Navigation Links
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 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.


'/>"/>
SOURCE The Rottenstein Law Group
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Baxter and The Alzheimers Disease Cooperative Study Group to Pursue a Phase III Study of Gammagard Liquid in Patients With Alzheimers Disease
2. HistoRx and Radiation Therapy Oncology Group Initiate Brain Tumor Biomarker Research Partnership
3. International Expert Group Initiates Largest Multi-center Phase III Trial to Evaluate NeuroAid(TM) in Stroke Recovery
4. President Clinton Highlights MWW Group at the 2007 Clinton Global Initiative for its Stop Neglected Tropical Disease Campaign
5. Ethics Group Asks USAID Inspector General to Investigate Legality of Grants to Soros Groups
6. Coley Pharmaceutical Group Receives $3.0 Million Milestone Payment from GlaxoSmithKline
7. Coley Pharmaceutical Group Diversifies Pipeline with First-in-Class TLR Antagonist for the Treatment of Systemic Lupus Erythematosus
8. Coley Pharmaceutical Group and Pfizer Nominate Additional Anti-Cancer Compound for Clinical Development
9. Medivations MDV3100 Demonstrates Substantial PSA Reductions in First Patient Groups Treated in Phase 1-2 Hormone Refractory Prostate Cancer Trial
10. Anpath Group, Inc. Announces Selection of its Disinfectant by the Washington Metropolitan Area Transit Authority (Metro)
11. Leading AIDS Groups Turn Up The Heat on 08 Presidential Candidates
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... , Oct. 10, 2017  NDS received FDA 510(k) clearance in ... medical-grade battery-powered display stand specifically designed for endoscopy environments. An innovative ... into a clinical solution to support the improvement of patient outcomes, ... Design ... Solution ...
(Date:10/4/2017)... WESTWOOD, Mass. , Oct. 4, 2017  According to the Centers ... by the end of October . PhysicianOne Urgent Care is helping communities ... Westchester, NY , by offering no-cost* flu shots through ... , as mandated by certain health insurance regulations. ... The best time to get a flu shot is by ...
(Date:10/2/2017)... Halo Labs announces the European launch of their new low volume, ... 2017 in Cambridge, U.K on October 4th. ... samples with unprecedented speed and sensitivity while using far less sample ... ... system ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which ... evacuation of the facility as part of a disaster drill on October 3rd. , ... and Shelton City Emergency Manager, as well as the Connecticut Long Term Care ...
(Date:10/13/2017)... Texas (PRWEB) , ... October 13, 2017 , ... Yisrayl ... this week that explains one of the most popular and least understood books in ... like cryptic and puzzling descriptions that have baffled scholars for centuries. Many have tossed ...
(Date:10/12/2017)... ... 2017 , ... First Healthcare Compliance (FHC), an industry leader ... range of technology and learning solutions at the 68th Annual American Healthcare Association ... held October 14–18, 2017 at the Mandalay Bay Resort in Las Vegas, Nevada. ...
(Date:10/12/2017)... ... 12, 2017 , ... The American College of Medical Informatics (ACMI) will present ... the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium ... Collen, a pioneer in the field of medical informatics, this prestigious award is presented ...
(Date:10/12/2017)... ... ... Leading pediatric oncology experts at Children’s National Health System will ... the International Society of Paediatric Oncology (SIOP) Oct. 12-15. Chaired by Jeffrey ... Disorders at Children’s National, and Stephen P. Hunger, M.D., Chief of the Division ...
Breaking Medicine News(10 mins):