FDA Seeks Expert Advice Regarding Risks of Metal-on-Metal Hip Replacements

FDA Convening to Discuss Metal Hip Risks Explains Ennis & Ennis, P.A.
By: Jami Angelini Haggerty
 
March 29, 2012 - PRLog -- Ennis & Ennis, P.A. reports today that the U.S. Food and Drug Administration is seeking expert scientific and clinical advise on the risks and benefits of metal-on-metal (MoM) hip systems.  The FDA also seeks input from practitioners and patients on the use of MoM hips systems and the management of patients with these devices during a two day expert panel meeting which will be held on June 27-28, 2012.  [www.fda.gov/newsevents/newsroon/pressannouncements/ucm297745.htm]

The committee will discuss the safety and effectiveness of MoM hip arthroplasty systems, which were intended to reduce pain and increase mobility by replacing the damaged hip joint in patients.  There are two categories of metal-on-metal hip arthroplasty systems:

1. Metal-on-Metal total hip replacement systems consisting of a metal ball (femoral head), a metal femoral stem in the thighbone, and a metal cup in the hip bone (acetabular component).  These systems are typically used in total hip replacements for mature patients with either inflammatory or non-inflammatory degenerative joint disease, correction of functional deformity and/or revision procedures when other treatments/devices have failed.

2. Metal-on-Metal hip resurfacing systems consisting of a trimmed femoral head capped with a metal covering and a metal cup in the hip bone (acetabular component). This system is intended for reduction or relief of pain and/or improved hip function for patients with arthritis, avascular necrosis or hip dysplasia, typically for younger patients, not suited for traditional total hip arthroplasty.

Numerous recent publications and studies have raised significant safety concerns regarding the use of MoM systems and their failure rates (particularly among women and systems utilizing large-diameter femoral heads), dislocations and metal poisoning.  The FDA is considering requiring more extensive pre-market review and testing requirements for MoM hip systems. It has already issued an order requiring manufacturers to conduct post-market surveillance studies to collect more safety data on these devices, including data regarding metal ions in the bloodstream.  

Ennis & Ennis, P.A. has been receiving calls relating to the Johnson and Johnson’s DePuy and Pinnacle Hip Implants; Wright’s Conserve and Profemur Total Hip Systems; Biomet’s Active Articulation E1 Dual Mobility and M2a-Magnum Hip Systems; Smith and Nephew’s Birmingham Hip Resurfacing Implant; and Zimmer’s Durom Cup.  “We advocate a recall on all metal-on-metal hip implants based upon the review of the literature, the high failure rate and the metallosis associated with these devices,” commented Attorney Holly Ennis.

FDA is opening a docket to allow for public comments to be submitted to the Agency regarding these issues before May 9, 2012. Submit electronic comments to http://www.regulations.gov. Written comments may be submitted to the Division of Dockets Management, Food and Drug Administration, 5630 fishers Lane, rm 1061, Rockville, MD 20852.
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Source:Jami Angelini Haggerty
Email:***@ennislaw.com Email Verified
Zip:33301
Tags:Metal Hip, Metal-on-metal Hip, Hip System, Metal Hip Risks, Ennis and Ennis
Industry:Health, Legal
Location:Fort Lauderdale - Florida - United States
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