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 jjrk_ch@swbell.net.
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.
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