Posted in Orthopedics by Arundhati
Parmar on March 12, 2014
FiDA
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At
AAOS, Consumers Union, through its Safe Patient Project, is asking surgeons to
support their demand to obtain hip, knee warranties from device makers when
implants fail early.
A consumer advocacy group has seized
upon the fairly mundane concept of product warranties to turn the heat on
medical device makers.
Consumers Union, the lobbying and
advocacy arm of Consumer Reports, sent letters to six top hip and knee makers
last September asking them to provide product warranties for early implant
failures. The letter
quoted the American Academy of Orthopaedic Surgeons in saying that 10% of
implants fail.
The group has now made a big push in
publicizing its message by organizing a campaign outside the annual meeting of
the American Academy
of Orthopaedic Surgeons, which kicked off Tuesday and ends on
Saturday, March 15.
Activists were handing out flyers
outside the Morial Convention Center in New Orleans that urged orthopedic surgeons to text
their support for manufacturer warranties. Here's what the flyer looked like:
In an interview at AAOS
Wednesday, Lisa
McGiffert, director of Consumers Union’s Safe Patient
Project, said that only Smith & Nephew formally responded
to the letter sent to orthopedic manufacturers in September. Two others
acknowledged receving the letter via email but never actually responded to the
request. The others did not respond. McGiffert couldn't recall which two
companies sent the acknowledgment.
What the group is asking for is not
unprecedented in the medical device world, she said.
"Biomet provides a warranty for a partial knee and
cardiac products have warranties," she said.
After receiving Consumers Union's
letter, Smith & Nephew responded that it is a "complicated issue"
because hips and knees can fail for a number of reasons, McGiffert said. It
could be the caused by the patient, the surgical technique or the device,
McGiffert recalled the company as saying in its response.
But McGiffert clarified that the group is focused on
"when the products are the problem." In other words, Consumers Union
is not looking for a blanket product warranty, but wants device makers to take
responsibility and stand behind the products when device-related problems cause
the joint replacement to fail.
"You get warranties for
flashlights, toasters and cars, for almost everything in the U.S.," she
declared. "I know they are less complicated, but this is something that is
going inside people's bodies. We think they ought to stand behind their products for a certain number
of years. They can decide how long."
The purpose to bring the campaign to
AAOS is to win support from surgeons and get feedback from them, McGiffert
said.
However, Consumers Union may not win
too much sympathy from the top brass at AAOS.
In a phone interview Wednesday,
outgoing AAOS president Dr. Joshua Jacobs said that the "vast majority of
orthopedic implants for joint replacement perform exceedingly well - 90% of
total joint replacements work 10, 15 years and beyond."
Jacobs did acknowledge that
"sometimes implants fail early, " but argued that "while
warranties seem like a good idea on the face of it, the issue is more
complex."
Echoing McGiffert's portrayal of
Smith & Nephew's response, Jacobs said that early failures could be caused
by patients, due to the manner the surgeon did the procedure or it could be
because of device problems. But sometimes "a complex interaction of the
three" can also lead to early implant failure. So it may not be as easy to
tease out which of the three factors caused the implant to fail.
And then there is the potential for
infection, which is out of everyone's control, that can contribute to a
failure.
"That cannot be addressed with a
warranty," Jacobs declared.
Overactive or obese patients can also
lead to implant failure, Jacobs noted.
However, another well-known orthopedic surgeon and
healthcare social media maven,
Howard Luks, disagreed with that assesment.
"I
don't think it's fair to blame the patient," he contended. "Once the
joint replacement is done, it's stable, it's done. They should be ready
to go. If the patient is obese, then why did you put it in? Device makers
understand who these implants are going into and the implants should meet those
needs. Or there should be a big red sticker on that says 'Do not put in a
patient with a BMI over 30.' So I think the patients have a right to ask for a
guaranty or a warranty on a product that is going in their body."
Luks
said that unless surgeons push the issue, device makers wouldn't move to
provide such warranties.
And it certainly appeared that way.
In an interview with DePuy
Synthes Joint Reconstruction at AAOS, executives punted the question of
warranties to the company's spokeswoman Mindy Tinsley, who responded like this:
"We understand the position that
Consumers Union has taken. We
are interested in continuing to have a dialogue about this. But I think
with joint replacements, it's a complex interaction of factors and revisions
have sometimes to do with the implant, sometimes with the patients, sometimes
with the technique. We acknowledged the letter but we haven't taken a position. This is an issue we
are continuing to explore."
Stryker
declined comment via email. A Zimmer spokesman at
AAOS said that "it's a complex issue and has a lot of factors surrounding
it." The spokesman, James Gill, also forwarded a statement from AdvaMed, the device
industry association, which argued that warranties for hip and knee implants
that involve complex procedures and involving many different players, involving
the patient and the hospital, may not be appropriate. However, it left the decision to provide
warranties to individual manufacturers.
Meanwhile, McGiffert said that Consumers Union has secured the
support of 50,000 patients who have sent emails to the top orthopedics device
makers asking for product warranties-- By Arundhati Parmar,
Senior Editor, MD+DI
arundhati.parmar@ubm.com
Submitted
by falascoj on March 14, 2014 - 9:32am.
Great graphics and story. I believe you have only hit the
surface on this story. Hopefully we will see followup stories on you asking the
medical device companies to come clean on why they are fighting the idea of
warranty. They are the only major industry or activity that operates that way.
The arguments that Mr.Gill has mentioned and the ortho surgeon are lame and I
can just see an automotive guy saying --- well be can't do bumper to bumper
because an F-150 is different then a Mustang. -Not
I've forwarded this article
to numerous groups as an example of a publication actually getting out in front
of the biggest deception on the American public since the Warren Commission.
