Monday, September 10, 2012

Mild v. Not So Mild or Vertos v. Dr. Fourney

Spine Nation:

If you haven't had the opportunity to read the article by Barry Meier from the NY Times on September 5th, 2012 entitled, "A Clash Over a Spine Treatment," please do take the time.   The article pits Vertos against Dr. Daryl F. Fourney who was a lead researcher in a clinical trial involving the "Mild" Device Kit for relief of spinal stenosis.  It seems the good doctor had an agreement with Vertos to report how his patients had responded to six month post-op treatment involving a decompression procedure of the spine using the Vertos "Mild."

This trial began with promising result, whereby patients showed signs of improvement. But then, Dr. Fourney's patients began complaining about experiencing pain, so severe as stated in the article, that the patients needed to undergo the type of back surgery that they were looking to avoid in the first place.  The essence of this article is providing the public with insight into the contentious world of testing or accumulating data, and the rules that allow companies to market products with little or no data proving the product or procedures long-term effectiveness.  Dr. Fourney may be one of those unusual physicians, he is an outlier in an industry that is blinded by profits over patient care.  It has become apparent that Dr. Fourney may have cared more about the long-term effect that this procedures net for his patients, rather than short-term results that can skew the data. Based on the content of the article, Fourney was compelled to notify Vertos that his report would describe the problems that his patients were experiencing after the six month trial. Vertos' response? The company filed a complaint against Dr. Fourney with the University of Saskatchewan accusing Fourney of scientific misconduct and violating "research ethics," by failing to follow the study's "original protocol" and by "independently" deciding to follow "his" patients for added time without seeking agreement from Vertos. Granted, the public does not have access to the language in the contract between Dr. Fourney and Vertos, but this brings up legal, ethical and moral issues in medicine and research.  Regardless of his participation in this study, the question must be asked, does a corporation have the legal right to dictate to a physician, let alone attempt to intimidate him when it comes to the safety and efficacy of a trial that involves his patients? Is Vertos making the legal claim that since Dr. Foruney was involved in their study, Vertos had legal right to control the outcomes of the  study, and anything less than what they were looking to achieve was unacceptable? Is Vertos response out of line when the company has gone to great lengths to undermine Fourney's reputation with the University? What does it say about the ethics and ulterior motives of Vertos? Could this be a case of look at whom is calling the kettle black? Isn't the surgeon held legally accountable for the safety and outcomes of his patients, regardless of the criteria set in any study? Based on the Citizens United decision, if corporations are people, is Vertos behaving in an ethical, if not amoral manner? Was the intent of the Study to accumulate data as quickly as possible to push this product through for approval and generate revenue in order to appease the investors?   

The "Mild" is a single use disposable instrument kit that is suppose to provide relief for patients with spinal stenosis consisting of seven surgical instruments.  The use of these instruments allows surgeons to use an minimally invasive approach to resect the lamina and remove portions of the thickened ligamentum flavum. Vertos claims that there have been over 10,000 procedures performed and insists that the procedure is safe and effective. But isn't there a difference between claiming that the procedure is safe versus whether the patients receive long-term relief? Is this a short-term panacea, a band-aid remedy or does this place closure on the affected patient? And then there are the other physicians in the study. Who are they? Are they paid consultants?  Do they have personal skin in this venture?  Those in the industry know that any study can be skewed or controlled to net the results appropriate for submission. In 2010 a Dr. Chopko published a short-term report on 75 patients, unfortunately, 30 of these patients have not been followed up because the investigator lost contact with them. Even though this happens in many studies, if Vertos and Chopka wanted to nullify Fourney's findings why not find these other patients to assess their long-term results? Publish the data. Why wouldn't Vertos want to assist Dr. Chopko to identify these patients to nullify Dr. Fourney's own personal results?

If Dr. Fourney has no other personal interests in a competitve product, why is Vertos behaving in this manner? Many questions can be asked to substantiate Vertos' complaint against Fourney. Patient profiling plays an integral role in the success and failure of any study.  Yet, is Dr. Fourney the cause of this debate, or is Vertos the culprit? If the study's protocol was poorly defined, is Vertos now attempting to cover its tracks? And then there is the CEO of Vertos, James Corbett, whom accuses Dr. Fourney of  a "gross misrepresentation of the facts," filing a formal complaint against Dr. Fourney with the University. Obviously Mr. Corbett comes from the school of thought that you can get more accomplished with a flame thrower than honey. The NY Times reports that in an interview, Corbett claims that he is not looking to suppress Fourney's study, he is only interested in making it accurate. As the C+C Music Factory use to say, "Say What?" The the question must be asked of Mr. Corbett, why the guerilla tactics? Could there have been flaws in Dr. Founey's methodology?  Possibly. Based on Dr. Chopko's letter to The Journal of Neurosurgery, he challenges Fourney's methodology.  Unfortunately, Dr. Chopko had a Rudy Giuliani moment and failed to disclose his ties to Vertos claiming "clerical error." Hasn't this become the defense of choice in most of these scenarios? Haven't we learned anything yet?

So in closing one has to ask the proverbial question, is this a case of double standards or not, TSB wants to know what you think?

126 comments:

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

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  2. What is strange is here we have anaesthesiologists doing this procedure. I asked one what training he had and his replied, well I am trained to do spinals and epidurals.

    I guess if dermatologists can do face lifts..well anything can go.

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    1. anesthesiology pain physicians are the most qualified to do this procedure.

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  3. Just watched the Mild video on their website. I think there are a lot of problems with this technique. I wouldn't go so far as to call it a Shaminectomy but it is very close, maybe S-haminectomy. Good for the doc for sticking up for his patients. (I just hope we don't find out he got turned down for a consulting gig or royalties from Vertos)

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  4. Chopko cannot find 30 of his 75 patients he published a rave short term review on and than claims good results post 6 months. Try to explain that to the FDA and the insurance companies. So even if the remaining 45 are successes (really?), his worst case scenario success rate is 60%.

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  5. White Coat Sociopaths vs Spinal Industry CEO Sociopaths

    Reminds me of those 1950s SyFy B movies where two gigantic monsters from the deep fight each other to their mutual deaths. Let's hope their mutual destruction finally sheds light on the real problem - the thoroughly corrupt clinical trial Class III IDE process that has destroyed more spines under the pretext of innovation. The spine industry and its investigator surgeons are circa 1950 monsters that neither justify their own existence by providing surgical solutions to spinal injuries which 9 times out of 10 are best left to be resolved with conservative treatment or even care if their clinical studies produce the safety and efficacy objectives. To these monsters, the fun is in the fight to the death of whoever is gaining the upper hand or leading edge in this industry. Orthopedic surgeons have sold out to the industry and now the surgeons are trying to show some independence (window dressing) un til their consulting fees checks clear. Both are useless old monsters that are becoming laughable because of the archaic devices they are trying to push on the market that the more intelligent, less greedy surgeons refuse to use for fear of destroying a patients spine.

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    1. A liitle direct maybe, but you did manage to capture the essence of the industry.

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    2. There is nothing subtle about a spine destroyed by junk spine science!

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    3. Go blog on MH and leave us alone!

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    4. Adolf - you remind me of someone historical who I just can't seem to put my finger on. But let me rephrase my last comment for sake of clarity: There in nothing subtlebabout the excruciating spinal pain after ones cervical and lumbar spines have been utterly destroyed bu junk spine science - imagine that experts in spinal kinematics never factored in the high probability of metal on metal spinal implants causing hetero-topic ossification, cobalt, chromium, nickel, titanium poisoning that pretty much destroys the first, the gastrointestinal tract (enzymatic destruction), then destroys the kidneys, liver, heart and lungs, eventually shutting down the organs due to systemic blood poisoning after leaving the hospital with a HAI due to non sterile reusable instrumentation surgical tools that are used over and over again on implant patients. This is just the tip of the metal on metal spinal junk science. Kiss kiss

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    6. Philemon, you learned some big word on MH. Too bad you can't use them in context.

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  6. In all honesty, how many other senior managers equal the level of douchebagolatry as Corbett and Enxing? Is there anyone inside the company, who came there excited to rep a disruptive technology and make oodles of cash who has a good word to say about either of these clowns?

    I can tell you the article has caused their top reps to head for the lifeboats, including their #1 money maker, who's name Ill keep anonymous, suffice to say it is eerily similar to an Orange-roofed hotel chain from the good old days of Americana.

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  7. This procedure is a total bandaid. They first marketed to spine surgeons. Surgeons pushed back and figured they would keep doing an MIS decompression and get better results without causing much more blood loss, etc. So, the company started marketing to interventional pain physicians. I worked with pain physicians for about 5 years before getting into spine...they are not surgeons. Also, I can't believe they bill for a laminectomy for the MILD procedure. Last, this has lead some pain doctors in my area to performing other decompressions and even facet screw cases and billing fusion in surgery centers! I appreciate developing new technologies and pushing the envelop, but make sure it works before falsifying data.

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  8. Enough already. I can't take it any longer. When will these "researchers" who fabricate data go to prison? We hear time after time the BS that goes on about fabricated results and only to hear that the researches are publicly humiliated as their only punishment. What the spine world needs is a conviction, jail time, loss of medical license. Once that occurs the BS data will cease.

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  9. And I was taught in school that peer reviewed research was, "science" and not BS propaganda. Wow! I must be getting old, I feel so enlightened.

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    1. Nada a one! Blame that on the big five. They support outrageous user fees charged by FDA to file - this way if an innovative product is being developed that shows promise, they will have few options to get it thru FDA process. Either they send in the lawyers with a brief case filled with Rusky Red money that needs to be laundered or they have to go hat in hand to the big guys in the hope that the big guy is in the mood to gamble on launching new product. Then the big guy sends in his attorneys with the black brief case filled with "toads". This is why we call these guys "toadies". They have the brief case filled with green back toadies.

      The first requirement for admission into the Billionaire Club is that you have got to swear that you hate humanity and worship gold. And that you have gotten your official sociopath bones by turning a blind eye to the mass suffering or deaths caused by your product and you have personally handed an official a manila envelop filled with cash during a back room negotiation.

      If you feel that you can get away with murder or say with an arrogant snear that everyone has their price, including Job - you are one of "them" who believes that the ends justifies the means and as one of them, totally untouchable. Sad, but humanity actually fears but reveres these sociopath personalities. And for some unfathomable reason allows them to get away with playing god with our health care. Whether it is lack of education on how to recognize when a corporation - CEO BoD has turned into a fascistic machine without a consience or that as an ordinary peron who do not possess skyscraper ambitions to control the lives and fates of millions you cannot fathom how those in power can lie, cheat and deceive resulting in damaging others quality of life - the answer is we were never taught how to recognize "evil" in a human being as a personality trait. We are taught that evil is outside of us - as in demons and Satan. We were lied to by our trusted institutions - so that when we come face to face with the working of evil - like how we are seeing that these huge corporations exist to capitalize on our pain and suffering, instead of following the call to "relieve suffering and heal where we can, knowing our limitations" - we see that evil is a living organism that becomes a necessity - a financial necessity for the entire cycle of pain suffering surgery implants and all of the numerous gears that are set in motion the minute a patient signs a consent form.

      This is why we tolerate "evil" and corruption in the medical field - because the second a person has a spontaneous healing or is healed naturally the entire corporate medical sham is exposed for what it is - just another necessary evil like war. Mercenary medicine breeds mercenary medical pushers - known as snake oil salesmen. Granted, there are many millions who need medical attention but not at the price we are all paying in this era of becoming Guinea pigs for the financial security of stockholders and corporate hospitalization. And the sick remain sicker while the rich get richer.




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    3. WELL SAID !!!!!

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  11. Thank you for giving information on spine surgery.It is really good and helpful for the people.Keep giving such a valuable information.I will wait for your next post.
    Regards:spine surgery in india

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  12. Jerry "The King" Lawler is going to be ok. Finally some good news!

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  13. An appeals court just completely reversed the $60M ruling against NuVasive handed down in October of 2010 for alleged infringement on the NeuroVision trademark. All penalties have been lifted, and a new trial has been ordered.

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  14. I have seen many contracts used to enroll surgeons in trials or evaluations. They all state that the company maintains 100% control of the data, and IF it is ever released. The public should know to scrutinize the positive literature carefully, and also to look hard at what is NOT being claimed. You know what the manufacturers want to say, and if they don’t say it, well you know that little part of the study just didn’t work out so well.

    Unfortunately we all need to be very skeptical consumers of health care. As for us inside the industry: if you make a dime off of a technology, and you would not be willing put your product into your own back, then don’t make any excuses to yourself about what is hypocrisy.

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    1. A company by definition cannot the owner of patients' data, and cannot block a surgeon from publishing results of work he has done provided he has got the necessary HIPPA clearance from his patients.

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  15. Will real surgeons come to the aid of pain specialists if they get a duralumin tear, nerve injury, infection ,or infection. I won't. these guys are only pushing the envelope to ripp off the public and patients. NASS should take a stand but it is owned now by non-surgeons. Pain management is a worse problem than surgery by a long shot. This should be seen as insurance fraud if they use a laminectomy code!!!
    N

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  16. BB - Fairly soon these huge device corporations will be getting their asses handed back to them after the product liability attorneys clean their clocks. The two monsters are now seriously wounded - with claims being filed in the hundreds on a daily basis.

    Stryker is wide open and vulnerable with two hip implants and two spine implants using the metal on metal cancer causing design.
    http://www.benthamscience.com/open/rptcs/articles/V002/40RPTCS.pdf
    http://www.fiercemedicaldevices.com/press-releases/seven-more-plaintiffs-sue-stryker-over-defective-hip-implant-devices?utm_medium=nl&utm_source=internal

    I am reading articles that are saying the pay out will top 800 Billion - and this is tipmof iceberg. Now is the time to call for a complete house cleaning inside the Device Evaluation Division over at the FDA. The whistle blower scientist nailed it and now millions of patients are permanently damaged due to FDA turning blind eye to this strategic corporate biomedical genocide for profit

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    2. 4:13PM is the light and truth so hard to take that you need to wish evil on another who speaks from experience.

      I Do have a metal on metal device implanted at C5C6. The device company and the surgeon never once disclosed to me that there was nickel in the unapproved and unauthorized artificial disc. By the way, it was illegally implanted in my spine months after the FDA order the study to the black lock box for being in violation of quality system control - as in contaminated with known and unknown pathogens.

      I have been suffering with this since 2008 and have: Tumors at disc site, necrotic bone and soft tissue, Oppl, osteolysis, metallosis from nickel and cobalt chromium poisoning, gastrointestinal problems and diabetes. Before the surgery I never had any of these medical issues, except allergy to nickel and steroids. If the fact that there was nickel in the device had been disclosed - I would not be here to give you something to be angry about.


      So there, you got part of your wish

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    3. http://florida-drug-litigation.com/metal-hip-implants-may-increase-risk-of-cancer/

      Metal- on-metal implants may increase risk of cancer

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  17. http://florida-drug-litigation.com/experts-recommend-a-ban-on-metal-on-metal-hip-replacements/

    Experts recommend a ban on metal-on-metal hip replacements

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    1. It's nice that all your links and responses come from personal injury attorney websites. Wow, what a surprise

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  18. 5:25pm Facts are facts - funny that it was research done at the University of Bristol that discovered the metal on metal connection to cancer!

    And how about this article from FOX NEWS: http://www.foxnews.com/health/2012/07/12/as-lawsuits-climb-jj-may-have-new-hip-trauma/

    Check out quotes from the Orthopedic Surgeon with the Mayo Clinic, Mary O'Conner.

    I have articles from all over - these articles were not written by the law firm - they are a compilation of articles from all over the world about the corporate perpatrators metal on metal mass murder - sounds like you may be one of them.

    How much suffering are you personally responsible for as some low level broom pusher at the warehouse for Stryker Spine?

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  19. As a physician we need to think of the patient first, do our best and tell the truth.

    The Mild procedure sounds like something the nonsurgeons should not be doing for several reasons.

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  20. "We now live in a nation where doctors destroy health, lawyers destroy justice, universities destroy knowledge, governments destroys freedoms, the press (media) destroys information, religion destroys morals and our banks destroys the economy." Chris Hedges http://www.ahrp.org/cms/content/view/854/70/

    With that said, I can only hope that there might be one last refuge left to mankind - which is that as humans, we still can still maintain our humanity for each other during this time of universal suffering, be it health or economic. If we humans destroy our own humanity whilst every institution implodes from it's own systemic corruptions we will have ultimately destroyed any chance of revolution of the spirit, mind and body and will have missed the golden opportunity to be the Survivors of the Fittest in the spirit of the meaning.

    I believe in a form of reincarnation - that is not lineal but multidimensional parallel universes of consciousness. If I did not hold on to this ancient shamanic thinking - which I recently found an article comparing food that provided a direct health benefit to a body part that it resembled that reminded me of the concept of sympathetic magic and healing, I would have given up a while back when I realized that the health care corporate game was stacked against me regarding the metal on metal poisoning from a contaminated device that was put on clinical hold months prior to my being deceived into the faux study.

    My physical body is finished - I live on 180 mgs of opiate pain medication per day. It has been a nightmare for my family and friends to process the biomedical double cross - but, I still have a partially working brain that will be the last to go. Therefore, I will ignore the slings and arrows of those human beings on this blog who say hurtful things out of ignorance or guilt and hope that you never have to endure the suffering of living in a body that is slowly dying from being poisoned by a combination of toxic metals. As for the sociopaths out there who may have gotten away with these crimes against our biomedical humanity ( victims of corporate genocide - or the mass murder of the economically disadvantaged) I can only hope that you have a life in a parallel universe where you can experience the true meaning of life - whichnis to be enriched by living and loving connections with another human being and to experience your own humanitynand compassion for those less fortunate. Please do not confuse kindness with weakness - as I would rip your psychopathic heart out in a New York minute if that were the only means of justice to balance the karmic scales. But if it is not me - trust me, it will be another warrior who will catch up with those black corporate magicians who pushed these poisonous medical devices on the market. I love to step aside and let the real karmic master rip your heart out and replace it with a metal on metal plastic time bomb.

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    1. I wish you peace, my friend.

      The problem is spelled out daily here: profit driven medicine and medical research is always going to have results like yours.

      As a researcher I can tell you it is just too damned easy to "massage" the data from any study, and some people have no problem doing so. But those people, I think are comparatively rare-- the bigger problem is that we all know who butters our bread, and retaining objectivity can be damned difficult if not only your job, but the jobs of your friends an coworkers depends on a certain result. It's so easy to see what you want to see, and so hard to actually see the truth. No one ever publishes negative results! (Or wants to pay for them, either!)

      A large part of the difficulty is corporate-sponsored research. Somehow corporations have to be able to determine safety and efficacy, but just as certainly the actual determination probably shouldn't be left up to them. How to actual work out the details of that...the devil is always in the details, isn't it?

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    3. I, also, wish you peace. After 1.5 yrs. I wonder how you are. Again, I wish you peace...

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  21. 5:06 pm - I must appalled your rare insight and objectivity. You nailed it! This is rare for someone so close to the data life cycle processing ( you stated that you are a researcher). As you said, the larger part of the problem is corporate sponsored research and right behind it, is government. Not just the FDA but the entire panoply of lobbyists, politicians and oversight committees who pinpoint problems, but otherwise do NOTHING to reform a system that is internally imploding from it's own version of the 7 deadly sins.

    Last, but not least, we have our industry men and women from lab coats nerds to hot shot sales nen and women trying to make a living by believing in their work product.

    And after all is said and done, there is the powerless patient, overwhelmed first by the pain and suffering and looking for someone to place their trust in - and that someone is usually the physician. This is where the snake swallows its tail. I am not a Christian, but the saying, "Physician, heal thyself first" is key. It is the physician who has the power to stop this madness - and hopefully the trust to gather the necessary momentum to start the "ethical revolution" to restore medical research to it's legitimate forum of trial, error and ethical objectives based on sound science. No more slapping 4 or 5 metals together like a set of gears and calling it motion preservation.

    Peace back to you!

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    1. It's 2012 and Americans still do not have a flexible spacer to take the place of a damaged disk in spite of the fact that that three US companies make them and sell them worldwide.

      In an earlier line of work I used to run into pharmaceutical salesmen and these guys are major A-holes and about all they do is what the guy who drives the bread truck does and the supermarket.

      Right now too many doctors wipe their butts on the Hippocratic oath. The medical community should be an advocate for public health.

      Hippocratic Oath: Modern Version

      I swear to fulfill, to the best of my ability and judgment, this covenant:

      I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.

      I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of overtreatment and therapeutic nihilism.

      I will remember that there is art to medicine as well as science, and that warmth, sympathy, and understanding may outweigh the surgeon's knife or the chemist's drug.

      I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of another are needed for a patient's recovery.

      I will respect the privacy of my patients, for their problems are not disclosed to me that the world may know. Most especially must I tread with care in matters of life and death. If it is given me to save a life, all thanks. But it may also be within my power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty. Above all, I must not play at God.

      I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose illness may affect the person's family and economic stability. My responsibility includes these related problems, if I am to care adequately for the sick.

      I will prevent disease whenever I can, for prevention is preferable to cure.

      I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.

      If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with affection thereafter. May I always act so as to preserve the finest traditions of my calling and may I long experience the joy of healing those who seek my help.

      —Written in 1964 by Louis Lasagna, Academic Dean of the School of Medicine at Tufts University, and used in many medical schools today.

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    2. Good to see again.

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  22. Philomena, how about consulting a book on grammar or a little spell check in the future?

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    2. 2:12 pm : Would you be so kind to help edit my posts as I am disabled due to metal poisoning coursing thru my bloodstream and blood brain barrier making it difficult for me to focus on spelling and sentence structure. I am having difficulty with my eyesight as week, due to optic nerve atrophy, which causes my vision to blurr. I noticed of late that I need to read with one eye shut so the lines don't blurr. Also, my fingers go very numb when I text or post messages, and the tips of my finger tips are dead, without feeling what-so-ever. Some times the tip of my right forefingernturns blue as if the blood circulation has been cut off. Two years after the metal on metal CerviCore device was illegally implanted into C5 C6, I was declared totally disabled by US Government . Any more abusive comments from you will be reported and I will enforce the Americans With Disabilities Act and request that your server ID be disclosed.

      This is NOT an idle threat - and if MM allows you to intimidate me while I attempt to exercise my right to freedom of speech, he will only have you to blame. I have not been discourteous to anyone here and am relayi g true facts about the dangers of metal on metal devices.

      Therefore, 2:12 PM you have been warned and I have rights as abdisabled American due to the device (metal on metal) destroying my spine when it was implanted in my C5C6 by a Stryker Spine surgeon who made a lot of money doing these procedures in spite of the well known dangers and Stryker violating clinical trial protocol prior to the study being set to the FDA Black Box on December 21, 2007. PS - it appears that the CerviCore metal on metal disc never complied with the "conditional approval" requirements set out by the FDA in 11/2005.

      It appears from evidence provided in Stryker Corporations SEC filings that the CerviCore never fully complied with the terms of the Letter of Conditional Approval dated sometime in November, 2005. There is a 45 day deadline that was ignored by Stryker Spine clinical trial managers - so that when the FDA inspectors issued it's Enforcement Warning letter on 11/28/2007, the CerviCore study could NOT produce letters from the FDA that lifted the 'Conditional Approval' and granted the CerviCore a Full Investigational Device exemption. It is unheard of for a pivotal study to operate for over two years under a Conditional Approval, since PMA applications require that the study had been granted a VALID FULLY APPROVED IDE.

      I invite anyone who questions the source of this information to please review Stryker's annual reports from 2004 until 2008 as well as the FDA's definition of Conditional Approval Letters with the (1) 45 day extension and (2) 60 day extension. The combined days gives a Conditional Approval approximately 3 1/2 months of operating under an IDE. If the terms of the Conditions are not complied within the statutory time frame - the IDE loses it's legitimate validity and the trial is to be on "Clinical Hold".

      There is no wiggle room unless there is "corruption" or secret deals going on in the back room. So, Mr. or Mz. 2:12 pm, please spell check the above and edit my sentence structure.

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    3. Philomena, it is great that you have decided to post on this open website. You clearly have had some serious complications from your treatment and have taken the time to educate yourself to some degree.

      I can only assume that what you say is true.

      I do however take issue with your overt threats above to 2:12. Complain all you want, enlighten us with your knowledge and experience but don't hide behind your disability! Threatening anyone who dare says anything contrary?

      Read his post again. What was so offensive?

      You asked, no, demanded that respect be given to your "attempt to exercise [your] right to freedom of speech" yet you threaten 2:12 with government sanctioned protection?
      What is it you want? To destroy everyone's life on this blog? This industry? To make everyone feel the way you do? Why?

      You need to hold accountable those who have done an injustice to you personally!

      I know many who have benefited tremendously from appropriate spine surgery.

      I wish you no ill but don't come on here with your sanctimonious attitude and lecture all of us as if peddle child porn.

      Keep posting but save the threats! I am sure we could all benefit from your experience and I hope you are able to find solutions to your problems. You might even be able to find someone on here that is willing to help?

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    4. Thank you for your permission to post - but I have learned that as soon as someone starts with criticizing another poster's spelling and grammar, it usually escalates into personal attacks as time goes on - if the initial condensending remark isn't addressed for what it is- which is an open invitation to get others to join in with his insulting comments.

      Metal poisoning and the resulting disabilities are extremely painful, and 2:12 pm remark was offensive in the context that he or she could care less about the pain and disability caused by the MoM devices. Perhaps I should have addressed his or her shallowness instead of calling him out for being a shallow smart ass.

      I am not accusing you guys of peddling smut by any stretch - it just boggles the mind that people in the spine industry are in such denial about using metal in the body. Did you know that gastrointestinal problems post spinal surgery, whether motion preservation or plate and screws is caused by metal ion released into bloodstream that destroys enzymes and binds to oxygen?

      Maybe you do and don't mind risking getting IBS or colitis and stomach cramps that are so intense that you hate to eat for fear of the next bout of stomach pain? Studies will tell you that gastrointestinal pain is 13% post spinal surgery, but they will not tell you that it is caused by the release of metal ions. Yet I am a lay person and immediately saw the connection - but your honorable surgeon doesn't???

      My only mission is to connect the dots and to help persons like myself understand how we were deceived by a faceless medical bureaucracy. Maybe as members of the spine industry you could question your corporations science. What if your kid herniated a disc and the surgeon never disclosed the fact that there was nickel in the device and your child had a severe nickel allergy that the surgeon denied was responsible for her severe pain and suffering? Put your self in a million other metal on metal victims out there - and remember, it has taken almost ten years to bring this to the public's attention and still the big 5 are going to fight the facts tooth and nail. Corporations that destroy people's lives for profit are no different then porn pushers of the worst kind. I am surprised you resorted to that analogy to begin with - as it never occurred to me to equate your blog with the worst of the worst subhumans who abuse children.

      I like SpineBlogger - but 2:12 pm was trying to start a flame war and get me kicked off. I usually only come on here for specific topics. This time is was in re clinical trial dispute. My injuries stem from being lured into a clinical trail that was halted months before the device was implanted into my cervical - so when surgeons start taking it upon themselves to change protocol instead of reporting that the protocol is deficient or implant OP 1 into 17 patients in Pamona Valley Hospital, I have to wonder who is guarding the medical masters of deception ? This is a trillion dollar industry and absolutely NO ONE IS BEING HELD ACCOUNTABLE!

      Delete
    5. Something you need to figure out:

      Anecdote does not equal data...

      You assertions are not supported by data and you self diagnosis being projected on the entire orthopedic industry are absurd.

      Ask the parents of the teenager who just had his face reconstructed with titanium hardware if they would rather not have had the option.

      Delete
    6. Philomena threatened someone?

      @ Philomena: The people who harmed you are above the law. You are one of thousands of victims of them.

      Delete
    7. Philomena-
      Any reports on metal-on-metal disc in widest distribution, Prestige? Stainless Steel, but still has nickel and cobalt chrome? Any reports of issues among your contacts? I see none reported as of yet, with thousands implanted, but lots of Cervicore.

      Delete
    8. 1:34pm

      I refer you to http://www.bmj.com/content/344/bmj.e1410
      Especially interesting is the section on "how commercialism trumped safety".
      As for your imaginary boy with the titanium face - sounds to me like the a tit for tat story. I read about a man in an iron mask when I was a kid. I can be just as shallow and cynical as you - but in all honesty, if it is a true story I hope he had a successful surgery and manages to get by with the least amount of metal poisoning. Fortunately, titanium ( without trace nickel) is rarely toxic if
      the person isn't allergic to pure titanium. But on the whole, I would not discount the fact that he
      will have toxic metal issues.
      As for you, I can only say that you are just another "opinion" and we all have one. Kiss kiss

      Why don't you google Mayo Clinic - metal on metal. It really is none of your business where I had my metallosis diagnosed - and it is NOT a self diagnoses.
      http://www.cobalt-chromium-toxicity.com/metal-on-metal-hip-implants.html

      Delete
    9. 9:00 pm in re Prestige : to date I saw one account on a spine health forum by a Sandy. I will try to locate it again and link it to your request. I have seen lots of bad things about the Pro Disc and the Charite. I am focused on CerviCore because it is the device that destroyed my spine.

      The Prestige disc adverse events closely resembled CerviCore. And the Prestige patient's cobalt chromium metal ion release test was over the top. Metal on metal is bad news no matter the name - they were a marketing ploy. They were never designed to preserve motion - otherwise once hetero topic ossification developed the surgeons would have recognized that the metal over traumatized the Spine causing it to over produce bone. This is the simple explanation - but all of these M o M caused this condition in over 50 % of the cases. This is the opposite result touted by the designers of these death traps.

      Delete
    10. 9:00 pm http://www.medhelp.org/posts/Back--Neck/Post-surgical-pain-after-cervical-disc-replacement/show/5607
      This is just tip of iceberg about Prestige complaints. There are 100 s of forums withs posts like these about all the the metal discs. The severe headache is caused by the metal toxins recirculating and numerous other causes due to the discs throwing the lordosis or curvature of the spine out of alignment. These devices are death traps and even more dangerous to remove.

      Delete
    11. One patient, "Sandy", out of thousands of patients implanted with Prestige, does not seem so high. I wonder if the difference in material and/ or design makes the difference? Truly, one patients with over the top ion levels need to be looked at. But on the whole, so far after many years and many implantations there seems to be a huge difference compared to all the Cervicore problems reported. And what of the Pro-C? You say there are problems reported by patients too, but yet that is not a metal-on-metal design?

      Delete
    12. 9:00 pm here is the worst case scenario prestige ADR case I promised you. When I read it, i was shocked and surprised by the identical adverse events she has to mine.
      http://www.spinepatientsociety.org/forum/artificial-disc-replacement/reactive-metal-blood-test-finally-confirms-i-need-help-find-doctor-do-revision-replace-adr-help-3202/

      Delete
    13. Philomena- I opened your link, and the postings by patients. There was a LOT of mis-statements and just false information by patients (bless them) who didn't understand or know what they had done. Poor results were reported after both fusion AND disc replacement. That is no surprise, nothing works 100%. Many had multilevel problems which decreases odds of success. I did not see a single complaint relating to Prestige except one for an oversized malpositioned one (clearly surgeon error) nor metallosis. Did I miss it? Maybe you mean to offer a link which better supports your assertions?

      Delete
    14. Philomena-
      We must both be typing at the same time :-) I will lookup your new link now.

      Delete
    15. Philamena-
      OK, I read your latest link. Yes, worst case scenario is a patient who is material-sensitive who is implanted with an implant of that material. Testing should be done before every surgery.
      Ten to twelve percent of the female population, and six percent of the male population, is estimated to have nickel allergy. If screening eliminates those nine percent, it seems as if a potentially valuable restorative therapy can still be beneficial for then maybe ninety-one percent of all prospective patients? Even fusion patients have their disaster stories, as you have referenced.
      What else do you propose for these sufferers?

      Delete
    16. 11:05pm I couldn't resist answering your last question. I propose that we create an alternative rehab spa where patients who have damaged spines can get natural herbal detox treatment and therapies. It would require at least a three month residency or stay where they can first get fully tested for the damage done from the metal poisoning, have special diet (all natural), aromatherapy, essential oil massages, and accupressure and puncture, et al.

      Our bodies have been traumatized and we need intensive natural therapy. We also need to have the discs removed first. Just a few thoughts of what I would do if some one gave me a magic wand. I would establish the retreat outside the US so the FDA couldn't stick its nose in our business since they allowed these death traps to be tested in humans without doing any feasibility tests. There is a lot more I would do - but I need to get a little shut eye. Thanks for being such a positive human being. I am going to set up a blog and get some stats. I may need them in the near future. Nite nite

      Delete
    17. To my buddy: I did a see spine surgeon in my area who implanted the Prestige discs and he said : " Our group stopped implanting these devices because they FAILED in the best candidates"
      I swear on my children's souls he said that. I went to him to have the disc removed and he told me that I was never a candidate for an ADR.

      Delete
    18. Philomena-
      I feel lots of sympathy for the plight of you and others who have proven to be allergic to an implant only after the fact. I, for one will immediately remind surgeons of the absolute necessity of material sensitivity screening patients before surgery.
      And maybe device manufacturers might take the lead in such an education program. I do think, however, that lumping all the implants together in the same category as universally harmful is not justified by the numbers at this time. Educated choice should still be made available to qualifying patients.
      Removal of your implants and rehab should be covered if negligence is found to be the case.
      I truly wish you the best possible future, it seems like it must be living hell.

      Delete
    19. More Prestige Complaints http://ehealthforum.com/health/cervical-disk-surgery-t143294.html#b.

      There are hundreds of spine forums to comb thru - here is another one with several complaints about the Prestige. For one thing, some people have immediate bad results and others the adverse events occur over time. Some as long as a year before the pain reoccurs. Another problem that you are not factoring in is hetero topic ossification and reversal of lordosis as well as adjacent segment disease. Worst of all is facet joint degeneration. I disagree, metal disc replacements in spine should be banned. You should check the results from the Charite - just horrible outcomes. I may lose a kidney after all is said anode done. None of these metal devices work - they are a total scam.

      Delete
    20. Most implants are not ferris so I don't the the Prestige piece of junk is made from stainless steel. They say it is stainless steel so you can't have an MRI when it is in you.

      Stainless steel contains 11% chromium. Chromium causes cancer. Chromium compounds are genotoxic carcinogens. Chronic inhalation of hexavalent chromium compounds increases risk of lung cancer (lungs are especially vulnerable, followed by fine capillaries in kidneys and intestine) The EPA recognizes chromium as a carcinogen.

      Philomena, Dr Michael E McCabe may be able to help you. He is an expert on joint implant poisoning.

      http://www.youtube.com/watch?v=KzgMXTEIUug

      http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1568823/

      Here is what Medronic is saying about the Prestige disk and a picture of it. I think they sell something like this at True Value Hardware. http://www.prestigedisc.com/pages/about_the_prestige_disc.html

      "While many factors contribute to the longevity of an artificial disc, the PRESTIGE® Cervical Disc has undergone significant testing to verify the safety and adequate durability of the device." LOL!




      Delete
    21. BB - interesting that MRIs are absolutely useless for imaging what is going on behind the spine, yet surgeons are still ordering them as level 1 imaging tests. This is a form of exploiting insurance companies to pay for useless test, making them more reluctant to orders teats that will produce tangible visible readable results. My original surgeon an advised another neurosurgeon I consulted for a second opinion about my escalating pain to have an MRI done as fist line of imagining test knowing all along that the artifact from the heavy metal (cobalt chromium nickel molybdenum titanium plasma) would distort the image and rending the test useless. Yet, he never disclosed to either of us that there was nickel in the CerviCore; or that none of the subjects were prescreened for any metal hypersensitivity. And this was supposed to be an FDA approved clinical trial. We later learned that CerviCore never got past a "Conditional Approval" status, which stated that conditional approvals came with a 45 day time frame for full compliance or lose it's Inestigational Device Exemption.

      The timeline for IDE went like this: first application for IDE was filed in late 2004 - as the IDE number was G 049010. According to FDA code, the 04 after 'G' is the year the IDE was submitted. This I D E was flat out DENIED. Then some time in 11/05 Stryker Spine was sent a
      letter of CONDITIONAL APPROVAL. Therefore, giving Stryker a lot of wiggle room, the CerviCore had until FEBRUARY 2006 to comply with the 45 day deadline for the conditional approval to convert to a full and valid approval. Yet, none of the Stryker SEC Annual Filings change the Conditional Approval to a valid IDE granted by FDA as is claimed in the same paragraph for the FlexiCore IDE. So that by the Annual 10K statement dated 2/28/2008, there s no mention of the CerviCore status upgraded to a valid and fully approved IDE granted! Also, on 11/28/2007, the FDA shut down the Mahwah plant for numerous quality regulation control violations, including all Class III devices that Stryker had hoped to file for PMA. Instead, Stryker could not produce the paperwork that . Class III devices were in compliance with regulations or approved FDA. And on 12/21/2007, all of their Class III devices,ie. CerviCore and FlexiCore were required by Public Law 110-85, TITLE VIII section 801 to be registered in a database called: Trial of device NOT approved or cleared by US FDA for any used.

      Because of the Secrecy surrounding device
      development there are no checks and balances in position to protect the safety or well being of a trial subject. It is all based on the corporate honor
      system - three words that make my heart tremble with fear, as it is well known that there is no honor among thieves or unethical corporate spin masters.

      Medtronics and Steyker will be the two corporations whose MoM spinal devices will be called into question by the FDA - and they absolutely should. I doubt very seriously if Medronics followed the prescreening protocols. I have read about 6 or 7 posts and the SAEs are indicative of sloppy research protocol. Please pardon me if I am getting sanctimonious - but recruits who are I gentoo ally enrolled into a trial who have contra- indications or exclusion criteria that should have eliminated them is on par with pre meditated murder. If you were a surgeon who turned a blind eye for cash, then you need to be criminally prosecuted.

      My spirituality is very clear on this judgment - an eye for an eye and a tooth for a tooth - not literally, but spiritually. This is a mistake we Hebrews make in this literal translation.

      Delete
    22. Hey Philomena, Wolomina or plain old just "making crap up". Please provide everyone with your studies showing a greater than 10% of the population with a nickel allergy.
      It's easy to make anecdotal statements with k ow "EMPIRICAL" data to validate.
      J

      Delete
    23. Philomena-
      I have been carefully reading your links, and your assertions, and despite being very patient and understanding, comments you are adding are only starting to show you are not backing up your assertions with facts. Instead I fear you have taken a position based on a small population of outcomes, and are trying to illogically blanket cover everything in an effort to try and make your position stronger. In fact is has the opposite effect. A LOT of those patient comments show extreem dissatisfaction with their FUSION outcomes. A lot of posts talk about immediate post-op pain, where any device involvement is likely negligible. And the same complaints are in the fusion groups too. And when you talk of adjacent level degeneration, that occurs in fusions, so are you against fusions ? When you try to lump all ADRs in the same group, you lose credibility too. The Charite had biomechanical design flaws which resulted in many failures, and it was yanked. It was not MoM. Many new designs of ADRs have non-MoM designs. Are you going to castigate all of them too based simply on your own experience with a simple matierial allergy, which evidence points to in your case? Sorry, I just can't go along with you on that, that's just patently not logical or reasonable, and does your argument no good. Furthermore none of the Prestige complaints refer to metallosis or allergy, perhaps due to difference of material from the Cervicore you say you have had problems with. ADR designs may offer a large number of patients choice of treatments to try and solve their neural compression issues while still maintaining function and flexibility. From your own links, nothing works 100%. Not even fusion. And not all ADRs will have metal ion issues with the vast majority of patients. Again, pre-screening for allergy is the key, as it always has been. Now that I'm seeing the unreasonable soapbox where you are crusading from, I'm far less supportive of your position. I think your reality is clouded by your own experience, and your adjenda is self-centered. Recommend you step back, review the facts, and adjust. Best wishes for the tough road ahead in dealing with your apparent implant allergy.

      Delete
    24. Wait everyone - I think a valuable clue may have inadvetently been leaked about all this-

      Per Philomena: "metal disc replacements in spine should be banned."

      I thought I may have smelled something fishy.

      Perhaps this is all just a marketing rant by a manufacturer's representative of future non-metal disc replacements? Any Hebrew ones in development in Israel maybe? Look at the clues provided, people.

      Delete
    25. Philomena, here are some treatments for nickle poisoning. http://www.ehow.com/how_2085600_treat-nickel-poisoning.html


      Be aware that nickel poisoning will occur if you inhale nickel carbonyl, eat contaminated food or drink contaminated water. It can also be absorbed through the skin from contaminated soil, water or by handling coins.


      Watch for common symptoms including insomnia, frontal headaches, irritability, vertigo, nausea, vomiting and difficulty sleeping.

      Read more: How to Spot Nickel Poisoning | eHow.com http://www.ehow.com/how_4486144_spot-nickel-poisoning.html#ixzz26ajyESTN

      Nickel and nickel compounds are well-recognized carcinogens. Only someone wanting to increase cancer in people would put a nickel shedding device in people.

      Delete
    26. 1:35 pm. You are a total liar. If you read the links, you would have seen that "Sandy" story is all about Metallosis. Furthermore, if you read all 253 posts one the one site and the number of posts on the three other sites I posted there were a number of complaints about prestige.

      Don't forget, metallosis was a banned word in Orthopedic Surgery and patients suffered years in silence or told by their surgeons they were still in the healing process.

      The best point for me s when a Neuro surgeon who was part of the Medtronic study told me and my husband that " his group is no longer implanting Prestige or any other discs as they do not work on the best of candidates". Plus, I was never a proper candidate for the study to begin with when the CerviCore was implanted illegally into my spine after it was black boxed.

      You sound like a corporate defense attorney. I was asked by someone if I knew of any problems with prestige or pro c. Since this was not my disc I am unfamiliar with the percentage of failures. But I do know there are plenty of failures with all of these metal devices because metal wear is always going to be a problem.

      I don't know if you have noticed, but since 2009 not many ADRs have been implanted - the FDA s refusing to approved or PMA Motion Preservation Devices or implant for the spine. Metal on metal has poisoned millions of people from the hip to spine. If your career is dependent on dealing with death traps, that is your choice. You are hurting a lot of people for a paycheck and your ego is so huge you can't accept the truth that this trend ( junk science) failed. If you can't read between the lines of the fake posts by people who write professional posts for the orthopedic industry than you are not only arrogant, but you don't even know your industry's spin tactic.

      Wait until your son herniated his neck and you tell the surgeon to use a metal on metal implant in his spine. I assure you, he will hate you for the remainder of his and your life. Metal does not belong in the spine and surgeons who are not whores for the industry know this and now are refusing to let you snake oils salesmen to talk them into unnecessarily harm any more patients. I got my answer from a neurosurgeon - you are getting your facts from your CEO, if you are in that industry. I suspect you work for Stryker Spine,

      Delete
    27. 1:50 pm A little paranoid are we. I am Hebrew! And I once visited Israel. LMAO

      Delete
  23. 2:12 Pm I would like to see how you function on 180 mgs of opiates a day due to living in excruciating pain from a spinal implant. I may have approximately 5 years left before I am totally incapacitated. The metals in my bloodstream are binding to the oxygen in my blood and I live with shortness of breath and low oxygen going to my brain. I really don't care about whether my spelling or grammar meets with your edification. My intent is to expose mercenary medicine and the sociopaths associated with promoting junk unsound science for profit. Your days are numbered in the orthopedic field of scamming patients in pain with implant devices that cause more damage than the original pathology.
    Arrogant people are incapable of humanity and compassion. They like to steal the limelight with hurtful one liners and hurling insults. They enjoy kicking someone when they are down - and in the past have gone so far to prove their superiority by crucifying an innocent man for thinking outside the box and introducing social concepts like ' love thy neighbor as thyself".

    My IPad changes words on me without my realizing it until after the text has been sent. I am not going to apologize for telling the truth about a subject that I have lived in pain with for almost 5 years. Once you have lived thru what I am going thru and treated like a leper because surgeons in the area are nothing more than white coat sociopaths you might understand why I could care less whether I impress your shallow spellcheck/grammar remarks. Metal poisoning causes cancer and is fatal left untreated. And the surgeon who intentionally (knowingly) destroyed my health will have more to worry about than my spelling and grammar.

    ReplyDelete
    Replies
    1. OK we get the point. We do not sell any metal on metal implants. What do you want us to do about it? Go file a lawsuits and start lobbying in Washington. Spouting off on The Spine Blogger will not further your cause at all.

      Delete
    2. Go to Settings>General>Keyboard and turn off Auto Correction on your I-Pad- that should solve one of your problems.

      Delete
    3. 4:10pm lethal medical devices are like bad street drugs. As reps, you are just the guy on the street corner who sells product for the Kingpin. So when a junkie dies from an overdose, who do the narc first go after? The pusher on the street - so that the message gets to the Kingpin that one of his pushers has been arrested. The same principle applies here - educate the pusher about the consequences of pushing a lethal medical device and the message will eventually get to the top.

      Some of us may not live long enough to go thru a lengthy lawsuit or lobby Congress( ye jest). This is because the big 5 device companies have ignored the complaints for years and the FDA does not get involved in personal Injury suits. Therefore, if you have a shred of humanity you will educate yourself in the event that you need a new hip or spinal replacement device (metals in plates release ions too) so that you don't become a victim of corporate bio- material genocide. When corporations fail to disclose the biomaterials used in a experimental product to get a PMA - they have committed fraud. Stryker Spine intentionally with held the fact that nickel was part of the biomaterial used in the disc that was illegally implanted into my C5C6. In addition to the fact that the devices were stored in non sterile packaging in a warehouse that the FDA shut down. If you think about it - if the warehouse was found to have widespread known and unknown
      pathogens, it was not just the CerviCore disc that was exposed to known and unknown pathogens. It was every single device stored in that warehouse down to the last screw that was potentially contaminated. This is not just my problem - this is a PUBLIC HEALTH problem worldwide, since Stryker ships their devices globally.

      Delete
  24. Very interesting, good to see people discussing this finally.


    Dan

    Buy Med Medical Supplies

    ReplyDelete
  25. http://www.bmj.com/content/344/bmj.e1410#ref-32

    British Medical Journal

    How Safe are Metal on Metal Implants and how commercialism trumped safety!

    ReplyDelete
  26. So tired of Berkeley Bally!September 13, 2012 at 7:16 PM

    Best part of this blog was seeing Bally Balless SHUT DOWN by MM. Again and again!

    ReplyDelete
  27. Philomena, are you sure your plethora of symptoms are due to a few molecules of metal in your body or is there a significant psychological component? If metal ions caused all you described, Florida would not have a single open hospital bed, but also no traffic jams.

    ReplyDelete
    Replies
    1. http://www.bmj.com/content/344/bmj.e1410
      How Safe Are Metal on Metal Implants
      metal ions and genotoxicity
      How commercialism trumped Safety

      It is just a matter of time before The geriatrics in Florida start flooding their orthopedic surgeons offices but you will always be stuck with traffic jams in Florida.

      Grow up, this debacle is going to hit the medical device hard and fast very soon. The orthopedic surgeons who were counting on their patients dying before they connected the dots will soon get their letters from the device companies, if they haven't already.

      The real crime is that physicians were well aware of the metal toxic effect and went ahead and implanted the devices. I suspect that the kickback may have been too lucrative to resist.

      I wont post here again. I am only following my conscience since I know how difficult it is to unmask the deceit and deception in the health care industry. You guys needs to make a living selling contraptions - I just thought I would appeal to your higher conscience. Plus I received a lot of response from other CerviCore and FlexiCore victims after posting here. They had no where to turn and not a clue as to why they were losing the use of their extremities and getting tests back for gastrointestinal diseases - since metal ions destroy gastric enzymes and bind to oxygen causing shortness of breath and vertigo.

      Peace out

      Delete
    2. Has Fat Bastard been banned from this blog?

      Delete
    3. This comment has been removed by a blog administrator.

      Delete
    4. Halleluja, has she really gone..!

      pity they don't take out the genioglossus

      Delete
    5. Fat Bastard is at the Buffett........he'll be done 4-5 days then I'm sure we'll here his rhetoric.

      Go Blue!!!!!!

      Delete
    6. Leave it to an industry shill to mock a victim in order to defend the massive wrong doing of his criminal industry.

      Delete
  28. "This comment has been removed by a blog administrator."

    This shouldn't exist on an OPEN forum.

    No free speech on SpineBlogger. Only what THEY like. Quickly read this before it is removed!

    ReplyDelete
  29. 2:37 pm why don't you investigate the adverse events caused by a combination of known toxic metals - like cobalt chromium nickel molybdenum! Every single organ becomes contaminated.

    If you represent a spine company that sells metal on metal products than you are part of the death chain. Believe it or not, but the MoM controversy might just reform your Industry in the long run. You should talk to the millions of patients who were harmed by these products - our lives have been devastated. The problem here is that you all are realizing that you are part of the problem. Instead of attacking the victim, why not learn about the problem and tell your corporate masters you refused to sell products that harm people. And PS - the reason I posted here is because the problem with these unsafe products getting on the market has to do with the massive fraud committed during clinical trials.

    ReplyDelete
    Replies
    1. This comment has been removed by a blog administrator.

      Delete
    2. @7:01A
      I can spell "hyperbole", but do you know what it means?
      So I guess all those auto repairmen who put on. Fake pads years ago were responsible for the spread of asbestos. Or what about all those in construction years ago who built building gs using materials such as lead and asbestos and mercury...
      Fact is that through human history we have striven to progress, and within that drive to progress we have failures. Some small, and some catastrophic.
      Why dont you go hit your Grandpa in the head with a hammer. I'm sure he used lead laced paint which you chewed off the window sill as a small tike. Now there's someone you can immediately go after for injustices I acted upon you. Go ahead. Pick up the hammer and give him a crack. You k ow he did it purposely you Weasley little f...
      J

      Delete
    3. Weasley. Auto correct sucks.
      J

      Delete
    4. @7:01A
      I can spell "hyperbole", but do you know what it means?
      So I guess all those auto repairmen who put on. Fake pads years ago were responsible for the spread of asbestos. Or what about all those in construction years ago who built building gs using materials such as lead and asbestos and mercury...
      Fact is that through human history we have striven to progress, and within that drive to progress we have failures. Some small, and some catastrophic.
      Why dont you go hit your Grandpa in the head with a hammer. I'm sure he used lead laced paint which you chewed off the window sill as a small tike. Now there's someone you can immediately go after for injustices I acted upon you. Go ahead. Pick up the hammer and give him a crack. You k ow he did it purposely you Weasley little f...
      J

      Delete
  30. So does this mean that no matter what the Blog topic starts out as, the discussion will just move to whatever philomena decides he/she wants to talk about?

    ReplyDelete
  31. Spoken like someone who is just so a part of the "Death Chain". Say, isn't that a device maker corporate motto? Oh sorry, it's a rock group.

    Be careful not to say anything that she might construe as offending her: she's already threatened to send out the govternment brownshirt goons to beat you up covered under the ADA !

    This. Is. Now. Her. Blog.

    ReplyDelete
  32. Philomena said
    "Any more abuse coming from you will be reported and I will enforce the Americans with Disabilities Act and request that your server ID be disclosed. This is NOT an idle threat and if MM allows you to intimidate me while I attempt to excercise my right to freedom of speech..."

    What about others' right of free speech? Don't like it? Don't read it.

    Oh, and toothless threat, IPs can and do change often.

    MM, regain control of your blog.

    ReplyDelete
  33. Mr Nieradka,

    I would like to see you become more of a patient advocate than a pot stirrer of the hyenas that make up your industry.

    I would like to hear you write about the 1000'a casualties that your industry has caused.

    The fact is, if it were not for people with spine and joint problems there would be no industry.

    I would love to hear you opine on more than the sleazy business practices, punitive lawsuits, industrial espionage and the egos of the buffoons who run it. Anybody can toss out cheap shots at companies and corporate gangsters. I would like you to answer some questions. Would you be willing to do that right here on your blog? If not why not?

    ReplyDelete
  34. IS BALLY BALDEZ .... PHILOMENA ?? :-0

    ReplyDelete
    Replies
    1. AnonymousSeptember 15, 2012 7:10 PM said, "IS BALLY BALDEZ .... PHILOMENA ?? :-0"


      Anonymous, why are you afraid of the truth coming out? Philomena is right. When Obama wins Holder will resign and his replacement is going to kick ass and take names so you may as well start ratting out your employees or fellow employees before they rat you out. In an industry that has been fined as often as the spine industry you would be wise to cover your butt. Just sayin.... ;-)

      Delete
    2. Wrong and wrong.

      The truth " coming out" is that over 90% of the time, there will be no allergies. 90% of patients should not be denied access to therapies just on the basis of crusaders with limited experiences, no proof, and their own adjendas.
      The other ten percent of the time, allergies should be tested for and caught before surgeries.
      What is so difficult for you to understand about that?
      Claims of metallosis are unproven in the spine. Show us data, not just words.

      Wrong about The Fraudulent One too. He will lose. Situation is the same as with Jimmy The Peanut Farmer Carter. Country in ruins financially, spit on abroad. Embassies over run after being left unguarded by naive non-leaders. Twenty percent jobless since many have given up and no longer try to even look for work, their industries long gone from America. Record number of families on foodstamps and the administration proud of it- why not 100%? Manufacturing dead from overregulation and only more being heaped on. Now Quantitative Easing to Infinity to save the insolvent banks, but kill the value of American's purchasing power of the dollar, so Americans become a third world country and you will pay $10 for gas and a loaf of bread. gnore the media and the polls. Wake up.
      Surprise big win for the other puppet.

      Delete
    3. AnonymousSeptember 15, 2012 10:38 PM Said

      "Wrong and wrong.

      The truth " coming out" is that over 90% of the time, there will be no allergies. 90% of patients should not be denied access to therapies just on the basis of crusaders with limited experiences, no proof, and their own adjendas.
      The other ten percent of the time, allergies should be tested for and caught before surgeries.
      What is so difficult for you to understand about that?
      Claims of metallosis are unproven in the spine. Show us data, not just words.

      Wrong about The Fraudulent One too. He will lose. Situation is the same as with Jimmy The Peanut Farmer Carter. Country in ruins financially, spit on abroad. Embassies over run after being left unguarded by naive non-leaders. Twenty percent jobless since many have given up and no longer try to even look for work, their industries long gone from America. Record number of families on foodstamps and the administration proud of it- why not 100%? Manufacturing dead from overregulation and only more being heaped on. Now Quantitative Easing to Infinity to save the insolvent banks, but kill the value of American's purchasing power of the dollar, so Americans become a third world country and you will pay $10 for gas and a loaf of bread. gnore the media and the polls. Wake up.
      Surprise big win for the other puppet."

      ************************************************************************************************************************

      The National Institutes Of Health would disagree!

      Electron Microprobe Analysis and Tissue Reaction around Titanium Alloy Spinal Implants

      http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2857498/

      Methods

      Ten patients (average age, 51.3 years), 6 men and 4 women, who had undergone previous lumbar fusions using pedicle screw instrumentation and who were now undergoing revision surgery were included in the study. The tissues obtained from the adjacent area of these implants were analyzed by light microscopy, immunohistochemistry and scanning electron microscope. After the removing the spinal implants, the changes of back pain and the spinal fusion were assessed.
      Results

      There were metal particles in the soft tissue in 7 cases. Histological finding observed mild chronic inflammation surrounding the deposition of the metal particles and the anti Cotrel-Dubousset 68 positive macrophages were observed at tissue adjacent to the metal particles in 5 patients. Scanning electron microscopy of the specimens showed metallic debris within the tissue and mapping of the metallic particles revealed the distribution of titanium in the tissue in 5 cases. Nine patients had successful relief of back pain after removing the spinal implants. Improvement of the back pain may be an association macrophage response rather than the metal particle.
      Conclusions

      The presence of metallic particles generated from spinal implants may serve as the impetus for a late-onset inflammatory response and late operative site pain.

      Here is another NIH finding on Toxic Spine Implants and Instrumentation.

      http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2219664/

      Here are some more links

      http://www.springerlink.com/content/v12265mt864u17q8/ Archives of Orthopaedic and Trauma Surgery

      http://www.ncbi.nlm.nih.gov/pubmed/11458158

      Keep in mind that even the screws and "spoons" they use shed toxic levels of metal but when it comes to a ball and socket implant that will undergo continual movement in all six axis much more toxic metal will be shed.

      Notice how the poster brought in the usual dog whistle BS? Jimmy Carter was a nuclear engineer who also farmed peanuts. It would seem that the poster has something against farmers as well as patients.



      Delete
  35. @ Philomena....

    You know you need to get that chunk of poison out your spine. There are ways to deal with the heavy metal poisoning it has caused but in lieu of that you will need a replacement or fusion but since there is so much necrotic bone your best bet may be a replacement.

    There are currently 4 motion constraining shock absorbing ADRs. They are:

    NeoDisk

    The M6

    Paradigm Spine's DCI

    Axio Spine's Freedom R Cervical

    I can't vouch for the safety and efficacy of these American made devices but commonsense would dictate that they are better than they junk the FDA allows in the USA.

    Commonsense also would dictate that removal of the toxic ADR in your neck will cause your symptoms to improve. Maybe after the upcoming house cleaning at the FDA you can get a compassionate use wavier but by then maybe these good ADRs will be approved as per Commission E's guidelines.

    ReplyDelete
  36. Bally - it is in the works. It will be a few months wait, but hopefully by holidays I will get this removed and get on a detox program.

    You need high resolution computer to see the image but here is the myelogram showing the tumors around the disc and the tumors on the vertebral.
    Go to : http:// CerviCoreSpine.com

    If tumors developing after two years doesn't shut these cretins up- nothing will and they are 'death trap dealers' by nature. Evil attracts evil - plus people love the big lie - especially if it makes them wealthy. The real joke is, the surgeon who designed my disc and implanted it, doesn't want to have anything to do with it any more. The surgeons will put these discs out of business by not promoting them. As my last Neuro surgeon said : Our group is no longer implanting them, they cause problems in the best f candidates".

    I will let the experts (surgeons) win my war. I just thought I'd give these snail oil salesmen for Stryker a run for their alpha rah rah bull shit. Stryker may have the CIA to cover it's ass but if Surgeons refuse to buy their products because of Strykers arrogance then their value as a competing device company is meaningless. Up yours Stryker !

    ReplyDelete
    Replies
    1. What I think happens is that some joker comes up with some junk design to lure naive investors. Let's think about it in the most basic terms. There is no advantage to a non shock absorbing non motion constraining disk design other than all the extra revenue their failure and design defects create.

      As you know, the ball and socket and rotate to far and that causes the facets to impact each other and that causes bone growth.

      Chances are Philomena you will feel much better and make a decent recovery.

      Delete
  37. Bally, I think I know why these extreme alpha salesmen dogs are so resistant to the findings of the BMJ and FDA in re metal on metal poisoning. They are afraid that the impact of the coming lawsuits is going to cause their corporations to slash jobs. They are living in their " fear center" instead of their "clarity center". They are so afraid of losing their jobs that they need to talk each other into believing that metals like nickel, cobalt, and chromium" aren't toxic, even when the DH&HS and FDA long recognized the genotoxic effects of these metals in the environment and human body.

    Kind of reminds one of Nazi German propaganda and the Big Lie. Sad, but sales people are dependent on the information they fed by their corporation. They have son little power to resist or influence their corporate masters that they first have to believe the Corporate lie just to get up in the morning. The so called smoothies who thought he was playing me and then twisted the facts to pull the rug from me didn't fool me for a second. He was fishing for information so that his corporation could find a way to erase anything negative being said about the devices they are pushing.

    For the record, I am only adverse to metal devices, whether they are metal on metal or metal that use nickel alloy. This is what destroyed my spine and numerous others in the CerviCore study. Metal wear and metal allergies are two different syndromes. But metal wear particulates are bad for everyone, regardless of whether they are allergic to the device. Mr. smooth operator (1:35 pm was his last post) is akin to a sadistic guard in a Nazi Death Camp that lured the little children with candy to Dr. Mengale's bunker for their "special medical treat". That is the image your writing left me with - you are a text book sociopath. If this post is removed so be it - it is only because cowards are afraid of the truth and the real numbers don't
    Iie. I have spoken with victims who never posted their pain and suffering online - but like the FDA mentioned in the past, Stryker simply ignores complaints because they don't give a flying F about patient suffering.

    Tick Tock goes the clock that keeps the time for the hangman.

    ReplyDelete
    Replies
    1. In order to be a good salesman you have to believe in the product and know the flaws of the competition. Since all the ADRs available in the US are essentially the same junk there is no competition so the one who walks out with the order from a hospital or a surgical group is usually the last one in the door or the one with the best kickback and bribe. Ultimately the blame falls on any surgeon who would place a toxic metal into a patient. The sales droids may not know any better but the doctor does although they too will claim ignorance.

      I recently talked to a doctor about the Plavix lawsuits and this arrogant bastard would not hear it in spite of all the evidence and fines related to the wrong doing. The entire industry is corrupt and therein lies the problem. There should not be a "medical industry". Health is not a commodity. Health is what separates us from life and death. Doctors used to follow the Oath. Today many don't.

      Doctors used to be the leaders in public health.

      Doctors used to be members of a profession that adequately policed itself.

      Today, doctors are tools of the "medical industry". I would have to think that an old time doctor would bristle at the fact that the profession of Hippocrates is now an industry that exploits human suffering for obscene profits.

      Your Nazi analogy is a bit unfair... to the Nazis. They actually believed the Aryan superiority BS so most of them were misguided. The medical industry has no similar delusions that they are doing anything for the greater good.

      Mengle, had he been part of the clinical trials today would have probably been more ethical than the greedy "investigators" that the industry hires to get their junk approved by the FDA.

      It gets worse... These clinical trial investigators often become PODS for the products they get approved. I addition they get paid really well for their work. They get sweetheart deals for their favorable reviews of the devices they test. This is like a movie company having the critics on their payroll.

      The entire process is corrupt. The entire industry is corrupt and as a result... people die.

      Delete
    2. Bally, for the record, you're posts are so well written that I may have to plagiarized you. You really express my pain and suffering better than I could. I am in so much pain that I find explaining how I got here from having a herniated disc to now living with tumors and necrotic bone to people like you, who understand what I had to research for four years somewhat healing. At least someone out there cares and understands. Thank you Bally. Very Much appreciated. I am getting out of this dark place - what goes around comes around. One car accident or fall can put one of these borg types in pur place. I wonder which device they will choose?

      Once a corporation takes the humanity from it's sales force, we have zombies chatting with surgeon- sociopaths with neither party giving a flying F about anyone's health care.

      American Surgeons intentionally ignored the metal wear problem with metal implants - their conspiracy of silence is where the real crime occurred. Every surgeon who implanted a metal device that failed to warn and prescreen the patient should automatically be convicted of criminal medical negligence. Metal wear dbris was a well known adverse events since the early '70s.

      He who accepts the King's coin whistles the King's tune! The surgeons who did the studies were all paid by the sponsors. There is no way in hell that a single study produced accurate life cycle data - moreso, since it takes approximately three to four years for the adverse effects of metal ion release begin to manifest.

      Stryker never even bothered to discuss the metal wear possibilities, nor did Stryker prescreen it's research candidate for metal allergies. Stryker never MENTIONED the fact that there was nickel in the device. This meant that persons with nickel allergies were intentionally being poisoned by Stryker and the surgeon. And when we complained about the pain that we had no idea was caused by Nickel - the surgeons and Stryker ignored us and reported to the FDA that there were no adverse events associated with the disc. If this isn't the definition of sociopathic behavior, what is?

      Remember, there is metal allergy which causes lymphocytic reaction, and there is metal ion release from either motion or corrosion which causes severe blood poisoning.

      Having both is a death trap - and all metals release ions whether static or in motion. Each metal bring a set of adverse events - but the one common denominator is that metal in body destroys enzymes and binds to oxygen. These are two precursors to Cancer

      Delete
  38. http://www.medhelp.org/posts/Back--Neck/Post-surgical-pain-after-cervical-disc-replacement/show/5607

    This is just the tip of the iceberg regarding failed artificial disc surgery using meta devices. The words metal allergy or metallosis was banned from the surgeons dialogue for obvious reasons.

    Surgeons played dumb when patients explained symptoms that were metal allergy or metallosis related. They played possum. It wasn't until 2010 when UK surgeons raised the red flag connection between pain post metal on metal implant and metallosis from wear metal release and lymphocytic reaction from nickel allergy. The Mayo Clinic has since made the connection. If a spine salesman tries to tell you any different so he can profit from your pain, perhaps we should save these comments so that Congress can determine who the real criminals are in spine sales. The corporate sales team who know they are not telling the surgeon or hospital the real risks or the surgeons who are ignoring the metal materials adverse reactions by failing to test each patient before implanting a device with a known toxic metal. Or perhaps all three should face congressional questioning- the salesperson who is only following orders, the corporation who invent positive claims and fail to report adverse events like metal allergies or metal wear particulates.
    If you had a conscience, what about all of the necks and lumbar spines In our servicemen who received metal on metal discs resulting in metallosis, after already suffering a serious injury from the enemy. In that case, the sales persons who continue to make the argument that metal devices are benign and only people who are allergic are harmed, and there is no such thing as metal wear articulates (metallosis) should be shot for treason.

    Metal wear debri is not metal allergy. They are two separate pathologies. Metal wear debri is metal that sheds from the device and infiltrates the bloodstream which them settles in organs like kidney, heart, liver, spleen and eventually mutates the cellular structure - as in genotoxic.

    I am not going to waste any more time trying to stop your criminal actions of selling products that you know causes harm because your company lied to you about their lethal bio- material. And all you smoothies sales men know your Corp is going to fire you first once the lawsuits start coming faster than a cigaret speed boat with a load of drugs. So drop the he man facade and educate yourself. And any time you read a perfectly written post lauding the success of their metal implant recognize it for what it is - a planted post to sucker people in pain to ask about it. It is the oldest sales trick in the book as well as the sleaziest.

    There is a special place in he'll for liars and even a more special place for liars who lie for self serving purposes that cause their victims more pain and suffering. Reasoning with smooth talking sociopaths like 1:35 pm - is the same as reasoning with a snake. Hack off it's head and pour gasoline on it and lite it on fire.

    Bye bye 1:35 pm. I am very intuitive - I predicted CEO MacMillans ouster months before it went down - I get a similar vibration about you - you are clearly heading for a fall along with your delusions about the benefits of metal artificial discs or hip replacements.

    It was an intentional corporate decision to not disclose the dangers of using metals in devices and there will be Congressional Hearings in 2013. Wear a red tie so I can waive bye bye to you.

    ReplyDelete
  39. Brazil,..Hazel,...Cashew,...Almond,...Pistachio,....Philomena,....

    ReplyDelete
    Replies
    1. Liar, Prevaricator, Deceiver, con artist, deluder, dissimulator, equivocator, fabler, fabricator, fabulist, false witness, falsifier, fibber, maligner, misleader, perjurer, phony, prevaricator, promoter, storyteller, Mitt Romney trickster, The American Medical Device Industry and its defenders.

      Your time is going to come. Heads will roll. Criminals will be brought to justice. Club Fed will be booked solid.

      Delete
    2. Now THAT'S funny chit! We can imagine you getting all in a huff, prancing around stomping your feet, with your panties in a knot.

      Thought you were a serious poster up until that one. Although maybe a seventeen year old one.

      Now we know you must be a troll for entertainment... MM himself for kicks?

      Delete
    3. AnonymousSeptember 16, 2012 2:11 PM

      You might want to get in on the qui tam gravy train before Uncle Sam comes in and throws the company officers and the boards of directors in jail. Chances are though you are merely I disposable salesman so far out of the loop that you don't have a clue what your company is up to.

      Delete
  40. 1:22 pm there is an old legal saying: when you cannot attack the facts attack the law. When you cannot attack the law, attack the facts. When you cannot attack the facts and the law, attack the victim.

    This is what cowards do 1:22 pm aka 1:35 pm
    Cowards attack victims, facts and laws. You get the yellow belly award.

    ReplyDelete
    Replies
    1. Well said Philomena! One of these liars got so desperate that they attacked President Carter and peanut farmers.

      They won't stay on topic and they won't address the facts, reality and the science.

      The science on metal poisoning from spinal implants is immutable. Leave it to some industry shill to attack a victim.

      STUDY DESIGN:

      Two cases of intraspinal metallosis causing delayed neurologic symptoms secondary to spinal instrumentation surgery are reported.
      OBJECTIVE:

      To present an unusual delayed neurologic complication after spinal instrumentation surgery.
      SUMMARY OF BACKGROUND DATA:

      Metal-related complications caused by orthopedic implants have long been a concern in the field of arthroplasty or internal fixation of fractures, but no such complications have been reported for spinal instrumentation.
      METHODS:

      Retrospective case report of patients with degenerative scoliosis who presented with delayed neurologic symptoms months to years after uneventful, but without secondary degenerative changes or dislodgement of the implants.

      RESULTS:

      In both reported cases, a granulation-tissue mass characterized by marked metallosis had been formed in the spinal canal adjacent to a loosened laminar hook.

      Keep in mind that in this case it was with fixed devices.

      http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2857498/

      Even fixed devices can shed high amounts of toxic metal. This has been known for a very very long time. You'd think that in the case of plates and screws they would use carbon fiber which is inert or they would use a coating on the toxic metal.

      Delete
  41. MSM, will you agree to an interview?

    ReplyDelete

  42. DON'T FEED THE TROLLS !

    ReplyDelete
  43. Bally: too funny your statement implying that these corporate borgs "think". I do not think that they are allowed to THINK. Once you become part of the corporate culture you can no longer THINK differently or in contravention to the Corporate Handbook.

    Stryker's BoD didn't approve of MacMillan dating an ex employee. I detested the egomaniac but I didn't know whether to laugh or cry for him getting ousted for his dating someone the BoD didn't approve.

    The world is turning into a corporate mind set - which is why civilization is loosing it's grip on reality and common sense. Not to mention - humanity. The Corporation is beginning to believe they are little kingdoms - and whoever owns the most Senators and Congressmen, run the government. Right now, with Device corporations, it is about owning FDA and FBI. So all we see now is Punch and Judy shows between the industry and government. Every day they each take turns at slugging the other one, but ultimately no one stays down.

    It is all show - and until people start writing to President and Senators about their Experience with medical butchery due to the illusion between surgeons and corporations nothing will change, fundamentally. This is going to be my next project - to build a blog for people to come on to document their spinal implant damage and be assured their story will be forwarded directly to senators and president as a call for an investigation into how surgeons could knowingly destroy a patient's spine and continue to treat the patient but never diagnose the metal allergy, metal wear corrosion and contamination issues. Or why their implants were never reported to FDA as required by FEDERAL LAW.

    This blog will be up and running within two weeks... And I will quote the federal law that the surgeons are knowingly breaking to cover up their illusion with the orporation they are being paid off to stay silent about the seriousness of metallosis and lymphocytic retain from metal allergy.

    This should get the party started...

    ReplyDelete
    Replies
    1. I would urge you to include the knee and hip implant victims as well.

      Name the butchers. Name the thieves.

      http://www.failedhiplawyer.com/

      There is a blog spot blog called drug and device law. They will probably ant to link you to you and you to them.

      http://druganddevicelaw.blogspot.com/

      It is very tough for our senators and congress people to do anything. The medical industry is ENORMOUS! They silence people quite easily. Health care spending dwarfs the $1.3 trillion of combined profitability generated by every corporation in America. I will say it again...

      Health care spending dwarfs the $1.3 trillion of combined profitability generated by every corporation in America.

      The American health care in industry is 20% of the US GDP making it the 4th or 5th largest economy in the world. They control the power.

      If you need any advice as to how to drive traffic to your blog/blogs let me know.









      Delete
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