Metal Hips Cause Levels 26x Cobalt Increase and 15x Chromium Increase

Title: The Effect of Different Bearing Surfaces on Metal Ion Levels in Urine Following 28mm Metal-on-Metal and 28mm Metal-on-Polyethylene Total Hip Arthroplasty

Abstract

Total hip arthroplasty (THA), or hip replacement surgery, is known to increase levels of metal ions in the body. This is because the implant devices can shed metal particles into the body. This can have many negative effects on THA patients.

One way to measure the levels of metal ions in the body is to test patients’ urine. This study compares two different types of THA devices to see which one produces higher metal ion levels, as measured by patients’ urine. The two types of implants they compare are metal-on-metal (MoM) bearings and metal-on-polyethylene (MoP) bearings.

This study looks at 92 hip replacement patients; some of them had MoM implants and others had MoP implants. It measures the amount of cobalt, chromium, and molybdenum ions in their urine one year after getting their implants and two years post-surgery.

The patients with MoP implants had only a slight increase in cobalt and chromium levels two years post-surgery. For the patients with MoM devices, chromium levels were 15 times greater two years after surgery, and cobalt levels had increased by 26 times.

The authors conclude MoM devices cause very high cobalt and chromium levels; they are higher than those allowed for on-the-job exposure in Finland, where this study was conducted.

Introduction

Metal-on-metal hip implant devices that are made out of cobalt and chromium became really popular because they were thought to be more durable. Many improvements have been made since the first generation of MoM devices came out in the 1970s. However, there are still many health problems associated with these devices, such as adverse reaction to metal debris (ARMD). ARMD is a type of hip implant failure that results in pseudotumors and fluid collections around the hip implant. ARMD is caused by metal particles rubbing off of the implant device and into the body.

Patients and Methods

92 patients were divided into two groups, those who had hip replacements with MoM implants and those who had MoP implants. All of the patients had Biomet hip implants with 28-mm head diameters.

The authors collected urine samples from the patients before their hip replacement surgery, one-year post-surgery, and two years post-surgery.

Results

X-rays taken two years after surgery showed that none of the patients’ implants had moved or been misplaced since surgery. Only 5 implants had fractured, and they were fixed.

Before hip replacement surgery, average chromium levels for both MoM and MoP patients were less than .01 µmol/L. One year after surgery, average chromium levels had risen to .12 µmol/L for MoM patients but were still .01 µmol/L for MoP patients. Two years after surgery, average chromium levels rose to .15 µmol/L for MoM patients and .02 µmol/L for MoP patients. Essentially, chromium levels increased a lot more for MoM patients than they did for patients with MoP devices.

Average cobalt levels before hip replacement surgery were 21 nmol/L for MoM patients and 19 nmol/L for MoP patients. One year after surgery, average cobalt levels had risen to 417 nmol/L for MoM patients but only 33 nmol/L for MoP patients. Two years after surgery, cobalt levels had risen to 538 nmol/L for MoM patients and 57 for MoP patients. In sum, cobalt levels were dramatically higher for MoM patients than they were for MoP patients.

Molybdenum levels were also measured for all patients, but there were no significant changes in molybdenum levels.

Overall there was a much greater increase in cobalt and chromium levels for MoM patients than there was for MoP patients. Cobalt and chromium levels for MoM patients ended up being much higher than what is considered safe in Finland.

Discussion

The authors found that 28-mm MoM bearings in THA patients yield chromium and cobalt concentrations in urine that are higher than those recommended for workplace exposure.

The authors used urine samples because metal ion levels in urine are a good indicator of the levels of metal ions in the entire body.

Although cobalt is necessary for the body, excessive amounts of it can cause goiter and heart failure.

Ever since MoM implants were introduced, there have been concerns about their possible link to cancer; in animal studies, high levels of cobalt and chromium particles produced cancer cells in the animals. Recent studies have also suggested that hip implants (MoM and non-MoM) can cause changes to patients’ DNA and chromosomes.

There is also concern about the effects that MoM implants could have on the fetuses of patients who become pregnant because cobalt and chromium can cross the placenta; this could cause developmental problems in fetuses.

In theory, people who have THA surgery should face higher metal ion levels than people who receive hip resurfacing (HRA) surgery. However, the studies on this subject show conflicting results. One study showed that cobalt and chromium levels for patients who received HRA were higher than those who got THA surgery.

Another study found that cobalt and chromium levels in HRA patients and small-diameter head THA patients were significantly higher than in large-diameter head THA patients 6 months after surgery. However, this same study found that one-year post-surgery, all of the patients’ cobalt and chromium levels were more or less the same.

Some studies have shown that MoM implants often wear down very quickly in the first one to two years after surgery. After this initial period, they enter what the authors call a “steady-state” of wear for many years, which means the implants shed metal particles at a much lower rate.

MoP devices seem to be safer than MoM devices when it comes to metal ion levels.

**It is important to note that this study was funded and sponsored by Biomet UK Limited, a company that manufactures MoM devices.

Reference

Tiusanen, H., Makela, K., Kiilunen, M., Sarantsin, P., Sipola, E., Pesola, M. Scandinavian Journal of Surgery 102: 197-203, 2013.

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Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

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Pseudotumor in a Patient with a Biomet Hip Implant

Research Title: Pseudotumor in Large-Diameter Metal-on-Metal Total Hip Articulation

Abstract

This case study focuses on a patient who experienced pain in her hip following a large-diameter metal-on-metal (MoM) hip replacement. She also developed a pseudotumor, which is an abnormal swelling of tissue that resembles a tumor.

Intro

MoM hip implants are thought to be more stable and durable than metal-on-plastic implants, so they’ve become a popular choice for patients undergoing total hip replacement or hip resurfacing surgery in the United States.

However, MoM implants can cause conditions like an adverse reaction to metal debris (ARMD) and metallosis. ARMD is a form of implant failure that happens when the device sheds metal debris and causes negative effects like pseudotumors and collections of fluid around the implant. Metallosis is a type of metal poisoning that occurs when the implant’s metal debris raises the amount of metal in a patient’s blood.

This patient developed a pseudotumor five months after receiving a Biomet Magnum device with the Taperloc femoral stem. Her complications have been observed in other cases.

Case Report

A 39-year-old woman came to the authors with a 2-year history of hip pain. She had previously experienced bone tissue death in her left femur (a condition called avascular necrosis) but did not have any other medical problems. Prior to developing avascular necrosis, she was very physically active. She underwent total hip replacement surgery and received a Biomet Magnum device with the Taperloc femoral stem.

Right after her surgery, she made a full recovery, reported no pain, had full strength in her hip, and had a full range of motion in her hip. Three months after surgery, she began to feel pain in her left leg. Four months after surgery, she felt squeaking and popping in her hip.

Five months after surgery, she had such severe pain in her left hip, groin, and buttocks that she used crutches and could not go to work. She had swelling in her left hip and thigh. Her hip was weak and had impaired mobility. X-Rays revealed that her implant was not loose and had not moved. Her device’s femoral stem had an angle of 11.3 degrees, and the shell had an angle of 9.7 degrees. Blood tests indicated that she was experiencing inflammation but no infection.

The doctors took a sample of fluid from her left hip and found a liquid that looked like coconut milk with some yellow grains in it, but it had no signs of infection. Analysis showed that the fluid had chromium levels of 707.6 μg/L of chromium, titanium levels of 60 μg/L, and cobalt levels of 1068 μg/L. These levels are much higher than what is considered acceptable or healthy.

The patient underwent revision surgery because of these unusual and painful symptoms. During the surgery, doctors found a pseudotumor surrounding the implant and removed it. The doctors also found a type of dead tissue that resembled cheese. This tissue was sent for analysis but showed no sign of infection. Another tissue sample appeared to have an impaired blood supply and scarring. An analysis of the tissue surrounding the implant also showed impaired blood supply and scarring.

The patient received a metal-on-plastic implant during revision. The components were the Converge titanium acetabular shell, the Durasul Polyethylene insert, and the Biomet head. Two years after revision surgery, the patient had no negative symptoms other than occasional severe sharp pain in her left hip groin.

Discussion

This patient’s Biomet implant failed because of its metal on metal bearing surface. The levels of chromium and cobalt in the fluid surrounding her hip joint were extremely high.

Pseudotumors are caused by implants shedding metal debris into patients’ bodies as they wear down. The release of metal debris might be related to the positioning of the implant’s components, implant devices rubbing together abnormally, the types of metal in the implant, the thickness of the implant components, and other factors.

The doctors believe the device failed because the femoral neck of the implant was excessively rotated forward (21 degrees). They believe this positioning caused the implant to wear down rapidly and shed metal particles.

This patient’s chromium levels were 18 times higher than the average measurements of other reports, and her cobalt levels were 13 times higher.

One of the authors has stopped using large-diameter MoM implants as his go-to device for hip replacement patients because he has seen way too many complications from the implants. The author has had to revise 25 implants because the implants failed to attach to the patients’ bone and caused the patients severe pain. None of the implants the author has given have dislocated. The author now only uses one brand of implant for MoM hip replacements because he has not experienced any complications with it.

Doctors need to monitor MoM implant patients very carefully, and they need to be very mindful of the way they position the implant because it can mean the difference between failure and success. Additionally, cup inclination should not exceed 50 degrees sideways and 20 degrees forward. The author also believes that large-diameter MoM hip replacement could still be used to treat degenerative hip diseases, but doctors must be very mindful of their implant choice and surgical techniques to prevent failure.

Reference

Shahrdar, C. The Journal of Arthroplasty, Vol. 26 No. 4 2011.

Want to Discuss Your Metal on Metal Hip Case?

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

Continue Reading Pseudotumor in a Patient with a Biomet Hip Implant

Biomet Magnum Hips and Heart Problems from High Cobalt Ion Levels

Research Title: Progressive Cardiomyopathy in a Patient with Elevated Cobalt Ion Levels and Bilateral Metal-on-Metal Hip Arthroplasties

Abstract:

Cobalt poisoning, which is also referred to as cobalt toxicity or cobalt disease, is caused by excessive levels of cobalt in the body. It is a rare but serious possible side effect of Metal-on-Metal (MoM) total hip replacements. This study focuses on one patient who received MoM hip replacements on both hips and suffered from worsening cardiomyopathy – a type of heart muscle disease – as a result. The authors believe this is the first-ever case where an MRI detected cardiomyopathy resulting from cobalt disease. Even after the MoM THA implant was removed, the patient did not make a full recovery.

Introduction:

Cobalt poisoning has occurred in patients with hip implants that are part metal and part ceramic; it has also occurred in patients with MoM hip implants. Cobalt poisoning has even occurred in patients who received revision surgeries to remove the broken ceramic components in their hip implants.

In four reported cases, patients developed cardiomyopathy after showing high cobalt levels in their blood; one of those cases resulted in death.

MoM hip replacements have also resulted in numerous complications due to the implants shedding metal debris inside of patients’ bodies. Up to 59% of MoM patients have experienced negative reactions to these metal debris in the tissue surrounding their implants. However, there are not as many cases where MoM implants have led to complications that spread throughout the entire body, as was the case with this patient.

This study presents the case of a patient who experienced cardiomyopathy after showing signs of cobalt poisoning from a MoM hip implant. Even after removing the MoM device, the patient’s heart problems continued to deteriorate so much that he had to get a heart transplant to avoid certain death.

Case Report:

This 54-year-old patient was quite healthy. He claimed no history of diabetes, tobacco, alcohol, steroid, or recreational drug use. He also said he had no complaints about either of his hip implants, which were Biomet M2a-Magnum MoM devices. The authors of the study met the patient 6 years after getting his left hip replacement surgery, and 5 years after his right hip replacement surgery.

11 months before the patient came to the doctors, he started feeling chest pressure, fatigue, and sweating when he went through his regular daily activities. He also complained of losing some feeling in both of his feet. He did not, however, have any vision loss or ringing in his ears.

After getting a heart ultrasound (echocardiogram), the patient was found to have several problems. First, he had mitral regurgitation, which is a leakage of blood in one of the heart valves. He also had stage II diastolic dysfunction, which is a type of heart failure where blood collects in the lower half of the heart.

When the patient first came to the doctors, he did not show any of the typical signs of hip implant failure. He said he was not experiencing any pain in his hip or groin. He was walking normally, had a full range of motion, and had no signs of any abnormal fluid or tissue formations around his hip implants.

However, metal ion blood tests showed his cobalt level had risen to 189 ppb and his chromium level was at 71 ppb. High cobalt and chromium levels are a common sign that MoM implants are negatively affecting the patient. Because of this, the patient agreed to undergo revision surgery for his hip implants.

Leading up to his surgery, the doctors were not yet sure what was causing his heart problems. An MRI showed that both of his heart ventricles were failing (this is a condition called biventricular dysfunction). The doctors then performed a particular MRI technique called delayed contrast imaging, and the doctors concluded that the image could be evidence of cobalt infiltration into the heart, even though there were no reported cases of an MRI being able to detect cobalt-caused cardiomyopathy.

Further tests concluded that the patient’s cardiac health was deteriorating. He also showed some signs of kidney failure. The kidney failure was most likely not directly caused by the high cobalt levels in the blood, but it was probably a complication associated with his heart failure.

The doctors took a sample of his tissue for analysis, which showed many concerning signs. The tissue showed, among other things, an increase in the size of the heart muscle cells (myocyte hypertrophy) and inflammation and scarring of the heart tissue (interstitial fibrosis). Although these findings are not unique to cobalt-caused cardiomyopathy, they can be evidence of it.

Overall, the patient’s diagnosis with cobalt-caused cardiomyopathy was based on an analysis of his heart tissue, MRI findings, cobalt levels, the patient’s symptoms, and findings during surgery.

Moreover, during the revision surgery, doctors found evidence of pseudotumors (enlarged tissues that resemble tumors) in the tissue surrounding the hip implants. They also found an abundant brown, creamy fluid that appeared metallic.

The only part of the implant that showed signs of wear was the femur implant (called a femoral head). None of the components were out of place.  The femoral heads were removed replaced with metal-on-polyethylene devices called Biolox Option Ceramics (CeramTec). Tissue samples from the operation showed signs of chronic inflammation and some tissue death (fibrinoid necrosis).

Nine months after the surgery, the patient’s cobalt levels had declined to 16 ppb and his chromium levels had declined to 32 ppb, but normal levels of chromium and cobalt are less than 1 ppb.

Despite the lower cobalt levels, the patient’s cardiac health continued to worsen. The patient was eventually admitted to the hospital with congestive heart failure and received an LVAD implant, which is only given to patients with very advanced heart failure. He has since had a heart transplant and is doing well.

Discussion:

To the authors’ knowledge, this is the very first reported case of cardiomyopathy in a patient with high cobalt levels and a Biomet M2a-Magnum hip implant. This is also the first case where an MRI was able to detect cobalt-caused cardiomyopathy.

This patient’s cobalt levels were similar to those of other patients who got systemic cobalt poisoning from other MoM implants. Cobalt poisoning has been seen in patients who received total hip replacement and surface hip replacement.

The heart problems caused by cobalt toxicity in this patient present a frightening consequence of getting a MoM implant because MoM hip replacements have repeatedly been shown to lead to increased cobalt and chromium levels.

What is unique about this case is that the patient’s heart problems did not improve after removing the MoM implant. He sustained permanent damage to his heart muscles, and his cardiac health continued to decline despite the removal of the implant.

Conclusion:

This case focuses on a patient who received MoM hip replacements on both hips. He experienced mild kidney failure and had cobalt levels greater than 60 ppb. His heart failure was so severe that he required an LVAD implant to keep him alive until he could get a heart transplant. These factors have been associated with reversible heart damage. However, doctors must recognize that certain hip implants can lead to irreversible heart failure.

Reference

Mosier, B., Maynard, L., Sotereanos, N., Sewecke, J. “Progressive Cardiomyopathy in a Patient with Elevated Cobalt Ion Levels and Bilateral Metal on Metal Hip Arthroplasties,” The American Journal of Orthopedics. March/April 2016.

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Tell Us About Your Metal on Metal Hip Situation

Maglio Christopher and Toale, P.A. is a national leader in metal on metal hip liability lawsuits. We have contacts within the orthopedic community and extensive medical and technical knowledge about these defective orthopedic hip replacements.

Our attorneys have sued almost all of the manufacturers in the orthopedic industry. In fact, our firm filed the FIRST metal-on-metal hip lawsuit in the United States.

Contact us at 888-952-5242 or fill out the online form below. Our Firm will review your information to determine if we can represent you.  We might even be able to review some of your medical information over the phone.

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