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FDA Metal-on-Metal Hip Implant Statistics Reveal 16,800 Adverse Event Reports in Last 10 Years Related to Metal-on-Metal Hip Replacement Devices

June 26, 2012

Metal-on-Metal Hip Replacement Complaints to the FDA in 2011 Far Outpaced Those Associated with Other Types of Hip Implants. FDA Advisory Panel Set to Meet Tomorrow to Discuss the Safety of Metal-on-Metal Hip Replacement Systems.

New York, New York (PRWEB) June 26, 2012

Parker Waichman LLP, a national law firm dedicated to protecting the legal rights of people injured by defective hip implants, was disturbed by a recent U.S. Food & Drug Administration (FDA) report revealing that metal-on-metal hip replacement devices were associated with some 16,800 adverse event reports from 2000 to 2011. The vast majority of those reports, more than 14,000, involved revision surgery to remove a failing metal-on-metal hip implant. In 2011, metal-on-metal hip implant complaints made to the FDA totaled 12,137, compared with only 6,332 associated with other types of hip replacement systems, according to a Bloomberg News article. [bloomberg.com/news/2012-06-21/hip-implant-concerns-reached-16-800-in-a-decade-fda-says.html]

According to Parker Waichman, the vast majority of complications associated with medical devices are never reported to the FDA. Therefore, it stands to reason that far more metal-on-metal hip implant recipients may have suffered from serious side effects that resulted in revision of their device.

According to a report from the Associated Press, some 500,000 people in the U.S. have received metal-on-metal hip replacement systems. When they were introduced, it was believed that metal-on-metal hip implants would be more durable than those made from plastic or ceramic. However, the FDA allowed the devices to be brought to market under its 510(k) protocols, which do not require human clinical tests. According to Parker Waichman LLP, the growing number of complications associated with the use of metal-on-metal hip implants indicate that the laboratory test used to asses the safety of these products were sorely inadequate. [google.com/hostednews/ap/article/ALeqM5gXnNAGOe1vm-lOyVEzbjyCpX45sA?docId=c49786ef5fbd41bd9f52ec4e33841a02]

Tomorrow, the FDA’s Orthopaedic and Rehabilitation Devices Panel will begin a two-day meeting to discuss the risks and benefits of metal-on-metal hip replacement devices. In a report issued in advance of the meeting, FDA staff revealed that its review of recent data suggests that metal-on-metal hip replacement systems are likelier to fail than other hip implant devices. According to the document, data from orthopedic implant registries as well as peer-reviewed journal publications and presentations at scientific meetings have suggested increases in potential safety issues associated with metal-on-metal hips, including:

  •     Local complications such as pseudotumors and aseptic lymphocytic vasculitis-associated lesions
  •     Early device failure and the need for revision surgery
  •     Systemic complications from metal ion exposure

[fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/OrthopaedicandRehabilitationDevicesPanel/UCM309302.pdf?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=fda%20metal-on-metal%20hip%20implants%20executive%20summary&utm_content=1]

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. Since then, a number of studies have found evidence that the recipients of metal-on-metal hip implants may face a significant risk of developing serious complications, including tissue damage, device failure, additional surgeries, disability, and possibly cancer. In February, for example, the British Medical Journal alerted the public about potentially high levels of metallic ions released by all-metal hip implants. The following month, the authors of a study published in The Lancet called for a ban on the devices, after finding 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. [bmj.com/content/344/bmj.e1410; thelancet.com/journals/lancet/article/PIIS0140-6736%2812%2960353-5/fulltext]

Regulators in the U.K. and Canada have already issued guidance to help doctors and patients deal with complications from metal-on-metal hip implants. The FDA, which last year ordered the manufacturers of metal-on-metal hip implants to conduct post-market safety studies of their devices, has yet to take similar action. Parker Waichman LLP and its metal-on-metal hip implant clients are hopeful that tomorrow´s advisory panel meeting 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. [mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON155761; hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/_2012/metal_implant_pc-cp-eng.php]

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.

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 device, 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).

Contact:

Parker Waichman LLP

Gary Falkowitz, Managing Attorney

(800) LAW-INFO

(800) 529-4636

http://www.yourlawyer.com

For the original version on PRWeb visit: http://www.prweb.com/releases/prweb2012/6/prweb9644637.htm


Source: prweb



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