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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Wednesday, June 11, 2014

Taxpayers Lo$e: No Warrantie$ on Million$ of Hip Joint Replacement$

The Hip Generation:  Despite Failures and Recalls, Manufacturers Offer No Guarantees

by BYRON HARRIS  FiDA highlight
Posted on June 9, 2014 at 10:14 PM
Updated Monday, Jun 9 at 11:06 PM

                Study: 2 percent of Americans have new hips, knees
                J&J to pay $2.5B to settle hip replacement suits
                British doctors urge against metal hip joints
                MORE: From News 8 Investigates

It's estimated that in 15 years, patients in the U.S. will be getting as many as 1 million hip implants a year.
The hardware is relatively simple, but the operation is expensive, ranging from about $15,000 to $60,000, depending on who's paying for it.
Despite the simplicity and the high cost, there are no guarantees for the product. And some people think there should be.
A hip implant consists of a cup implanted in the patient's pelvis, and a ball implanted into the end of a patient's thigh bone.
The hardware costs as little as $350 to manufacture, but the selling price can be as much as $6,000, doctors say.
But despite the markup and the simplicity, the parts of a hip implant are not guaranteed.
If a hip fails and gets recalled, who pays for the new surgery... and the hardware?
“You do, or your insurance company, Medicaid or Medicare,” said Suzanne Henry, a policy analyst for the Safe Patient Project, part of Consumers Union.
And hip implants do fail.
“I’ve got a scar 16 inches long,” said Mary Rodriguez, who lives in Frisco. “I've got so much scar tissue, it feels like knots. Every surgery you have, there's more.”
Rodriguez isn’t exactly sure what's wrong with her hip. Her first transplant three-and-a-half years ago was a disaster.
She found a second doctor to put in a new one last fall. It's a definite improvement. Her pain has been cut in half, but it's still tremendous, she says.
“I take Oxycontin twice a day,” Rodriguez said. “I take hydrocodone twice a day. And then I take Naproxen for the swelling.”
Some doctors tell their patients what brand of implants they provide. Many don't.
Doctors told Rodriguez the manufacturer of her first hip, but not for her second. She doesn't know exactly what's in her body, or what exactly was done to her hip.
Consumers Union surveyed implant patients about their operations.
“When we asked them, 'Do you know if your device is under a warranty,' or, 'Do you even know what kind of a device you have,' the vast majority responded and said they didn't know the device and they just assumed there was a warranty,” Henry said.
Consumers Union has asked hip manufacturers to provide warranties on their hardware.
“We simply want them to cover problems with the device. And I think they have the tools to do that,” Henry said.
When Consumers Union wrote to the six major medical device makers, asking them to respond to the warranty idea, only one replied favorably. But that company, Biomet, has since been bought by another, so its warranty policy is unknown.
Manufacturers know when their products are failing, but face little or no cost when they do.
The cost for new hardware, surgery and rehab is borne by insurance companies and Medicare — the taxpayers.
Do manufacturers know what their failure rate is... and do they keep it secret?
“They certainly don’t advertise it,” Henry said. “What we’ve seen in the past when there were problems with metal-on-metal hips is that the manufacturer — specifically DePuy, a subsidiary of Johnson & Johnson — was aware of the failure rate and did not inform the public.”
In the Johnson & Johnson case, the manufacturer has already settled one lawsuit for $2.5 billion.
Implant failure rates from Britain and Australia helped force the settlement. National failure rates are not kept in the United States.
And so far, there’s no sign of hip warranties.
“If one company starts, they might find that that's what separates them from other companies, offering a warranty,” Henry said.
About 95 percent of hip implants are successful. Only a portion of those that aren't are due to faulty hardware.
The hardware business is extremely profitable. And regarding warranties, the manufacturers’ answer to patients so far remains: “See you in court.”

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