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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Saturday, November 2, 2013

HealthwatchUSA conference focuses on device implants.


Published: October 31, 2013 

By Jim Warren — jwarren@herald-leader.com   FiDA highlight
A health conference Friday in Lexington will explore various patient safety issues, including the potential risks of joint replacement implants.
"Many people in their 40s and 50s are having these devices put in today, expecting them to last 30 or 40 years. But anything mechanical eventually fails," said Dr. Kevin Kavanagh, the conference coordinator.
The meeting also will focus on the new federal Sunshine Act, which requires public disclosure of payments to doctors by pharmaceutical companies and manufacturers of medical devices.
Kavanagh said that medical devices like artificial joint implants offer advantages, but they can pose risks to patients. "They are largely unregulated, and many of them have had inadequate testing," he said.
Implants don't come with a guarantee, he said.
"You buy a toaster, you get a guarantee," Kavanagh said. "But you get a complex hip implant that may cost tens of thousands of dollars, and it comes with no guarantee. Without that, it's very hard to find out how long these devices are even supposed to last."
The Consumers Union contends that implant manufacturers should be required to guarantee their products.
Joleen Chambers, founder of the Failed Implant Device Alliance, is a keynote speaker at Friday's conference.

Jim Warren (859) 231-3255.



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