The Hip Generation: Despite Failures and Recalls, Manufacturers Offer No Guarantees
by BYRON HARRIS FiDA highlight
WFAA
Posted on June 9, 2014 at 10:14
PM
Updated Monday, Jun 9 at 11:06 PM
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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.”
E-mail bharris@wfaa.com
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