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Metallosis, Metal Poisoning, and Heavy Metal Toxicity

February 10 2018 | Blog
  • While hundreds of thousands of U.S. patients undergo hip replacement procedures each year, this seemingly standard surgery carries the risk of severe side-effects and complications – and the use of some of the common replacement implants may merit a lawsuit.

    Today, an estimated 2.5 million Americans live with hip replacements. According to one study published in 2015, the annual number of hip arthroplasty surgeries skyrocketed in the previous decade. The study mentioned that in the year 2000, 138,700 of such operations were performed while in 2010 the number more than doubled, reaching 310,800. Provided that the number of hip replacements surgeries has continued to grow at the same rate in the last 7 years, there will have been 489,982 such operations performed in 2017 alone.

    Dangerous Complications

    While total hip replacement has become a standard procedure that helps hundreds of thousands of patients annually to alleviate pain and regain mobility, it is still a very invasive surgery that can result in serious complications. These complications can include dislocation and inflammation but also blood clots and infection. Patients who were fitted with a metal-on-metal implant can also experience metallosis or metal poisoning. This type of complication has led in recent years to more than 28,000 lawsuits against hip replacement manufacturers. Many of those lawsuits resulted in multimillion-dollar settlements or jury verdicts.

    Metallosis

    Metallosis, also called metal poisoning, is a condition induced by the build-up of metal particles in the body. These particles may find their way into the bloodstream or accumulate in the tissues and organs of the body. This can lead to allergic reactions, nerve damage, or bone damage.

    Metal-on-metal hip implants are a common cause of metal poisoning. In this type of procedure, a metal cup and a metal head are fitted together to form an artificial joint. However, when these two parts rub against each other during normal movement, the resulting friction creates microscopic debris of metal ions. These tiny metal particles can affect the immediately adjacent tissues, and if they are released into the bloodstream, they can affect other tissues and organs as well. The build-up can also cause pseudotumors, or pockets of fluid, to appear around the affected tissue. The symptoms of metal-on-metal hip-replacement induced metallosis may include (according to the FDA):

    ●      General hypersensitivity reaction (skin rash)

    ●      Cardiomyopathy (heart problems)

    ●      Neurological changes including sensory changes (auditory, or visual impairments)

    ●      Psychological status change (including depression or cognitive impairment)

    ●      Renal function impairment (kidney conditions)

    ●      Thyroid dysfunction (including neck discomfort, fatigue, weight gain or feeling cold)

      Metal Poisoning Treatment

    In order to stop further metal shedding and build up, in most cases a revision surgery is needed. This means that the metal-on-metal implant will be removed and replaced with another type of artificial joint. Currently, hip replacement implants are also made of ceramic materials and plastic. It has to be noted, however, that revision surgeries carry a risk of their own. Extensive tissue damage around the joint caused by metal shedding and weak structure of the adjacent bones can cause fractures. Still, revision surgery is currently the only known, effective remedy for metal poisoning caused by a metal-on-metal hip replacement implant.

    Lawsuits

    Metal-on-metal implants were marketed as more durable and reliable than the previously used materials. Instead, they have proven to cause a number of severe side effect, like metallosis, and have an unusually high failure rate. For one particular model, the failure rate reached 43%,  which means almost one in two models resulted in a need for revision surgery. This caused some manufacturers to announce market recalls of their artificial joint devices. For example, in 2010, Johnson & Johnson’s DePuy Orthopaedics recalled its ASR hip replacements.

    Since the causal link between adverse health effects caused by metal poisoning and metal-on-metal hip replacement devices is well established and proven, many of those who needed a revision surgery for their implant decided to file product liability lawsuits against major manufacturers. Legal action is currently underway against a number of companies, including:

    • Johnson and Johnson’s DePuy Orthopaedics
    • Smith & Nephew
    • Stryker
    • Zimmer
    • Wright

    In the past few years, many such lawsuits have already resulted in settlements or jury verdicts favorable for the plaintiffs.

    In 2013, Johnson & Johnson agreed to pay out an estimated $2.5 billion to settle the claims of about 8 thousand patients who had received the company’s ASR hip system. More recently, in December of 2016, the same company was ordered to pay out more than $1 billion to six plaintiffs who claimed they had experienced complications and health damage due to the defectively designed Pinnacle implant (manufactured by DePuy). In addition, only a month ago, six more plaintiffs were awarded $247 million by a jury in Dallas in connection with the same hip implant product.

    Other manufacturers involved in lawsuits that resulted in settlement payouts for injured parties included Wright (as of this past October, the total settlement of more than 1,300 claims reached the amount of $340 million) and Zimmer (the company settled most of its lawsuits in March 2016 for an estimated $314 million; in addition, in March 2017, Zimmer was ordered to pay out $2 million in damages to a man injured by Zimmer Konectiv hip implant).

    Do I have a claim?

    If you have experienced serious complications after a hip replacement surgery, including the symptoms mentioned in this article, or if you had to undergo revision surgery, chances are high you might be able to pursue damages for your injuries. As mentioned above, in most cases, claims and lawsuits against implant manufacturing companies are based on product liability. Under this legal principle, the manufacturer may be held liable for design defects and flaws that resulted in health damage. In some circumstances, claims based on medical malpractice may be filed as well.

    Individuals who may have suffered from complications related to the following devices, products, and systems may have a claim:

    ●      DePuy ASR XL Acetabular Cup System

    ●      DePuy ASR Hip Resurfacing System

    ●      DePuy Pinnacle Acetabular Cup System

    ●      Zimmer Holdings Durom Acetabular Components

    ●      Smith & Nephew R3 Acetabular System

    ●      Biomet M2a

    ●      Wright Medical ProFemur Z Hip System

    ●      Wright Medical Conserve Plus Total Resurfacing Hip System

    ●      Centerpulse Orthadapt and Inter-Op

    ●      Corin Cormet 2000

    ●      Encore Orthopedics

    ●      Exactech R3

    ●      RingLoc+ Modular Acetabular System

    ●      Birmingham Hip Resurfacing System and Hip Replacement

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