Metal Hip Replacement Recall
Metal-on-metal hip replacements have been linked to a dangerous condition knows as metallosis, a serious diagnosis of heavy metals in the blood. If you or a loved one has been diagnosed with METALLOSIS and had HIP REPLACEMENT SURGERY using a metal-on-metal device, you could be entitled to MONETARY COMPENSATION. Complete the form below, or call one of our experienced attorneys TOLL FREE at 1 (888) 255-2956.
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METAL ON METAL HIP REPLACEMENTS HAVE BEEN LINKED TO METALLOSIS, OR HEAVE METALS IN THE BLOOD

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Stryker Announces Rejuvenate Hip Implant Recall

CANCER ALERT: Metal-on-Metal Hips and Prosthesis with Poorly Designed Metal Femoral Neck/Tapers Release Potentially Carcinogenic Cobalt Into Body

UPDATED INFO RELEASED NOVEMBER 2016:

On August 26, 2010, DePuy, a subsidiary of Johnson & Johnson (J&J), recalled its DePuy ASR metal on metal (MoM) hip system. The ASR MoM system was identified as causing increased incidents of metallosis or adverse tissue reactions (commonly referred to as ALVAL – short for aseptic, lymphocyte-dominated vasculitis-associated lesions). The patient’s immunological response often involves the creation of pseudotumors by which the body is attempting to wall off the insulting agent or toxic substance. After the ASR hip recall and commencement of litigation, metallosis relating to other MoM systems surfaced, including: the DePuy Pinnacle MoM system; the Wright Medical Technology Conserve system; the Biomet M2a Magnum or large diameter head system; and the DJO Encore MoM system. Litigation began relating to those allegedly defective hip systems largely premised upon a position that the metal on metal design itself, though touted as promoting longevity, did not provide benefits that outweighed the risks of metallosis and related injuries to patients. This was confirmed by the Food and Drug Administration (FDA) in its issuance of a 522 Post-Marketing Surveillance Study – by which these companies were required to initiate a study similar to a clinical trial to determine the true risk benefit profile and undergo proper scrutiny.

In addition to MoM systems, however, other metallosis problems surfaced in relation to the taper neck junction, stem and/or taper and trunnion connection. These connections by which the head or ball is affixed to the stem involve metal on metal configurations or combinations. Moreover, other manufacturers designed modular neck systems with an additional metal piece used to interface between the head/ball and top of the stem. These systems are likewise being litigated and allegations are made that the design and type of metals are defective. They include: Stryker Rejuvenate and ABG II modular neck system; Stryker Accolade TMZF; the Wright ProFemur; the Zimmer M/L taper with Kinectiv Technology; the Omnilife Apex Arc system; and Smith & Nephew SMF stem.

Scientists and physicians have published a significant body of literature associating MoM systems and those with metal on metal taper/trunnion corrosion and modular stem configurations with both localized hip related tissue death and cyst formation. Moreover, consensus has grown regarding systemic effects from the release of cobalt and chromium in the body of patients with a failing hip system, including: eye sight loss; hearing loss; cognitive impairment; cardiomyopathy and polycythemia. However, questions have always been raised about a potential for cancer secondary to failing hip systems. Early literature discounted this association. However, the U.S. Department of Health and Human Services have just published its 14th Report on Carcinogens which now includes the metallic element cobalt and cobalt compounds (that release cobalt ions in vivo). The National Institute of Health’s official announcement includes the following:

Cobalt and cobalt compounds that release cobalt ions in vivo are being listed as reasonably anticipated to be a human carcinogen. The listing for cobalt includes different types of cobalt compounds that release ions into the body. It does not include vitamin B-12, because cobalt in this essential nutrient is bound to protein and does not release cobalt ions. Cobalt is a naturally occurring element used to make metal alloys and other metal compounds, such as military and industrial equipment, and rechargeable batteries. The highest exposure occurs in the workplace and from failed surgical implants. The listing for this metal and its compounds is based largely on studies in experimental animals.

The Report on Carcinogens prepared by the National Toxicology Program (NTP) is a federal program which operates with the goal of safeguarding the public by identifying substances that may affect human health. It can be found here:

http://ntp.niehs.nih.gov/ntp/roc/monographs/cobalt_final_508.pdf

If you or a loved one suffered from elevated metal ion levels and onset metallosis, please contact us for an immediate consultation.

 

July 5, 2012 - Stryker has announced a voluntary recall of the Stryker Rejuvenate Modular and ABG II modular-neck hip stems. The recall was made voluntarily, over concerns of potential risks associated with modular-neck stems. The Stryker website reports that the risks include the potential for "fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling."

Like previous metal-on-metal hip implants that were recalled, the alleged issue is an increased risk of metallosis, which occurs when metal hip components rub against one another, releasing particles of chromium and cobalt in the blood. Acording to Stryker, if you are experiencing pain or swelling at the joint site, you should speak with your hip surgeon.

Metal-on-Metal Hip Replacements Linked to
Heavy Metals in Blood

Currently, our artificial hip investigation is focused on identifying all patients with past hip replacements who have been diagnosed with elevated cobalt, chromium or titanium levels and/or heavy metal toxicity, a condition often called “metallosis”. Unfortunately, the metallosis disease process may go unnoticed for a long period of time – the patient may experience no symptoms until suffering tissue death and the hip prosthesis begins to fail. Fortunately, detecting metallosis is not difficult. A simple blood test administered by your health care provider can determine whether you have elevated metal ions in your blood stream.

Metallosis

Recent scientific literature strongly associates heavy metal toxicity to many hip systems on the market. Most cases of metallosis appear to come from early wear in hips systems involving both a ball and liner made of metal. These his systems are called Metal-on-Metal (“MOM”) systems. A recent study has revealed failure rates as high as 49% with some MOM hips. Some studies show hip replacement failure rates of 49%.This same literature has also identified metallosis occurring in polyethylene or ceramic based hips due to metal debris from the metal junction between the ball and femoral stem called the trunion or tape neck junction. While the reasons for failure are often complex, one of the primary concerns for patients is that elevated metals may lead to tissue death and damage around the artificial hip ultimately causing its failure. Another growing concern is that metallosis may lead to systemic injuries such as: liver and/or kidney damage; eye sight and/or hearing loss; enlargement of the heart; and bladder cancer.

Background

Acetabular systems have gone through significant design changes over the years. One of the main design modifications relates to the chosen materials used in manufacturing the ball and liner which make up the bearing surface interface. Materials used total hip replacement systems (and more recently, resurfacing systems) have historically included polyethylene and ceramics. However, research and development efforts turned to the prospect of coupling a metal ball and metal liner or mono-block principally directed at the goal of increasing device longevity due to known wear rates, measured at 5 and 10 years, relating to poly and ceramic components. However, manufactures are responsive for ensuring that patients are not placed at unreasonable increased health risks. FDA - The United States Food and Drug AdministrationRecently, the metal-on-metal design has come under heightened scrutiny by the scientific community, medical providers, the FDA and consumer attorneys. Fueling this increased scrutiny, a large number of adverse event reports have been received by the FDA from physicians, surgeons and patients relating complications to the metal-on-metal design. Data from European and Australian Registries (which track product performance and measure failure rates) have documented increased failures with the metal design including metallosis processes.

The range of side effects, including:

  • pain
  • inflammation
  • swelling
  • loosening
  • early failure
  • premature revision surgery.

Unfortunately, unlike the failures which were seen with poly and ceramic component failures, metal on metal bearing wear releases metal ions causing serious and life threatening toxic response to the localized tissues in the hip. At the very least, metallosis starts to kill tissue proximate to the failing hip. This necrotizing of tissue can reach the outer reaches of the hip very quickly and cause damage to both the hip bone (within the acetabulum) and tendons and supporting structures.

In August of 2010, the DePuy ASR hip implant system was recalled after the Joint Registry within the United Kingdom revealed very high failure rates. Sales of the ASR in Europe preceded sales in the United States by 3 to 4 years. Accordingly, this high failure rate provides a dire and ominous forecast for patients in the United States. A systematic review of institutional reports detailing early failures in the ASR in Europe reveals that women are at increased risk for failure within the first several years due to the typically smaller sized hip device. Due to very tight clearance between the ball and mono block of the ASR (80 to 120 micrometers) and shallow clearance of the design, the ASR was destined to failure before its first sales. For men, due to the larger diameter of their components, the mean failure rate for metallosis takes place between years 4 and 7 post implant. Due to this latent period (latency), the product remained on the market in Europe (and the U.S.) longer than it should have.

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