DePuy hip recall lawyers at Pintas & Mullins Law Firm report that the orthopedic unit plans to phase-out production of all metal-on-metal hip implants, including the Pinnacle and metal component the Complete.
Johnson & Johnson, DePuy’s parent company, recalled its other all-metal hip replacement, the Articular Surface Replacement (A.S.R.), in 2010 due to extraordinarily high early failure rates. Traditional ceramic or plastic hip replacements typically last about 15 years before wearing out; metal-on-metal hip patients were experiencing implant failure just a few years, and in some cases, a few months, after initial surgeries.
Revision surgeries, particularly in the types of patients who need hip replacements in the first place, can be exceedingly dangerous and take a huge toll on the body. Because of the 2010 A.S.R. recall and extraordinarily high reports (upwards of 500,000 in the U.S. alone) of adverse events in all-metal hip devices, in January 2013 the FDA proposed tightened regulation, including further testing, on these implants.
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According to the proposal, metal-on-metal hip implant manufacturers will only be allowed to continue selling the devices if they are able to prove the devices are safe and effective. Previously, manufacturers only had to prove the devices were similar in design to products already on the market (such as ceramic hip implants). To the peril of hundreds of thousands of patients, these manufacturers were not required to conduct clinical studies on live patients before selling their all-metal devices.
All-metal hip implants are one of the largest device-related failures in recent memory, as they were, at one point in time, implanted in an estimated one of every three hip replacement patients. In addition to the hundreds of thousands of expensive and painful revision surgeries, large numbers of patients were also experiencing metallosis, or metal poisoning, from the implants.
These implants consist of a ball and socket joint made from a blend of metals. When the joints move against one another, during walking or any other type of leg movement, tiny particles of metal are released into the bloodstream, causing severe tissue, muscle, and bone damage. If this occurs for a long period of time, the blood and surrounding tissue can become poisoned by the metal ions, ultimately causing irreversible cell death.
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DePuy is currently facing about 10,000 A.S.R. lawsuits and another 3,300 cases involving the Pinnacle – numbers that are expected to grow considerably. In a statement, the company cited declining surgeon demand and the recent FDA ruling as the reason for the phase-out. Sales of the Pinnacle and the metal component the Complete will end in August 2013.
Indeed, the use of all-metal hip devices has plummeted, and it is unclear whether other metal-on-metal manufacturers, such as Biomet, Styker and Zimmer, will phase out their products or conduct clinical trials in accordance with the FDA’s new standards.
We recently reported of a study by the Hospital for Special Surgery which found that MRIs may be useful for identifying metal-on-metal patients who may require revision surgery, before symptoms begin to manifest. MRIs can locate inflammation of the joint lining, referred to as synovitis, long before the body begins producing symptoms of the condition.
By the time it starts to feel painful tissue around the joint has already been damaged, possibly even deteriorated, making revision surgeries that much more complicated. Tissue death and the consequent collection of fluid are often undetectable by radiographs or computed tomography scans (CTs), so the use of MRI scans is welcomed.
The most recent A.S.R. implant failure lawsuit resulted in a $8.3 million payout by DePuy. Metal-on-metal implant lawyersat Pintas & Mullins Law Firm are currently investigating cases involving these devices. If you or a loved one was implanted with an all-metal hip device, you may be entitled to significant compensation, and should contact a skilled attorney as soon as possible.