Should I be worried if I have a metal-on-metal hip but no symptoms of hip failure?

The most common symptoms of hip failure include severe pain, aching and swelling in the hip area. Upon examination, doctors will often find that these symptoms started due to the release of metal particles that can damage the surrounding tissue.

What if I have a metal-on-metal hip but do not have any problems right now?

If you have a metal-on-metal hip but no symptoms of hip failure, you should keep yourself informed. Metal-on-metal effects are still being studied, and more information will continue to come out.

This month, The Lancet reported a case study of a 55-year-old German man who had been diagnosed with severe heart failure caused by cardiomyopathy. He was deaf and almost blind. He also had a fever, hypothyroidism, and reflux oesophagitis. The doctor suspected cobalt intoxication based on these problems and the fact that his medical history indicated he had undergone hip replacement surgery a few years back. The radiograph of his hip showed evidence of metal debris. He also had enlarged lymph nodes on his left hip. A blood test confirmed that the levels were high, and he underwent revision surgery soon after.

Upon examining the explanted devices, doctors found damaged areas of the chromium and cobalt femoral head. They concluded that the high cobalt levels were due to the metal wear on the hip device. After revision surgery, his cobalt and chromium concentrations decreased, and the patient stabilized and everything but his hearing and vision improved.

Importantly, according to the publication, the symptoms the patient reported did not include hip pain or swelling. The doctor made the diagnosis based on the known effects of cobalt intoxication.

It is important to note that the scientific effects of metal on the body are still inconclusive. This man’s case may be an isolated event. Regardless, staying alert and receiving needed care is an important step to staying healthy.

So What Do I Do?

Bring up any concerns with your doctor. If you have not discussed monitoring your metal-on-metal device with your doctor, we suggest you make an appointment to do so.

Recently, the FDA released guidelines for physicians to follow when monitoring metal-on-metal hip recipients. Those guidelines identified various imaging tests that can be useful for doctors to identify problems. X-ray imaging was not listed as a reliable way to detect metal-on-metal damage, so do not assume your doctor is monitoring your device if he or she is only taking x-rays!

In addition to the imaging tests, the FDA recommends that metal-on-metal patients receive blood tests that record metal ion levels in the body. Although the FDA concluded there is not sufficient evidence that blood tests are needed for patients who do not have symptoms of hip failure, we recommend that anyone with a metal-on-metal device requests these tests. We have personally seen many cases in which high ion levels were recorded long before symptoms of hip failure presented. Additionally, a study published last year in the British Medical Journal found that high metal ion levels predicted hip device failure, even in symptomless patients.

Should I get an attorney if I do not have symptoms?

You should at least talk with one. There are statutes of limitations on product liability claims that can bar your case regardless of its merit. Our firm is pursuing these cases throughout the country. Our attorneys and staff are extremely knowledgeable and can answer any questions or concerns you may have. Contact us for a free consultation before it is too late to pursue your case.

FDA Publishes Guidelines for Chromium and Cobalt Testing

It is very important that patients with metal-on-metal implants are monitored and receive the appropriate chromium and cobalt testing. As we pointed out in a post last fall, definitive answers to metal-on-metal questions are difficult to come by:

Since the manufacturers of MoM devices did not study the effects of metal wear, people have likened the advent of metal-on-metal hips to a large, uncontrolled experiment. Thus, the studies that are now underway are reactive in nature and have minimal foundation to build from.”

The problems that have been reported relating to metal-on-metal wear can undoubtedly generate anxiety and worry for hip recipients and their families. Recently, the FDA released a set of guidelines to help establish uniform chromium and cobalt testing and diagnostic procedures for orthopedic doctors who are treating metal-on-metal hip recipients. This is a step in the right direction, as doctors have been forced to work off of little to no official guidelines when it comes to monitoring metal-on-metal hip recipients and interpreting results of various diagnostic methods.

FDA Guidelines for Chromium and Cobalt Testing

Soft Tissue Imaging

The first method discussed in the FDA report is soft tissue imaging. Depending on the individual circumstances, the FDA recommends one of the following:

  • Magnetic Resonance Imaging (MRI) with metal artifact reduction (MAR)

This technology offers the best visualization of soft tissue surrounding a metal-on-metal hip implant and uses non-ionizaing radiation. Panel members at the June 2012 Orthopaedic and Rehabilitation Devices Advisory Panel Meeting recommended this method over others that were discussed. However, this method is contraindicated for some patients with implants.

  • Computed Tomography Scan (CT) Scan

CT scans offer the best visualization of implant positioning and bony tissue. However, they use ionizing radiation and provide lower soft tissue visualization. Image artifacts from the implant may distort the images.

  • Ultrasound

Ultrasound allows soft tissue visualization without metal artifacts and uses non-ionizing radiation. However, it provides a lower resolution soft tissue image and has a limited depth penetration.

These tests will show the tissue surrounding the implant and any distortions in the imaging will alert your doctor to metal artifacts (particles of metal) around the implant. Your doctor can determine which test is most appropriate for your situation. Keep in mind that his or her decision may also be based on what types of tests insurance will cover.

Chromium and Cobalt Ion Tests

As you likely know, elevated metal ion levels (e.g. chromium and/or cobalt) are a concern for anyone who has a metal-on-metal hip. Ions are not visible on the imaging tests listed above, so a blood sample must be tested in order to detect them.

The FDA says that anyone who develops symptoms should be tested. However, a recent study provided evidence that blood metal ion tests can be used to measure the risk of early joint failure. The study also suggested that elevated metal ion levels, regardless of symptoms, warrant concern. This means that even symptomless patients who have undergone metal-on-metal hip replacement surgery could still have increased ion levels that predict implant failure. For this reason, we recommend that metal-on-metal hip recipients undergo chromium and cobalt testing regardless.

The FDA specifies blood test methods they believe will produce the most accurate results. These tests are rarely done in your doctor’s office; he or she will most likely send you to a lab to have them done. The FDA also specifies the criteria a lab should meet to generate the most accurate results. Many doctors have already been using labs that meet these criteria, but some may be using testing labs that are outside of the FDA’s new guidelines. Before you get tested at a lab, we recommend checking with your doctor to make sure the lab meets the FDA’s criteria for accurate chromium and cobalt testing.

Talk to your doctor

If you have any concerns or questions about your implant, do not hesitate to talk to your doctor. The FDA guidelines are not meant to replace the need to see your doctor; it is important that you keep he or she in the loop when it comes to your condition.

Do you have a Case?

If you have a metal-on-metal hip and have not yet spoken with an attorney, we recommend that you do as soon as possible. There are statutes of limitations that can bar your claim if it is not filed by a certain date. There could also be additional cut-off dates to file your claim based on settlements. Contact us for a free consultation.

Have you been told you need revision surgery?

The explanted device can be a crucial piece of evidence and it should be preserved with the surrounding tissue. We do this for our clients using a company that specializes in device preservation. If you have been told you need a revision surgery, it is best to contact us as soon as possible so that we have time to preserve the device.

Biomet Hip Settlement – M2a Magnum Hips

We are happy to report some good news regarding a recently-announced Biomet hip settlement. Yesterday, the Court proposed a settlement between Biomet and the Plaintiff’s Steering Committee (PSC) of the multi-district litigation on behalf of all plaintiffs who suffered a metal-on-metal  (MoM) related failure of their Biomet M2a 38 or Biomet M2a Magnum hip device.  As we anticipated and hoped, the settlement structure is in many ways similar to the ASR settlement that we reported in late 2013. However, as we previously warned, each hip litigation varies and might produce slightly different results.

Who is eligible for the Biomet hip settlement?

Plaintiffs who have undergone revision surgery on their Biomet M2a 38 or Biomet M2a Magnum hip more than 180 days after it was originally implanted are eligible for the settlement. Cases that have not undergone revision surgery will be dismissed without prejudice on or before September 12, 2014, if a revision does not take place by that date. The injuries necessitating the revision surgery must have been caused by metal-on-metal wear.  Other reasons for failure, such as infection or trauma, do not qualify.

How much will plaintiffs receive?

We cannot speculate on individual amounts at this time. However, reports say that Biomet will pay at least $56 million to settle the claims in the MDL. The Biomet hip settlement agreement includes a base award of $200,000 for eligible plaintiffs. This amount is subject to deductions based on the date of implantation, amount of time between implantation and revision, and other factors. Notably, the base amounts for the Biomet hip settlement will not be subject to discounts based on age, BMI, or smoking like they were in the DePuy ASR settlement.

In addition, certain factors may “enhance” the compensation a plaintiff can expect to receive. Examples of enhancement cases have not yet been released. Stay tuned for updates.

To our clients:

If you qualify, we will be sending you an update letter as soon as possible detailing the settlement agreement and next steps. Please keep in mind that, in settlements of this size, distribution is a slow-moving process. Deadlines are spaced out over a large period of time in order to accommodate such a large number of cases. Thus, we ask that you follow these guidelines unless you consult with your attorney first:

1.)  Do not spend the money until you have it. Even if we do confirm with you that your case is eligible for settlement, the base value could be subject to discounts based on the facts of your case. In addition, we cannot guarantee a deadline by which you will receive funding. Settlement funding depends on many factors beyond our control, and after we have submitted everything on our end there is little we can do to expedite the process.

2.)  Do not talk to loan funding companies. They charge extremely high interest rates over short periods of time. Again, we cannot guarantee when you will receive funding, and you could end up owing most or all of your settlement back to them.

3.)  Do not post on social media about the settlement. Posting on social media about your case is never going to help it, but it does have the potential to hurt it (see more).

4.)  Be wary of anyone (besides us) who calls you to talk about your claim. The period between a settlement announcement and fund distribution can be an opportune time for scammers to prey on plaintiffs. If you are not sure who is calling you or how they got your information, don’t be afraid to ask.

5.)  Be wary of anyone trying to get you to switch attorneys. Now that people have heard of the settlement, the competition for these cases is fierce. Marketers can make a lot of money selling your name and number to other law firms, and they will often tell you whatever you want to hear to try to get your attention. Sticking with your current attorney is, in most circumstances, the best route specifically because our attorney has already prepared your case for settlement.

If you have not yet hired an attorney:

It is very important that you speak with us as soon as possible. Plaintiffs are not eligible to participate in the settlement unless their case is filed in the MDL on or before April 15, 2014. That does not simply mean that we must hear from you by that date. It takes months to prepare these cases before we can file them. We must hear from you very soon in order to file your case on time for the April 15th deadline.  Further, there are statute of limitation laws that could bar your claim if your case is not filed by a certain date. Statute of limitation laws vary from state to state and are determined on a case-by-case basis.

These cases still depend on our ability to prove that your injuries were related to the metal-on-metal design of these implants. We have some of the top expert physicians reviewing our cases and making sure your case is as strong as possible before we file it. If you have metal-on-metal Biomet hip, please contact us to speak with one of our attorneys. We look forward to helping you.