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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.
DOWNLOAD the full document as a PDF – MOM hip implant systems
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Why does it appear Smith and Nephew is trying to hide behind the pre-emption laws and not face accountability. Their Birmingham hip resurfacing device was approved for marketing in the USA in 2006, first of its kind. Orthopedic surgeons looked at this newly innovated device as a means to help patients and perhaps avoid total hip replacement. When the bhr hit the marketplace an estimated 30%-40% of hip revisions were the bhr. The competition was minimal. All the statistics we read from the Smith and Nephew rant and rave how their device is out performing the competition, this may be true, but what Smith and Nephew fails to tell us is the adverse events numbers on this device since used in the USA.
Not a gambling man I would wager the failure rate on the bhr exceeds the acceptable of 1% by a significant number.
They have recalled a liner from their R3 ace tabular hip and recalled another component from their bhmr hip. They continue to sell a device that may help some folks however, it has hurt more folks than is acceptable to standards.
Part of their approval pma by the FDA was studies reflecting data on post approval
was to be provided, along with protocol and they were to conduct and submit additional studies on the metal particle ions and what affect the ions could have on human beings.
Any information provided on the post approval is utter non sense, it tells me nothing,
that could have possibly helped me and 1000′s of other innocent victims.
It shows me they used 18-21 year old people for their reported data, again controlled by a single PR actioner.
Where are the studies on metal ions ????
The pma approval of the bhr was an absolute farce and embarrassment, for me to read as a US citizen. The obvious conflict of interest between the inventor
and his approval by the FDA of this device is so apparent my 10 year grandson could
see, not to mention the lack of unbiased data and the expressed concerns on unknowns of metal ions and the impact they could pose to the human body.
McMinn the partial inventor even said to the manufacturer Smith and Nephew he thought they may be moving to quickly to market this device not knowing what potential adversities could pose to human safety re: metal on metal and particles of metal entering the human body.
The FDA’s conditional approval asked for this information in 2006, they are still asking the same questions: that is they need more information.
Bullshit, Smith and Nephew claims they have identification numbers on every part, they have records of how many times the device was sanitized so how difficult would it be to go to the larger orthopedic hospitals find out how many units were implanted from 2006,07,08,09,10,11,12 and how many revisions were necessary due to the bhr device failing years 2010,11,12.
The sales of the bhr will probably show fewer and fewer used in the later years, WHY ???
Had I known in 2007 when I had the bhr implanted what I know today I would have never in a million years had the bhr implanted.
Just because Smith and Nephew isn’t as large as some of the other manufacturers don’t kid yourselves their BHR is potentially hazardous to your health ask those of us who have had the quality of life once enjoyed taken away forever.
Howard Sadwin
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