Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Twitter: @JjrkCh

Monday, November 14, 2011

Failed implanted medical devices-Senate hearing Tuesday 11/15/11

Click here to view video of Steven Baker's comments.

My name is Steven Baker.   These are my comments to be presented to the
November 15, 2011 - 2:30pm Senate Health, Education, Labor and Pensions full committee on Medical Devices: Protecting Patients and Promoting Innovation.

Have any of you heard of the 1950’s radio/TV show ‘Truth or Consequences’?  The medical device industry lobby is playing the game ‘NO Truth and NO Consequences’ with Congress.  Congress is enabling this industry to fleece the taxpayer of essential and limited healthcare funds and endanger patients and their families for profit.  You must change Federal public policy.

On October 5 - ten years ago - I was a valued 23-year union millwright, proud Air Force veteran and father of two middle school children living on Cardiff Lane, less than a mile from Republican Congressman Erik Paulsen’s Minnesota 3rd district office.  That day I was offloading a clients’ catalog printing press to be compressed at a scrap yard when another worker’s mistake pushed me - forcing me to fall four feet down into the scrap.  My right arm was badly mangled.  Seven surgeries and 8 years later, it was clear that I could not return to the work I loved and I reluctantly began receiving SSDI for my permanent injury.  My surgeon recommended that I consult the Mayo Clinic because there was a new innovative elbow joint replacement option that would reduce pain and increase function. 

The Tornier Lateral Elbow prosthesis was surgically implanted in my right arm on May 19, 2008. It was paid for by private insurance covering my work injury.  The healing process went well for several weeks, but then I noticed that - during movement - it would make a popping or creaking sound. Early in September 2008 in a phone conversation, I told my sister, Joleen Chambers, that the elbow was blue/green and I was in extreme pain.  She was so concerned that she took it upon herself to fax the Mayo Clinic.  On September 29, 2008 the prosthesis was surgically “revised” just 4 months after the original implant.  The surgeon designer told me he would re-attach the radial stem to the head, but both components were removed and confiscated for 1 year.  I asked the doctor to report the adverse event to FDA MedWatch.  He didn’t.  On November 18, 2008, number #5009052 was assigned to my self-report.  Freedom of Information FOI reported March 4, 2009 that the file could not be located.  There was no investigation.

I am now in medical and legal purgatory.  The private insurance company is balking at paying for another surgery, I am in extreme and constant pain, the elbow does not function, my teeth are falling out because I have been prescribed long-term, maximum dose hydrocodone pain medication which dries the mouth, producing cavities that weaken my teeth so much that they disintegrate & disappear as I sleep.  Tornier declines to help innovate a custom device solution.  The Mayo Clinic sent me a letter stating that no care other than federally mandated emergency care would be provided.

I have done all the normal things an enlightened and empowered patient could do.  I have tried to communicate first with my doctor, the hospital patient affairs office, the trustees of the Mayo Clinic, my U.S. Congressman Erik Paulsen, the U.S. Senators Al Franken and Amy Klobuchar and the FDA.  All this I have done while disabled, medically impoverished and in pain. 

Too late, I learned that medical devices are not properly regulated.  Implanted medical devices should be given the most rigorous scrutiny, yet they are
cleared through the 510(k) process that on July 29, 2011 the IOM-Institute of Medicine-reported should be scrapped.  There is no clinical testing prior to clearance and no national independent, robust post-market registry to show that innovations are any improvement over no surgical implant device or the ones that are currently available!   Legal entitlement of the medical device industry conflicts with patient’s individual civil rights.  My Mayo Clinic surgeon was the designer of the device and he also is paid to train other doctors by that device company-contrary to Mayo stated policy of having only salaried physicians on staff. 

Joint replacements are now the #1 expenditure of Medicare. The life cycle of medical devices from inception to FDA clearance to market to surgical implant excludes the patient stakeholder.  Patients/consumers and their advocates should be full voting partners in this endeavor.  Marketing, politics and lobbying currently drive decisions by practitioners, purveyors, and payers in selecting what they anticipate to be life-enhancing implanted medical devices.  Experience, data and science are evaded and suppressed.

On May 28, 2009 I had an appointment with Representative Paulsen.  He and his staff offered me no constituent services and the meeting was brief.  The revelation that he is spearheading the effort to eliminate medical device industry Medical Device User Fees clarifies his cavalier attitude about the failed implanted medical device that brought me to his office.  My elbow was produced by Tornier, a company with its’ world headquarters just 6 short miles from his office.

Because of my disability I must leave my family and my life-long home in Minnesota each winter to avoid the painful cold and dangerous icy conditions.  

Valuable jobs in the medical device industry will be secured only by a regulatory system that truly rewards safe and effective innovation.  I am a big fan of innovation and proved it by twice trusting Tornier, the surgeon/designer and the Mayo Clinic with my life.  My advice to this committee:  halt this dangerous game of NO Truth and NO Consequences.  Properly regulate this industry.

Contact :
Steven Baker 952.261.5204
Joleen Chambers
1717 Arts Plaza #2109
Dallas, TX  75201
h 214.965.9730
m 214.394.4432
Failed Implanted Medical Devices  
Twitter:  @JjrkCh

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