CBS Atlanta 46Thousands Living With Recalled Body Part 3-02-2011

By Stephany Fisher, CBS Atlanta Anchor
ATLANTA WATCH VIDEO
Taking the dog for a walk is something Mary Ellen Lebeda used to take for granted until three years ago, when her right hip gave out and had to be replaced.
"It was very hard. You have to learn how to walk again," she said. "It's painful, very painful."
At 41 years old, the mother of two thought surgery would make things better, but the pain only got worse. "I kept saying to the doctor, 'OK, when is this pain going to go away? When it is supposed to feel normal again?" Lebeda said. "Then finally, I got a phone call saying, 'Guess what? This is recalled."
The artificial joint implanted in Lebeda's body had been recalled.
Its makers, DePuy Orthopaedics, recalled the ASR Hip System in August because it was wearing out faster than expected in some patients. But Atlanta attorney Richard Schlueter, who's representing about 30 metro Atlantans with the defective hip, said DePuy downplayed side effects that are far more serious.
"They started seeing something that's commonly referred to as metallosis," Schlueter said.
As the device wears, it can shed metal particles and cause swelling, pain and permanent tissue damage. Schlueter said one particular metal is a real cause for concern -- cobalt.
Dr. Caroline Abruzese said our bodies need cobalt, but there is such a thing as too much. "When levels are elevated, we're not sure of all the effects, but some of them may be harmful," Abruzese said. Cobalt levels below one part per billion are considered normal. Levels above five parts per billion are highly toxic.
"Mine are 9.9, so to me, that's dangerously high," Lebeda said. "The patients we're seeing are having anywhere from 20, 30, 40 levels parts per billion," Schlueter added.
Abruzese said some people can tolerate high levels of cobalt, but others -- especially those with diabetes or impaired kidney function -- may experience big problems.
"It can affect the heart and cause symptoms like chest pain and shortness of breath, it can affect the kidneys," she said. Other potential problems include ringing in the ears, called tinnitus, visual changes and even weakness or numbness in the hands and feet. Some of these symptoms may be reversible, but for many people, including Lebeda, getting back to normal will require another painful surgery.
"Knowing what I have to go through, I'm mad," Lebeda said. "I shouldn't have to go through this. You get it done once, you trust that they're putting the right device in you, and then this happens."
If you have the ASR Hip System, Abruzese and Schlueter suggested that you ask your primary care physician to check your cobalt and chromium levels, even if you aren't experiencing symptoms.
DePuy declined an interview, but did issue the following statement:
"DePuy's top priority is and always has been patient safety. In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new information from the UK National Joint Registry as part of the company's ongoing surveillance of post-market data concerning the ASR Hip System. After reviewing this data, DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System. This data showed a five-year revision rate of approximately 12 percent for the ASR Hip Resurfacing System and approximately 13 percent for the ASR XL Acetabular System, which was not in line with previously reported data.
DePuy's previous analyses of collective post-market data from a variety of sources -- including national joint registries, published literature, company-sponsored clinical trials, internal complaints data and external clinical research reports -- had shown lower revision rates.
We understand that this recall is concerning for patients, their family members and surgeons. Since the recall decision was made, DePuy has worked to provide patients and surgeons with the information and support they need.
DePuy is committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary. DePuy will also pay for reasonable expenses related to receiving care, such as lost wages and travel costs.
The company has made detailed recall information available on Depuy.com and has created a help line for patients to have their questions answered and submit claims for reimbursement. We encourage patients to call the ASR Help Line at 1-888-627-2677."


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