Showing posts with label replacement recall. Show all posts
Showing posts with label replacement recall. Show all posts

June 25, 2012

Metal-on-Metal Hip Implants Tied to Metallosis?


Corrosion, serious tissue reactions and metallosis are all possible side effects for recipients of the metal-on-metal hip implant. The safety of these devices has come under serious question with many recipients requiring revision surgery to remove the harmful devices. The DePuy ASR was recalled in 2010 due to studies showing it corroded much more quickly than other types of implants, most notably those made of ceramic and plastic. Once corrosion occurs in the metal hip implant the tissues surrounding the implant can become inflamed or soft tissue masses, lesions and necrosis can occur. The femoral heads as well as the acetabular cup of the DePuy hip implants are constructed of cobalt and chromium. The past few years have seen serious concerns regarding the metal chromium and cobalt particles which shave off when the femoral head and acetabular cup rub against one another during any activity. Once the levels of corrosion reach the unsafe stage the implant will likely have to be removed during a revision surgery.

Journal of Anthroplasty Study

A recent study in the Anthroplasty Journal compared the levels of corrosion on the femoral heads of the metal hip implants with those constructed of metal-on-polyethylene which implements a synthetic liner between the metal cup and femoral head. This liner acts as a buffer between the two metal pieces meaning there is less chance of the small metal ions slivering off and causing metallosis or metal toxicity in the bloodstream. The metal ions in the bloodstream can lead to kidney and liver disease or certain types of cancer, while the metal shards which lodge in surrounding tissues can lead to serious inflammation, tumors and even bone loss.

January 7, 2011

DePuy ASR hip replacement recall


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Cobalt and Chromium Blood Toxicity in Hip Replacement Patients Chromium Poisoning and Cobalt Poisoning in the DePuy ASR hip replacement recall 

By Attorney Andrew Sullo
SULLO & SULLO, LLP

 


DECEMBER 15, 2010 - HOUSTON — DePuy hip replacement recall by DePuy Orthopedics, Inc.’s metal-on-metal hip replacement system sent shockwaves through the international medical community. Given the fact that these devices have gained great popularity in recent years among orthopedic surgeons and patients alike, reports that the ASR XL Acetabular System and ASR Hip Resurfacing System were prone to early failure were met with great fear and unease. 

Since the DePuy hip replacement recall, many of the 93,000 people worldwide who received an ASR hip implant have been scrambling to find answers to pressing health-related questions, especially as stories of blood toxicity, metallosis, chromium poisoning, cobalt poisoning, and other metal poisoning issues in patients have reached the public. And while countless studies have confirmed the consequences of metal wear debris from faulty orthopaedics, many people are still left with grave concerns regarding the the DePuy hip replacement recall. 

To date, the most widely researched side effect of DePuy’s defective hip replacement devices is the aforementioned metallosis, which the Journal of Bone & Joint Surgery describes as “aseptic fibrosis, local necrosis or loosening of a device secondary to metallic corrosion and release of wear debris.” Design problems with the recalled DePuy ASR hip replacement system cause the metal components such as chromium and cobalt to rub against each other and shed microscopic metal particles into the body, which can result in soft tissue damage, inflammatory reactions and bone loss. 

Of particular interest are the remarkably high concentrations of cobalt and chromium that have been found in patients with metal-on-metal hip resurfacings. In some cases, patients with recalled hip replacement implants have been found with 100 times the normal levels chromium and cobalt in their bodies. 

The potential adverse effects of systemic cobalt and chromium ion elevation are the subject of ongoing investigation. While their individual implications on the body are somewhat understood, their combined effects are not. Doctors are struggling with patients’ questions because they simply do not have the answers. But based on existing research we do have some insight into the long-term ramifications of blood toxicity, chromium poisoning, cobalt poisoning and metallosis and sadly, it is not promising for DePuy patients.

Research relating to the hip replacement recall – Metallosis, Chromium Poisoning & Cobalt Poisoning

As early as 2003, researchers at the Municipality of Vienna Gersthof Orthopaedic Hospital in Austria found that patients with metal-on-metal total hip replacements had higher cobalt and chromium levels than those in a control group. Their findings, published in the Journal of Orthopaedic Research, showed cobalt concentrations up to 50 times higher and chromium concentrations up to 100 times higher, and called for the careful monitoring of patients to ensure that any local or systemic complications are detected early on.
In 2006, a study published in the British Volume of the Journal of Bone and Joint Surgery found a correlation between metal ions from hip resurfacing and reduced T-cell counts. Researchers discovered that elevated cobalt and chromium levels in patients with metal-on-metal hip resurfacings were associated with statistically significant decreases in the level of CD8+ cells (T-cytotoxic/suppressor cells).
In the same publication in 2007, a review by researchers from University of Bristol in Bristol, UK, demonstrated the long-term effects of metal-on-metal arthroplasty. The team compiled data describing the release, dissemination, uptake, biological activity and potential toxicity of chromium and cobalt debrispotential harmful effects on immunity, reproduction, kidney function, development, the nervous system and carcinogenisis. released from alloys currently used in modern orhopaedics, which included a list of
 
Doctors from ANCA Medical Center in Ghent, Belgium, released a study in 2008 showing a direct correlation between inclination of the acetabular component and metal ion levels in hip implant patients. Their research found that there were significantly higher levels of metal ions in patients with steeply-inclined components, and that high concentrations of chromium and cobalt are toxic; are known to interfere with a number of biological functions; can result in fluid or mass formation with subsequent destruction of soft tissues; and can result in bone resorption leading to loosening of he implant or fracture of the femoral neck.
Finally, hip replacement patients with metal-on-metal implants have been shown to pass chromium and cobalt ions to their infants during pregnancy, according to research presented at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS). Data showed that there is a correlation between whole blood metal ion levels in the mother and her infant at the time of delivery, which proves that the placenta is not a complete barrier to the transport of these harmful substances. 

The known risks of failure of DePuy ASR hip implants are clear, and evidence of their dangerous, long-term health consequences is substantial. All patients should consult their physicians about regular monitoring in order to detect potential problems before it is too late. If you or someone you know received a defective DePuy ASR hip implant, you should also obtain the counsel of an experienced personal injury attorney. The DePuy hip is part of one of the biggest hip replacement recalls in history. The skilled team at Sullo & Sullo, LLP will aggressively defend your rights and make sure you get the compensation that you deserve. Call us at 1-800-730-7607 for a free legal consultation today.