Tuesday, June 28, 2011

The Carousel of Biologics

Blogger Nation:

Now that your children have completed the school year, and your college students have come home, hopefully to a summer job, TSB hopes that each one enjoy great quality time with your family.  Life is short, seize the moment, and every now and then, smell the roses.  Now back to the blogging world.

On Tuesday June 28th, 2011, John (God, am I a pain in the ass to Medtronic) Fauber from the Milwaukee Journal Sentinel publish an article entitled; "Researchers Sound Alarm on Medtronic's Infuse Years Ago." A journey back in time brings the reader to 1999 when clinical reports began to surface that a new biological product had surfaced that was going to herald a new modality of treatment that would safely regenerate bone in patients that were subject to back fusions.  Then something naughty happened.  CT scans were starting to reveal unwanted bone formation in the spinal canal. As TSB has asked on numerous occasions, how many of us heard those stories from various surgeons?  The clinical trial that was set to enroll hundreds of patients had to be stopped.  Unfortunately, it would be five years before Medtronic would publish a paper on the halted study.  As the results of ectopic bone formation was published, the paper downplayed the significance of this occurrence.  Based on these findings the question must be asked of our bloggers; "has monetary and commercial progress skewed the medical communities ability to report clinical outcomes in a regulatory and transparent manner?"

David Malone M.D., a Tulsa, Oklahoma surgeon reported that he had two patients that had required multiple surgical revisions.  One patient's biological response was so explosive that he needed a second revision because the boney ingrowth was larger than before the first revised surgery.  Dr. Malone was quoted as saying that the secretaries in the clinic could even identify which patients received INFUSE by assessing the post-op x-rays.  Good ol' Ronnie Pickard, a then top excutive at the Evil Empire agreed to a confidential settlement with the patient.  Obviously, Mr. Pickard was unavailable for comment for the article.  Dr. Malone goes on to report that in 2002 he sent a letter to the FDA making them aware of his experience with INFUSE.  The FDA read the letter into the record and then gave INFUSE its stamp of approval in late 2002.

The 2004 paper has drawn much criticism from the spine community.  Was there a systemic failure by the medical and scientific community by not reporting the various medical complications associated to INFUSE?  As in any battle to conquer the market, collateral damage occurs.  Could Medtronic and the surgeons involved have taken a mercenary attitude in the commercialization of INFUSE, accepting the fact that there would be casualties?  In addition to the many questions surrounding the politics and financial implications surrounding INFUSE, one must ask the question whether ethics, good science and medical advancements take a back seat to commercial interests, especially when the potential of hundreds of millions of dollars are at stake?

Marybeth Thorsgaard, the Mouthpiece of Medtronic, issued a statement on behalf of Medtronic, stating, the patients that were enrolled in the original study, were made aware of potential adverse events related to ectopic bone formation.  The article goes on to identify the usual suspects that have been involved with Medtronic over the years, Reggie Haid, Ken Burkus, and Charlie Branch. None of the aforementioned surgeons responded to e-mails from the Milwaukee paper.  In closing, it looks like the INFUSE saga is just beginning to pick up some momentum.  Considering that Medtronic has experienced flat growth and downsized its workforce, are they in a position to be broadsided by a potential torpedo?  As INFUSE continues to get bad press, will this affect their estimated revenue stream of $1 million dollars per day for this product?  And, did the FDA commit a major faux pas when they failed to acknowledge that INFUSE was a pharmaceutical and not a device? You know what Joni Mitchell once sang;

"And the seasons they go round and round, And the painted ponies they go up and down,
We're captive on the carousel of time, We can't return, we can only look behind from where we came
And go round and round and round in the circle game."

134 comments:

  1. David Malone is a stand-up guy. I remember selling to a spine surgeon that was part of this study. He too, had a couple of cases that had ectopic growth. The FDA should require public disclosure (in detail for 10years!) of any study that is started and stopped for any reason. Clearly, MDT was using this study to enhance sales in posterior applications. When it failed it was quietly hushed up -- and the community at large was none the wiser -- and given that physicians can choose to use things off label -- had they had foreknowledge of this hushed up study -- maybe they would have been less aggressive in their indications expansion of Infuse.

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  2. I know of one surgeon in Birmingham, AL that was part of the posterior InFuse study. He had ectopic bone growth in the majority of his cases and then the study magically disappeared.

    Of course the InFuse pimps at NASS et al, will tell the masses it was "dosing" while they pack ungodly amounts of InFuse into the gutters to obtain a fusion (and get it published with zippo comments).

    Medtronic has a long long way to fall before their #1 position in the spine market is threatened. But watching them squirm is damn fun.

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  3. Agreed that David Malone is a good guy, and as you've stated TSB, we all heard about this and read these reports back then. But at the end of the day, and if I'm not mistaken, it was dosing and technique that accounts for many of these early complications. It was the first time a surgeon had to be strategic about where they didn't want the spine to fuse.

    The simple fact that Medtronic have gone on to sell as much BMP to as many surgeons for as long as they have is for me the strongest indication that surgeons believe they have ironed out most of the contributors to early complications and found a suitable home for the technology in their arsenal. Cost and better understanding of less frequent complications (e.g. the recent RE discussion) will prompt suitable restraint from the "new technology euphoria" we've seen in recent years. But does anyone believe its place in the algorithm won't stay?

    So "surgeon reported ectopic bone formation very early on with BMP use" and did the right thing by telling Medtronic, the FDA and the rest of the world about it. Where's the news?

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  4. From an ex-medtronic employee.... I had a surgeon using infuse posteriorly. Inserting into the disk space with a funnel due to many revisions caused by ectopic bone. It still didn't help.

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  5. TSB, wasn't this study a posterior interbody study? Which stopped due to these findings the author is referring to? Then infuse was approved for alif with Lt cage which was a totally different ide study. Is MM just blogging to blog or trying to add value?

    So if a company has a potential product, thinks it might work for a specific procedure. Does a study and finds out it has different results and stops the trial (as the should). Then they are hiding something?

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  6. "Are they hiding something?" You betch your sweet arse they are! Transparency and full disclosure. Patients deserve to know and in the world of internet activity -- at least they can have access to information so that they can ask better questions of Regis Haid and Ken Burkus.

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  7. You notice too that MDT did nothing -- absolutely nothing to slow down indications creep. They new the potential for ectopic bone growth and cervical dysphagia ... and did nothing about it. They were silent. "Where are all your bitches now, Mr. big time Pimp?"

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  8. One of the problems is Medtronic consultants dominate the editorial and educational review boards of the major medical societies and the major clinical journals.

    Only what the surgeons and Medtronic want you to see gets published. It's like having the Medtronic marketing department running these groups.

    So ... While the news of the failed study is "old" ... Medtronic is well aware of off label use and the associated problems but has done NOTHING to educate the surgeons. All we get is lip service/dismissed at meetings and Medtronic reps hiding behind the IFU.

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  9. At least Medtronic doesn't have the infuse quotas for the sales reps like they used to. The DOJ should check out what the market for on label use was and compare that to what they were expecting the reps to sell. Hmmmmm.... Pushing off label use?

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  10. Medtronic should take a firm stand supporting the added value of this technology and the surgeons who decided to use this product.  These attacks on Infuse and the Spine Industry could be a watershed moment for the new Medtronic leadership.

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  11. 8:51

    And what arguments would they have at their disposal?

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  12. 8:51 may have a point. There are some similarities to Acromed and pedicle screws in the early 90's. Acromed was selling pedicle screws off-label because surgeons wanted to use them. Some bad press, law suits and Acromed distanced itself from its customers. I know many docs had long lasting negativity toward Acromed because of that.

    I also tend to agree with 7:32 in that they tested Infuse for PLIF, found problems with that indication and they stopped the study. The did the study under an IDE, disclosed results to FDA and appropriately stopped it. That's how its supposed to work. The "I" in IDE is investigational.

    Is it MDT obligation to publish those negative results in the journals. Those of us in the business knew about that study through scientific meetings, the original InFuse meeting, and 'word on the street.' The word was out and it didn't seem that there was a 'cover-up.'

    Off-label use is legal. If physicians want to use a product off-label they should educate themselves on the risks. The information was out there. If they couldn't find it then they probably wouldn't have found it in Spine either.

    If you can prove that MDT was promoting the product for an indication they knew was flawed- then go there. But I don't think its fair to say it was covered up. For the docs that used InFix for a PLIF, they either did so at their assumed risk and either abandoned it shortly or made it work. If they continued to use it even if they had an unacceptable outcomes, well, that's an issue and its their responsibility.

    I do think there is a problem with the journals though and the concentration of consultants that lies on the review boards. These guys have a responsibility to ask questions and challenge authors. Its different than a podium presenation where there is no peer review. If peer review is corrupt, we lose the quality science.

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  13. Boooooooooriiiiiiiiiiiiing!!!!!!

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  14. 10:23 are you a doctor or did you just stay at a Holiday Inn Express last night?

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  15. Both- regardless it's a bullshit topic. Bullshit really- who cares?? it's either POD POD POD POD POD POD, or what ever the latest thing the fatass brothers are BBQing, dumb ass musical references
    or some BS topic that no one give a dick about

    have a great day!

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    Replies
    1. I give a dick, my surgeon was involved in CT but aborted after 2 patients were fucked up, he wrote MDT advising it be stopped, in 02 wrote FDA telling same, in 04 but the boring bullshit in me, then proudly says at 2 WK post op visit after xray "looks great, it shows 6 mos healing". Where was he when I had several bone growths removed and 1/8" of my clavical shaved???????

      My surg was used "off label" with no cage but only a PC of twisted wired that shows up on xray looking like a PC of bailing wire wrapped around my disc, literally!!

      BTW way after surgery my surgeon also proudly said he got in there and decided to experiment and was very happy the way it turned out.....fucking jackass!

      If I go to sears and get a product I'm unhappy with they refund money, with a smile usually.

      One other thing, according to his half ass written surgical report he never closed me just it open.....still wondering why I had 19 staples removed. Jack ass again!!

      Live my life and tell me about your undersized dick!

      Jackass 2 !!

      Delete
  16. 12:35 you can log onto OTW and watch RY and TV massage one another, a true love festival hey didn't VBros invest in the platform?

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  17. Really?? We're going to blog about Infuse and a study that vaporized years agao??

    2 words: WHO CARES??

    What's next? An open debate as to why the BAK cage failed long term?

    laughing,, this board has become very stale.

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  18. 6:44 here again ... my point is simply that MDT knew that they had an ectopoic problem in their PLIF study ... word of mouth -- talk on the street doesn't cut it 10:23. Guys like Burkus and Haid either out of ego or greed (the two are inseparable) more than willingly promoted the 'good of Infuse' could they not just once reference the PLIF study or the need to stay on indication.

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  19. 1:50 here again... no body cares. not a soul.

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  20. ok.. well, why don't we talk about the DBM that used glycerin as a carrier and KILLED all the rats in the study!!! oh my gosh!!!

    would you like to hear some band camp stories too??? anyone????

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  21. I'd love to hear a good band camp story,,

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  22. International Biologics is selling to pods... Stay away

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  23. This comment has been removed by a blog administrator.

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  24. PODS!!! that's where all the money is!!! good for international Bio!!! smart guys!!!

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  25. Over the past two and a half years, TSB has learned that people read what they want to read, interpret the story or blog post based on their own lives experiences, and love to profess how smart they are. Regardless of our readers opinions, what some have missed is the key point. Has there been a systemic failure by the medical community when it comes to an unbiased and scientific approach that is not corrupted by money and personal gain?

    To quote Dr. Chris Bono:

    "The spine care field is currently at a precarious intersection of professionalism, morality, and public safety. As physicians and journal editors, we felt an obligation to present a thorough examination of this controversy."

    Medtronic CEO Ishrak's response is pure grandstanding by a CEO, "Integrity and patient safety are my highest priorities." PLEAAAASE, Ishrak, its all about the Benjamin's, and it has always been about the Benjamin's. Today, Medtronic's M.O. is to distance themselves from those that have been outed or are considered outsiders. Contingent on whose information one discerns, the incidence of adverse events in connection to INFUSE use has ranged from 10 to 50%.

    As good of a surgeon as Zdeblick is, where is his credibility when he has a vested interest in Medtronic's success and has received over $20 million in royalties? Would he be siding with Medtronic if he wasn't receiving royalty payment. In the end, science will prevail, but until then the court of public opinion rules.

    When researcher involved in studies ranged from $12-$16 million one must asked the question, can an individual be objective in their observations or are they tweaking the facts.

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  26. Here's the bottom line:

    The science has been there on this product, yet surgeons continue, AND ALWAYS WILL, to decide on their own whether or not to use Infuse.

    They're all aware of the possible negative outcomes & side effects, yet they continue to call for it in surgery?

    Why? Because it works and fuses anything & anyone and that's really all that they care about in the end.

    Bringing in $1M+/ day in revenue for MSD, Infuse isn't going away anytime soon.

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  27. Orthovita has finally closed the deal with Stryker.
    Any word on how integration will work? The Vita rep here is well connected and I don't know how they can give his position to a Stryker metal rep. Not much Stryker biz here either.

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  28. How about let's get back to who MM really works for. Clearly it's not Medtronic - Duh (winning?). I'm thinking Depuy. I don't recall ever seeing anything negative on this blob.

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  29. The new generation of Medtronic reps are thin skinned unlike us former grizzly vets, chill out every major wire service has covered this story today except for Ryorto and Orthoworld

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  30. Grizzly Vets? Oh you must mean Pickard, Lukianov, LoGuidice, Bennett., the Memphis Mafia after that group no wonder the blue suits moved in

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  31. Good article...interesting times. How did they mask this for so long. They have made over 5billion in infuse... Can't feel to bad for them...made out like bandits!

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  32. Very well. Greta post. Guys smell the roses every now and then and feel the need to be alive and relaxed.

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  33. So, there are TONS of BS products on the market (ceramics, silicated pixie dust, magic stem cell drywall, cadaver leftovers) that DON'T DO SQUAT!

    But the complaint is that Infuse works TOO WELL?

    HAAA!

    Every surgeon I know that uses Infuse regularly just chuckles at this.
    And THEY KEEP USING IT BECAUSE IT WORKS!

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  34. "Regardless of our readers opinions, what some have missed is the key point. Has there been a systemic failure by the medical community when it comes to an unbiased and scientific approach that is not corrupted by money and personal gain?"

    To quote Captain Renault: 'I'm shocked, shocked to find that gambling is going on in here!'

    The reason this board is 'stale' is the industry is stale. Just when you think it's got to change...it doesn't.

    TSB has done his best to pump the well dry and admirably so. Unfortunately, now it's just a guy on a hot sunny day in the desert pumpin' on a well that produces nothing but an annoying squeak. We amble around posting inane commentary like a bunch of parched zombies laughing at his attempts while, quietly hoping to see some water.

    My advice TSB, redefine your mission and rebrand the blog. Either indulge the zombies full bore and pull in some Google ad space dollars for local singles and DUI attorneys, pull the plug, or maybe create a community of problem solvers (clinical, legal, governmental, etc.) and develop an open source dialogue for people who earnestly want to move forward and thrive.

    I'm done with rants on BMP, PODs, old school vs. new school rep trash talk, inconsequential executive movement and the perennial wine of whether or not Globus will go public (I'd put my money on the world ending in 12/2012 before a Globus IPO BTW).

    This site is a reflection of an industry that feels like bad movie that just won't end, my popcorn's gone, I've got to take a leak, and now I'm pissed my wife talked me into even coming. Oh and I'll be smelling the roses brother, as I leave the theater and walk home alone.

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  35. Wow, check out: http://www.spine.org/Pages/ConsumerHealth/NewsAndPublicRelations/NewsReleases/2011/pressrelease1_062811.aspx

    NASS has apparently decided to become an organization representing surgeons and patients's interests and not the unofficial marketing arm of Medtronic. It'll be interesting to see how this wholly industry sponsored society will do now that they've publicly bitten the hand that feeds them.

    It was the right thing to do, that normally brings unfortunate consequences.

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  36. Dear 10:27

    Contrary to "your opinion," the well is dry because there isn't anything interesting to write about, so that you can be entertained at no charge. If you want to be entertained go to OTW so that you can read the nine thousandth and ninety ninth article on stem cells. Your commentary is truly a reflection of your selfishness. Albeit, it's nice to know that you include yourself in calling everyone on this board, "zombies." Your observation is correct, there isn't anything new in Spine that is exciting and cutting edge, something that creates a new shift, something that improves the outcomes. This blog is a reflection of this industry, and you are staring at yourself in the mirror. Thanks for your commentary, now go to work and sell something. And if you can't sell something, see if you can broker a deal for your surgeon. Maybe he will come up with another screwdriver for your pedicle screw.. After years of partying, the cold hard fact is that your livelihood is in jeopardy. Maybe you should have thought about doing something before it became too late to change the course. Reality is a bitch, now deal with it.

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  37. In support of several previous posters, and even MM himself ...

    In my humble, old spine sales guy, opinion, this is not really about Infuse, or Medtronic. It's about how an industry leader doing what it does best (develop and promote products) has influenced the peer-review foundation of scientific/medical research community.

    Medtronic has done a great job promoting Infuse, just like Medtronic is supposed to do. But, in so doing, they may have jeopardized the fundemental integrity of the scientific process in this small fraction of the medical community.

    What is coming to light here is not the fact that Infuse, if used improperly, might have negative outcomes (We have all known that for a long time). What is coming to light here is a crtitical flaw in the regulatory and peer-review process. Now the question should be "How can we fix this mess and bring integrity back to the journals (especially "Spine") and the societies (especially NASS)?

    p.s. I doubt MM is affiliated with DePuy Spine, or any other spine company. He hasn't bashed DePuy Spine because there hasn't been anything truly innovative or interesting in that company in a long time.

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  38. TSB,

    Out of respect, I'll clarify my intent as it was obviously missed:

    1. I've read your blog (since inception) for information, not entertainment. My commentary is that repetition has made the later a dominant theme, in my 'opinion'.

    2. My commentary is a reflection of my frustration. Perhaps sharing that is self-aggrandizing, but selfish?

    3. Yes, as we both stated, your blog is a reflection of the industry...and unfortunately that's exactly my point. Neither are getting it done for me personally and as a result I stopped 'partying' long ago and have prepared for this change.

    TSB, I've long respected the site and your opinions, but I think I might have 'chipped a little bone' with my post. My fundamental point was and is, if you want to keep pumpin' that well, peace be with you, I won't be. If you want back up your stance as being as defender of "The Truth, Just Causes and The American Way" then I think there is another way and I look forward to it.

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  39. "Reality is a bitch, now deal with it!".....I love that!

    TSB, like you, I am a synic as I have invested +16 years in this Industry....and I have seen, experienced, & participated in the good, the bad, & the ugly.

    Still, we ALL now get to confront the "reality" that 2 states, NC & FL, who are legally & financially challenging the efficacy of what we are all involved with. If we cannot "put up" the objective & untainted data that shows our surgical interventions bring relief & restoration to the patients, whose lives we are all involved in & accountable for, directly and more often indirectly...then, we are all in for a lower standard of living, & rightfully so.

    Can we ALL continue to all be united to deliver the BEST outcomes, products, & service to the patients we treat. Can we get these folks off the table quickly, help move Spine surgery into a more Outpatient procedure, and move people back to their lives & families in a week or a month, instead of to the PM&R purgatory? WE CAN DO THIS...& if we do....nobody cares, if we get to take it to the Bank too....thats Capitalism in HealthCare, that works! Get 'r Done!

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    1. Yes I am a patient. At age 53 underwent a Postlateral Spinal Fusion with BMP and Matronic (4) Screws and Rods at L4 L5, BMP was place in the lateral gutter, and the surgeon was well recommended. My surgery was pushed from 10am to after 5pm and he and another surgeon spent 1.5 hours instead of the 3. Well I ended up 4 times more pain and 24/7 suffering as a result. This for one thing is inhumane. I know have Kyphosis 42 degrees, I have pain in the lower and mid back, ribs, both legs and can't walk due to tightening pain in the lower back and right foot. Went from grade 1 spondelolythesis to grade 1 anterolithesis. The surgeon was not at my followup visit but promised I should be improving by 3mos, 6mos, and possibly 1 year. Well 3 plus years later, deteriorating symptoms. I am a mother, wife, daughter and step daughter unable to do more than exist, suffering and deteriorating. Would anyone in the medical profession do this to another human being with no remorse. Do unto others as you would have done unto you. I would not treat a pet this way let alone another human being. At least take the initative to follow up with your patient and try to correct the problem at your cost; otherwise put me out of my misery!

      Delete
  40. "In an email dated July 3, 2004 to which he attached a draft of one Infuse paper he was lead-writing, Dr. Burkus wrote his co-authors and Medtronic executives: "Come in off the porch and put down the sparklers, bottle rockets and M-80s. This manuscript will start the real fireworks." He then solicited from them "additions/criticisms/changes" and "deletions.""

    WSJ 6/29/2011

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  41. We deserve what we get. We all started believing our own BS. WE were all making a lot of money ... now the bill for the party is due. This is just beginning of a very difficult time for spine. PODs will eventually go away. Consolidation will happen. Mostly because, CMS and private pay insurers will adopt the Milliman guidelines for lumbar fusion. When that happens we'll all be selling rubber dog poop to novelty shops.

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  42. For those of you who have an interest in creating your own topics of conversation:

    www.spine-forum.com

    I include that link with the upmost respect MM. Your blog is fantastic and for someone who's been in the industry only a year, I learn from it every day.

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  43. Just finished reading this, what is everyone's beef? This story has now been splattered in the Milwaukee Journal, NY Times, and the WSJ. In addition, it is the surgeon community that laid down the guantlet in The Journal of Spine. jMHO. Even crazy Bachmann is using metaphors like she has a titanium spine, maybe one of the Medtronic consultants can fuse her mouth.

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  44. It was also great fun seeing on the Today show this morning as a news item (loved how it was repeatedly referred to as a "drug").

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  45. A note from Robin Young: what worries me about the Spine Journal and the reaction is that it is blaming surgeons and companies for having a learning curve. You know, first there was the InFuse learning curve, now there is the surgeon and industry learning curve. How we as a group understand and make room for the former will define, I think, whether the medical industry in America is entering a dark age of innovation. How we understand the second learning curve – namely the unfolding revelations about the effects of corporate payments to surgeons, surgeon societies, clinical studies and peer review journals will determine whether “science” will continue to slip into a netherworld of cynicism and mistrust.
    The full tilt blast of The Spine Journal, as then echoed and magnified by the Wall Street Journal and the New York Times, grabbed each spine surgeon and each company who supplies spine surgeons by the neck and shook them, demanding that they come to terms with such fundamental concepts as investigational trials, salesmanship, investigational bias and payments for intellectual property.
    One conclusion from the articles and editorials in this week’s The Spine Journal are that none of the above is acceptable. No investigational trials. No salesmanship. No investigational bias. No payment for intellectual property.
    Is that where we want to go?
    Because it is not where we came from. Orthopedics, indeed all of medicine, came from messy backgrounds. Charnley had over 300 consecutive surgical hip replacement failures – in a row. There are no virgin births in medicine. It’s messy. It is risky. It’s biased.

    I don't think we should take the attacks on InFuse as a lesson to stop investigational surgeries. I DO think that we need to scrub clean the Journals and the authors and make good on all the existing structures to squeeze bias out of scientific papers.

    decidedly not anonymous,
    Robin Young

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  46. Robin,

    Great points. I too think we should take the bias out of clinical papers.

    Regards,
    Timothy R. Kuklo, MD

    http://www.nytimes.com/2009/05/13/business/13surgeon.html?pagewanted=1

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  47. Anybody remember Link Charite? There was a learning curve there too. Read page 281 of 'Money Driven Medicine' where Dr. McAfee was cautioning surgeons as to the 'steep learning curve' for implanting Charite ... and that was for on-label indications. "The story of Charite disc captures the secrecy, the scientific uncertainty, the financial pressures, and the potential for conflict of interest that clouds the development, approval, and marketing of medical devices in the United States."

    The problem with Infuse is not mastering a learning curve ... its the story of conflict of interest. The issue here is simply physicians with ulterior motives. More should have been done by MDT to study ectopic bone growth and limit indications expansion -- BTW, indications expansion is Robin's definition of 'learning curve'. Your surgeon does what every surgeon does, sometimes with the encouragement of his sales rep ... he takes the data and extrapolates ... 'humm, if it works in lumbar, why wouldn't it work in cervical or PLF or PLIF?' This is not learning curve ... this is indications expansion. If physicians had used the product in the Lordotic LT and dosed it as per prescription -- I don't think you'd have these problems. Learning curve mastered by reading the directions and abiding by them.

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  48. BMP = Big Money Product

    Corruption is everywhere in this industry. When was the last time that a "landmark" study came out highlighting a high rate of negative outcomes for a product?

    When big companies invest BIG dollars into a key product, what is the outcome?

    ALWAYS positive,,

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  49. Disclosure: Still work for Medtronic.

    Researchers are motivated by many factors like money, recognition and favorable outcomes to just name a few. There are bad apples all over academia that tarnish the data. The complications that the WSJ claims were not reported by the researchers is unacceptable, but some doctors report what they want to report and that hurts all of us.

    How many customers have threatened their business unless they were given a study or better yet, how much business have you won giving a surgeon a study. Plenty of blame to go around here.

    Infuse is the most innovative medical product that has been introduced since Penicillin and the majority of you who have jumped on this bandwagon would have Infuse in your back in a second if you needed surgery, so ease off on the rhetoric.

    Infuse has been on the market for 10 years now and after hundreds of thousands of surgeries, the benefits FAR out way any of the unfortunate complications. Yes, the majority of those surgeries were off-label and yes, prior leadership made the mistake of not conducting a TLIF study, which would have been enormously beneficial and taught us a lot about how this product worked in that environment. But let’s be honest, if any of you were in charge and had the option of spending 40M on an IDE study, or let the product fly off the shelf I can assure that most of you would have done the exact same thing………nothing. It’s a numbers game folks, get used to it. This is what our society and business schools have taught us and will continue to teach your children.

    The PLIF study was stopped for two reasons. #1 some surgeons were not following the procedure during the study and #2 those adverse events from those sites would have had negative effects on the outcome of that study. It wasn’t the product it was the user. This product has revolutionized fusion rates around the world and if we have learned anything with Infuse, it WORKS!! Anything that works well and is used excessively will always have consequences.

    Some other key facts:

    Infuse was awarded the Prix-Galien USA award which if you don’t know, is the equivalent of the Nobel Prize for Bio Technology products. This award is not given lightly.

    Wyeth (Phizer) takes 50% of every dollar sold so please take that into consideration before throwing out the inflated profits of this product.

    The FDA is no shining star when it comes to being the medical device watchdog. Look at their history of unbelievable blunders in approvals i.e. Phen-Phen, Celebrex etc. It takes two.

    This subject is the exact reason we need patient registries in this country similar to Europe. The patients in these registries are tracked for decades and data is easily attainable and accurate. Thanks to HIPPA you won’t ever see if in the US.

    The surgeons are just as culpable in this as anyone. When something works, they use more of it and the indications become thinner and thinner until the outcomes become too negative to ignore and they always blame the product. Look at BAK, X-Stop, Trans 1, Dynamic rods etc.. Fads are always short lived.

    Be thankful you all have jobs and start concentrating on the things that really matter, our health, our families, our country and getting that knucklehead out of the White House.

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  50. With the 4th of July just around the corner its still not too late to buy some Purple Pork Masters Barbeque sauce and add fireworks to your day!!!!

    http://www.purpleporkmasters.com/sauces.html

    At only $6.99 a bottle for the classic or $7.99 for competition grade it is THE perfect addition to your celebration!!!


    Salute your nations Independence with a truly chomp-o-licious parade or mouth-watering BBQ!

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  51. 3:23 Nice retort.Was all of the info presented at this year's NSM?

    You should actually go work for Nuvasive since you clearly enjoy "drinking the kool aid".

    How much Infuse is sold in your territory? I also bet none of your accounts even know that a small or medium size exist,,, just Lg. & XL?

    The plain fact is that MSD has ALWAYS known the side effects of this product along w/ the fact that most every surgeon uses it outside of its approved indication, but they have simply chosen to repeatedly turn a blind eye as the revenues are simply to large to turn away.

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  52. 3 words...

    It's over Johnny.

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  53. Infuse is here to stay, and as long as Biologics are the future, Medtronic and it's ownership of various types of BMP will lead the way.

    What we all need to do a better job of (Medtronic and competitive reps) is instructing our surgeons how to use and how much of it to use. How hard is it to plug a little bone wax behind your TLIF cage, Docs?

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  54. I for one have seen revisions that Infuse was used primarily. You are dead wrong about putting that stuff in my back. We still don't know what effect this has on the body long term..... the truth shall set you free. The press on this is only going to get worse. Squirm baby squirm!

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  55. Bone wax behind the cage? Is that in the literature? Still teaching off-label use huh?

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  56. 3:23

    The most innovative product sense pennicillin. Give me a break. First off spine patients are a relatively small sub set of patients although they have a relatively high cost to treat thanks to your wonder drug. It certainly has revolutionized fusion rates as nearly a decade before Infuse BAK cages published an IDE study with a 100% fusion rates for single level AlIFs. Aren't single level AlIF's the easiest thing to fuse after cervical fusions? Please provide some data that it works in the posterior lumbar or cervical. Oh you can't becuase their are too many complications associated with the product when used in those areas.

    Here is the short list
    Ectopic Bone
    Dysphagia
    Immune response (This one is going ultimately going to be the largest problem, OP1 reports a 40% immune response using a stricter assay. Can you say cancer, osteoporosis or god knows what).
    Hyper active Osteoclast activity - bone resorption, wait I thought we were supposed to be growing it?
    A few more and the last one that trumps them all...

    Death

    Sign me up I would love to sell it, especially at negligible commissions.

    Didn’t we already get George Bush out of office?

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  57. Looks like Ishrak was able to call on his old friend at GE Jeff Immelt to ask the Nightly News to bag the evening report on INFUSE. What's a matta Ishrak, afraid of a little bad press, or are you going to be another one of those thin skinned Medtronic CEOs?

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  58. I have watched spine surgeons refuse to believe there are any side effects and object strenuously to any restriction on the amount they use for their fusions (the more the merrier theory). I have seen them switch hospitals, picking the institution that allows them to use however much they desire. When confronted with these studies they just do not care- a complication simply means another opportunity to operate. Then we have the guidelines for surgery blithely ignored- it really sours me on my fellow physicians and the lack of integrity they show. I am sure spine surgeons realize that eventually we are going to see the indications strictly followed and business is going to dry up like the Dust Bowl states in the last century. In the meantime they will continue to push every envelope they can and operate as much as possible- unfortunately they are one of the few groups who should be able to retire anytime if they have saved even a small percentage of their earnings over time. I am ashamed to see these men and women, especially the ones in these studies, call themselves physicians.

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  59. BMP works very well. It fuses where it and the carrier are placed. If the product ie carrier is in the neural canal you get "ectopic" bone growth. If you over pack or hyper concentrate you get osteoclasts making cystic changes that radiographicly mimic infection. But the product does give higher fusion rates than another possible graft material.
    ALIF approach poorly done without care around parasypathetics draped over L5-S1 is what causes RE, not BMP. I have used this product anteriorly since it was available, it does NOT cause RE.
    RE is higher transparitoeal than retroparitoeal and is again approach related. Please don't send us back to IBG days of nonunions and donor site complications.
    ACDF will be shown to be safe with the right dose of BMP. The study is done and results will be published. Dosing is again critical but with essentially 100% fusion rates.
    Itvis easy to bash big companies but this is really a revolutionary product that allowed quicker recovery shorter LOS and higher fusion rates.

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  60. I was wondering what happened to that Nightly News story that never came. Touche MDT.

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  61. A little Bone Wax behind the cage ??

    It's back to Memphis for three weeks of training chumpy.

    Learn your anatomy and avoid the Blue Cool Aid.

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  62. Unfortunately, this story will hurt all of us, not just MDT or those research doctors.

    This fits nicely into the narrative about the "big pharma, and medical tech company" abnormal profits, and the greedy doctors.

    Yet again, we have provided the politicians shelter from tackling the real problems faced by our nation, and now become convenient scapegoats for the all fraud and corruption associated with our dysfunctional health system.

    The baby will again go out with the bath water. Infuse has its indications and helped with certain circumstances. Now, because of scrutiny, and likely class action litigation, we will fear using it in the proper situation. We took a good thing, and let greed ruin its potential use.

    We need to hunker down. This storm will be a long one.

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  63. @ 5:06 you sir are a dimwit....

    Ectopic Bone - In off label use yes, doctors know the risk.

    Dysphagia - Again, in off label use yes, doctors know the risk.

    Immune response - Garbage...proof that BMP-2 causes this?

    Can you say cancer, osteoporosis or god knows what).- See above....

    Hyper active Osteoclast activity - bone resorption, wait I thought we were supposed to be growing it? - HYPERDOSING dimwit

    And death???? Seriously dude.... go punch yourself in the sack.

    This will pass as quickly as all the other scrutiny that has come upon Infuse in the recent years. The only indication in spine is in an ALIF with LT CAGE...period. If a surgeon chooses to use it in another manner is the rep supposed to refuse? Hell half the time the reps being told to get a kit of infuse are not even employees of MDT, rather a competitor. So who's job is it? The docs have known all along of potential complications and they know the ON LABEL indications. The main beef with this latest story is questioning the integrity of peer review groups by the Spine Journal.

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  64. 6:00,
    Who said BMP caused RE? Ectopic bone formation when used in the disc space does not only occur when the carrier is placed in the canal. The blood clot the forms in the epidural space can become the carrier. I had surgeons use BMP only inside the PEEK TLIF cage and still had MAJOR ectopic bone formation and/or cyst formation requiring revision.

    The problem is that BMP does, in fact, make bone grow. But instead of developing a technique or carrier that would make it work effectively in various applications, MDT just let it take off wild west style. Would I have done differently? Not sure I can can honestly say that I would have. Its pretty tempting to let the docs decide and still pull in $744M/ year (closer to $3M/ weekday) and not have to do expensive IDE studies for every single indication. But then again, I don't run a multi-billion dollar international technology company. I think the revenue generated warrants the study for the safe use of a product with huge potential to help people, and also the potential to harm people.

    MDT clearly sold outside the indications. They hired Hal Matthews as Medical director and all you had to do to sell it off label was submit a request from a doctor for off label usage info directly to Dr. matthews and he would call or write and describe how to use it in off label cases and would also state any studies done for that type of case. They said that was legal because he was an MD, even though he was an employee of the company.

    The stuff grows bone, but you don't necessarily want bone in some places. It is still in its nacency as far as how it can be used effectively and safely. The question is who is gonna do the studies and develop the proper carriers for each application.

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  65. It is interesting that Tommy Volmar's LinkedIn profile claims he "Broadened FDA indications through $20M IDE study to expand into TLIF/PLIF market", yet I haven't heard of any FDA clearance for PLIF/TLIF. Also of interest in his profile is that Infuse growth slowed to 1.8%. Thats pretty dismal for a product that has grown from $0 to $744M in 10 years.

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  66. Wow, everybody here seems to be looking for someone to throw under the bus.

    Are any of you old enough to remember Pogo? "We have met the enemy and he is us."

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  67. To Robin Young: Come on! I don't think anyone at the journal is saying don't make money. In fact, the opposite seems to be true. They're saying make money--make lots of it. Innovate your ass off. Investigate. Publish. Just disclose the money you do make so docs and patients know and can determine if there is bias. Disclose all side effects and complications. Be honest. I know that's a hard pill to swallow, but people get pissed when they find out you lied or lied through omission. It's not about Dark Ages--it's about adding some light to a current dark and murky process.

    If NBC killed that story because MDT made a phone call, then they are scum. "Watchdogs" my ass.

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  68. Here's a great article about Infuse and I'm betting this Dr. is still packing his cages (google the guy, he makes his own cages.) full of infuse while waiting for the MSD checks to arrive in the mail.

    http://blogs.wsj.com/health/2008/11/19/surgeon-i-can-implant-this-pen-inside-someones-brain/

    What great comments! It's laughable almost.

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  69. BMP is a very powerful biologic which has been presented by MSD and its heavily paid surgeons for years as a virtually risk free answer to all your grafting questions.

    As a powerful biologic, yes, it grows bone, but also has significant effects on many many other physiological systems. Just a short search on PubMed can inform you about quite a few of them, including the mechanism by which some cancers metastasize.

    Dismissing all the side effects seen as the result of user errors is incorrect and grossly irresponsible.

    More research is needed to better understand the interactive role(s) BMP-2 and the other 50 factors play in growing bone.

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  70. Stems cells have tons of data, lets use them! They will cure any cancer Infuse creates.

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  71. "Infuse is the most innovative medical product that has been introduced since Penicillin..."

    Now, in my best "Seth and Amy" voice I have to say "Really...."

    Hmmm... I don't know, let's start with:

    Kidney Dialysis, shall we. Millions of people going from dead to alive from one invention. But that's not as innovative as Infuse of course.

    Perhaps the Heart-Lung machine, which has enabled virtually every open heart surgery performed on the planet. But no, growing bone is much more innovative.

    And staying a little closer to home, how about the artificial hip. Restoring mobility and a pain free life for tens of millions around the world. But no, that pales in comparison to Infuse.

    Way to blow your credibility less then a quarter of the way through your message, moron.

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  72. I just started reading through this string and got to the post where the person said that infuse was the most innovative invention since pencillin.

    I spit water all over my desk when I read that.

    I subsequently read everyone else's responses and wish that I had read this string earlier cuz' I wanted to be the first to respond.

    One word: quinine

    Total the number of bmp related fusions and compare that to the lives saved from the various plasmodium strains in malaria. I much prefer NOT sh*tting all over myself as I lay dying as opposed to getting the life saving one level TLIF.

    I really hope you don't open your mouth in front of doctors and simply drive sets around. Wait, I am not sure I am comfortble with you behind the wheel. You really should take the bus. Really.

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  73. 2:23 I couldn't agree more with you. That's right up there with John Belushi ranting about the Germans bombing Pearl Harbor. Danek Zombies. Shadow of their former selves. Pathetic.

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  74. Robin - please don't put a genius like Sir John Charnley in the same boat as anyone from Medtronic - http://www.johncharnleytrust.org/trust/perfection.html.

    Sir John Charnley may have had failures but he at least fronted up and dealt with them and he did not seek to influence peer review journals or government agencies to launch his crazy new hip device.

    How many medtronic reps/execs/docs on the pay roll would inject bmp into themselves to test what the side effect may be?

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  75. Laughing,, Yes, exactly, fusions did not occur prior to the introduction of Infuse. Where would we be w/ out it?

    "Infuse is the most innovative medical product that has been introduced since Penicillin..."

    Could be one of the most assanine things that I've EVER read.

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  76. Mega Distributors are next on the Senate target list. They know thats how the big companies hide all their shady deals. Wait until they start investigating how the big 3 "maintain" those 4 million dollar territories. The docs will always walk away clean. The reps will do prison time. Hope you like cinder blocks and steel bars.

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  77. 3:23 has an awfully "spine Implant" -Centric view of the Medical community. Shame. He should read some other journals besides Spine and get a clue at what is going on.

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  78. I'd keep playing, I don't think heavy stuff is coming down for quite awhile. Oh, Rat fudge.

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  79. Does anyone else find TSB's injection of song lyrics annoying? I tune out whenever I get to that part.

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  80. 3:23.……why do some dbags always have to get political? Shouldn't you be patrolling another blog or website?

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  81. The title of this thread is "THE CAROUSEL OF BIOLOGICS" could we maybe talk about something else besides MDT? How about an intelligent discussion on some of the other biologic products available today? For instance, perhaps we can share experiences on some of the trophic cellular products out there ie. Puregen, LiquidGen, NuCel, BioDfactor, etc. Now that we know Robin Young visits, perhaps he can share his insight!!!!!

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  82. Ohhh Lookie here :

    Medtronic just released Fenestrated Screws overseas for use with bone cement.

    What an innovation.
    Dougy Doody King you Rock!
    The hits keep comIng haha.

    Hey wait, we can shoot Infuse down those right?

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  83. 5:25
    Start your own blog, you can then entertain yourself, or even sing to yourself. Matter of fact, you can write about anything that you care to discuss with yourself.

    6:57
    How many major wire services have carried the MDT story this week? Don't think its news worthy, read some of the more intelligent comments on this post. It may even get you to think, and god forbid you exercise your own free will, especially in this industry. As for Robin Young, please type in www.ryortho.com and read ten thousand and one variations on the benefits of stem cells in dogs, cats, horses,meniscal tears, and even some related to spine.

    You know what the great Linda Ronstradt once sang: "it's my party and I can cry if I want to."

    Have a great holiday, and ask the VBros to send Spineblogger some free Bar-B-Que Sauce for the free advertising.

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  84. MM - keep up the good work.

    5:25 - Did you wake up on the wrong side of the floor in Mommy's basement????

    I'll be "wastin' away again in Margaritaville" this weekend while your stupid ass sits in front of the tube and plays with his x-box.

    Rock on MM!!!!

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  85. Hey MM, no big deal.. but I don't think Linda Ronstradt ever covered that song. It was Lesley Gore's song.

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  86. I don't have any cases today :( might as well start drinking, cheers!

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  87. Actually she covered it on an old album, maybe as old as TSB

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  88. Infuse is getting hammered in the press but BMPs are a medical marvel none the less. There are tons of clinical research and published papers on infuse. Name a product that have as good or better results than iliac bone graft. With a Prix Galien award to boot. Sure, off label account for majority of sales but so does lateral mass screws and pedical screws in peds. How about vertebral body replacement instead of interbody cage, the list goes on. for all those rep, name me a biologic you would rather carry than infuse.....InQ, bioglass, osteocel..I think not...docs would rather go back to the crest.

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  89. To Anonymous
    You obviously have not had your whole life destroyed by a product that a large company knew what they were doing.
    I, a single mother of two have been destroyed by multiple surgeries with many more in site

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  90. Dear 1:30,
    Some of us have chosen to NOT work for Medtronic (and Sofamor-Danek before that). I would not sell InFuse (rh-BMP2), ... not now and not 10 years ago. Believe it, or not, there are a number of reasonable, smart people who don't think it's wise to use mega-doses of one BMP when there are, literally, scores of them needed to work in a balanced concert to regulate healthy bone growth.

    I wonder ... why does the package insert says it can only be used one time in any one patient? Hmm, better get it right the first time.

    BTW -- what the hell is a Prix Galien? If the prize is so dang important then you wouldn't have to tell us how important it is.

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  91. 1:30,

    Lateral mass screws are used off-label because nobody wants to pay for the IDE study. Everyone knows what lateral mass screws are and they use them when it is apporpiate. There has been no IDE study (that I'm aware of) on lateral mass screws.

    Pedicle screws are used off-label in pediatrics for the same reasons stated above. There has been no IDE study (that I'm aware of) on pedicle screws in pediatric populations.

    The same is not true for Infuse. There have been IDE studies for TLIF, PLIF and ACDF. They were each abandoned because the results were not favorable.

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  92. Okay, time to chime in on a few items.

    MM - keep the lyrics coming. Kinda cool, invokes memories, and hey, everyone needs their schtick. That's yours and it's not bad.

    BMP grows bone like gangbusters - nobody's disputing that. But many fusions were performed pretty well before and if the risks don't outweigh the benefits, then it ain't right. Hell, I don't want a cruise ship in my bathtub even if it is a better boat than my duckie.

    Overall, BMP is a great product and once everyone figures out how to use it when and well, it'll be one of the great contributions to spine surgery.

    Finally, to the unfortunate patient posting at 2:55, sorry, but if you believe BMP "destroyed your whole life", I'm sorry to say this, but you've lost all credibility with me, because I presume you are either ignorant, malicious, or misinformed. The following will sound mean, and while each item may apply or may not, I believe it illustrates why I cannot take your statement at face value.

    BMP is a tool used in spine surgery. It alone cannot destroy your life. The condition you had that merited the surgery (or didn't, but you hoped it did) contributed the most. The weight you didn't lose to try to alleviate your back pain contributed. The smoking you did for years and didn't quit contributed. The physical therapy you didn't try hard enough at contributed.

    If it was due to the BMP and you it was used off label, the surgeon contributed. If it was used off-label and the rep convinced the surgeon to do it anyway, then they both did.

    BMP is a product to grow bone. It sits on a shelf. It cannot do anything to you.

    And yes, every time I hear a patient testimonial that XYZ product or procedure "gave me my life back" I want to heave for the same reason.

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  93. Dear 6:59 P M
    Regarding your comments
    1. I was a 42 year old 5'5" 118 lb female at the time of my first surgery
    2. I have never smoked or done any illegal drugs and drink approximate 4 glasses of wine/ week.
    3. I AM a Physical Therapist who underwent 3 hrs of therapy before my first surgery
    4. I am 100% disabled but cannot live on SS Disability and raise two children with their dad unfortunately here

    I had surgery on my L5S1 with Infuse...8 weeks later back in for emergency surgery as I had an excessive amount of ectopic bone froth surrounding my L5S1 nerve, lifting it up, along with bone surrounding my dural sac and up through my spinal canal.
    No fault of the neurosurgeon, my L5S1 nerve was cut creating permanent nerve damage, pain and numbness to my toes. My dural sac cut creating a large CSF leak which left me with a 4 cm cyst within my spinal can which took 1 1/2 years to dissolve creating even more extreme pain.
    My 3rd surgery was 1 yr 4 mo ago to try to correct more damage.
    I have to go through at least 2 more surgeries to prevent further nerve damage and disability. The bone continues to grow 4 yes later.

    I get myself out of bed everyday to go to work with extreme pain, fatigue and disability. I can no longer treat patients but I have no choice to do what I have to do.
    My life no longer consists of vacations with my kids, walks in the park. Friends help me with carpooling, grocery shopping, errands,etc.
    You will most likely say, " How can I work if I am so messed up?"......I do what I have to do to raise my children.
    If it was not for my children I would of given up a long time ago.
    I am in severe pain throughout my back and both lower extremities to toes with one side completely numb.
    I do not complain as this will change nothing

    If only I had a bone graft instead of Infuse.....that would have healed
    Obviously you have not lived my life or you would not be so quick to judge.

    Just continue to appreciate "jumping out of bed" as one never knows when their whole life will be changed forever because of a companies deceit and lies with no thought to us "Little People!"

    Have a great night 6:59 PM !

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  94. 11:08

    I'm sorry for your pain and suffering. Do you know how much InFuse was used? And who was the surgeon?

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  95. 11:08


    Assuming you are not trolling here (Which you may be) can I ask what type of implant was used with your Infuse? If it was not LT Cages then your surgeon is at fault due to the fact that any other implant used with Infuse in an ALIF application would be off label. I am sure you will reply back and say it was LT Cages so lets move on.
    The warning label insert in the Infuse packet includes a warning about possible ectopic growth, its a known complication. I truly feel bad for all your difficulty and challenges with your surgery, unfortunately there is a risk with any of this as I'm sure you know.

    This is all starting to sound like the witch hunts of the pedicle screw days. Anyone remember seeing pictures of drywall screws in the newspaper with an attorneys ad asking if you have had "Back Screws"?

    Sofamor Danek at the time was essentially the only company to fight those battles and win thousand of lawsuits that ultimately allow all of us in sales to do what we do.... i.e sell pedicle screws! If they had caved like everyone else our environment may be much different.

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  96. 8:05, SD was not the only company fighting those battles. AcroMed, with less means and more law suits than SD, fought just as hard. In the end they came up with a solution that relieved all their customers, as well as SRS, NASS and the other organizations, of any legal liability related to the use of screws. If patients had filed suits claiming malpractice because screws were used, they disappeared. AcroMed's huge mistake was that they had no idea how important PR is in explaining complex issues to the public at large. SD pounced on that weakness by spreading the false rumor that AcroMed had sold out its customers, which they emphatically did not. You apparently drank their koolaid.

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  97. Sorry MM, but Linda Ronstadt never covered "It's My Party"...trust me on that one...maybe she once sang it live in a Honky Tonk in Tucson when she was a teenager...lol.

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  98. i saw her sing it in Dallas many years ago with the late Andrew Gold, Russ Kunkel, and Leland Sklar

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  99. I do have all my records to know how much infuse was used and exactly what was implanted
    I do know the surgeon who performed the first two surgeries and he knows me well.
    This is a true story of someone angry as the company knew what was happening and I knew this years ago through research but could do nothing about it

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  100. I assume they didn't make a live recording of it though...lol...you said she covered it on an old album!!!
    Was Karla Bonoff there???? Hate to tell you this MM, but your are out of your element...leave the music history to us older, but maybe not necessarily wiser, musicians who were actually "around" in that period..haha

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  101. Question for anyone out there. Is Alphatec Spine and Apatech one in the same? Is there a connection between the two as a financial entity? And how many manufactures of BMP are out there? If an itemized hospital bill states BMP Infuse Bone Graft does this mean it is the Medtronic product you are all blogging about?

    And should I worry about all this bad news about Infuse since my husband's fusion last November included a TL Cage and Infuse BMP? Should he have a follow up xray within a certain period of time to be sure there is no abnormal bone growth? Thanks is advance for anyone who can answer these questions.

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  102. Alphatechs - all the same
    One maker of Infuse
    Yes this is the product being discussed
    No you should not worry.
    A good spine surgeon follows up with xrays at 3-6-12-24 months.

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  103. The person above is confused. Apatech is a biologics company owned by Baxter and is not part of the Alphatec organization.

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  104. To 10:16 PM 7/2: Are you the same blogger that screams "witch hunt" to anyone who poses a rational question or comment? When someone is charged $22,000K for a finger full of BMP Bone Graft for one fusion, and then a few months later reads all this Medtronic "shhh! let's not tell the public what we really know about our product". Yeah, you betcha I'm going to stay informed. I care about health matters pertaining to my loved ones. Wouldn't you? Sounds like you're on a "bitch hunt". Your the one bitching up the wrong tree., or should I say trying to shame us for asking what is ours to KNOW.

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  105. Well hell since you put it that way 11:08, SUE the bastards!!
    You might want to sue the hospital that marked up the Infuse 400% as well, AND the insurance company for agreeing to pay that much and paying for a product that you feel is going to harm your family etc etc blah blah....

    This is what you are after, so give it a shot!

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  106. Hey 2:21 why all the venom? It's a holiday weekend, you shouldn't even be on this blog. Are you having a bad day, or, are you from Medtronic? Have you ever had back pain? If not, how can you relate? Have you ever had a loved one fall terminally ill? If not, you cannot really understand someone's plight. Have you ever had to change your mothers or fathers diaper yet? Count your blessing. If you're healthy, please take this Independence Day weekend and open your eyes and ears, and don't spew so much animus towards your fellow man. Ever wonder why we Americans have so little tolerance for one another, yet, we're quick to help some Iraqi, Afghani, or Libyan, and sacrifice the lives of our children all for that illusion that you call freedom? Yes TSB is making a political statement. When it comes to our own nation and its people we lack compassion. Now go crack open another brewski, throw some shrimp on the barbie, and tell your wife and your kids that you are the luckiest person in world. Peace and Happy Fourth for all its worth to all our bloggers.

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  107. Will MDT sell it's spine franchise? At least one analyst is suggesting it as a possibility...

    http://blogs.forbes.com/matthewherper/2011/07/05/will-controversy-lead-medtronic-to-sell-its-spine-business/?partner=yahootix

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  108. 11:08, 6:59 here. You're right, much of what contributes to adverse outcomes in spine surgery doesn't apply to you. But even without BMP your likelihood of a successful low back surgery is far from certain.

    Everything you describe was a known complication from the procedure and from BMP. If the surgeon had not used BMP and you had a non-union, and on the revision surgery you suffered nerve damage and a dural tear, you arguably could assert that the surgeon should have used BMP. The many thousands of patients who have received BMP in their successful fusion surgery would likely support that contention.

    I understand your plight, and I very much sympathize with your situation, but I don't share your view of a single source of blame that merits the statement that BMP "destroyed" your life. Having a back problem, and even having spine surgery, may have destroyed your life, but having complications from BMP was only one part of it.

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  109. Well thought out response 2:01

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  110. I really am aghast at the reps, engineers and doctors who are blaming the patient who shared her story. Clearly from her explanation Infuse had a lot to due with her outcome and complications. Furthermore, clearly Medtronic promotes Infuse off label as 95% of their sales come from off label usage. I know a lot of doctors that use Infuse and I haven't seen an LT cage used in years! How many informed reps, doctors, engineers and Medtronic corporate representatives would want Infuse in their spine surgery? One I am not having and ALIF, two I am not having an LT cage and three I would not allow them to implant infuse in my body if they paid me millions. This is a device that we don't know the proper dose (all drugs have a dose response study), indication, correct patient or long term complications. I believe that Medtronic's greed in promoting Infuse risks them losing their market position more than by any other company catching them in sales. Ask Boston Scientific what happened to their company! Medtronic will soon be facing pacemaker, stent and Infuse issues and if they have a leadership problem now wait till those problems come down the pipeline. Sad too, because obviously Medtronic is a huge company, with tons of cash and great products but we will see how this all turns out. And for the Medtronic kool aid drinkers on here can you explain the Wall Street Journals and other outlets that have reported cervical deaths to your product. You have taken a surgery with 94% success rate with very few complications associated with it and turned it into a chance of death. Congrads you have really advanced medicine with your wonder drug. Can you explain to me how you have all these great studies and data to support your product and outcomes and yet they can't find the patients in these studies and your lead clinical investigator is kicked out of the Army for falsifying patient records and the signatures of the other investigators. Can you tell me why every study on ACDFs, PLIFs, TLIFs and Posterior Lateral fusions was stopped? You realize that is where your surgeons are using them but it is the patients fault? How about educating your surgeons on your product? That is the companies and reps responsibility and not the patients.

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  111. Nice 8:25! I agree! No Infuse for me. Use Osteocel!

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  112. Stryker will buy medtronic...watch.

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  113. You are an idiot! Osteocel is junk!

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  114. 2:01, your comment is thoughtful, but in this case I would side with the patient as the reason for the re-op was execessive bone displacing/encasing the nerve root. Although nerve roots may be damaged in pseudarthrosis revisions because of scar, the chance of this happening when removing bone is much higher. In addition the time frame of just 8 weeks post initial surgery is telling as to what the root cause is (no pun intended).

    Osteocel, Trinity, Puregen, etc: improperly cleaned allografts/DBMs without a shred of evidence. Stay clear. Can anyone spell "iliac crest cancellous bone" harvested using a trapdoor technique?

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  115. http://www.medcitynews.com/2011/07/infuse-controversy-may-force-a-sale-of-medtronics-spine-business-who-would-buy/

    To keep it simple I'll copy and paste my post from May 25th.

    "Same as it ever was, same as it ever was..."
    Talking Heads
    ______________________________
    Anonymous said...
    10:42

    In a word, No.

    The continual, negative PR is destroying the brand. InFuse is quickly becoming a ruptured nuclear reactor in the MDT Spine Bag.

    Google search InFuse in a couple of days as you might a potential patient after a consult. I'd be guessing between the solicitation for class action lawsuits, cervical deaths, and shot you'll lose virility you might end up doing what most drug companies recommend, 'seek advice from your physician if you are at risk for any of these complications.'

    Yes, this is what happens when you sell a drug like a bone graft.

    May 25, 2011 10:50 AM

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  116. Remember the days....."Sure doc, Infuse will grow some serious bone.....Let me know when your pts grow a tail!" Ever heard of too much of a good thing? Thanks bmp-2.

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  117. 6:18 and others - please note that I did say that it sounds like the complications from BMP "contributed" to the patient's outcome.

    I'm just tired of hearing a "blame" game that seems to repeatedly place all of the credit for failure, or success, in the hands of one particular technology. It's either the patients and the lawyers when the outcomes are bad, or the companies and the media touting their wonderful success stories when the outcomes are good. As we discussed earlier, short of the heart-lung machine, kidney dialysis, vaccines and other such breakthroughs, rarely is any one technology due single handed credit for the outcome of a treatment.

    I am very much a believer that surgeons by and large do what they believe is in the best interests of their patients, and let's not forget that their professional success lies in alignment with the patient's success as well.

    I also know that surgeons may rely on studies and corporate guidance TO BEGIN using a product, but thereafter, especially after gaining substantial experience, they rely much more on their personal experience. The fact that BMP has been used for years now and so strongly integrated into routine clinical practice suggests that it has many merits. And the surgeon obviously chose the product for this patient for those reasons. That adverse events were experienced is very unfortunate, but the blame for the patient's overall outcome lies in some proportion with their condition, their surgeon, and their unfortunate luck as well.

    2:01

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  118. Do fellow bloggers think the Infuse PR trainwreck will make the spine space even more toxic? As if insurance pushback on ddd fusion and price erosion were not enough.

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  119. 9:26 - Yes, it certainly doesn't help.

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  120. 6:18 - ICBG via the 'trap door' technique? WTF is that approach?

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  121. 9:35. Simple. You make 3 cuts, two short full thickness vertical ones from the top down about 2 cm apart and one horizontal beginning in the outer table connecting the distal ends of the two vertical ones to just under the periosteum of the inner table. You than can open the crest much like you use a knife to take the top of a boiled egg. The periosteum acts as the hinge. Now that it is open you curette out the cancellous bone you need, and then close the crest again. This way you reduce complications like hematomas and avoid the notch in the crest that interferes with wearing a belt. There is also less pain.

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  122. 9:26

    Yes. IMO, anyone who thinks this is just bad news for MDT is huffin' paint.

    Think about it, if analysts from Wells Fargo are speculating that MDT might need to sell the division because of the overall liability it represents, tangentially, one can imagine regulators and insurers are not going to be any more interested in loosening the reigns of oversight on the spine/ortho space and subsequent product commercializations.

    In other words, I think this is very big (and not so good) news for all participants.

    My opinion.

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  123. 9:26- yes. This is like 20/20 with pedicle screws, except that this time the uninformed media and ambulance chasers have an ally in a journal editor who is willing to prostitute his academic credentials for the limelight.

    The "Critical Review" paper reads more like a political book rallying the base than a scholarly publication. Being his own editor, did he have to go through a peer-review process to get this published? He should be forced to start a website that discloses his expert witness consulting income and academic appointments when the lawsuits start piling in. Wait until you see this guy show up on cost-control panels, and pulling in the speaking fees at insurance meetings and ambulance chaser conferences.

    This negative press will lead a lot of surgeons to choose less-controversial biologic products for fusions. I can't think of a single one with 1/10th the published scientific data of BMP. If you think we don't know what the true safety profile of BMP is, wait until there is massive use of that slew of unstudied mystery cocktails. What will that lead to?

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  124. 11:40. We still do not know the true safety profile of BMP. It all boils down to the fact that if Danek had been more open and honest about their data, and continued to do some fundamental research, the same side effects would not have caused 1% of the commotion they do now. As it is, Danek reaps what it sowed.

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  125. Not a single adverse event, complication or harmful effect reported by Medtronic related to Infuse in their studies to get the product approved. Can you say wow. This is going to be a field day. I knew I should have gone to a one year law school last year. You could make a great living in this industry suing PODs, Medtronic, Wyeth, FDA etc. So many smart people doing so many stupid things.

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  126. Dear 3:23,

    You mentioned:

    "The surgeons are just as culpable in this as anyone. When something works, they use more of it and the indications become thinner and thinner until the outcomes become too negative to ignore and they always blame the product. Look at BAK, X-Stop, Trans 1, Dynamic rods etc.. Fads are always short lived."

    It appears you were drinking the blue kool-aid again mentioning dynamis rods.For youor sake, I hope your not blaming the doctors for putting FrAgile in a hostile environment. Check the films in your next revision, it is the implant that was failing not the surgeons technique. My have we come a long way from the pedicle screw litigation!

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  127. I have suffered from complications from this product,at (No)time was I given any information or talk from any entity Drs. Nurses Anesthesia Drs.Hospital No I am a layman who can not determine for myself or have a right to even be told any possible complications from this particular part of the surgery that I needed
    according to my Dr.I am not stupid just purposely kept ignorant of what was to used on me during surgery. And I suffered begging for help 3 yrs,as there was problem from the get go.
    And of course as I am an non-deserving patient being that its Workers Comp,I am looked upon like a welfare case,even though I won in court Medical for life to ensure of my care.I was not after money just not given up on after losing ability to work and being determined as disabled.I worked 2 jobs walked up to 5 miles a day.Happy mother and human being. BMP removal had to be done,but Oops its growing were they can not reach,yes it was tried only to cause a puncture and immediate patch and and tap for days.Causing more time in the hospital. And yet the Dr. has not even ordered a CT to make sure he does not accept workers comp anymore.I am
    screwed and I am aware of it.There is so much more to my BMP case and I have for the 1st time in 3 years heard intelligent conversations about what is really going on with a product that no matter what is going to proceed ahead WHY) Money and free handed use with no kind of repercussions except to me. What is a person to do,lay down and shut up or fight this product to be use only with a full on showing of its ugly side.I only want people to have a choice and knowledge to make a decision for there self.I know its not 100 bad and Drs are not 100 bad either,I demand responsibility to inform and disclose to patients who are worthy of not being left in the dark and blamed for this growth of boney formations that are dangerous to my body long term. Thanks for the interaction everyone on here. Pamella

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  129. I was giving infuse during a posterior fusion in 7-'06. I am still under the care of the surgeon who did the surgery. There is no doubt that my general health and spine disease was made much worse. since then my thyroid stopped working, I had cysts on my hip joint and had a THR. The pain in my spine and both legs is a daily issue. Also have severe nerve damage to the bladder. I was not on any pain meds prior and now am on Percocet and oxicontin. With little relief. This is a tragic lesson and many patients are paying the high price with severe pain and nerve damage.

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    1. By the way I was one of those patients who was participating in a 5 year research program. I was to be evaluated in 3mons, 6 mons, and then at one year. And every year for 5 yrs. I never was asked any questions after the 1st year. I often wondered why way back then. I was and still am being followed by the surgeon who performed my surgery with the rhbmp-2. As I already stated my health as well as the spine pain and both legs down to my feet and also bladder is still an on-going nightmare for me. Because of all the issues I have experienced I never looked up the information on Infuse that is now all over the computer. I just thought I was the only one going through all this medical issues. Seems I am not the only one after all. I recently talked to my surgeon about all this and all he shared with me is that he no longer uses it. Which says a lot to me.

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