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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Tuesday, September 10, 2013

Warranty on hips, knees: Consumers Union petition needs your signature!

Guarantee that knee, fix that hip!
The most important (and expensive) product you may ever buy doesn't come with a warranty. It's time we change that.
Medical device manufacturers are making billions by selling knee and hip implants to Americans who want to feel better and play longer. But when these devices fail, patients – as well as taxpayers – are faced with costly bills to replace them.
Manufacturers claim implants are safe and of high quality. If that's true, why aren't all the major companies (only Biomet warranties one of its knee products) backing up these implants when they fail? 
Consumers Union has sent the top six hip and knee makers details of what should be in a strong 20-year warranty, and asked them to comply. Sendyour own message now, and let's make sure manufacturers – notpatients – are on the hook when products fail!

Artificial hips and knees need a lemon law, says Consumer Reports
By Joel Keehn   FiDA highlight
Published September 10, 2013
Consumer Reports  On Twitter:  @ConsumersUnion and @CUsafepatient
Imagine if you had to take a new car back to the dealer to get a defective part fixed and you, not the manufacturer, had to pay for the work. Well, that’s the situation with artificial knees and hips.
Nearly 20 percent of the hip replacements done each year and 10 percent of the knee replacements are revisions, often done because the original device was defective. Those follow-up surgeries tend to require longer hospital stays than the initial procedures, pose additional risks, and have a higher price tag, too. Yet their costs are passed onto consumers or their insurance companies, including Medicare.
That’s one of the reasons Consumers Union, the policy arm of Consumer Reports, says manufacturers of hip and knee implants should give patients warranties, guaranteeing to replace defective devices at no cost. That, they say, is not only fairer to patients, but might encourage companies to make their devices safer and more durable.
“While patients may be told by their surgeon how long a device can be expected to last, they rarely get a guarantee in writing since most hip and knee implants do not come with a warranty,” said Lisa McGiffert, director of Consumers Union’s Safe Patient Project.

The SafePatientProject recently gathered information from the Food and Drug Administration on hip and knee implant recalls over the past 10 years, and found that all major manufacturers had recalled a product or line of products. And some of those recalls involved products that posed real risks.
See our surgery Ratings for hip and knee replacement as well as our advice on smarter hip and knee repair. Our hospital Ratings offer detailed information on more than 4,000 hospitals nationwide. 
For example, since 2003 about 750,000 Americans received metal-on-metal hips, which were supposed to last longer than devices made with ceramic and plastic. Not only were such hips more likely to fail, but also some patients experienced debilitating symptoms from metal debris that flakes off the device over time, including heart damage and neurological problems.
Knee implants have not failed as often or as dangerously, but the Safe Patient analysis found that hundreds of knee-implant components have been recalled since 2003, often because they were shipped with the wrong part, a wrong size part, a missing part, or a part built for the left side etched as a right, or vice versa.
As our earlier report on dangerous medical devices found, most hip and knee implants are allowed on the market without being reviewed for safety and effectiveness by the FDA. Instead, under current law, the companies simply have to demonstrate that the devices are “substantially equivalent” to a product already being sold. Since most new hip and knee implants are similar to ones already on the market, manufacturers can gain approval through the FDA’s fast track 510(k) clearance process without having to prove the device is safe and effective.

“Medical device companies claim that current law provides adequate protection for patients and that their implants are dependable and safe,” said McGiffert. “If that’s the case, they should have no objection to offering warranties to back up those claims. Patients and taxpayers shouldn’t be on the hook for the cost of replacing devices when they fail.”
The Safe Patient has urged the makers of hip and knee implants, including Biomet, Inc., DePuy Synthes, Smith & Nephew, Stryker Corporation, Wright Medical Technology, Inc., and Zimmer Holdings Inc., to provide a 20-year warranty that:
covers the full cost of the revision surgery, including the device itself, the surgeon and hospital costs, and patient out-of-pocket costs;
establishes a clear system for patients to use, including a toll-free phone line and a registration number to track the claims process, with physicians charging the device company, not the patient; and
does not eliminate the patient’s right to sue if he or she uses a warranty.

In addition, you can contact (Chief Medical Officer) (Deputy Chief Medical Director) 
Lead purchasing decision-makers in the U.S. who need to know from each of you that implanted medical devices are poorly vetted globally, they harm people permanently, the harm is preventable and patients are not given informed consent.

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