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Recently Added
DePuy Hip Replacement
and FDA Failed Adverse Event Reporting
The U.S. Food & Drug Administration (FDA) has received nearly 300 complaints about the ASR™ XL Acetabular Cup System since the beginning of 2008. Unfortunately, these complaints demonstrate that a considerable number of patients who had this ASR hip device surgery required revision surgery soon afterwards to fix the initial ASR problem.
What went wrong?
The number of complaints plays down a typical product's problem. Sadly, the problem is further neglected because many doctors and hospitals never bother to file reports with the FDA.
And wouldn't 300 hip replacement complaints be considered a problem that requires investigation? Patients are at great risk for a second replacement surgery.
The FDA did not approve the ASR resurfacing system in the United States; it was approved abroad only. In 2005, the FDA approved the ASR™ XL Acetabular Cup System for use in traditional hip replacement. The medical device was not required to undergo clinical trials but instead was cleared through a regulatory pathway.
Medical devices are evaluated using a risk-based classification system which determines regulatory pathway. Medical devices are ranked into one of three classes: Class I represents low-risk devices such as examination gloves which don't require performance standards. Medium and high-risk devices (Classes II and III) such as hip implants and defibrillators follow specific regulatory requirements which differ greatly.
The FDA has been criticized for being too lax and inconsistently applying standards so they are looking at ways to improve the process. Medical device makers are not too happy about more surveillance.
Have you or a loved one suffered severe pain and/or a second surgery to fix the first DePuy implant? That is so wrong! You may be eligible to file a medical device hip implant claim for compensation. Find out how the Anapol Schwartz attorneys at law can help you.
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