Follow on Google News News By Tag Industry News News By Location Country(s) Industry News
Follow on Google News | Upcoming FDA Metal Hip Implant Meeting is Critical to Many of Those SufferingEnnis & Ennis, P.A. details the purpose of the FDA advisory meeting scheduled for June 27-28, 2012 which will discuss the safety and effectiveness of metal-on-metal hip implants
This FDA meeting was prompted after metal hip implants were linked to almost 16,800 adverse events in the U.S. from 2000-2011, and upon review of registries, which reflected high rates of failure. [1] The national registry in England and Wales revealed the revision surgery rate after five years for metal-on-metal implants was almost three times as high as other versions. Another registry by HealthEast Care System in Minnesota revealed the revisions rate was four times higher than metal and polyethelyne implants. The FDA Executive Summary Memorandum breaks down the results of six different registries, all of which are consistent with an increased failure rate in metal-on-metal hip implants. [2] While many physicians are no longer utilizing the metal-on-metal devices, thousands upon thousands of patients have already had these devices implanted. As a result, the FDA has already issued an order requiring manufacturers, such as Biomet, DePuy Orthopaedics, Encore Medical, Wright Medical, and Zimmer, to conduct post-market surveillance studies to collect more safety data on these devices, including data regarding metal ions in the bloodstream. Ennis & Ennis, P.A continues to receive calls relating to the Johnson and Johnson’s DePuy and Pinnacle Hip Implants; Wright’s Conserve and Profemur Total Hip Systems; Biomet’s Active Articulation E1 Dual Mobility and M2a-Magnum Hip Systems; and Zimmer’s Durom Cup. “With the evidence of increased failure rate and metallosis associated with metal-on-metal hips, we advocate a recall on all of these devices,” commented Attorney Holly Ennis of Ennis & Ennis, P.A. “It is not necessary to keep them on the market because there are safer alternatives, such as the ceramic and polyethelyne devices, that do not carry the increased risk.” Ennis & Ennis, P.A. recommends that anyone with a DePuy Hip Replacement or any other all-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/ Ennis & Ennis, P.A. continues to offer free, nationwide, confidential consultations to anyone who has an all-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. that concentrates its practice in mass torts and represents individuals against pharmaceutical companies and 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, Plavix, Pradaxa, Zoloft/Birth Defects, Prozac/Birth Defects, Zimmer Hip Recall, Wright Conserve Hip Implant, Multaq, Medtronic Infuse Bone Graft, Fresenius Granuflo Dialysis, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin and Ocella Birth Control Pills. Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights. Call today toll free 1-800-856-6405 or visit www.ennislaw.com. [1] http://www.fda.gov/ [2] http://www.fda.gov/ End
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||
Account Phone Number