Ennis & Ennis, P.A. Explains that a British Registry Reports of Accelerated Failure Rates Associated with Metal-on-Metal Hip Implants
Online PR News – 16-September-2011 – – The National Joint Registry for England and Wales reported that metal-on-metal hip implants contain an ever-increasing failure rate. Interestingly, the Articular Surface Replacement (ASR) manufactured by DePuy Orthopaedics, Inc., a Johnson & Johnson Company, was recalled last year and had the highest failure rate of approximately 33 percent within the first six years.
While a British registry issued this report, Americans should be wary because the United States does not have such a registry, yet has the highest rate for artificial hips and knee implants. In fact, of the 90,000 ASR units sold worldwide, 40,000 of them were used in the U.S. Additionally, the ASR was used in England and Wales before it was used in the U.S., so complaints in our country will continue to increase in time.
The British data further revealed that is was not just the ASR that failed; all metal-on-metal devices had a rapidly increasing failure rate overall vs. traditional hip replacement. This data is consistent with the limited U.S. data wherein the U.S. Food and Drug Administration (FDA) received more than 5,000 adverse event reports in the first six months of 2011 regarding metal-on-metal hips, according to The New York Times.
In February 2011, the FDA issued a public health communication about metal-on-metal hip implants and noted that it was “actively working in several areas to assess the safety and effectiveness” of such implants, including a comprehensive review of risk-benefit profiles, utilization trends, patient selection criteria, pre-operative patient counseling, surgical technique, follow-up, and revision rates associated with metal-on-metal hip systems in the United States, as well as adverse events that may be associated with increased levels of cobalt and chromium in the bloodstream (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm241769.htm).
Then on May 6, 2011, the FDA issued orders to 21 manufacturers of metal-on-metal hip systems, including DePuy Orthopaedics, Stryker, Zimmer, Biomet and Wright Medical Technology, for postmarket surveillance studies, which required the companies to provide additional studies regarding the possible adverse health consequences of the implants.
Ennis & Ennis, P.A. recommends that anyone with a metal on metal hip implant system, who is experiencing pain in the groin, hip or leg, swelling at or near the hip joint, or a limp/change in walking ability, first seek medical attention. Then file an adverse event report with the FDA at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. Lastly, consult with an experienced attorney.
Ennis & Ennis is offering free, nationwide, confidential consultations to anyone who has a metal-on-metal hip replacement system by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.
Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C. Ennis & Ennis, P.A. concentrates its practice in mass torts and represents individuals against pharmaceutical companies worldwide as well as medical device makers.
Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.
Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin and Ocella Birth Control Pills.
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