searcy law Skip to Content
Contact Form Map & Directions Videos

Metal Testing: New FDA Guidelines (Part II)

Defective Medical Devices

This blog is a continuation of our “Metal Testing: New FDA Guidelines” which you should read first if you want more information on how to test for metal artifacts in your hip.

Metal Ions

This is a picture of unrefined cobalt ore. Metal ions are tiny molecules of this type of metal which can float free in the bloodstream.

This is a picture of unrefined cobalt ore. Metal ions are tiny molecules of this type of metal which can float free in the bloodstream.

Metal ions are different from metal artifacts. They are microscopic, so you cannot see them with your naked eye. Metal ions also do not show up on the imaging tests described above – the only way to test for metal ions is to test for their presence in the bloodstream. Of course, this is a scary thought because it means that metal ions are circulating to every part of your body instead of being contained to just the area around your hip like metal artifacts.

The FDA currently recommends that metal ion testing be done in patients who “develop any symptoms that may indicate that their device may not be functioning properly.” We recommend that you ask your surgeon or doctor to test for the presence of metal ions if you have a metal-on-metal hip, even without pain, and especially if your hip has been recalled. There are two kinds of metal ions that you will want tested if you have a metal-on-metal hip.

Cobalt is important to test for because it can cause a wide range of symptoms. Some of these symptoms involve the heart and can make it enlarged and have trouble pumping blood (called cardiomyopathy) as well as causing the blood in your body to become thicker. Cobalt poisoning can also cause thyroid problems and can possibly damage your nerves. We’ve even heard reports of severe fatigue and unexplained rashes which go away after the source of the metal ions have been removed (the metal-on-metal implant).

Cobalt should be tested using an “inductively coupled plasma mass spectrometer” (ICP-MS) which should be equipped with either “collision cell”, “dynamic reaction cell technology” or a “sector field inductively coupled plasma mass spectrometer”. You don’t need to understand the technology behind these different testing devices, but do make sure that your doctor is sending your whole blood to a CLIA-certified lab. CLIA certification means that the laboratory has been certified in the use of “Clinical Laboratory Improvement Amendments” which makes their testing much more reliable. Many commercial labs without CLIA certification do not have the technology to accurately test for cobalt. It is also very easy to contaminate your whole blood sample with foreign objects.

Chromium is also important to test for using the same devices as cobalt. To ensure accuracy, you should make sure that your doctor uses a CLIA-certified lab that provides its own collection kits that are free from metal contamination. It is important for your doctor to have accurate test results, and not all doctors are entirely knowledgeable in metal ion testing. However, the prevalence of failed metal-on-metal hip implants has required them to learn a lot more about this topic.

Finally, we recommend that you also get your titanium levels tested. The FDA has not yet come out in favor of this type of testing, but from what we see in our clients, titanium testing might be incredibly important to your health. This is a rare test, however, and your doctor might not agree with you when you ask to have your titanium levels tested.

The reason we recommend this test lies in the findings of our experts when they have analyzed some of the hundreds of metal-on-metal hips we have in our possession. Testing has shown very high levels on titanium on parts of these devices where titanium shouldn’t be, so we have reason to believe that titanium may also be present in the bloodstream, just like cobalt and chromium.

Regardless of whether you are able to get this kind of testing, please pay attention to your symptoms if you still have a metal-on-metal hip. Talk to your doctor if your hip hurts or if you start experiencing strange and unexplained symptoms. Even if you still have a metal-on-metal hip inside of you and especially if you have your hip taken out, please give us a call and we’ll evaluate your case for free.

Share This

Hear What Our Clients Have To Say

"Amazing law firm! As an attorney myself I can say that they truly care about their clients and it shows!"
Posted By: Clinton Cimring