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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Sunday, May 4, 2014

They recall cars: but not failed hips?


WFAA   FiDA Highlight
Posted on May 1, 2014 at 10:00 PM
Updated today at 7:30 PM

Your car may be a lemon. But is your artificial hip?
So many Americans have artificial hips that we could be called the hip generation. But, Americans may know more about their automobiles than what’s inside their bodies and as many as a million may be suffering damage they don't know about.
Generally, a hip replacement is very effective, but the process remains costly, unregulated and, some say, potentially harmful.
Right after her total hip replacement, Rebecca Thompson said she felt a “clicking” in her new joint. But, her DePuy hip had been on the market for years — tried and true, the company said.
Not until several years after Thompson, who lives in Burleson, got her hip did DePuy publicly admit it had a problem and recalled the device.
“It was like, ‘They recall cars, they don’t recall body parts. What’s going on?’” she recalled.
A total hip replacement consists of a cup and a ball. From the early 2000s until 2010, those components were often made of chromium cobalt metal in what's called metal-on-metal hips. As the parts grind against each other, they can produce particles of chromium cobalt that can cause a dangerous condition called metallosis in which metal debris builds up in the soft tissues of the body.
It’s a condition Dr. Stephen Tower of Anchorage Alaska knows firsthand.
As an orthopedic surgeon, he has replaced more than a thousand hips. An active outdoorsman, when his own real hip started bothering him, he had a new one installed in himself.
But soon the artificial hip was as painful as the real hip it replaced.
“The toxic effect of the cobalt destroyed all the ligaments around the hip,” he said. It also produced “pseudo tumors,” or non-cancerous fleshy growths.
He began studying the chromium cobalt levels in his own blood, as well as his patients.
“They were clearly experiencing neurologic toxicity or psychological toxicity or cardiac toxicity from that hip,” he said.
He said that in the last decade, up to “90 percent of the hips that have been replaced in the United States are potentially at risk for problems.”
Artificial hips are increasingly sold as products, with advertisements appearing in, among other things, national newscasts. And for most Americans, their new joints work very well.
“In the United States we perform about 400,000 hip replacements each and every year,” said Dr. Jay Mabrey, chief of the Department of Orthopedic Surgery at Baylor University Medical Center and a Professor of Orthopaedic Surgery at the Texas A&M School of Medicine.  He’s also former chairman of the FDA’s Orthopaedic Device Panel.
“Total hip replacement is one of the most successful orthopedic procedures,” he said.
That said, Mabrey added, “metallosis is a huge problem for certain types of implants.”
“I have a lot of patients with these metal on metal hips,” Mabrey said, and “when they move after sitting for a while, they get that click… That’s metal on metal. Just like your car engine, you really don’t want metal rubbing up against metal.”
Science is starting to view the amount of chromium cobalt in the bloodstream with more concern than in the past. The threshold for concentration in the bloodstream, Mabrey says, used to be 7 parts per billion of chromium cobalt. “Some people think you should be concerned at 2 to 3 parts per billion.”
On April 19, Texas Rangers fans got a firsthand look at what a successful hip operation can do.
Pitcher Colby Lewis got his first win on the mound since 2012. It was his second major league start since having his hip resurfaced, an operation similar to a total hip replacement. And it has, so far, helped turn around his career.
The price for miracles like this hard to determine – even for doctors.
“A lot of this is confusing to surgeons,” said Dr. Stephen Tower in Alaska. “A lot of this is funny money. People get these incredibly high bills and what actually gets paid is a percentage of that.”
A hip can easily cost more than a car.
Scott Abram has had three total hip replacements. One has been problem free; the other, a source of constant paint that ultimately had to be replaced.
Hospital records show his insurance company was billed more than $20,000 for his most recent hip. The total bill for that one was $60,000. He doesn't know how much was finally paid by his insurance company.
The price pales in comparison to the agony he’s endured for eight years.
“I'm in pain every minute of every day and all night long,” he said.
He’s an airline pilot, but the pain has kept him from working for nearly a decade. . 
“There wasn’t a great deal that was explained to me ahead of time,” he said. 
What he didn’t know was that his hip was never rigorously tested. Like other devices, it was approved by the FDA in a shortcut process called 510 k. 
“If they were similar to other products on the market then you could release these other models onto the marketplace, without adequate testing or data,” said Dr. Shezad Malik, a Dallas physician who is also a lawyer. He is suing the company that made Scott Abram’s hip.
Hips are failing, he says, at a rate higher than the public realizes.
“In Australia and the UK, they’ve found actually double digit failures,” Dr. Malik said. “And the failure rate can be as high as 50 percent at five years.” 
In the last 10 years, there have been 578 different recalls of hip implants from six major manufacturers, according to the Safe Patient Project, which is affiliated with Consumers Union.
The problem is, most patients don’t even know what kind of hip is in their body.
“We don’t know how many of those patients have died. Others may not be mobile. Families don’t know what’s going on,” Dr. Malik said.
One manufacturer, DePuy, has already settled a class action lawsuit for $2.5 billion. It faces another class action lawsuit for another of its artificial hip models. Other manufacturers are being sued as well.
But lawsuits won't solve the problem for the 1 million people with chromium cobalt in their hips across the country. Like owners of recalled cars, they could be headed for a crash and don’t know it.

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