New York, NYDePuy Orthopaedics, a unit of Johnson & Johnson, announced this week that it is withdrawing its artificial hip implant.
The action follows reports of the implant - known as the ASR - failing on patients, and generating metallic debris which can cause additional health problems such as inflammatory responses, muscle and soft tissue damage.
The ASR is a metal-on-metal implant, and the microscopic metallic debris it generates may result from a design flaw. Additionally, the ASR can be difficult to position properly, which can also result in problems for the recipient.
According to a report in the New York Times, the FDA has received approximately 300 complaints since January 2008, from people who have had to undergo surgical replacement of the ASR because the implant had failed. However, this number may only represent a fraction of the people who have experienced medical or health problems from the device, as the majority of adverse events tend to go unreported.
According to Dr. Stephen Graves, the director of an Australian implant database, the problems with the ASR have been apparent for some time, including early failure rates at a significantly higher incidence than that seen with competitors implants. DePuy pulled the ASR from the Australian market in December 2009.
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