Ennis & Ennis, P.A. Comments on The New York Times Article Reporting the Surge in Complaints to the FDA and the FDAâ€™s Request for more Studies
Online PR News – 30-August-2011 – – 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, which was more than the agency had received in the prior four years combined, according to The New York Times. The majority of these adverse event reports involved patients who have either had, or will have, a metal-on-metal (MoM) hip removed as a result of injuries caused by tiny particles of cobalt and chromium that the devices shed as they wear. â€śThis report is consistent with the complaints we have received from potential clients who are devastated because their metal-on-metal implant is only lasting a couple of years, at best, when they are supposed to last approximately 15 years,â€ť reports Attorney David Ennis.
According to August 22 The New York Times article, hip replacements are one of the most common procedures in the United States and at one point the MoM implants had accounted for nearly one-third of the estimated 250,000 replacements performed each year (http://www.nytimes.com/2011/08/23/business/complaints-soar-on-hip-implants-as-dangers-are-studied.html?pagewanted=1&_r=3&ref=health). To conduct its analysis, The New York Times reviewed complaints filed with the FDA for the past four years for several implants, including the Acetabular Replacement System (ASR) manufactured by DePuy Orthopaedics, Inc., a Johnson & Johnson Company, as well as the Durom Acetabular Component (Durom cup), manufactured by Zimmer Holdings, Inc. Interestingly, the DePuy ASR XL Acetabular System, which was voluntarily recalled last year by Johnson & Johnson, received approximately 7,500 complaints, while Zimmerâ€™s Durom cup, which was voluntarily recalled in July 2008, received 1,600 complaints.
The initial questioning of the MoM devices began in April 2010, when the United Kingdom's (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) issued a medical device alert that included specific follow-up recommendations for patients implanted with MoM hip replacements (http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con079162.pdf). The recommendations included blood tests and imaging for patients with painful MoM hip implants. However, the U.K. data at that time may not have been directly applicable to the experience in the US because some of the devices available in U.K. are not marketed in U.S. Therefore, the FDA began a process of gathering additional information about adverse events in people with MoM hip implants within the U.S.
In February 2011, the FDA issued a public health communication about MoM hip implants and noted that it was â€śactively working in several areas to assess the safety and effectivenessâ€ť 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/default.htm).
Then on May 6, 2011, the FDA issued orders to 21 manufacturers of MoM 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.
For now, an increasing number of surgeons have stopped using MoM hip implants in favor of alternatives that are considered safer. Meanwhile, the FDA is awaiting reports from metal hip implant manufacturers and will review the matter in greater detail later this year.
Ennis & Ennis, P.A. recommends that anyone with a MoM 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 MoM 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. specializes 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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