Wednesday, February 16, 2011

Minsurg: Instant Karma's Gonna Get You

Instant karma's gonna get you, Gonna knock you right on your head
You better get yourself together, Pretty soon you're gonna be dead
What in the world you thinking of, Laughing in the face of love
What on earth you tryin' to do, It's up to you, yeah you.

As recent as December, 2010 Minsurg the company that markets and sells the TruFuse for use in facet fusion surgery sued a number of named defendants who sell competing systems.  Minsurg sought a preliminary injunction against its competitors.  During the evidentiary hearing, Minsurg argued that selling a product that can be used in a "patented method" constituted infringement.  Upon listening to the argument.  Magistrate Judge Jenkins denied the motion.  The decision to deny the motion turned on how important "minimally invasive" was.

Minsurg owns U.S. Patent No. 7,708,761 better known as the "761" patent which protects a method for performing spinal surgery.  The "method" employed insertion of a portal vis-a-vis an MIS opening, accessing the joint space via the portal, insertion of the drill bit, removal of the drill bit, insertion of the dowel or plug, insertion of the tamp, tamping the dowel or plug into place, and removing the tamp.

Legally, Minsurg needed to establish that it was likely to succeed on its merits, would suffer irreparable harm, and the public interest would be best served by granting the injunction.  The major obstacle was that the "761" patent protects a method of performing surgery.  The defendants argued that they were not the surgeons, nor were they performing surgery.  Minisurg claimed that the defendants infringed on the patent, actively induced their customers to practice the method and thereby contributed to the infringement.  The bottom line; to establish an act of direct infringement one must practice the method.  Fortunately for the defendants, they were not performing surgery.

The court did not agree with Minsurg that its competitors induced their customers to infringe on the method.  The court's rationale was that if the surgeons were not utilizing an MIS approach for implantation, and that the implantation of the competitors implants was via an open incision, the competitors were not infringing upon the patented method.  In addition to the court's rationale, the onus was on Minsurg to prove that surgeons that had implanted competitors products had utilized an MIS approach, and since Minsurg had no evidence, they had no argument.  In the end, it was much wasted capital and all to do about nothing.  You know what the great John Lennon sang;

We all shine on, like the moon, and the stars and the sun,  Well we all shine on,  Come on and on and on and on..........


  1. Welcome to the jungle
    We got fun 'n' games
    We got everything you want
    Honey we know the names
    We are the people that can find
    Whatever you may need
    If you got the money honey
    We got your disease


  2. Jungle Welcome to Jungle....................

  3. Welcome to the jungle
    Feel my, my, my serpentine

    --Eminent Spine, Bad to the Boner

  4. Funny how Minsurg's former VP of Sales now works for a competitor he repeatedly called douchebags. I wonder what that makes him?

    Hope everyone enjoyed their Porsche trip!

  5. The company(ies) that were dropped from the suit because they 'may have' made a deal must feel pretty silly right now... Just par for the course for those legal teams though. Burple Power.

  6. Another product that was STOLEN from a respectable surgeon whose novel concept fell into the hands of unscrupulous, narcissistic,money-grubbing people with little or no intelligence to come up with their own products. It's apparently not criminal but the ethical behavior is absolutely shameful!!! And yes, KARMA WILL PREVAIL!!! Just like Frazier went down so too will the cheaters and thieves like KH and NuFuse.. ..or is it Nufix now due to the name similarity and obvious bastardization of the product when it was NuFuse?

  7. When they've tortured and scared you for twenty odd years
    Then they expect you to pick a career
    When you can't really function you're so full of fear
    A working class hero is something to be
    A working class hero is something to be

  8. Is not Bacterin's product now called OsteoLOK..after two or three suits against them?

  9. Shame on Minsurg, or should I say 'sham' developed by Minsurg. Karma's a bi^&h.

  10. 9:33 I am not a Sales Rep and not a surgeon. Rather I invested my family's hard earned savings in Trufuse. Can't tell you the last time they gave updates to shareholders. In your opinion, how screwed are we?

  11. Good luck with that one. The minsurg product can and does migrate posteriorly. I haven't seen a case in my area for 8-9 months.

  12. I've been a distributor for three of these type of products. None of them successfully fixed, locked, or fused the facet joints as they were promoted. What many don't seem to realize is that anything inserted into the facet joint when the patient is lying on a table will feel like it adds stability. But, when the patient stands up, it's a whole different ballgame. It's more like snap, crackle and then pop at that point.

    It was a great concept if it actually worked and had some clinical evidence to support it.

    Easy come, easy go and there's always another day!

  13. I have been selling the most biomechanical implant of the facet implants (bone based) for the past 2 years and have only had 1 case that I know of back out posteriorly. On the post op films I am not convinced the implant was ever in the joint but regardless. I don't have the data but I havent seen the above posters results in my area.

  14. 5:35 PM

    The most biomechanical implant? Please, let us all know what such biomechanical marvel exists.

    Having an engineering background, autograft and allograft implants have been used in the spine for decades, and primarily as spacers between the vertebral bodies. Most usage is in conjunction with a plate or screw system to provide support and load the graft properly to promote arthrodesis. However, the use of a graft of any shape or size to solely pin, lock or fixate a joint of the spine is not well documented.

    First and foremost, the facet joints operate in a multidirectional fashion. A graft, of any shape or size, would simply erode faster than arthrodesis would occur, thus causing the graft to loosen and migrate. This is the problem that the various companies selling these devices face and it does not matter if the graft has barbs, ridges, fenestrations or is larger than the original hole created for it.

    Even if this type of implant were to remain in the joint, it is highly unlikely that arthrodesis would be the outcome or that the graft would ever incorporate.

    Studies of both autograft and allograft bone properties are numerous. Cortical allograft incorporation is the slowest and least complete in incorporation. As much as 50% to 90% of the graft is composed of necrotic bone at 5 years after transplant. Enneking and Mindell have studied the histologic incorporation of such grafts. An external bridging callus is formed slowly at the donor-host cortical to cortical junction. An internal bridging callus is formed at a more rapid pace at the donor-host cancellous to cancellous junction. Each callus only superficially penetrates the graft.

    Being an engineer in spine, we sometimes think that if the product works in testing that it will also work just fine when adapted to surgery. I will admit that is not always true and I believe that is the case with these facet fusion implants. One can perform all of the biomechanical testing necessary, but the only test that counts is the one in the real world with patients. I have not found one single company in this area that has documented clinical results that are peer-reviewed. What I have found is companies exhibiting incorrect biomechanical data, Oswestry Disability Index studies and retrospective studies that do not prove that their devices actually have an outcome of arthrodesis. Where are the computed tomography images to prove arthrodesis?

    The Oswestry Disability Index and retrospective studies are a joke! Anyone in this area should know that when a burr, drill bit or punch is inserted into the facet joint to create a hole for these devices, a nerve root ablation occurs. So, the pain generator has been eliminated and the patient thinks they are better. But, if the outcome does not result in an arthrodesis, then the procedure has actually served to destabilize the joint even more than prior to the procedure.

    Now, from what I have heard, there are a few companies that are marketing their products to pain management specialists. Of course, the pain management specialists would jump all over an opportunity to code for an arthrodesis. I do not know what it pays the doctor and the facility, but I would bet that it is pretty good. It is a shame that it’s not about the patient any longer, instead it’s about reimbursement. Surgeons and companies have chosen to just overlook a failing device and just move the patient to the next stage of treatment.

    So, again, what is the biomechanical marvel you are talking about? My bet is that you have just been led to the bar and chose to drink the Kool-Aid. You even admit in your posting that you don't have any data.

    Look beyond the coding and think of the patients. Try some humble pie and a Samuel Adams, it may just taste better in the end.

    1. What do you think of the biomechanics and probable outcome of placing a PEEK cage into a disc space as an adjunct to a microdiscectomy. No other secondary stabilization.

  15. It's the reason some butchers, I mean surgeons like to use these products because they can bill for a fusion. Otherwise, 7:26 is correct, these dowels rarely if ever incorporate, so another gimmick that surgeons get paid for using by the people that run these sham operations. Actually let me apologize to the butchers, they probably have more integrity than some of these surgeons.

  16. Did the VP really call Bacterin douchebags???

  17. Excellent post 7:26! Quite succinct and informative. I wish this post would be moved back to the top of the blog because I don't think we have heard the last on this important topic. Obviously, there are some issues with Facet allograft implants and I think the industry needs to vet it out! If indeed the grafting procedure is a sham, then we need to expose it for what it is so that the 3 companies that are trying to kill each other will just go away... ..or find a new Sham Wow to market!

  18. 8:27 AM

    It's more than just three products involved in this litigation. Just to name them, they are as follows:


    As far as I know, none of the companies that are associated with the above products have distributed any peer-reviewed studies that clearly state that they work.

  19. Do pedicle screws fuse by itself? How about PLIF/TLIF/ALIF spacers? Why would someone think a facet spacer would fuse on its own? Pedicle screws and spacers are designed to provide stabilization. Autograft or biologics provide the source for fusion.

    When a surgeon preforms a PLIF/TLIF/ALIF do they implant pedicle screws and a spacer and stop. Of course not because the patient will not fuse. Fusion requires the proper surgical technique and autograft or a biologic.

    I watched surgeons for 20 years take a drill and burr down the facets and pack them with local bone and they fuse. Over the past few years I’ve watched surgeons insert a facet dowel for stabilization and a biologic posterior laterally for a fusion.

    Not everyone in spine is a crook and not everyone doing this proceedure is doing it for the money.

    I do have a problem with PM and IR doing this proceedure and calling it a fusion if all they did was drill a hole and insert a dowel.

  20. 8:02

    I agree with only some of what you are saying. It is true that surgeons have been burring the inner articular surfaces of the facet joints and placing local bone in them for years to create a fusion. And yes, it has worked quite successfully. However, since that is true, then why the need to place a bone dowel in the each joint? Bone dowels that are priced at $3,500 or more for two, but probably only cost a couple of hundred dollars to manufacture. Instead, the surgeons should just continue to use a burr, pack in some autograft and thus save the hospitals thousands of dollars for this procedure. There is no medical necessity to place a bone dowel, as many insurers have already identified that in many reimbursement bulletins that have been sent out over the past year.

    Again, there is no sufficiant amount of clinical evidence that has been exhibited stating it's better over traditional methods of facet fusion. I mean, the forces of moving joints, etc have been documented to break even pedicle screws and rods. But, now we're all supposed to believe that a bone dowel is going to stop those forces?

    And yes, not everyone is a crook, but at the same time the focus has become more about reimbursement and driving facility dollars than it is about the patients undergoing these procedures. So, essentially pateints are the ones getting robbed here.

  21. Isn't Ron Popiel trying to buy these companies? This aquisition would mesh well with his Showtime Rotisserie, GLH, Chop-o-Matic, Electric Food Dehydrator and Pocket Fisherman products! He could cook some chicken, spray his bald spot, catch a fish and all while getting a fake, I mean facet, fusion.

  22. And don't forget Dan Aykroyd's famous Bass-0-matic

  23. It's funny (Not Really). I read all the negative comments posted but have many patients that have received the desired and planned results from the trufuse facet fusion. The paients are very happy with their results. I use a biologic with it. Patients get a bone growth stimulator to help the process.

  24. It has a place. Use the bone dowel as an adjunt with your metal when a facet is left in tact. Been doing it the same way since it came out a few years ago. It'll add a fusion area and decrease the % of patients needing spinal stimulator. No downfall. I also always use grafton paste with it.

  25. To 8:02,
    The dowel is not to replace screws when screws are needed. They are used as stand alone for mechanical back pain such as dfd, also used with hemi-lami decompression on older patients to help add stability and decrease the percent of patients that will need a larger procedure a year later. These are "minor instailities", not gross instabilities that require rods/screws/interbodies.

  26. Here's where I think the rubber meets the road. Surgeons could just use a burr to make a hole between the facets and then tamp a cortical allograft matchstick into the hole, then place their patient in a lumbar brace to achieve the same results. The bone dowels, no matter from which company, are cortical in nature. So, there's nothing special about them at all. Don't give me this, 'well, it's a precision milled graft' as justification for the costs of the dowels.

    I think their cost, along with no clear clinical evidence that they work, is what has raised concerns in the medical community. And clearly, the use of these bones dowels with pedicle screws is just adding more cost to a procedure and, not to mention, not medically necessary.

    These bone dowels, in the end, just end up in the gutter (lateral gutters) when they migrate and serve no purpose but to increase the income of those using them.

    Has Jim Jones been reincarnated or something? It seems that a lot of people are drinking too much KoolAid on this one!

  27. 12:36

    Great point. Cortical bone is never going to create a fusion or incorporate rapidly. In fact, it seems like the surgeon should just burr up the facet joints and then take some local autograft and stuff it in the burr holes. Brace the patient for 6 weeks and I believe there would be a better outcome.

    From my understanding, some of these companies are getting upwards of $5,000 for a pair of cortical dowels.

    Wow, I could buy cervical and lumbar grafts for a lot less then two small dowels.

  28. Hey 5:35 and 7:26,

    This just shows that you don’t know anything about allograft at all or even what you are selling. You refer to it as an implant, when allograft is not an implant at all. Never was and never will be. Allograft may be ‘implanted’ (used as a verb), but never is an implant (used as a noun). Allograft by definition is a transplant tissue, not a surgical implant. This is true of any bone dowel or plug on the market today for facet fusion, as they are simply donor tissue used for transplantation.

    A surgical implant by definition is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Medical implants are man-made devices, in contrast to a transplant, which is a transplanted biomedical tissue.

    Just to prove my point further, I did a random search on Google Images with the search term ‘surgical implants’ and then reviewed the findings. Not one image was of allograft tissue, especially human bone. Instead, every image of a surgical implant was of devices constructed from man-made materials. Allograft, although it is retrieved, processed and then distributed, is not a man-made material.

    7:26, you claim to have an engineering background so you should know better than to refer to allograft as an implant. Most surgical implants have to undergo a FDA 510K prior to approval. However, allograft has an exemption from FDA testing requirements under a 510K and is instead regulated under Section 361 of the Public Health Safety Act (42 USC Section 361).

    5:35, you are selling transplanted tissue, not surgical implants. Please, on behalf of all the millions of donors out there, respect the tissue they have donated by referencing it correctly. No matter what the donated tissue is, those donors have given so that the transplant recipients may hopefully have a better caliber of life.

  29. You're right, it is tissue and not an implant at all. So, does than mean that all manufacturers and distributors of these facet fusion allograft bone plugs have to be properly registered with the FDA's CBER Division? I would think so, but I know a few of the distributors that are associated with these companies and searched to see if they were registered as a distributor of tissue and they were not.

    Since these grafts are tissue, then how are they affected by temperature, since some reps probably carry 'trunk stock' of these products?

  30. Having watched this space for almost two years now, I am now starting to see the end may be near for the companies marketing these products. I would have thought by now that at least one company in this space would have collected and disseminated some real clinical data, but much to my dismay they have not.

    Instead, what I see each week, when I perform a search on Google, etc, is that more and more insurers are simply stating that are not paying for these procedures any longer because they consider them not medically necessary or investigational. For instance, just take a look at the following links:

    And if that’s not enough, the AANS has even issued a statement. The AANS, in its Technical Assessments, goes so far as to say, “Marketing has been primarily aimed at non-surgeons in outpatient pain clinic settings. There is no published data to assess safety, efficacy, or outcomes. There is no relevant biomechanical data available to use as a comparison to currently performed spinal fusion procedures. Manufacturer sponsored literature is very limited in number, scope and follow-up. In conclusion there is insufficient objective information to evaluate the safety and utility of this device or to make recommendations regarding clinical usage”.

    Now, what I have heard from a few sales reps is that some of the companies marketing these products want them to tell their surgeons to code the procedure as a posterior or posterior lateral fusion in order to get them paid. As all of us know, that have been in the spine market for some time, posterior lateral fusions are done by overlaying graft material in the lateral gutters or over the transverse processes after proper decortication. In fact, studies show great success from this method. But, wait a minute, now one has to have the addition of a bone dowel in the facet joint in order to insure it’s a fusion? Give me a break.

    I think, somewhere else in this blog, it says that the estimated cost of a pair of these bone dowels is between $3K and $5K to a facility. If they get coded as a DRG 460 at the facility level, that means the facility gets over $20K from Medicare for two small bone dowels that probably cost no more than $500 a pair to manufacture. Unreal when you think that some facilities have capitated pricing in place allowing only $3K for a one-level construct with pedicle screws and rods. And, not to mention, there are numerous biomechanical studies on pedicle screws that show they, in fact, work.

    I guarantee that insurers saw a drastic spike in the number of posterior fusion procedures and that is what has caused them to make changes to their policies. Those changes are trying to limit spine fusion procedures, again probably because of all these hocus pocus magical bone dowels, and that could cause those patients who really are in need of spine fusion to be denied of the opportunity.

    To me, all this sounds like a bunch of marketing puffery and biomechanical bullshit. When is the madness going to stop?

  31. Did anyone ever meet that bleeding lip hill-billy that knows nothing about his companies facet product at one of the spine shows? Wow. I will never touch that product or it's procedure. Educate, educate, educate!!

  32. I've suffered from facet joint locking for years now, and have been researching facet dowels to fix my problem. After reading all the posts, I feel very discouraged, as I'm not a candidate for fusion, and facet blocks and rhizotomies haven't worked for me. What is on the horizon for people like me, who suffer from facet arthropathy, and need a minimally invasive stabilization procedure?

  33. August 19 -
    You could do facet screws. Lots of MIS/Percutaneous systems out there.
    Maybe de-corticate and add a little allograft too-
    Good Luck!

  34. LOL. I cannot believe i decided to look up what is going on with this "has-been" product. But I did. That is such a true comment on the overweight, hillbilly, bleeding lip guy that works/worked for them. I saw him at a few of the trade shows over the years and he ALWAYS had bleeding lips. I also stood there while listening to him and he really didn't know what he was talking about, at all. My surgeon and i laughed and walked away. A few of the companies have idiots like that at their booths. Never understood that.