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

Thursday, November 8, 2012

Gratitude for Blog interview by 'Confident Voices' Beth Boynton

November 7, 2012 By Beth Boynton
“Escape Fire” is a documentary film that explains how broken our healthcare system is in some big ways and inspires focus on people who are working to make it safer, kinder, and more cost-effective.  We can do amazing things in USA healthcare, but not always.  And when things go wrong, patients, families, and even healthcare professionals suffer terribly. As tragic as such eye-opening experiences can be, some people respond by trying to understand what went wrong and why and then work to prevent similar problems from happening to others.  In today’s post, I interview Joleen Chambers, who’s brother, Steven had elbow replacement surgery at the Mayo Clinic.  The replacement elbow failed, leaving him with more suffering and a healthcare system that is unresponsive and unaccountable.

Tell us a little bit about your background.
I grew up in small town Minnesota in a family of three children. I am the middle child and my brother is younger than me by 4 years.   After college I married and completed my education with a MS in Rehabilitation Counseling in Chicago.  I have enjoyed living on the east coast and the last two decades in Dallas, TX.  I am active in support of the arts locally and of women’s leadership programs statewide and nationally.
What led your brother to seeking a right elbow replacement at the Mayo Clinic?
My brother is a life-long Minnesotan, Air Force veteran and father of two young adults.  For seven years he attempted to overcome a severe work injury by having 7 surgeries of plates and screws to hold his elbow together.  Maintaining employment as a millwright (a 20 year-long job that he loved) became impossible.  Finally, his surgeon in Minneapolis, MN told him about the Mayo Clinic option to have an elbow replacement
What happened after the surgery and how is he doing now?

Steven was quite confident immediately after the 5/19/2008 elbow replacement that he would have significantly less pain and more functionality, but at just 4 months, he felt and heard the elbow “pop” and the pain began.  My advocacy began one morning when I called Steven and he was in so much pain he could not speak/think clearly.  His arm was yellow, green, blue, purple & black.  I phoned his surgeon/Tornier device designer, Shawn O’Driscoll and Steven was told to return to the Mayo Clinic.  On 9/29/2008 the elbow was “revised”.  When Steven read the clinical records he learned that two components were removed.  Steven asked that the surgeon report the elbow to the FDA MedWatch because a revision of a joint replacement is considered an adverse event.  The surgeon refused (and is not legally required to report unless there is a fatality).  Steven reported as #5009052.  I became his ‘scribe’ because of his injury and the amount of correspondence that was required.
How did the Mayo Clinic respond to concerns about the elbow and your brother’s persistent problems?
 There was an astonishing disconnect between the marketing (patient-centered care) and the reality of care for this harmed patient.  A registered/certified letter I wrote to the Mayo Trustees went unanswered.   Steven and I met with Mayo Clinic Patient Affairs to no effect.  Steven was referred to surgeons with less experience than the original surgeon (trained by Tornier and only on cadavers!).  July 10, 2010 Steven received a letter stating that Mayo Clinic would provide only federally mandated emergency care because of ‘communication and trust difficulties’ with no notice and no appeal. This summer I applied and competed for a scholarship to the Mayo Clinic Social Media Summit and I was ‘unselected’. 
What are your concerns about the surgeon, the medical device, (elbow replacement) and the medical device company?
I believe that the surgeon/designer is conflicted by his profitable business association with the medical device company.   His elbow (which is an innovation on the more traditional Morrey elbow) had not been proven to be safe and effective.  It was FDA approved through FDA 510(k) process that does not require clinical testing.  The Institute of Medicine  7/29/2011 report states that 510(k) is flawed legislatively.  In Canada, the elbow had been recalled.
What are your concerns about the judicial system in situations where medical devices fail and or cause problems for patients?
Lawsuits (especially class action, i.e. metal-on-metal hips, surgical mesh, ICD, etc.) highlight that current regulation of implanted medical devices is in disarray and does not protect patients.  Patient harm from implants is catastrophic and cannot be compensated in a court of law.  It is too little, too late! 
Tort reform limits the cases that injury lawyers can afford to take and Supreme Court Riegel v Medtronic gives the medical device industry preemption from state courts.  The system is corrupted because there is no feedback to/accountability by the medical device industry that prompts responsiveness to reduce/eliminate patient harm. 
What are you doing to make healthcare safer?
I use social media to join with other patient advocates, consumer organizations and activist legislators to support

their efforts and to stay current with progress towards:
             Medical device registry accessible to patients,
             Unique device identifiers (UDI),
             Product warranty,
              FDA Patient Representative stakeholders with full voting rights,
             Rescind/reduce medical device industry judicial entitlements.
Do you and/or Steven have anything you would like to ask Dr. O’Driscoll?
I would ask him, if he believes that his treatment of my brother fulfills the Hippocratic Oath he took and to please explain.

Steven would ask Dr. O’Driscoll two questions:

1. How do you justify continuing to implant Tornier elbows when the patient harm is so catastrophic and the failure rate is undetermined?
2.  What was it about my communications that prompted you to request of Mayo Clinic that I be medically abandoned by the entire institution without appeal?

Thanks Joleen,  for all of your work to help create safer kinder healthcare.  You can reach Joleen Chambers at

I wonder how tricky boundaries we face in healthcare sometimes and ask how we have create systems that respond to patients when we think we can help them but shut down when we fail.
To understand more about our struggling healthcare system and get involved, watch the movie, “Escape Fire” on Itunes or through  “Escape Fire” Website.  The trailer itself is full of talking points!

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