Osseointegration, Misinformation and Cover-up Exposure

[Mark Lesek]

Osseointegration, Misinformation and Cover-up Exposure

Further to my previous blog I have thought long and hard and researched the perceived attitude by the US medical and prosthetics industry. Looking at facts on the internet (public domain) and my insight and patient knowledge of the program something did not add up. Was there a good reason why osseointergration has not had a fair debate in the US? Either misinformation, creating fear of infection, or no information , example: Tonya Murray’s response to my last blog, (she had never heard of this treatment).

It turns out the US have been working on this all along. The VA through the University of UTAH http://utah.technologypublisher.com/technology/3452 have done research and clinical trials on osseointergration and lodged provisional patents. Up till now there has been no human implants performed, only an anonymous free thinking American who challenged the US medical culture by travelling to Sweden with financial sacrifices, who is now enjoying new function and quality of life.

The US program has two provisional patents in place with slightly changed protocol using electro therapy to supposedly aid integration. It will only be a short time before there will be a high demand and this treatment will be sanctioned by the FDA and the VA so hundreds of American servicemen who have lost limbs in combat will benefit from new function. Currently there are three systems in the world for orthopaedic osseointergration, the true pioneers the Swedish and followed by German company Esska, (legs only) also the English have their own system based on a deer antler anatomy to grow skin onto metal. (Intraosseous Transcutaneous Integration)

I believe after my own careful research the Swedish option is the best and has the most successful outcome to date. The original is the best.

All this technology has intellectual property attached. My argument being essentially patriotism and resenting some other country being ahead of the US is the cause of blocking of FDA approvals. This way the US medical system has full control without being dependant on foreign countries. Professor Roy D Bloebaum of the University of Utah, is heading the research in the US. This doctor has spent and received qualifications in Australia but has been pipped at the post by the Australians at the Alfred Hospital in Melbourne in collaboration with the Swedish, the Australians seeing the advantage of the synergistic relationship between the two countries.

My prediction is that after the intellectual property is finalised and some brave American steps forward this will quickly go from a risky experimental surgery to as American as apple pie in a very short time but also with a short memory about the previous criticism of foreign treatments. Suddenly this will be fashionable because Americans have changed the protocols and claim it is their own invention. The FDA has been blocking the diplomatic and ethical Swedish approaches for years which is a travesty, considering the war amputee veterans and their lost function.

In conclusion osseointegration in the US is inevitable soon depending on internal medical politics and attitudes to foreign technologies.

[Mark Lesek]

I am one of  these people Osseointegration is the answer.I was told the same thing about my prosthetic arm. This was the only thing that got me wearing an arm again. Amputees at my level normally always give up.  http://www.heraldsun.com.au...

/news/victoria/yes-we-can-rebuild-you-bill-langenhorst/story-e6frf7kx-1225904695360?sv=f7f51ce34816405e9f035d27e073c37e

  This chap in Australia got his function back and walking again when he was told he was too short for a prosthetic leg.  Human trials start soon in SLC Utah.  http://osseointeg.ning.com/

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Yes, we can rebuild you, Bill Langenhorst

www.heraldsun.com.au

HE never thought he would walk again, let alone stand up to have a beer. But revolutionary treatment has this 50-year-old on the move.

[Mark Lesek]

This was written 2 1/2 years ago and has proven to be absolutely correct, well done USA.  You have your first titanium medal.  Osseointegration is now as American as apple pie!   Corporate USA has a finger in the American Pie. Congratulations to the team in SLC this is one of the biggest advances in Amputee history.  It will change amputees life and function for the better.  I am living proof of this. 

[Mark Lesek]

Finally success. I have been lobbying for this for 5 years .I have been to SLC Utah and have met these people and called them Monday Morning Quarterbacks. IT WORKED. I partly shamed  them into this but also set a example and role model that this treatment works .The USA, welcome to the Titanium Club, you have some catching up to do now to the rest of the World in relation to this treatment . Congratulations from Mark Lesek, the trickiest but most successful Osseointegrated amputee in the World.http://www.techventures.utah.edu/news/2012/07/u-researchers-develop...

http://www.oandp.com/articles/NEWS_2012-07-26_05.asp

[Mark Lesek]

Thank you Carol for liking this.I am sure Ossointegration will get you walking again.

[Jon Kuniholm]

Carol - you can contact Integrum through the contact info at the bottom of this page: http://www.integrum.se/ As I'm sure you're aware if you've read through the discussion on this page, OI remains an experimental procedure with promising results, a very high expense (nearly $100,000), and a very high level of complication relative to other elective procedures (10 to 20% vice 0.05%). The complications can include the loss of joints not involved in the amputation, so has the potential to leave you less capable than before the complications. While the amount of activity on OPP by proponents of the procedure could lead you to a different conclusion, there is no endorsement of OI by the Open Prosthetics Project. We are an educational forum and pride ourselves on a spirited discussion of these issues based in fact. Please make sure that you are well informed before you consider any elective surgery.

[Carol Millar]

Please give me contact details for doctors in Sweden.  I am keen to have osseointegration for my right leg. Carol

[Wolf Schweitzer]

http://www.eska-implants.de/cms/upload/info/artikel-handicap-2-2005... ESKA Implants Article: Rather sobering but far more realistic information. Only medium length to long stumps (the ones that also can be set up with sockets) are biomechanically allowed to get osseointegrated; very short bone stumps (where sockets are a real problem) are not (!) suggested to get osseointegration due to risk of fracture. For people with diabetes, Osseointegration is contraindicated. German health insurance examines submissions on case by case basis and seems to be very reluctant - resulting in patients paying themselves. Hygiene and body care and cleaning are a top priority for the patients. Gauze wraps of the metal implant site are to be changed several times a day. Tanning and regular showering of your body are advised - but bathing in obscure pools or lakes, or exhaustive hikes are specifically discouraged. - - As I told you already a few times now, that osseointegration is not adding degrees of freedom but reducing them. If you believe otherwise you simply have not read the right type of instructions. Now you are really happy to join us in our outdoor pool season all next summer but I am afraid that even healthy people get regular, often and cumbersome fungal-bacterial infections there. Now, I can afford that - in the worst case I get an itchy ear canal. You on the other hand will live in permanent fear of infection. - Other than that, osseointegration does not seem to solve problems that sockets cannot solve.

[Jon Kuniholm]

Am I going to have to pull over until the two of you behave?

[Jon Kuniholm]

They are accurate (according to currently published data), and yes, I'm saying that to some extent,
because included in that 10 to 20 are those who could be, in the long run, denied the performance of their elbows, knees, shoulders, and, in the extreme, their lives.

I believe that there is a Humanitarian Device Exemption (HDE) in the US, so they're not completely denied access. To the extent that anyone is currently denied access, the lack of FDA approval is an indication that the procedure still has significant risks that continue to be dealt with in research. FDA approval to market the procedure as mainstream and with managed risk will most assuredly come when these things are in fact true.

As I've stated before, I think that osseointegration is a promising procedure, and may, in the long term, be a viable one for many patients. At this point, however, despite the benefits, it must be compared to other elective procedures with much lower complication rates, like ACL knee surgery, or lasik or other eye surgery. These complication rates are orders of magnitude lower, less than a half of a per cent.

The more that this discussion remains rooted in fact rather than hyperbole and rhetoric the better.

Please check out the academic literature here, and add to it if you have references that contribute to the dialog:
http://www.mendeley.com/research-papers/collections/1182231/Limb-Os...

[Jon Kuniholm]

10 to 20 per cent failure rates are experimental.