they are approved for. A surgeon should make the decision on how they want to use the product. A rep may repsond to a surgeon on "outside the label" questions when the surgeon asks these questions. Not proactive offering of advise or as you say "persuading" or "convincing". Its answering these questions and helping offer your knowledge or input that make a rep valuable to the surgeon and why he/she may use you. Interpersonal skills, likability, work-ethic, knowledge and most of all trust is why a rep is successful. We can agree to disagree but I think it's shollow and short-term to say a rep's job is to convince and persuade a surgeon to use implanted product. Similiar to TSB's previous Blog on Boxano and growth maybe companies have such unrealistic and short term expectations of their sales teams, ecspecially the new hires.

      I'm glad this dialogue is here. It's hard for any rep in any organization to have all the facts on off-label use of a product and what you can and can't say and that's becasue the FDA is not clear on what you can and can't do.

      All this is IMHO and hopefully just creating some interesting conversation.

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    4. What needs to happen is when a doctor or company breaks the law with medical devices they should be fined. If that misuse results in death or injury doctors and members of that company should face criminal prosecution.

      Here is what patients said when asked about the FDA and the medical industry and what should happen when they break the law.

      Only if killing and maiming innocent Americans for the sake of obscene profits is treason. 58 (16%)

      No. The FDA protects American from bad food and medicine.9 (2%)

      Yes, and their punishment should be a firing squad. 251 (72%)

      No. Somebody needs to protect the struggling and altruistic medical industry from all the greedy lawyers. 30 (8%)

      The FDA is the enforcement wing on the medical and food industry. Medronic, J&J and Stryker own the medical device division of the FDA.

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  18. It doesn't appear this is lawsuit is accusing the doctor of doing anything wrong. Never mentions that in the article. What is does say is the manufacturer knowingly promoted, manufactured, labeled, a product that was not FDA approved and that caused in direct harm to the patient.

    Would hate to be the defendant here because lots of information is going to come out that I am sure the company does not want in the public arena.

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  19. Where can I get a lateral plate?

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  20. OPTI-MESS!! That product has been promoted off label for years. A lot of surgeons in florida doing revisions. Matt M is the biggest joke and the company turnover is evident of the management team.

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    1. I heard Matt M was the rep in the case. He bought his job by investing $$$ in the company.

      OPTI- UH OH!

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    2. Matt M. is a Regional Manager not a rep.

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    3. yes, matt m is a rm, that is exactly the point about the bad managment team. he is going to have to sell some of his gold chains when the company folds.

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    4. Matt started as a rep with Spineology, invested a ton of his "kyphon cash-out" money which was his expedited nod into management (glorified rep).

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    5. What you say is this manager had a personal financial gain to get docs on board. What kind of conflict does that have for the company?

      If true that does not look good for opti-mess.

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  21. That is a device searching for an application ever since Kyphoplasty's took a bath with that POS study.

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  22. You think these comments are insane, you should see what some distributors are charging hospitals for this product, OMG

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  23. Now that you mention price, I saw a DP charge a surgicenter $9,000 for the pouch with graft, and then we wonder why the industry is under assault, if people are stupid to pay this amount they deserve everything they get.

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    1. how is this pouch being coded? Reimbursement?

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  24. Is this the same thing as the bag o bones

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  25. Yup sometimes sold by Billie Bag of Donuts

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    1. You mean he Billie from Alphawreck?

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  26. Lame product adds nearly 40 mins to a surgery.
    Upwards to 10k a level, I have their list price sheet!
    What a joke/scam.
    Doctors Wake the f*ck up.

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  27. Folks at MDT used to refer to this as the bag of sh*t!

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  28. Wow I just heard Coflex is getting pma approved.

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    1. Coflex isn't getting PMA approval for at least another 2 years. The math doesn't work. Spinal Motion has been at FDA for 3+ years and do has PCM.

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  29. When is Globus I mean Spineolgoy going public?

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    1. Aug 1. $16.00 ~ $18.00 per share, Wow.

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  30. I love that song, "good times bad times", who sings that? Please tell me it's Sir Mix-Alot.

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    1. Led Zeppelin............Sir Mix-alot, LMAO

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  31. Is MDT desperate? They are letting the NY Dist. Spinal Associates to carry the Centinel Spine stand alone devices - Stalif. It seems they are selling it under the name Lake Medical. WTF This is unprescidented for MDT.

    Granted the Sovereign and Prevail devices blow. Does anyone know if they are going to let the direct sales force or the other distributors carry it as well. Is MDT going to buy Centinal spine? any rumours? Is McGann grasping at straws to keep things together

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    1. That's not unprecedented. 2-3 years ago Brad Rummer (the Texas distributor for Medtronic) started a spinoff company outside of Medtronic peddling smaller niche products like Annulex. Some say that was one of the reasons he was asked to leave.

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    2. Direct reps DO carry other than Medtronic products. The company made an investment in an expandable cage product that a couple of reps in Phoenix carried for 20% comm

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  32. I think MDT see's the writing on the wall....spine is on the decline and they better allow distributors to grab revenue where they can.

    MDT has revenue streams from other offerings outside of MDT spine and so should the distributors.

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  33. MDT direct reps carrying LDR as well !

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  34. Plenty of MDT distributors and direct have been carrying other companies products that they don't have like ISPs for some time (I know they have the S-plate). Now MDT might or might not know about it.

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  35. I work for one of the major VCF companies was called by Spineology recruiters twice (this was after they were required to discontinue marketing for fractures of the anterior column). First question he asked me: Do I have relationships with surgeons or IR docs doing VCFx? Was called once in 2009 and again in 2010. There is no question these guys have every intention of doing things unethically in order to boost revenue. They target the physicians doing the cases but keep it off their literature to avoid a more obvious violation and then claim "it's the physician's choice." Hope they get what they deserve.

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  36. The company got wise and no longer promotes for VCF---Fusion is where it's at. I used to be a distributor for Spineology and dropped them. No data to support fusion and off label. With a bounty of expandable cages in the market place why risk my business? This technology was innovative 10 years ago. They missed the window-----without FDA approval I won't carry in my bag.

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    1. Not sure if everyone here is that well informed. Isn't Spineology in its 2nd IDE study with FDA right now? How could they be doing that study if there were problems? If they get the FDA clearance, as it looks like they will, how are you guys going to respond?

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  38. I would like to say this. My Dr used this optimesh and it ruptured about 4 months after surgery. The dr didn't tell me it was off labeled and I signed a consent but if I had known it was off label I wouldn't have done it. It's hard to prove in a court of law that a dr or manufacturer is negligent until a hundred people report it. I am left with nerve damage to my left leg because my Dr who wouldn't acknowledge that the optimesh went bad and I had vertebrae on vertebrae for 8 months. I had to find a different Dr who within 5 mins after looking at an x-ray saw there was no disc. This company needs to stop putting this device on the market period. My life has changed forever because of this horrible product

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  39. My wife is considering Vertebral Augmentation using Optimesh for a T12 compression fracture which is 4 months old and doesnt seem to be getting better.Our neurosurgeon has done 200 of these procedures in last 10 years with only 2 problem cases, both with much more severe factors than my wife's. We are considering this as an alternative to a Kyphoplasty procedure which uses material which could leak and lead to serious complications as a result. We arent sure which is the best course. With only 30% improvement since the accident just waiting it out for another 4-12 months doesnt seem to be a desirable opion.Any helpful information or advice appreciated.

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  40. My "bag of bones" burst as well. Trying to get insurance to approve revision and ALIF with peak cage. My doctor used it for a l4-5 fusion. A little less than a month in I think it burst and he refused to admit it. I too had to find a different doctor.

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