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Hip Implant Maker Recalls Product After Lying to FDA to Gain Approval

DePuy Orthopaedics Inc., lied to the FDA to gain approval for its new hip implant device, but was forced to issue a recall when faced with evidence that the ASR XL Acetabular Hip Implant System is defective.

Several thousand patients could have avoided their injuries caused by the implants if the DePuy had complied with the proper FDA approval process. Instead of complying with the proper procedures, DePuy lied to gain access to a shortcut. DePuy claimed the ASR XL hip implant was substantially equivalent to existing hip implant products which allowed the product to go to market without conducting clinical testing or trials to demonstrate safety and efficacy.

DePuy told the FDA the ASR XL would be used for ordinary hip replacements when in fact it was not to be used for ordinary hip replacements, but for a different surgery - articular surface replacement. DePuy falsified and twisted its reports to the FDA to shortcut the approval process and injured thousands of people in the process.

The first problem an ASR recipient will likely notice is pain and failure to heal after surgery. Groin, hip and back pain is common as are various sounds like "crunching, popping or cracking." The pain can cause recipients to limp, favor one leg and experiencing rising out of and sitting down onto seats. Less common problems include heat and swelling from the implant site, rash, discoloration and even fever.

The first treatment option is to clean debris caused by the defect from the implant. However, this option is often ineffective. Many patients need to have their hip surgery redone with effective hardware. In addition, the heavy metal debris generated by the product defect may put recipients at an increased risk for various cancers related to heavy metal toxicity.

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