Hip implant recall affects 600 Danes

Authorities failed to inform all the affected patients of the danger, report media

Some 600 Danish hip patients were the unlucky recipients of hip replacement prostheses that have since been proven dangerous and recalled by their manufacturer. Some of those patients are still in the dark about the danger.

Between 2005 and 2010, almost 600 Danes received the now-recalled ASR hip implants. In August 2010, the American manufacturer of the implants, DePuy Orthopaedics, announced that it was recalling the ASR hip prostheses after discovering that the implants’ metal components were shedding miniscule metal shavings into the body under the friction of normal daily movement.

Those metal shavings could cause joint, muscle and nerve damage, among other problems, the company announced.

Unfortunately, some 93,000 patients worldwide received the implants before the company acknowledged the design flaw and announced a recall. Some 600 of those are in Denmark.

“It was a design failure that frankly wasn’t picked up until they were implanted in thousands of patients,” doctor Kevin Bozic, an orthopaedic surgeon at the University of California at San Francisco Medical Center, told Arthritis Today magazine.

When DePuy Orthopaedics did recall the hip prostheses, the Danish medical agency Lægemiddelstyrelsen left it up to individual surgeons to contact their patients who received the implants and inform them of the situation.

Nearly 18 months later, however, some of those patients still have not been told that they are living with a health-threatening implant inside their bodies, reports Politiken newspaper.

“If we went out on every street corner and shouted out that these prostheses are dangerous, a lot of patients would be made very nervous,” Søren Mikkelsen, the head surgeon at Regionshospitalet in Silkeborg, told Politiken.

Regionshospitalet is the hospital where the most ASR prostheses were implanted in Danish hip patients.

Mikkelsen told DR news that all 151 hip replacement patients who received the ASR prostheses at Regionshospitalet had been informed of the recall. Mikkelsen regretted, however, that it had taken the hospital some months to contact everyone.

“Half of them have been examined, and the rest of them will be. I hope we can examine everybody before we end up in a terrible situation where someone’s pelvis or hips are injured,” he added.

Dorthe Falkenberg is one hip replacement patient who received an ASR hip prosthesis at Regionshospitalet. Falkenberg was given the ASR implant in July 2010, just weeks before it was recalled.

But she says her surgeon never told her that it had been recalled and could endanger her health. She only learned that there was a problem after reading an article in consumer magazine Kontant, she told the same magazine.

According to Kontant, UK doctors and medical researchers began reporting problems with the ASR implants as early as 2007.

To date, seven of the nearly 600 Danish hip patients who received the ASR hip prostheses have had them removed and received monetary compensation from the national patient insurance agency for undue pain and suffering.

Symptoms that the ASR implants may be failing include pain and walking difficulties, according to DePuy Orthopaedics. The company encourages all people with ASR hip implants to contact their surgeons for an examination, whether they have experienced discomfort or not.

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