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
Acetabular systems have gone through significant design changes over the years. One of the main design modifications relates to the materials used in manufacturing the ball and liner which make up the bearing surface interface. Historically, total hip replacement systems (and more recently, resurfacing systems) have were made of polyethylene and ceramics. In an effort to find more durable, longer lasting hip replacement systems, manufacturers began investigating the prospect of coupling a metal ball and metal liner or mono-block. Unfortunately, it seems that manufacturers have neglected their duty to insure patient health safety in their quest to manufacture a more durable hip replacement system. Unlike the poly and ceramic hip replacement systems, as MOM hip systems wear metal ions are released potentially causing serious and life threatening toxic response to the localized tissues in the hip. While the full range of systemic dangers associated with the release of metal ions is still being investigated, it is clear that, at the very least, metallosis starts to kill (“necrotize”) tissue proximate to the failing hip. This necrotizing process can progress rapidly, causing damage to both the hip bone (within the acetabulum) and tendons and supporting structures.
Recently, 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 includes pain, inflammation, swelling, loosening, early failure and premature revision surgery.
In August of 2010, the DePuy ASR hip implant system was recalled in the United Kingdom after the Joint Registry (a joint replacement tracking system) revealed very high failure rates in recipients of the ASR. The ASR hip implant system went on sale in Europe approximate three to four years prior to being sold in the United States. Unfortunately, the United Kingdom’s experience may be a warning of an epidemic of failures soon to be experienced in the United States. A review of the scientific and medical reports on the ASR failures in the UK reveals failures in women typically occurred in the first several years after receiving the ASR hip implant system. In men, the failures took somewhat longer to happen, averaging between years 4 and 7 post implant. Because it took years for ASR recipients and the medical community to realize the health danger posed by the ASR system, the product remained on the market in Europe (and the U.S.) longer than it should have.
Manufacturers of MOM hip implant systems were not required to demonstrate the safety of their new systems through rigorous clinical trials before being approved for sale in the United States. Instead, the manufacturers of the ASR and all other MoM hip systems were only required to go through the “510K premarket approval process.” This process is an abbreviated procedure in which companies do not have to perform clinical trials and perform thorough premarket sale analysis.
Metal hip implants that have been linked to metallosis include:
FDA ORDERS POST MARKET SURVEILLANCE (PS) STUDIES FOR ALL MoM HIP SYSTEMS
On May 6, 2011 FDA issued 145 orders for postmarket surveillance studies.
The entities include: Advanced Bioresearch Association, a regulatory affairs firm consulting with medical device and pharmaceutical companies American Ortomed Corporation, now dissolved Biomet Inc., makers of the M2a-Magnum™ System Large Metal Articulation (Total MOM Hip) and ReCap (Resurfacing Femoral Head , not MOM system), and others no longer marketed C.R. Bard Inc., no current MOM system DePuy Orthopaedics, Inc., a Johnson & Johnson company, makers of ASR (Total Hip, Resurfacing, Recalled); Pinnacle Metal-on-Metal (Total Hip with Ultamet Insert), and others no longer marketed. Downs Surgical Ltd., no current MOM system Encore Medical, now DJO Surgical, makers of metal-on-metal liners for use with FMP acetabular system, and others no longer marketed Endomedics, Inc., no current MOM system Implantology Corporation, no current MOM system Joint Medical Products Corporation, acquired by Johnson & Johnson April 1, 1995 Link America, Inc., no current MOM system Med-Tek Corporation, no current MOM system Orthopaedic Device Corporation, no current MOM system Orthopaedic Manufacturing Company, no current MOM system Osteotechnology, Inc., no current MOM system Pfizer, Inc., no current MOM system Stryker Orthopaedics for Howmedica Osteonics Corp., markets the Cormet Resurfacing System in the US; MITCH PER Mini Hip (resurfacing, not marketed in US) and others no longer marketed Synergy Orthopaedics Intl., Inc., no current MOM system Techmedica, Inc., no current MOM system Turnkey Intergration USA, Inc., no current MOM system Waldemar Link GMBH & Co. KG, no current MOM system Wright Medical Technology, Inc., DYNASTY® Acetabular Cup System with A-CLASS® Metal-on-Metal; Conserve (Partial Resurfacing); Conserve Plus (Total Resurfacing) and others no longer marketed Zimmer Spine, Inc., (Zimmer), Durom/Metasul (Total Hip, Recalled) and others no longer marketed.
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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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