Cobalt Chromium Toxicity

How Prevalent is the Issue of Metal Poisoning from Metal-on-Metal Hip Replacements?


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According to government statistics and studies performed by the Mayo Clinic, the number of hip replacement surgeries performed in the United States has increased substantially in the last few decades. From 2000 to 2010, the number of procedures performed in patients 45 and older more than doubled, from 138,700 to 310,800. Among patients 75 and older, the number grew 92 percent. For those aged 45 to 54, the number grew an astonishing 205 percent.  Millions of people who have undergone hip replacement surgery had their hips replaced with metal-on-metal implants, such as the DePuy Pinnacle hip system. But in recent years, these hip implants have been the cause of serious bodily damage for people who have received them. Because of the way these implants function, chromium and cobalt ions can seep into surrounding tissues, destroying muscle and bone and spreading to the lymph nodes, spleen, liver and kidneys.

How prevalent is this issue?

Wear-related complications are somewhat common for people who have had hip replacements. In fact, one in eight of all total hip replacements requires revision within 10 years, over half of which are due to wear-related complications. The same kind of complication can lead to the release of cobalt and chromium ions, causing metallosis. While the exact number is unknown, we are now facing a situation where millions of hip replacement patients in the United States are potentially at risk.

If you are the recipient of a metal-on-metal hip implant, such as the DePuy Pinnacle, you may be suffering from long-term exposure to cobalt and chromium ions. The resulting damage can lead to pain and suffering. Our law firm has dedicated itself to fighting for the victims of defective hip implants and other medical devices. You can reach our attorneys at Kershaw, Cook & Talley PC by calling 888-817-2527.

DePuy Pinnacle Trial Status (Week 7 10/13-10/16)


DePuy Pinnacle Trial Status (Week 7 10/13-10/16)

Monday, October 13th was Columbus Day and the courts were closed.

On Tuesday, October 14th, the defendants called Dr. Roger Emerson, an Orthopedic Independent Medical Examiner, to the stand.

Dr. Emerson returned to the stand on Wednesday, October 15th. His testimony was followed by Dr. Math, an orthopedic radiologist.

Andrew Ekdahl, the ex-president of Johnson & Johnson’s DePuy unit, returned to the stand via video deposition on Thursday, October 16th. He was followed by Dr. Lisa Pruitt, defense witness, and a mechanical and biomedical engineer who teaches at the University of California, Berkeley. Her testimony will resume Monday, October 20th.

Metal-on-Metal Hip Implants and Revision Surgery


Patients undergo hip replacement surgery in order to improve their quality of life. Hip replacement surgery is supposed to increase activity levels, improve range of motion, and ease pain and suffering. Unfortunately, after their index (initial) surgeries, individuals soon find their hip replacement is hindering rather than helping. This is often the case with metal-on-metal hip replacements.

Metal-on-metal hip systems such as the DePuy PinnacleDePuy ASRStryker Rejuvenate, Stryker ABG IIStryker AccoladeWright Pro Femur and Wright Conserve, have the highest failure rate compared to any other hip implant. Most individuals experience serious complications and subsequent failure with these implants. Complications from metal-on-metal hips include cobalt-chromium toxicity, metallosis, pseudotumors, infection, loosening and implant wear, joint stiffness, and fracture. These complications cause implant failure. Implant failure requires a second surgery, known as a revision surgery. A revision surgery requires removing the failed implant(s) and replacing with a new device.

Revision surgery is more complex and risky than the index surgery because it is more invasive. Therefore, the risk of complications is greater with a revision surgery than initial surgery. The implants are more likely to loosen, migrate, and fracture since the bone and hip joint are severely manipulated from the previous implant.

Is your DePuy Pinnacle harming you?


People might think because the DePuy Pinnacle is not recalled it may not be harmful. This is false!  

The DePuy Pinnacle is a metal on metal hip replacement system: the ball and socket of the device are made of metal. Nowadays, the words “metal on metal” are enough to trigger a worried response from individuals implanted with these types of hips. And rightfully so.

With metal on metal implants, like the DePuy Pinnacle, the metal ball and metal socket rub against each other during activities. Metal is also released from implant parts where two components connect. Metal release results in metal ions to wear off the device causing damage to bone and soft tissue surrounding the implant and joint. This is known as an adverse local tissue reaction or adverse reaction to metal debris.

Adverse reaction to metal debris can cause pain, device failure, and implant loosening which may lead to needing a revision surgery. When metal ions are released into the bloodstream, it can precipitate a systemic reaction and cause other issues including skin rash, cardiomyopathy (a heart condition), neurological impairment, psychological changes, and thyroid abnormalities. The long term effects of exposure to these metal devices is unknown.

We highly recommend you speak to a doctor immediately if you have a DePuy Pinnacle whether or not you are experiencing the aforementioned symptoms. 

October 2014 Stryker Litigation Update



Hi. This is Stuart Talley. Bill Kershaw and I are the attorneys responsible for the Stryker Rejuvenate and ABG II hip cases. We are providing an update on the litigation status currently pending in Minneapolis, Minnesota before Judge Donovan Frank.  Right now, there are about 4,000 cases filed and that number goes up every day. We receive phone calls from new people every day who are having problems with their Stryker hips. By the next update, there will probably be around 6,000 cases on file.

We have not had a status conference with the court for a couple of months. The next one is set for November 6, 2014. In the interim, there was a lot of paper work filed with the court on discovery issues. Discovery is the process where we get documents from the defendants; we take depositions of the defendants, their engineers, executives, salesmen. The idea is developing evidence we will need for trial.

One of the big battles brewing in this case involves documents. In this case, Stryker informed us they produced all their documents. To date, we received about 700,000 pages. It seems like a lot but in the context of cases like this, it’s really a drop in the bucket. In other hip cases we’ve handled, defendants typically produced anywhere from 20 to 60 million pages of documents.  We’ve looked at Stryker’s documents and discovered enormous gaps in email production. Email production is where you see most of the documents. There are generally millions of emails between engineers, between sales reps, where we find the best evidence for the case. We discovered certain key witnesses produced one email or none at all. From our standpoint, it appears documents were destroyed or simply not produced.

We are trying to get a deposition from a Stryker representative to find out what happened to all the documents. We also want to know if they were destroyed. And if so, is there a way to get them back. Sometimes, emails or deleted documents off a server can be retrieved from backup tapes. Companies often have servers with large amounts of data backed up on tapes. Those tapes are then stored in a separate, safe location apart from the facility with the servers. This ensures that if there is a disaster they can use the tapes to restore data. We hope there are the backup tapes on emails we can use to fill in the gaps.

Stryker does not want us to take that deposition, and filed a motion to quash the deposition. They asked the judge to prevent us asking questions regarding the documents and where they went. This issue will be decided on November 6. If it’s determined Stryker destroyed documents, and they destroyed documents knowing of an impending lawsuit (after the recall), it poses serious consequences for Stryker. If you can show the knowing destruction of evidence, judges have lots of remedies available to punish the party that destroyed the evidence. Judges can impose monetary sanctions, issue sanctions, or jury instruction sanctions. An issue sanction is when the judge has an issue deemed admitted by Stryker. For example, say there are key documents showing Stryker knew about the problems with the hip before it was put on the market. If we can’t prove this as a result of documents that were destroyed, the judge might enter an issue sanctioned so jurors are told at the trial Stryker knew there were problems with the hip before they put it on the market. With a jury instruction sanction, you can have the judge advise the jury that Stryker destroyed evidence in the case, and for purposes of deciding the case, they can assume there were documents that probably would have hurt Stryker down the road.

The correlation between prostheses failure and elevated metal ion levels in patients


This study focuses on whether or not higher metal ions in the blood could help determine the likelihood of prostheses failure in patients with metal on metal (MOM) implants or total hip arthroplasty. The study involved 597 patients who received hip implants approximately one year prior. Patients with failed prostheses and patients with non-failed prostheses were compared via their blood metal ion levels. A prosthetic was considered a failure if they were revised, a revision was pending, or the patient reported poor hip function.

Patients with failed implants had elevated cobalt and chromium blood levels compared to patients with non-failed hips.  Patients with failed hip resurfacing (replacement of the joint’s articular surface) had less blood cobalt levels than patients with failed total hip arthroplasty (surgical removal of the femur’s neck and insertion of a stem deep within the bone connecting with the pelvic socket and liner). There was not a significant difference in blood chromium levels between the two procedures.

The presence and amount of the metal ions were good indicators of whether or not a hip would fail. There was a 23% increase in failure among patients with a total hip arthroplasty for each increase in 1 part per billion (µg/L) of metal ions. Whereas, patients with hip resurfacing had a 5% increase in failure with each increase in 1 part per billion (µg/L ) of metal ions.

In conclusion, there was a direct correlation between higher levels of blood metal ions and metal on metal hip resurfacing and total hip arthroplasty failures.

Source: Surveillance of Patients with Metal-on-metal hip resurfacing and total hip prostheses

Correlation between Smoking and Risk of Revision Among Patients with Hip Replacements


Significant Correlation between Smoking and Risk of Revision Among Patients with Metal on metal (MOM) hip replacements

World wide, an estimated one million people are implanted with metal on metal (MOM) hip prostheses. It was originally believed that the MOM prosthesis would have a decrease in implant wear over time. However, recent studies and case reports demonstrate the contrary. MOM total hip arthroplasties indicate a higher failure rate in comparison to other types of hip prostheses. Some prominent effects that result in an elevated failure of the MOM bearings include aseptic loosening (loosening of the total joint replacement) and a hypersensitivity to the metals.

Metal hypersensitivity can cause a myriad of health issues such as osteolysis, severe and chronic pain, infection, and periarticular tissue reactions, which is aptly named an adverse local tissue reaction (ALTR). These all subsequently contribute to the high rate of failure of the MOM prostheses. In addition to the ALTR, there are reported cases of massive bone and tissue necrosis (death) along with the formation of periprosthetic pseudo-tumors. In terms of hip implant revisions, those patients suffering from pseudo-tumors had worse revision rates than those that did not.

Metal hypersensitivity, or metal sensitization and allergy, stems from the release of cobalt and chromium found within the metal bearings. In this study, it is also found that smoking patients with MOM hip prostheses led to poorer results of the hip prostheses than non-smokers. This is due to the association between the traces of cobalt and other metal elements found in cigarette smoke, and the elevated metal ions from the prosthesis. These two sources of metal are potential triggers for an increase in metal hypersensitivity and contribution to a higher risk for revision.

In this study, patients were separated into two groups: never-smokers and ever-smokers. The ever-smokers were further subdivided into current smokers and former smokers. The main concern with the study focused on an all-cause revision, known as any change or removal of a single or multiple prosthetic components. The causes of revision were divided into the following categories: aseptic loosening, infection, dislocation, periprosthetic fracture, impingement, or implant migration. During the revision, findings for ALTR were also recorded. These findings included metallosis, presence of pseudo-tumors, and tissue necrosis (death). In addition to the aforementioned subdivisions, the study was further divided into two sub-cohorts among patients with MOM, cobalt-chromium alloy hip prostheses versus patients with non-metal, ceramic-on-polyethylene (COP) hip prostheses.

The results of the study indicated that ever-smokers in both the MOM and COP cohorts suffered from secondary arthritis as a result of surgery. Among ever-smokers and never-smokers with MOM prostheses, the revision rate was more than tripled for the ever-smokers (8.7 revisions per 1,000 persons) compared to the never-smokers (1.5 revisions per 1,000 persons). The reason for such a discernible difference between never-smokers and ever-smokers with MOM prostheses was an increase in an adverse local tissue reaction (ALTR) among the ever-smokers. In conclusion, there is a strong correlation between smoking and an increase failure rate of MOM hip replacements. This association was not definitively evident among never-smokers and ever-smokers with COP hip arthroplasties.

Source: Strong Association between Smoking and the Risk of Revision in a Cohort Study of Patients with Metal-on-Metal Total Hip Arthroplasty http://onlinelibrary.wiley.com/doi/10.1002/jor.22603/pdf

 

Metal Implants and Hypersensitivity


Metal Hypersensitivity

Metal hypersensitivity is an immune mediated response resulting from exposure to certain metals such as cobalt and chromium. An immune mediated response occurs when there is a trigger, like a foreign agent, that causes an immune reaction. These triggers can range from seasonal allergies to specific cells responding to an exposure of metals. It is important to differentiate between the immune reaction from an allergen, like pollen, and a metalloid material. Whereas a seasonal allergy generates immediate symptoms, like itching, watery eyes, and sneezing, a metal allergy induces a delayed response to the exposure of these elements.

Once your immune system is exposed to new metals, your body creates an immunological memory. This occurs because certain cells called T-lymphocytes recognize the metals as a foreign body and want to create a memory in order to activate immune responses. This is the body’s defense mechanism if the metals continue to be present, or are reintroduced, in the body. After formation of immunological memory, if you are exposed to the metal again, the body will activate an inflammatory reaction in order to better defend against this foreign object. This gives the delayed response of metal hypersensitivity. The symptoms of delayed hypersensitivity are analogous to the reaction you would get from a food allergy or insect sting.

 

Symptoms of Metal Hypersensitivity

Contact dermatitis, most commonly known as a skin rash, is the most suitable way to describe the main symptom of metal hypersensitivity. Other symptoms include but are not limited to: blisters, vesicles, erythema (redness), pruritis (itching), and inflammation around the area of exposure. Due to its delayed nature, symptoms may not appear until a day after contact with the metal and may take many days to return back to normal.

Metal implant devices, such as Metal on metal (MOM) hip prostheses, lead to a more complicated metal hypersensitivity. It is difficult to describe the effects of a MOM implant because the field of visualization is restricted since the device is implanted within the body. However, studies demonstrated an immune response and hypersensitivity in the tissue areas interacting with the debris from implanted devices. Wear debris is the result of movement, friction, metal corrosion (metal oxidation), and metal ions released from the device. This can cause severe pain, swelling, limited range of motion, joint effusion (abnormal buildup of fluid between layers of tissue in or around joints), inflammation, and osteolysis (bone loss).

What happens to my device if I have a metal hypersensitivity?

Wear debris is a by product of corrosion of the implant material. Metal ions and particles are released into the surrounding tissue over time. People with a hypersensitivity to the metals of their implant will react differently compared to those who don’t have an allergy due to the triggering of an adverse response. As previously mentioned, an inflammatory response is triggered when the immune cells are exposed to the metals like cobalt and chromium. The response ranges from mild to severe depending on the extent of the sensitivity, levels of metals within the body, and wear debris. Persistent inflammation, due to the MOM implant, can cause muscle spasms, myofascial pain, headaches, tinnitus (ringing in the ear), vertigo (dizziness), and angioedema (swelling under the skin). A chronic inflammatory reaction from continued exposure, from a MOM device, can lead to loss of bone strength, implant loosening or fracturing, and osteolysis (bone loss).

Testing for Metal Hypersensitivity

It is difficult to test because the environment on the skin is different than the periprosthetic area deep within the tissues. There is a blood test called lymphocyte transformation test (LTT) which determines if a patient suffers from metal hypersensitivity. The LTT measures the proliferation of T lymphocytes which are the immune specific cells that form the immunological memory in response to metal exposure. The blood is collected and put within special tubes in order to decrease the risk of contamination. Similarly, it is tested within a laboratory that follows strict procedural protocols and standards to avoid contaminating the sample.

 Metal Hypersensitivity and Implant Performance

Approximately 25% of people with properly functioning MOM devices have a metal hypersensitivity and more than 60% of people with malfunctioning MOM devices have a metal hypersensitivity. This is a stark and alarming contrast which is attributed to the poor implantation. There is also a greater failure rate as a result of metallosis, hypersensitivity, and adverse local tissue reactions (ALTR). Hypersensitivity is strongly correlated with poor implant performance and generally makes revision difficult and risky as a result of the body’s reaction.

Source: Metal Hypersensitivity to Implant Materials By: Marco Caicedo, Ph.D

http://www.tmj.org/site/pdf/Metal_Hypersensitivity.pdf

Metal on Metal Hip Prostheses and Total Hip Arthroplasty Effects on Auditory and Visual Health


In the United States, there are over half a million patients implanted with metal on metal (MOM) hip prostheses. The typical elements released by the metal on metal hip prostheses are cobalt and chromium. The normal levels of cobalt and chromium within the body are below a microgram per liter of blood, or below a part per billion. The term microgram per liter is analogous to parts per billion. There are studies demonstrating that a normal range is within 0.1 to 0.3 micrograms per liter. According to this study, patients with well functioning MOM hips, had cobalt-chromium blood levels between 1.5 and 2.3 micrograms per liter. This is ten times higher than normal physiological levels and significantly contributes to the potential for cobalt-chromium toxicity, or metallosis. In association with metallosis, the study indicates that failure with prostheses was connected to visual and auditory issues resulting from elevated cobalt-chromium levels. There is a strong correlation between device failure with visual and auditory dysfunction.

In addition to the aforementioned findings, the study determines whether or not chronic low levels of metal exposure result in obvious physiological effects on the auditory and visual systems as well. In order to determine the effects of chronic low levels of cobalt-chromium, participants met with both an otolaryngologist and an ophthalmologist in order to determine primary or pre-existing pathologies within the ears and eyes, respectively. Subjects then underwent objective and subjective audiometric testing in order to assess auditory health and function. Similarly, the subjects demonstrated their visual health and functioning via subjective and objective visual testing. There were two types of participants in this study: those with MOMHR and those with total hip arthroplasty (THA). The participants in this study were then separated into groups based on their age and time since surgery. The participant’s blood tests also revealed that those with MOMHR had a blood, plasma, urinary cobalt and chromium levels that were 5 to 10 times higher than the THA participants. In terms of objective audiometric and visual findings between the MOMHR and THA groups, there was no observable difference, and patients in each group had similar auditory and visual function.

There is no conceivable evidence between MOMHR and altered brain stem responses for patients with exposure to chronic low metal levels. However, there is optic nerve atrophy (damage) in patients with exposure to high metal levels in their system  which reflects visual loss among this specific population. Whereas patients with long term exposure to low metal levels had no obvious association with auditory or visual defects, the patients with malfunctioning hip prostheses and elevated metal levels (up to hundreds in micrograms per liter) suggested visual and auditory defects.

Source: Auditory and Visual Health after Ten Years of Exposure to Metal-on-Metal Hip Prostheses: A Cross-Sectional Study Follow Up http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0090838

 

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