Artificial hip replacement procedures have become relatively common with well over 300,000 procedures successfully performed every year in the United States. That number continues to increase, and the vast majority of patients are happy with the results - a durable, comfortable, properly moving hip joint. However, as more procedures are done, many new products and technologies enter the field – and not all of them are safe.
DePuy Hip Implants: Metal-On-Metal Technology Not As Safe As Originally Claimed
Metal on metal implants have caused complications for doctors performing surgery and presented a danger to patients. The materials used in the metal-on-metal implants (usually cobalt-chrome and molybdenum) were thought to be more durable than their older-model ceramic counterparts; however, that technology may not be as good or safe as originally claimed. Case in point – DePuy Orthopedics.
The DePuy ASR Acetabular Cup System, DePuy ASR Hip Resurfacing System and DePuy Pinnacle Acetabular Cup System were supposed to be the best of the best. However, the recent DePuy recall of the first two products – and consumer complaints about the latter – tell a different story.
DePuy Hip Implant Claims: Experts Say DePuy Failure Rates Are 12 - 13%
One of the largest manufacturers of metal-on-metal hip replacements, DePuy Orthopedics, recently recalled its metal-on-metal hip replacement systems – the ASR Acetabular Cup System and the ASR Hip Resurfacing System.
Research found that, instead of resulting in longer-lasting and durable new hip replacements, these products often sloughed off metal ions into the surrounding tissue, causing tissue damage, bone loss, and in some cases immediate and intense pain. Even before the DePuy ASR recall, the failure rate for metal-on-metal implants had been unusually high – an astronomical 12 - 13% – resulting in expensive surgeries to isolate the cause and replace the defective part, not to mention the pain and suffering that come with having damaged tissue and bone.
DePuy Hip Implant Lawsuits Allege The Company Knew About Defects
There is considerable evidence that DePuy Orthopedics knew their implants were defective and inappropriate for the market long before their recall – but failed to warn consumers about those defects. In fact, the U.S. Food & Drug Administration (FDA) had received over 500 complaints about the ASR Acetabular Cup System and the ASR Hip Resurfacing System through its Adverse Event Reporting (AER) over the past few years.
In addition to complaints made through the FDA, studies have shown that the coverage angle range for the acetabular component of the DePuy ASR implant - a critical factor in the likelihood of unsafe levels of toxins entering the body - is unusually sensitive. Similarly, the cup position and design for hip resurfacing is also critically important for preventing the release of metal ions as the cup rotates. So, the question becomes – how was this product ever approved by the FDA?
DePuy Hip Implant Lawsuits Allege That ASR System Is Defective & Not The Same As The Company's Pinnacle System
The DePuy ASR Acetabular Cup System is a metal on metal system that the company claimed was “substantially similar” to it's device already on the market – the DePuy Pinnacle Acetabular Cup System – which is why the ASR system did not go through the FDA's PMA, pre-market approval, process that requires extensive clinical trials to prove that the device was not dangerous.
The DePuy Pinnacle Acetabular Cup System, which many surgeons and patients now say is also defective, was designed to be fastened to the bone with screws. However, the DePuy ASR Acetabu
In addition to complaints made through the FDA, studies have shown that the coverage angle range for the acetabular component of the DePuy ASR implant a critical factor in the likelihood of unsafe levels of toxins entering the body is unusually sensitive.
Posted by: Jones Wright | 12/24/2011 at 07:08 PM