Cobalt poisoning, DePuy ASR Hip, Executive summary, FDA, Food & Drug Administration, Gaithersburg Maryland, Hip Replacement, metal, metal-on-metal hips, Orthopedic surgery, Smith & Nephew, UNited States
Prepared for the June 27-28, 2012 Meeting of the
Orthopaedic and Rehabilitation Devices Advisory Panel
I. Introduction and Purpose of Advisory Panel Meeting
Hip arthroplasty devices, including metal-on-metal (MoM) hip systems, have been available and in use within the United States for over 50 years. They are frequently used to relieve pain and restore joint function in patients with chronic hip pain or disease which is not responsive to more conservative therapy.
All told over 400,000 hip arthroplasty procedures are performed in the United States on an annual basis (Appendix A).
With widespread use of these MoM hip systems, more information has become available regarding clinical performance as well as adverse events. Recent data from orthopaedic implant registries as well as peer-reviewed journal publications and presentations at scientific meetings have suggested increases in potential safety issues associated with MoM hip systems including:
- Local complications such as pseudotumors and aseptic lymphocytic vasculitis-associated lesions (“ALVAL”);
- Early device failure and the need for revision surgery; and
- Systemic complications from metal ion exposure.
FDA believes that in keeping with its public health mission, it is appropriate to have an open and transparent dialogue among manufacturers, physicians, researchers, the public, and FDA to review currently available data regarding MoM hip systems in an effort to better characterize any potential and real safety risks and generate scientifically-based recommendations for the clinical and patient communities on how to best communicate and mitigate them.
This Advisory Panel meeting is not intended to: (1) reassess the original market entry data; (2) discuss the current or future classification of MoM hip systems; or (3) discuss mandated postmarket studies (i.e., “Section 522” or “post-approval” studies) currently underway for MoM hip systems.
Download full paper here: FDA Executive Summary Metal-on-Metal Hip Implant Systems Prepared for the June 27 – 28 2012 Meeting
- The US Drug Watchdog Now Offers To Find The Best Possible Attorneys For All Recipients Of The Recalled DePuy ASR Hip Metal on Metal Hip Implant-Before Time Runs Out (prweb.com)
- Prominent Metal-on-Metal Hip Implant Attorney Dismayed by Statements from DePuy Orthopaedics Official Regarding Evaluation of Metal-on-Metal Hip Replacements (prweb.com)
- Wright Medical’s Response to Smith & Nephew’s Response to WMT request to Deny BHR PMA (earlsview.com)
- Parker McDonald Reports On FDA Hearing On Metal-On-Metal Hip Implants (prweb.com)
- Suffering of Thousands Prompts FDA Hearing about Hip Implants (earlsview.com)
- Despite the Reasons AGAINST – FDA Advisory Panel Recommends Conditional Approval of Smith & Nephew’s BIRMINGHAM HIP Resurfacing Technology (earlsview.com)
- Safety Of All-Metal Hip Implants Under US Scrutiny – International Business Times (earlsview.com)
- DePuy Pinnacle Hip Implant Failure Initiative Considered “Vital” (earlsview.com)
- FDA Reports16,800 Metal On Metal Hip Implant Adverse Events (earlsview.com)
- Recipients Injured By Metal-On-Metal Hips Speak Out Against Dangers of MoM Hips – SFGate (earlsview.com)