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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Thursday, February 27, 2014

Patient advocates enlist orthopaedic surgeons' support: AAOS New Orleans

    
Posted by Daniela Nuñez, Consumers Union  FiDA highlight

Since last September, Consumers Union’s Safe Patient Project has been calling on the top hip and knee manufacturers to warranty their products. A warranty would cover revision surgery for patients if their implant is defective –for example, if the implant breaks, fails to adhere to the patient’s body or emits metal particles into tissue or blood. Shockingly, only one hip and knee implant part comes with a warranty, yet more and more patients are getting these implants installed in their bodies.
To help us understand what patients really need, we’ve asked thousands of people with artificial hips and knees to tell us what they expect from a good warranty. Now, we’ve started asking orthopedic surgeons who implant these hip and knee devices what they think about our warranty idea. As experts in their field, we think they’d give us some good input. A surgeon in Florida shared his thoughts on warranties in a guest blog post. Some orthopedic surgeons in Washington state had helpful comments, with several stating an interest in the idea. And a researcher who has analyzed hip and knee implants retrieved from patients over the past 30 years reached out to us with a very useful perspective on the issue.
In our newest effort to get more feedback from surgeons, our Safe Patient Project team will head to the American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting in New Orleans March 10-14, 2014. We tried to pay the registration fee for us and several patient safety activists, but an AAOS representative told us that this is a “private meeting and not open to those outside the medical field or official exhibitors.” So, we will be outside the meeting and around New Orleans ready to talk to surgeons about why we think hip and knee manufacturers should back their products with a warranty and identifying supporters.
Unfortunately, many patients are left in the dark on how long their hip or knee implant will last — even though most people are given an estimate, there is not a solid guarantee to back that up. Patients also need a clear process to follow if their device fails unexpectedly, something that is routinely offered with warranties. And when a hip or knee implant fails, insurance companies, Medicare and patients are forced to foot the bill while the implant maker doesn’t have to pay a dime. That should change.
Surgeons play an important role in the success of a patient’s hip or knee replacement. We look forward to getting their feedback! And we hope we can enlist their support for warranties.
(If you are an orthopedic surgeon, please email us your thoughts on a warranty at safepatient@consumersunion.org. If you’ll be at the AAOS conference, let us know!)


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