Cobalt Chromium Toxicity

How Do I Reduce the Risk of Cobalt Toxicity from a Metal-on-Metal Hip Implant?


hip

When a person undergoes surgery to receive a metal-on-metal hip implant, there is a future risk of being exposed to chromium and cobalt ions that scrape off the implant due to friction. Symptoms of exposure may include localized pain, severe inflammation and swelling, evidence of tissue death, evidence of bone loss and asymptomatic masses. Other symptoms may include fatigue, nausea, visual impairment, headaches, mood changes and rashes.

Any person who has a metal hip implant and experiences the above symptoms should seek immediate medical attention. Blood tests can be used to identify whether a person has too much cobalt or chromium in his or her blood. The longer a person is exposed to elevated cobalt or chromium levels, the worse the prognosis. If caught early, there is a much better chance of a full recovery.

Is There Anything I Can Do to Minimize My Risk of Cobalt-Chromium Toxicity?

If you have had your hip replaced with a metal-on-metal implant, you should always be alert for the signs of cobalt-chromium toxicity. If you have kidney disease or a compromised immune system, you are at a higher risk of complications. Even if you are not having symptoms, it is still possible that you are being exposed to unhealthy amounts of cobalt and chromium ions; after all, it can take years for the condition to become symptomatic. The best way to protect yourself is to have your blood frequently tested for unsafe cobalt or chromium levels. Some doctors advocate getting tested once per year; others say that as often as once every three months is the best practice to follow.

Cobalt-chromium toxicity is but one of many potential problems caused by metal-on-metal hip implants. Many lawsuits have been filed on behalf of patients who have suffered complications related to hip implants. If you have been injured or had to undergo painful procedures due to your hip implant, call Kershaw, Cook & Talley PC at (888) 817-2527.

The 510 (k) process and metal on metal hip implants


Currently, various medical devices enter the marketplace via a regulatory pathway, the 510(k) process, monitored by the Food and Drug Administration (FDA). The 510(k) process loosely evaluates for safety and effectiveness, and approves the clearance of new medical devices based on ones that are substantially similar and previously cleared.

There are 3 classes of devices:

  1. Class 1: low-risk devices (e.g. toothbrushes, dental floss, band aids). Class 1 devices are subject to minimal regulatory controls. 
  2. Class 2: moderate- risk devices (e.g. powered wheelchairs). Class 2 devices require greater regulatory controls. 
  3. Class 3: highest-risk devices (e.g. metal on metal hips, replacement heart valves). Class 3 devices are supposed to undergo the highest level of regulatory control known as Premarket Approval, or PMA. 

According to the FDA, Premarket Approval (PMA) requires manufacturers to submit an application if they intend to market any new products containing new materials or differing in design from products already on the market. A PMA submission must provide valid scientific evidence collected from human clinical trials showing the device is safe and effective for its intended use.

However, many class 3 devices do not undergo PMA. They are cleared through the 510 (k) process, claiming substantial equivalence to preamendment devices, or comparable devices already on the market. Unfortunately, this allows companies a means of avoidance in testing their products for safety and effectiveness before releasing them on the market.

 

Closing Arguments in the DePuy Pinnacle Trial began October 21, 2014


Closing arguments in the DePuy Pinnacle Trial started Tuesday, October 21, 2014. Closing arguments are essentially where each side, plaintiffs and defendants, summarize the evidence put forth at trial and argue their case to the jury.

In this case, Mark Lanier, the plaintiff’s attorney, will likely argue that DePuy was at fault for the plaintiff’s injuries and the jury should award her damages accordingly.

On the other hand, the defendants will likely argue that the plaintiff’s injuries were not caused by the Pinnacle implant but rather caused by negligence from her doctor, or other factors, and should deny recovery.

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.

Hip Surgery: The Importance of Doctor-Patient Communication


An open and honest dialogue with your doctor before surgery contributes to better outcomes. This means providing your physician with a comprehensive medical, surgical, and social history. This also ensures the doctor gives you the best care in creating a plan that fits your specific needs. Before any surgery, it is essential to voice any questions or concerns you might have.

The American Academy of Orthopedic Surgeons (AAOS) created a list of questions which may help in discussions with your doctor:

  • What are your experiences with specific hip implant devices and how often do you use one over the other?
  • What are the risks and benefits of different devices (metal-on-metal, metal-on-polyethylene, ceramic-on-polyethylene, and ceramic-on-ceramic devices)?
  • If applicable, what is the surgeon’s personal experience and outcomes with the respective devices?
  • If your surgeon recommends a certain device, ask why that hip implant is the best for your situation.
  • What are the major and/or most frequent complications of surgery?
  • Is the skill and experience of the orthopaedic surgeon more important than the device or procedure?
  • Can you give me any information on outcomes and complication rates?
  • If I do not have surgery, what is the risk?
  • How much pain can I expect, and how will it be managed in the hospital and after I go home?
  • How long will the device last, and what can I do to make it last as long as possible?
  • What are the pros and cons of minimally invasive (mini-incision) surgery? Does it really make a meaningful difference in the result, or does it pose unnecessary risks?
  • What will I be able to do/not do after my total joint replacement?
  • Is therapy necessary after surgery?
  • How long will I be in the hospital?
  • Will I be able to contact you after the surgery if I have a question or problem?

What should I do if I have a metal on metal hip?


A series of product recalls involving prosthetic hips occurred recently. The design of these hips led to the release of toxic levels of cobalt and chromium (the metal the hips are made of) into the patients who receive them.  These metals cause extensive tissue damage in the hip and other areas of the body. This usually requires additional surgery to repair. Kershaw, Cook & Talley currently handles cases involving the following types of hips: DePuy PinnacleDePuy ASRStryker AccoladeStryker Rejuvenate, Stryker ABG IIBiomet, and Wright Medical.

Many individuals are unsure what to do when they find out their metal on metal hip is defective or recalled. Kershaw, Cook & Talley recommends the following steps:

A) Find out what name and model hip you have. There are various ways to do this:

  1. Contact your orthopedic surgeon by phone. 
  2. Request a copy of your medical records in writing from the orthopedic surgeon’s office or hospital where the surgery was performed. 
  3. Check your implant card. Often times, after surgery, your doctor gives you an implant card which states the hip name and type. 


B) Check to see if your hip implant was officially recalled (if not, you may still have a case).

  1. You might have received a recall letter notifying you that your hip implant was recalled. 
  2. If you did not receive a letter, ask your doctor if your hip implant was recalled. 


C) Have your blood tested for cobalt and chromium:

  1. Tell your doctor you want to get your blood tested specifically for cobalt and chromium. 


D) Get a MARS MRI:

  1. MARS MRI stands for Metal Artifact Reduction Sequence MRIA MARS MRI is an imaging technique which minimizes metal artifact (i.e. parts of the implant) while maintaining image quality.
  2. You will most likely have to request this imaging study from your orthopedic surgeon. 

F) Call our office for a free case consultation and if you have any more questions regarding your metal-on-metal hip. 

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. 

DePuy Pinnacle Trial Update: Week 6 10/6-10/9



We are providing an update on the ongoing DePuy Pinnacle trial now pending in federal court in Dallas, Texas. This is the very first case to be tried in front of a jury in the country. There are about 6,000 cases now pending against DePuy by people who were injured by their Pinnacle hips. We are now in the sixth week of the trial.

This week in the trial we continued with the defense case and the witnesses DePuy is putting on the stand. They introduced a series of expert witnesses to talk about all of the things DePuy did to test and get the Pinnacle hip approved by the FDA. The purpose of the testimony is to give jurors the impression that DePuy is a responsible company, and that they performed all the appropriate tests the FDA required, and really didn’t do anything wrong. There is a problem with that argument. The way the FDA works is unique. A lot of people believe when the FDA approves a product, they thoroughly investigated the product and decided that it’s a good product, it’s safe, and the warnings are adequate. The truth is something different. With medical devices, such as hips, manufacturers are not required to test the device. They can get approval from the FDA to sell the device with almost no testing at all if they show the device is substantially similar to another design that is already on the market. The issue with whether FDA approval means the device is safer, or the company did the right thing, really doesn’t mesh. So, when the FDA approves a device, they are not saying they tested it. The FDA doesn’t really test devices. The FDA relies on manufacturers to test the devices, and the manufacturers tell the FDA they tested the device. That’s when the FDA approves the device.

DePuy is trying to create the impression that because this was FDA approved it was a safe device and their testing was appropriate. In reality, this isn’t true.

The next phase of the trial will be the plaintiff’s rebuttal witnesses, present witnesses to rebut the arguments the defendants have made.

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