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Cobalt poisoning, DePuy, DePuy ASR™ Hip Resurfacing System, DePuy ASR™ XL Acetabular System, DePuy Orthopaedics, DePuy Pinnacle System, Food & Drug Administration, Hip Replacement, Johnson & Johnson, lawsuit, metal, Metal-on-Metal components, Metal-on-Metal DePuy hip device, UNited States
Hip Checked
By: Shana Leonard; Published: Tue, Jul 12, 2011 – 10:49 am

Although they do boast some clinical advantages, metal-on-metal hip implants have come under fire in recent years as adverse reactions continue to come to light. While most bearing-material combinations generate minor wear debris, MoM implants have received flack for increased particulate production and the potential danger associated with metal ions found in the blood stream. Furthermore, metal wear particles have been found to damage the tissue and bone surrounding the implant. As a result, patients with MoM implants may experience pain or implant loosening, and, ultimately, may require revision surgery. In fact, MoM implants are twice as likely as metal-on-polyethylene designs to require early revision surgery, according to Australia’s orthopedic registry.
The emergence—and proliferation—of such data has cast a shadow on MoM implants that has grown substantially darker with the 2010 DePuy ASR system recall, which resulted in lawsuits, a mainstream media blitz, and a lot of headaches for DePuy. But perhaps the final nail in the coffin of MoM implants comes from FDA. In May, the agency issued 145 orders to 21 manufacturers of MoM implants for postmarket surveillance studies in what has been deemed an uncharacteristic move. It claims that this information will contribute to a better understanding of MoM implants and their safety profiles.
With FDA scrutinizing MoM implants, doctors shying away from their use, and patients rallying against them, the future is looking somewhat bleak for all-metal hip implants. So, what now? It’s likely that physicians will increasingly pass over metal-on-metal designs in favor of more-traditional bearing surface combinations, such as tried-and-true metal-on-polyethylene designs, for example. Ceramic-on-ceramic implants are also gaining traction for certain demographics, despite a well-publicized squeaky setback several years ago. Seeing potential in this area, Zimmer, for example, recently introduced the ceramic-on-ceramic Maxera implant optimized for younger and more active patients; however, this device is not yet available for commercial distribution in the United States.
Also eyeing the advantage of low-wear ceramic, DePuy is trying to regain its competitive advantage—and public trust—with the launch of the Pinnacle CoMplete acetabular hip system in June. The CoMplete is the first ceramic-on-metal hip implant approved for use in the United States.
Regardless of the next big bearing material combination, however, implant OEMs can be sure of one thing: The industry is changing. Thanks to the MoM brouhaha, future implant designs will likely have to undergo more-extensive premarket testing and evaluation. And hip implant OEMs will just have to grin and bear it.
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I always see Zimmer,DePuy, in the news regarding hip problems. What about Smith & Nephew or any other company heavily involved in hip device manufacturing, why aren’t they mentioned ? Better yet why aren’t all metal on metal hip devices put on hold ?
How can I, in good conscience put a DePuy, or Zimmer, or Smith & Nephew etc. device in me after these companies and others, have paid the Federal government over $300 million in fines for unscrupulous marketing ( kickbacks, paid to doctors,hospitals,distributors etc), they still have not provided sufficient information to me and others, why I and too many others are suffering phyically,mentally, financialy, still in pain from using their products.
These companies seem to avoid addressing these questions head on, by providing a newer version of the old model, or plastic devices that have healthier particles enter are bodies and provide us with ? I can’t answer this comment because there doesn’t seem to be enough data. Maybe we will get another chance to be Lab Rats.
Respectfully
Howard Sadwin
Howard
Yes – I wonder how the management of these companies sleep at night.
It will only be a matter of time and we will find there are a lot more Smith and Nephew problems out there.
Having said that – I suspect that more science went into their products than DePuy – and that is why the failure rates are lower and confined to types like you and me!
BUT – cobalt chrome (tempered) as used by these manufacturers is nasty stuff – especially in a MoM hip.
Why they can’t come up with something less noxious I can’t figure – must just be a matter of cost…
Earl
You are correct in your comments. The CEO’S sleep great, just keep those big bonuses coming in.
I believe the FDA had adverse warning from doctors regarding the use of cobalt chrome. There was innsufficient and incomplete data as to the affect these metals could have on people.
No one listen to the warning letters sent by Doctors regarding this concern and other concerns.
Well the results are now becoming apparent with each day, another person is unjustly suffering with pains,aggrevation, loss of the quality of their lives etc.
Howard
Howard
I am forming a very uncharitable view that the FDA has enormous Government pressure on it NOT to break with the status quo as the materials they should make joint replacements out of are well known, available BUT more expensive – would put up the national health costs…
I think ALL CEO’s must know what is going on – but “deny-ability” is the name of the game – blame some poor worker in a factory somewhere for not following procedures… yeah right…
Earl