DePuy, DePuy ASR Hip, DePuy ASR™ Hip Resurfacing System, FDA, Food & Drug Administration, Health, hip, Hip Replacement, hip resurfacing, hip revision, Medicine, metal, Orthopedic surgery, public health mission, science, Smith & Nephew, Technology, UNited States
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:
1. Local complications such as pseudotumors and aseptic lymphocytic vasculitis-associated lesions (“ALVAL”);
2. Early device failure and the need for revision surgery; and
3. 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.
- Metal hip implants tied to depression, cancer, vision problems – The Recall Lawyers (earlsview.com)
- HIP | Chronic intoxication with cobalt following revision total hip arthroplasty (earlsview.com)
- Metal-on-Metal Hip Implant Study Finds Side Effects May Include Bursal Cysts of the Iliopsoas, Bernstein Liebhard LLP Reports (prweb.com)
- Woman Implanted with Biomet M2a Magnum™ Hip Implant Alleges Metal-on-Metal Device Caused Metal Poisoning, Other Complications in Newly Filed Lawsuit by Parker Waichman (prweb.com)
- US Drug Watchdog Now Urges All Depuy, Zimmer Stryker, Biomet, and Wright Metal on Metal Hip Implant Recipients to Get Blood Tests & Offers the Names of the Best Law Firms (prweb.com)
- What Happened to the FDA Request for More Hip Implant Studies? – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts (earlsview.com)
- Self-serving Smith & Nephew Caught Out? Mortality and implant revision rates of hip arthroplasty in patients with osteoarthritis: registry based cohort study | BMJ (earlsview.com)
- All-metal hips ‘wear down faster’ – Behind The Headlines – Skegness Standard (earlsview.com)
- Smith and Nephew Issues Failure Warning on Metal Hip Implant – Florida Mass Tort Attorneys, Lawyers | Searcy Mass Torts (earlsview.com)
- Metallosis-induced Iliopsoas Bursal Cyst Causing Venous Obstruction and Lower-limb Swelling After Metal-on-metal THA | Orthopedics (earlsview.com)