You may think if a doctor prescribes a medical treatment, it's been thoroughly tested. But for at least one type of treatment, you'd be dead wrong.
Dr. Stephen Tower is an orthopedic surgeon. When the arthritis in his hip became too painful to bear, he decided to get a metal-on-metal replacement. But the new hip caused him so much agony, exhaustion and depression that he had to have it removed.
"The tissues around the hip had been destroyed and that metal debris was spreading down my thigh," Tower said.
Tower said normal friction in the artificial joint caused cobalt - a toxic metal - to be released into his body, leading to serious tissue, heart, brain and thyroid problems.
"This particular type of hip was called the ASR XL," said Consumer Reports' investigator Nancy Metcalf. "It was made of chrome cobalt metal, but it was never clinically tested before the FDA cleared it to be sold. Because of high failure rates and complications like Dr. Tower experienced, it's now off the market."
Atlanta attorney Richard Schlueter is representing dozens of clients who received the now-recalled implant. And it's estimated that several thousand people in Georgia are affected.
"I've had clients of mine that have had as many as six surgeries and have been without a hip for as much as a year," Schlueter said.
In 2010, Calhoun Police Lieutenant John McGivern was rushed to the emergency room, having developed a near-fatal infection five years after the defective hip was implanted.
"I just thought I'm going to go in there and they're going to give me a pain shot," McGivern said. "About 50 days later, I woke up. I was in a coma."
Thirteen surgeries later, he returned to work with a new hip but said life will never be the same as it was before.
"It has changed everything, totally. I can't walk very far, I can't run. I can't stand very long," McGivern said.
And after racking up more than $1 million in medical bills, the company that made the ASR hip has refused to pay, leaving McGivern in dire financial straits.
"It's a recalled hip and I feel like they're responsible," he said.
And Schlueter said time is running out for victims to pursue legal claims. "I would encourage anybody that has this device to consult with a lawyer to at least know their options and to make sure they bring a claim before the statute of limitation runs," he said.
While metal-on-metal hips have been widely criticized, a Consumer Reports investigation has found there are other dangerous devices that are being implanted.
"Hundreds of thousands of women have had mesh slings inserted to support internal organs as they age, like the uterus and bladder. Again, these products were never clinically tested before being marketed for this use," Metcalf said.
Lisa Clark lived with pain for nearly 10 years before realizing it was the surgical mesh, implanted to help support her bladder, that was causing her pain.
"Painful intercourse, just movement, if I was sitting wrong, just with anything - it was horrible," Clark said.
The FDA's own database shows thousands of complaints about the mesh, including debilitating infections. Yet it's still on the market - not even classified as high-risk.
"The number one complication is erosion or extrusion, also known as exposure. They literally come back out through the skin. That usually causes bleeding and a lot of times it'll cause pain," explained Dr. John Miklos, a vaginal reconstructive surgeon.
Miklos said women need to understand the risks before surgery. "There is a potential risk of a second surgery. There's a potential risk of going back in on the second surgery and having further complications. When the mesh is in place, it is hard to remove."
But it's not impossible. In the last 14 months, Miklos and his partner, Dr. Robert Moore have removed mesh from nearly 100 patients, including Clark.
"It's just night and day. I have no more pain," Clark said.
Still, patients aren't guaranteed a cure. Miklos said sometimes there's permanent damage, even after the mesh is removed.
In both cases, the devices were cleared by the FDA through the 510(k) approval process. That means they were 'substantially equivalent" to other devices already on the market. Last year, the Institute of Medicine called for the 510(k) process to be eliminated because it could not guarantee safe and effective devices.
"We strongly believe that the FDA should require rigorous testing for implantable devices just like they do for prescription drugs now," Metcalf said.
Consumer Reports says creating a national registry is essential to keeping track of implanted medical devices and to alert patients if there's a problem. Currently, there's no such tracking in the U.S. and it's estimated only a fraction of device problems actually do get reported.
Click here for more information from Consumer Reports.
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Friday, May 17 2013 7:16 PM EDT2013-05-17 23:16:53 GMT
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