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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Friday, October 4, 2013

Defective Implants: Warranty?

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] 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.

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