Study Cites Women More Likely to Experience Hip Implant Failure

Often, when elderly people fall and break a hip, people react as if this injury may be a death sentence.  The reason for this kind of alarm is that with reduced mobility, increased pain, and the risks for fixing the bones, an elderly person's health could very well suffer.  

Hip implant makers sought to remedy these fears, offering a sturdy hip replacement that could increase mobility and offer people a richer lifestyle. Of the approximately 400,000 Americans with hip implants, a new study cited in USA Today states women are 29% more likely to experience a failure in hip implants. This U.S. Food and Drug Administration funded research was recently published in the JAMA Internal Medicine, a highly prestigious medical journal. This research has prompted many consumers, particularly the elderly, to question whether or not they are at risk for injury due to a failed hip implant. 

The Danger for Injury that Hip Implants Pose to Consumers

There has been a marked increase in consumer attention to failing hip implants recently.  Specifically, thousands of consumers have sued a popular hip implant maker, Depuy, as a part of the Johnson & Johnson brand for alleged injuries and side effects from particular hip implants. The Depuy ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System have been voluntarily recalled by the company in response to alleged injuries. These alleged injuries include:

• grinding in the socket
• joint dislocation
• fragments of metal lodged in other organs and tissue
• organ damage
• tissue damage
• internal bleeding
• failure of the device
• pain and swelling
• tissue death
• fractures and broken bones
• parts coming loose inside your body

These devices hold high potential for painful injuries if they fail inside consumers' bodies.  The voluntary recall was intended to prevent further consumer injury.  If you have suffered an injury due to your hip implant, please call a skilled personal injury and product liability attorney today to discuss how you may be able to obtain compensation for your injuries. 

FDA Demands Medical Device Manufacturer Provide Information to Determine Device Safety

The U.S. Food and Drug Administration is losing its patience.  In a recent letter to St. Jude's Medical, the FDA has called for more information on its popular heart defibrillator lead, called Durata.  After over 278,000 patients have been implanted with the lead, the FDA is still lacking the information it requires to determine whether consumers have suffered any injuries.  The FDA is demanding the company provide information it desperately needs to assess its safety and potential for injury to consumers. 

Last fall, FDA inspectors visited their factory in California and came away with serious concerns.  These focused upon nonconformities in their manufacturing processes, which the FDA feels could be problematic. Specifically, the FDA wants to know how St. Jude Medical monitors device safety, what kinds of records are kept, and how they address safety concerns. 

Could You Be at Risk for Injury

The FDA is essentially worried that consumers may be at injury given their lack of information.  Specifically, the FDA wants the following information:

• rates of injury among users in clinical trials and continuing data
• testing procedures
• corrective action procedures
• testing design verification
• multiple lead holders

According to the FDA's public letter to St. Jude Medical, these procedures are not being followed to ensure safety of its devices. If St. Jude Medical fails to provide evidence that these have been corrected, the FDA has warned the company that these devices will not be approved for use in America. 

The FDA is desperately trying to asses whether or not consumers have suffered injury due to "misbranded" leads.  Because reports were not submitted in a timely fashion, the FDA is unsure of whether the device has malfunctioned and potentially injured or killed people. 

If You Have Been Injured

The FDA has not been able to assess whether consumers have suffered injury from the device as evidenced by their public letter available here.  In an absence of this critical information, the agency is threatening to impose civil penalties and to notify federal agencies currently using the device.  Consumers who have suffered injury using this device are encouraged to call the FDA to report it.  Consumers should also notify a skilled product liability attorney to determine whether or not they may have a case against the manufacturer.