Metallosis Caused by Defective Hip Implants
Metallosis is a serious medical condition that has caused complications in patients with surgically placed hip implants. Some hip replacement or hip resurfacing devices contain metal-on-metal components, and toxic metallic particles have leaked into the bloodstream and bodily tissues. After undergoing surgery to replace a diseased or damaged hip, some patients have suffered symptoms of metal poisoning, along with premature device failure which often requires multiple revision surgeries.
Many patients suffering from metallosis have filed claims in the hip replacement lawsuit against the manufacturers of the defective devices. If you or a loved one has experienced any adverse complications, you may be entitled to significant compensation. Contact our product liability specialists to arrange a complimentary case evaluation.
About Hip Prosthetics and Metallosis
Aging baby boomers have created a lucrative market for hip replacement surgery. The hip bone is vulnerable to arthritic conditions, bone loss, and accidental injury, which can cause pain and immobility. Patients suffering from these conditions can benefit from a full, partial, or resurfacing procedure, all involving implant surgery. In 2015, U.S. surgeons performed an estimated 378,000 total hip replacements, and the number is expected to grow to more than 500,000 by 2020.
In 2015, U.S. surgeons performed an estimated 378,000 total hip replacements, and the number is expected to grow to more than 500,000 by 2020.
Hip replacement systems and components are made of ceramic, polyethylene (plastic) and metal. Some products contain only small amounts of metal and others are almost entirely comprised of chromium, cobalt, and molybdenum metals.
Components of a prosthetic hip joint are designed to rub against each other, and this repetitive friction has been shown to cause shedding of microscopic particles. The metal in the implant can also corrode, leaving patients with debris in the bloodstream and surrounding tissue. Blood tests have revealed elevated serum cobalt levels in some patients, an indicator of metallosis.
Metallosis is a form of metal poisoning that is potentially very serious, and can be fatal without treatment. The condition is considered relatively uncommon among implant patients, but some widely-used devices have seen a higher incidence. Manufacturers DePuy Orthopaedics (Johnson & Johnson), Stryker® Orthopaedics, Wright™ Medical Technology, Zimmer Holdings, and others have faced numerous lawsuits concerning their devices.
Cobalt is found in batteries, tools, pigments, and other common products. When the metal is ingested or inhaled, cobalt poisoning can cause symptoms similar to metallosis. In hip surgery patients, metallosis tends to accompany other complications, including the death of tissue (necrosis) and bone (osteolysis), which leads to premature device failure.
Initial symptoms may include pain, increasingly audible sounds coming from the area near the implant, and a feeling of instability when walking. Individual patients may also experience a wide range of additional symptoms, including:
- Fever and weakness
- Cognitive or psychological changes
- Cardiac problems (cardiomyopathy)
- Neurological problems including sensory changes (auditory or visual)
- Hearing impairment
- Thyroid dysfunction
- Renal function impairment
- Skin rash
Benign pseudotumours have also been discovered in hip resurfacing patients, and are considered to be an inflammatory reaction to cobalt absorption. These masses need to be removed to prevent further tissue damage and osteolysis. A journal article reported that the only variable correlated with the presence of a pseudotumor in the study’s participants was elevated serum cobalt levels.
Diagnosis and Treatment
Metallosis is diagnosed using blood testing, radiographs, and digital imaging. The condition can be confirmed by the presence of a dark or cloudy fluid accumulated in the tissue surrounding the hip joint. The tissue may be swollen and discolored, exhibiting a gray hue.
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For treatment, any fluid build-up will need to first be drained, and then a revision surgery is necessary to replace the defective implant. Surgery is considered to be the only effective treatment for metallosis. The prosthesis must be replaced, and bone grafting will likely be required to repair an osteolytic condition. Complete removal of the metal debris is difficult and requires the surrounding tissue to be excised. Post-surgery tissue damage is often reported in metallosis patients.
Patients experiencing premature device failure may be forced to undergo multiple revision surgeries. Some patients require an additional procedure less than a year after their initial surgery. Revision procedures can be complex and are frequently not as successful as primary surgeries.
Official Warnings and Recalls
The Food and Drug Administration (FDA) has issued public warnings about metal hip replacement and resurfacing devices. They posted a safety communication in 2013 that advised surgeons and patients to consider alternatives to metal-on-metal devices because of metal poisoning and other health concerns. Additionally, the agency website continues to update a “Concerns About Metal-on-Metal Implants” article, which cites safety alerts issued in Australia, Canada, and the United Kingdom.
Several metal-based devices have been recalled or withdrawn from the market, including the Rejuvenate Hip System and ABG II Modular Neck Hip Stems made by Stryker®, and the ASR™ XL Acetabular System and ASR™ Hip Resurfacing System manufactured by DePuy Orthopaedics. DePuy still sells the PINNACLE® ULTAMET Acetabular Cup System, but offers ceramic and polyethylene replacement options for the metal components.
An Influx of Lawsuits
Over the past decade, thousands of lawsuits have been filed against several hip implant manufacturers, accusing them of marketing a faulty device, failure to warn of associated dangers, and other allegations. There have been many significant settlements, as well as a number of multi-million dollar courtroom verdicts.
Corporate wrongdoing and negligence can cost innocent patients dearly, including a reduced quality of life for an extended period of time.
Plaintiffs have received compensation for damages related to metallosis and premature implant failures. Manufacturers had claimed that their metal devices were more stable than those made from other materials, and would last for decades. However, civil complaints cite claims of fractures, loosening, and complete failure within a few years, requiring invasive revision surgeries.
Some claims against hip implant manufacturers have already been resolved, including::
- In March 2013, a jury awarded a Montana man and his wife $8.3 million after he suffered metal poisoning and numerous complications from his DePuy metal-on-metal hip unit.
- BioMet®, Inc., manufacturers of the M2a-Magnum™ and M2a-38™ hip replacement systems, settled hundreds of cases in multidistrict litigation (MDL) in 2014. Patients complaining of premature device failures shared a $56 million settlement.
- Also in 2014, a $1.43 billion settlement was reached in a mass tort involving hip implants made by Stryker® Orthopaedics. These devices were found to have caused metallosis and other complications.
- In November 2015, an $11 million verdict was awarded to a female patient who suffered metallosis from her Wright™ Medical CONSERVE® Plus hip implant. The judge reduced the award to $2.1 million, but ruled that the negligence verdict would stand. The award included $1.1 million in punitive damages.
- In March 2016, DePuy was ordered to pay a $502 million jury verdict for five plaintiffs who had received a PINNACLE® ULTAMET hip implant that failed.
A few hip replacement manufacturers have also been accused of bribing physicians to recommend their device to patients. There have been several multi-million dollar fines levied against these corporations by the U.S. government.
Seeking Compensation for Losses
Corporate wrongdoing and negligence can cost innocent patients dearly, including a reduced quality of life for an extended period of time. If you have suffered because of a defective medical device, you may be entitled to compensation for your injuries. Please contact our legal team to arrange a free case evaluation and explore your legal rights.