Defective Machinery: Should Hip and KneeReplacements Come With Warranties?
By William Heisel USC Annenberg – Reporting on Health
October 04, 2013 FiDA highlight
During my last eye exam, my doctor
persuaded me to start wearing reading glasses. I should keep my regular pair
for driving, watching football, and enjoying the films of John Cusack. But
I should wear reading glasses for what I’m doing right now – writing this blog
post.
When I received them, though, they
were so powerful that I felt like I had knocked back half a bottle of vodka. I
tried them for a few days but could never shake that shaky feeling. So I called
the optometrist and, to my surprise, I was told just to bring them back in.
They were under warranty and new lenses would be cut for me in a few days.
Now, imagine if that eye problem I
had was a hip problem or a knee problem or just about any other part of my
musculoskeletal structure. If
a doctor inserted a hip replacement that didn’t end up working and actually
made my life worse, I would be out of luck. Warranties – common in so many
aspects of our lives – are not common in orthopedic devices.
And there’s a good case to be made
that should be. Witness the massive recall of Articular Surface Replacement Hip
Systems sold by DuPuy. The New York Times wrote recently:
The implants were recalled in 2010,
but the documents show that
as early as 2008 DePuy executives were told by a number of surgeons, including
its own consultants, that the device appeared flawed. That was never disclosed
to doctors who were putting the device into patients, nor were other
unfavorable internal studies. By the time of the recall, the device had been
implanted in about 93,000 patients around the world.
And no warranty. DuPuy has tried to
make up for the problems by offering
financial assistance for patients’ recall-related medical costs,
according to company
president Andrew Ekdahl.
But what about making it explicit up
front – as with my glasses – that device failures within a certain timeframe
should be automatically replaced or that a refund should be received?
The Consumers Union’s Safe Patient Project is making a
push for warranties on hip and knee replacements. I met with their team during
their state-hopping campaign this week, and they raise some good arguments,
rooted in a Consumers Union
review of replacement products. Their main points
include:
•
All major manufacturers have
recalled a product or a line of products for defects over the last decade.
•
Most hip and knee implants are allowed on the market without being
reviewed for safety and effectiveness by the Food and Drug Administration.
•
The cost for additional surgery
and a replacement device is now largely paid by patients or their insurance
companies, including Medicare.
•
Revision surgery costs more,
results in longer hospital stays, and can often lead to additional surgeries.
•
An estimated 18 percent of hip replacements and 8 percent of knee
replacements in the U.S. are for revisions, and the cost for these procedures
is likely in the hundreds of millions of dollars per year.
The counter argument is also about
costs. Were device makers to cover all costs for all device failures, they may
be seriously hurt financially. Also, is there a reasonable expectation that a
certain percentage of any product made and sold will fail and do consumers
necessarily have a right to get a new one as a result? I used my glasses as an
example at the beginning, but if the rechargeable
battery in my iPhone fails (making my device useless) I’m out of
luck.
I will explore warranties in future
posts. Let me know your ideas, too. I’m at askantidote [at] gmail.com and on
Twitter wheisel.
Explanthis (Joleen Chambers, FiDA)
Another
issue to consider is that currently there is no patient outcome registry. Consider the thousands implanted with
failed metal-on-metal hips and transvaginal surgical mesh. Proprietary and profitable medical
device companies either missed the signal of device failure or chose to ignore
it. The patient harm in the wake
of these private businesses becomes a public health cost borne by all of us. A warranty would be a simple signal to
the company to balance patient safety with marketing and sales efforts.
