FDA Seeks to Require All-Metal Hip Makers to Prove Safety of Devices
Jamie ShellerJanuary 21, 2013 10:27 AM
(866) 735-1102 Ext 475
The U.S. Food and Drug Administration has issued a proposed order seeking to require manufacturers of metal-on-metal total hip replacement systems to submit premarket approval applications, which prevent manufacturers from selling the implants, which are associated with among the biggest medical device failures in decades.
Under the proposal, makers of artificial hip systems with all-metal components would have to demonstrate the devices are safe and effective as a condition of continuing to sell their existing inventory or obtaining approval for new all-metal designs, The New York Times reported.
Metal-on-metal hip implants, including the A.S.R., or Articular Surface Replacement, made by DePuy Orthopaedics, a unit of Johnson & Johnson, have been among the most vexing orthopedic devices for patients in the past decade.
An estimated 500,000 patients in the United States (one in three since thier introduction 15 years ago) have receved this type of device, which have been linked to adverse events, including painful, and costly, "revision" surgeries for thousands of patients.Additionally, metallic debris released as the metal joints wear down cause soft tissue and bone damages, causing some patients to suffer disabilities.
According to the proposed order, any hip replacement system made by a manufacturer that fails to submit a premarket approval application "would be deemed adulterated" and not fit for use. The proposed order is available online.
Our law firm is handling numerous claims on behalf of individuals injured by the A.S.R. Time is running out to file a claim.
Studies have shown that this ASR implant can cause a build up of metal ions in your blood and fluid in your body over time.
Call Sheller P.C. to disucss your legal rights at 800-883-2299 or visit us online to fill out a form here.