A hip replacement device leaching metal into the blood stream ... is it dangerous? We sort out the facts and take a look at the evolving technology used in joint replacement surgery.
Sheila Prahin, Hip Replacement Patient: "I struggled getting in and out of cars, doing all sorts of things. The pain was excruciating at times, especially if I sat for long periods."
hip gave out, she did her homework -- consulted with specialists and researched implants.
Sheila Prahin: "We went through the whole thing of looking at the device and having meetings , and we actually held it in our hand we got to see it.
Successful joint replacement surgery in 2008 left her pain free and back on her feet.
Sheila Prahin: "I felt it was a huge relief after I had it compared to the pain I was suffering prior."
Then, just two years later, a letter arrived. Sheila's artificial hip -- a metal on metal implant -- had been recalled.
Sheila Prahin: "I just wanted to cry. It was just devastating news."
It's devastating for surgeons, too. In his 32 years of practice, Dr. James Kudrna has perfomred more than 15,000 hip procedures.
Dr. James Kudrna, Orthopedic Surgeon: "I work in a community practice. Many of the patients I take care of are my neighbors and friends. And so you develop a close relationship. I understand it's hard on the patient, but I've had many sleepless nights worrying about my patients with this."
Joint replacement is as much art as it is science. The skilled hands of a surgeon coupled with sturdy instrumentation may sound like an ideal union, but doctors admit, no device is perfect.
Dr. Kudrna: "Overall they perform miraculously for what we do. But are they perfect? No."
Ironically, it may be the pursuit of perfection that dooms some implants and leads to product recalls. From the earliest devices to the most modern, implant technology advances at rapid speed.
Dr. Kudrna: "Routinely, with the way technology changes, we see devices come out on the market and after five, six or seven years, another device comes out and everybody switches to use the new device, and, hence, we don't have that long-term data on many of the devices that have been out in the marketplace."
Sheila's now recalled hip performed well in early trials, but a British registry that tracks devices noted an increase in re-operations. Now doctors are testing Sheila's blood for metal particles, a sign of mechanical failure.
Dr. Kudrna: "The body fluids lubricate all of these bearings, and when there is a lack of lubrication, it's no different than your automobile running with no oil in the crank case. With lack of lubrication, there's excessive wear. And in the metal hip, that creates cobalt and chromium particles."
It's not the particles that concern doctors, it's what they may cause -- inflammation and pain -- much like the symptoms patients experienced before surgery.
Dr. Kudrna: "There is no evidence they cause cancer or are carcinogenic in any way."
For now, Sheila says her hip feels good. It's the unknown that doesn't sit so well.
Sheila Prahin: "It's just there. It's not like you can pick it up and throw it out of your body and say, 'From here on out I'll be ok.' But it's there and we don't know what the end result of it is."
In the end, she may have to undergo another operation to replace parts of her implant.
Dr. Kudrna: "We'd love to see 25-year follow-up data on everything we put in a patient, but we don't have that."
Doctors are finally getting their wish. A national registry -- similar to those used in Europe -- is now in place to help U.S. surgeons and consumers track implant devices and how they hold up in the long run.
To learn more about the American Joint Replacement Registry, go to www.ajrr.net
To contact Dr. James Kudrna, go to www.ibji.com
For more health news and information, check out www.HealthKey.com