Depuy ASR Plano

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Depuy ASR Plano:Research Links Metal-on-Metal Hp Replacement Systems to Mental Health Issues

Research Links Metal-on-Metal Hip Replacement Systems to Psychological Health Concerns
The authors of a first-of-its-kind research project suggested physicians treating patients who have had hip replacement surgery involving a metal-on-metal joint system to watch the patients’ neuropsychiatric state because of potential heavy metals making their way into the blood.
According to the research, the presence of these heavy metals may lead to psychological troubles which include major depression and dementia like symptoms.
The research, created by the National Center for Biotechnology Information and under the umbrella of the National Institutes of Health chronicles patients in the United Kingdom who had the surgery and received a metal-on-metal hip replacement system, such as DePuy Orthopaedic’s Pinnacle system, which has since been recalled.
Up to now, the producer of the Pinnacle system, has been found liable for hundreds of millions of dollars in damages to patients who suffered difficulties after their implantation. The Pinnacle system was discovered to have both design and manufacturing defects, resulting in the failure. DePuy Orthopaedics is a subsidiary of Johnson & Johnson. Metal-on-metal hip replacement systems use a metal ball and joint, rather than a plastic or ceramic joint. However, these systems failed at a unusually high rate, requiring revision surgery or surgeries and causing other issues, such as irritation at the implantation site. Another problem has been the heavy metal shavings that could lead to bleeding at the implant site or leech into the patient’s bloodstream. This issue is called “metallosis.”
Metal-on-metal hip replacement systems use cobalt and chromium, each of which can result in several health problems.
The NIH study found that the cobalt and chromium particles were having psychological health effects on the patients: “We present the first case series suggestive of clinically significant depressed mood and neurocognitive impairment following MoM hip failure with concomitant chromium and cobalt toxicity.”
The case study acknowledged that a few of the mental health problems could have originated from worry about the hip replacement system failure and potential ramifications. However, the researchers determined that there was more at play: “Neurocognitive abnormalities however might be mediated by either static brain damage due to chromium and cobalt toxicity or could symbolize a dynamic process, that is an early onset dementia caused by metallosis. If the latter is the case it might have major, as yet unrecognised, ramifications for public health.”
The researchers determined that metal-on-metal hip replacement systems should be removed even if they have not yet broken down: “Other than revision surgery there is no effective adsorption or chelation therapy for chromium and cobalt, and if such therapies could be safely developed, it may avoid the requirement for additional surgery. In the meantime, to protect neurocognitive function implant removal conceivably need to be as quickly as possible after toxicity is discovered.”
Although the research workers documented the possible impact on product liability cases continuing and in the future, they commented that patient health is much more critical than commercial worries: “There are additionally potential public health implications for the care needed by many thousands of patients who have potentially suffered MoM related cobalt and chrome toxicity, should progressive cognitive decline be found in this group and the associated requirements for dementia care. This has some relevance to product liability litigation worldwide. However we believe that any commercial factors should be set aside in the interest of public safety and the bioethical principle of social justice.”
The research centered on patients in the UK who experienced hip replacement systems with a metal-on-metal ball and joint. The researchers reduced their patient list to 10 patients whose systems had failed. They discovered that before revision surgery, nine of the 10 were being affected by harmful amounts of chromium and cobalt in their blood.
All nine of the patients met clinical conditions for depression at a “moderately severe” level.
Seven of the nine exhibited short-term memory loss.
Other psychological difficulties seen in the patients included confusion, complications with tests of concentration and word finding troubles.
--authored by Rick Fahr.


DePuy Pinnacle Metal-on-Metal Hip Replacement System Found at Fault in Texas Lawsuit

DePuy Pinnacle Metal-on-Metal Hip Replacement System Found at Fault in Texas Lawsuit Johnson & Johnson has been ordered to pay out close to a quarter-billion dollars to six plaintiffs in a so-called “bellwether” lawsuit. The case, in a Texas federal court, pitted the defendants against the company for Johnson & Johnson’s faulty DePuy Orthopaedics’ Pinnacle metal-on-metal hip replacement system. DePuy Orthopaedics is a subsidiary of Johnson & Johnson. Based on a Reuters story on the case, jurors granted the victims $247 million in damages or injuries. Metal-on-metal hip replacement systems use a metallic ball and joint system, as opposed to other hip replacement systems who make use of ceramic components. The metal-on-metal systems fail at a much higher rate than other kinds of systems. The failures cause joint pain and internal bleeding in the hip area and can cause metallosis, an issue that occurs when metals get into the blood stream. Most metal-on-metal system failures lead to remedial surgery. Hip replacement surgeries have skyrocketed in recent years, with upward of 300,000 such surgeries being performed in the United States yearly. The condition often known as osteoarthritis is a leading cause of hip failure. Based on the Reuters story, jurors found that DePuy’s Pinnacle system had a faulty design. Jurors also determined that the companies failed to alert consumers about the hazards of such systems. The story noted that nearly 10,000 lawsuits have been filed in the United States against Johnson & Johnson for use of the DePuy Pinnacle hip replacement system. The combined trial is another in a number of “bellwether” trials in connection with DePuy Pinnacle metal-on-metal hip replacement system. The objective of the trials is to help the trial judge determine if similar cases should go forward and provide the defendants a sense of their future liability. The Texas suit was the fourth “bellwether” trial with regards to the DePuy Pinnacle system. The defendants won one trial, but plaintiffs have won the last three - two in Texas and one in California. Up to now, Johnson & Johnson has been ordered to pay out hundreds of millions of dollars in damages to victims of the flawed hip replacement systems. --authored by Rick Fahr.

MOM Link to Dementia/Heart Disease

Metal Hip

Metal-on-metal hip replacement systems have been known to cause various problems — including painful revision surgeries and the accompanying physical rehabilitation — but researchers have recently discovered a potentially new and devastating side effects — a link between metal-on-metal hip replacement systems and dementia and heart disease. According to a story published by the Daily Mail in London, Great Britain’s Medicines and Healthcare products Regulatory AgencyBritain’s Medicines and Healthcare products Regulatory Agency recently notified the public that patients who have had metal-on-metal hip replacement systems implanted will be “called in” for X-rays and blood testing to determine if the heavy metals in the systems are causing any “adverse reactions.” The medical personnel will be trying to determine chromium and cobalt levels in the patient’s blood. Those two heavy metals have been linked to both dementia and heart disease. Metal-on-metal hip replacement systems, such as Johnson & Johnson’s DePuy Orthopaedics Pinnacle system, use a metallic ball joint to replace the hip. Other systems use ceramics, plastics or other materials. The problems associated with metal-on-metal hip replacement systems stem from wear on the joint. That wear may cause the system to fail entirely at much higher rates than hip replacement systems made of other materials, which leads to surgery to fix the system. Additionally, the metal shavings can lead to irritation at the implant site and to the metals entering the blood system, a condition known as metallosis . Hip replacement surgeries have become popular in the United States, with surgeons performing upward of 300,000 such operations each year. Several thousand lawsuits have been filed against Johnson & Johnson for its metal-on-metal hip replacement system failures. DePuy’s Pinnacle system has had a particularly long string of issues, starting with its design and production. Testimony in trials in the United States and abroad has revealed that the Pinnacle systems were not correctly manufactured and that a design flaw led to a higher-than-normal failure rate. Johnson & Johnson no longer sells the Pinnacle system, but tens of thousands of people have had it implanted. Regarding the Great Britain cases, the Daily Mail story quoted Dr. Neil McGuire, clinical director of medical devices for the regulatory agency as saying that prudence mandates checking the overall health of patients to ensure that the hip replacements aren’t causing other problems. “We’re always balancing depriving people of the benefits of these devices versus protecting people from harm,” he told the newspaper. “We don't want to set a lot of hares running if there's nothing to find. It may be at the end of it we say, ‘There's nothing to see here folks.’ --authored by Rick Fahr.


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