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
- Revision rates associated with metal-on-metal hip systems in the United States
- 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 hip implants systems and provide additional information to the public as it becomes available.
The greater effort of the FDA was prompted by recent recalls of metal-on-metal joint devices, including DePuy's ASR system and Zimmer's Durom Acetabular Component. DePuy, a Johnson & Johnson company, recalled its ASR devices globally after the National Joint Registry of England and Wales made public data showing that, within five years, about 12% of recipients of the hip resurfacing system and about 13% of recipients of the acetabular system needed corrective surgery. The Rottenstein Law Group maintains a website on the hip replacement recall.
About THE ROTTENSTEIN LAW GROUP
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was recently founded by Rochelle Rottenstein, who has more than two decades of experience as a lawyer, to represent clients in consumer product injury, mass tort, and a class action lawsuits in a compassionate manner.
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|SOURCE The Rottenstein Law Group|
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