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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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:
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
If you or someone you love has been diagnosed with metallosis, or heavy metals in the blood due to a metal-on-metal hip replacement, you could be entitled to monetary compensation. Call us toll free at 1 (888) 255-2956, or complete the form below.
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