Thousands of Injured Metal-on-Metal Hip Replacement Patients Hopeful FDA will Issue New Guidance Following Meeting on Implant Safety
Parker Waichman LLP and its metal-on-metal hip replacement lawsuit clients are hopeful the FDA will issue new guidance to aid the thousands of patients who have suffered serious harm as a result of failing metal-on-metal hip implants.
New York, NY (PRWEB) June 25, 2012
Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective medical devices, reports that the firm and its clients are eagerly awaiting the outcome of this week’s Food & Drug Administration (FDA) advisory panel meeting on the safety of metal-on-metal hip implants. The firm and its clients are hopeful that the FDA meeting, scheduled for June 27 and 28, 2012, will ultimately result in much more stringent regulation of metal-on-metal hip replacement devices, as well as guidance for dealing with the serious complications associated with metal-on-metal hip replacements. [fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm297745.htm]
Parker Waichman LLP is representing scores of people who have suffered serious injuries, including pain, premature hip implant failure, and the need for revision surgery, allegedly due to the defective nature of metal-on-metal hip implants. Lawsuits involving DePuy Orthopaedics´ ASR hip implant devices have been consolidated in a multidistrict litigation before Judge David A. Katz in the U.S. District Court for the Northern District of Ohio (MDL 2197). Additional claims involving a metal-on-metal version of DePuy’s Pinnacle hip implant system have been consolidated in a multidistrict litigation before Judge James E. Kinkeade in the U.S. District Court for the Northern District of Texas (MDL 2244). Parker Waichman LLP also recently filed several lawsuits on behalf of plaintiffs allegedly injured by metal-on-metal hip implants manufactured by Biomet Orthopedics.
Metal-on-metal hip implants have been the subject of growing concerns since the August 2010 worldwide recall of the DePuy Orthopaedics’ ASR Hip Resurfacing System and ASR Acetabular System. The recall was issued after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. Since then, a number of studies published in the Lancet, the British Medical Journal, and other respected journals have found evidence that such devices can shed potentially dangerous amounts of metal debris into patients’ blood streams, leading to serious health risks, including tissue damage, device failure, additional surgeries, disability, and possibly cancer. [depuy.com/asr-hip-replacement-recall]
In February, the British Medical Journal alerted the public about potentially high levels of metallic ions released by all-metal hip implants. The following month, The Lancet published a study showing that metal-on-metal implants failed at a rate of 6 percent in five years, as opposed to the 1.7 to 2.3 percent seen in their plastic or ceramic equivalents. The authors subsequently advised a ban on the devices. [bmj.com/content/344/bmj.e1410; thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960353-5/fulltext]
Already, regulators in the U.K. have advised that some patients with large diameter metal-on-metal hip joints should have annual blood tests and possibly MRI scans for the lifespan of the joint. In May, Health Canada issued a warning for patients to be aware of metal hip replacement problems and adverse effects. [http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON155761; hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/metal_implant_pc-cp-eng.php]
According to a report from Bloomberg News, in documents posted in advance of this week’s advisory panel meeting the FDA reported that nearly 16,800 adverse events associated with metal-on-metal hip implants were reported in the U.S. from 2000-2011. Of those, more than 14,000 involved revision surgeries, in which a defective implant was removed. Just over 8,000 reported extreme pain. Adverse event reports in 2011 totaled 12,137 for the metal-on-metal hip replacement devices, compared with 6,332 associated with other types of hip implants [http://www.bloomberg.com/news/2012-06-21/hip-implant-concerns-reached-16-800-in-a-decade-fda-says.html
As part of its ongoing investigation of all-metal hip implants, the FDA´s Orthopaedic and Rehabilitation Devices Panel will meet on June 27th and 28th to discuss the risks and benefits of the devices. The panel will examine failure rates and modes of metal-on-metal hip implants; metal ion testing; imaging methods; local and systemic complications; patient risk factors; and considerations for follow-up after surgery. Parker Waichman LLP and its metal-on-metal hip implant clients are hopeful that the advisors will issue recommendations that will ultimately lead to new guidance for the monitoring and treatment of metal-on-metal hip implant recipients.
Parker Waichman LLP continues to offer free legal consultations to victims of metal-on-metal hip implant injuries. If you or a loved one experienced premature failure of your implant or other health problems associated with a metal-on-metal hip implant, please contact their office by visiting the firm’s Defective Hip Implants page at http://www.yourlawyer.com. Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).
For more information regarding defective hip implant lawsuits and Parker Waichman LLP, please visit: yourlawyer.com or call 1-800-LAW-INFO (1-800-529-4636).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney
For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/6/prweb9639923.htm