Initially, metal-on-metal hip implant systems were preferred over ceramic and plastic devices. They were thought to be significantly more durable, with reduced wear characteristics, improving resistance and flexibility. In 2010, about 16 percent of surgeons were using metal-on-metal implants, according to a survey by the American Academy of Orthopaedic Surgeons. Following the recent FDA warnings on all metal implants that percentage has dropped to 10 percent and continues to drop even further.
Many patients with the Pinnacle metal-on-metal hip implant are experiencing the same problems associated with the ASR implant. These complaints and complications include:
• Pain and swelling
• Limited Mobility
• “Metallosis” which is the presence of high levels of cobalt and chromium in the bloodstream which can lead to the destruction of tissue, muscle and bone as well as cardiovascular, neurological, renal and thyroid problems.
• Premature loosening
• Device failure and the need for device removal and replacement
Dr. Mary O’Connor, an orthopaedic surgeon at the Mayo Clinic in Jacksonville Florida, has not used metal-on-metal hip implants for years due to her concerns with metal poisoning. “We’re simply seeing the tip of the iceberg with metal-on-metal failures,” Dr. O’Connor states.
Mindy Tinsley, a DePuy spokeswoman, differentiates the newer Pinnacle hip system from the defective ASR device: ‘Litigation is what it is, but the ASR is a very different system and has a very different design and has very different clinical performance [than the Pinnacle]”. Ms. Tinsley states that ASR was “recalled because it was not performing as it should.” DePuy is closely monitoring the performance of the Pinnacle system and is “very confident” in it products and will vigorously defend itself against lawsuits she indicated.
Currently, approximately half a million patients in the United States have received metal-on-metal hip implants. It is estimated that orthopaedic surgeons used the Pinnacle system in 150,000 patients. The fear of similar medical complications with the Pinnacle system is very real given its similarity with the ASR implant. However, as of today, there has been no recall of the Pinnacle system.
The FDA continues to monitor and research problems reported with metal on metal hip implants. On June 27-28, 2012 the FDA convened an Orthopaedic Surgery and Rehabilitation Devices panel of advisers to investigate metal on metal hip implants. The panel concluded that there were few if any reasons to use metal on metal hip implants in light of the risks. See FDA website for complete agenda . The FDA continues to collect data and maintains a database for doctors to report problems with the Pinnacle hip implant system.
Dr. David Langton, a British orthopaedist who has collected data for the British Orthopaedic Association and the British Hip Society for several years and studied metal on metal hip systems estimated that:
• Failure rate of the ASR system is nearly 80% at 8 years and the
• Failure rate of Pinnacle system has a failure rate of 16% after 6.5 years
Dr. Langton believes that as the metal debris from the metal on metal hip implants is released into the bloodstream and tissue more and more patients will be affected and failure rates will increase.
The medical products liability attorneys at Keefe Bartels are hard at work doing their part to protect people from the harm and danger posed by the use of defective and unsafe metal-on-metal hip implants such as the ASR and Pinnacle systems. If you or someone you know has had hip implant surgery with a metal on metal implant and is experiencing any complications, you may have a legal claim or lawsuit and be entitled to compensation. Contact the trial attorneys at Keefe Bartels to see if they can help you. Keefe Bartels
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2012-09-28 | Add a Comment
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