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Rottenstein Law Group Applauds New Efforts of U.S. FDA to Look More Carefully at Metal-on-Metal Implants After DePuy Recall
Date:3/7/2011

NEW YORK, March 7, 2011 /PRNewswire/ -- The Rottenstein Law Group, which represents clients with claims stemming from the recall of defective hip replacement devices manufactured and sold by DePuy Orthopaedics, is fully in support of the FDA's announced intention to consider carefully the safety of metal-on-metal joint implants.

At a new set of pages on its Web site, www.fda.gov, the U.S. Food and Drug Administration states the following:

FDA is actively working in several areas to further assess the safety and effectiveness of metal-on-metal hip implants. Some activities include a comprehensive review of:

  • Risk-benefit profiles
  • Utilization trends
  • Patient selection criteria
  • Pre-operative patient counseling
  • Surgical technique
  • Follow-up
  • Revision rates associated with metal-on-metal hip systems in the United States

In addition:

  • As a part of our effort to better understand possible adverse events associated with metal debris from metal-on-metal hip systems, we continue to review published literature, Medical Device Reports (adverse event reports) submitted to the Agency, post-approval study reports and data from several orthopaedic device registries from within and outside the U.S.
  • We have requested and will be reviewing device retrieval analyses from the manufacturers of the hip systems distributed in the U.S. This will help us understand how and why certain metal-on-metal implants fail over time.
  • We are pursuing collaborations with multiple partners domestically and internationally to fully understand the post-market performance of metal-on-metal hip systems and to document the occurrence of and signs and symptoms associated with specific adverse events.
  • These efforts allow us to continue to investigate the safety and effectiveness of metal-on-metal
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SOURCE The Rottenstein Law Group
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