File a Lawsuit Against Metal-on-Metal Hip Replacement Device
Any patient who has been implanted with a metal-on-metal hip replacement device could be at serious risk of complications and health problems. These problems can include adverse local tissue reactions, cobalt and chromium poisoning, metallosis (metal poisoning), pseudotumor formation or device fracture. Within just a few years of having the device installed, conditions like these may cause a metal-on-metal hip replacement to fail. This may lead to the need for a risky revision surgery in order to remove a failing metal-on-metal hip replacement and replace it with a new one.
Research has shown that as many as 14 percent of patients with a metal-on-metal hip replacement may require revision surgery within just seven years of the initial surgery. Other types of hip implants have a much lower rate, averaging just three percent.
Parker Waichman LLP represents scores of plaintiffs in lawsuits related to metal-on-metal hip replacements. Devices that are currently under investigation include:
- Biomet M2a Hip Replacement System
- DePuy ASR XL Acetabular System (Johnson & Johnson)
- DePuy Pinnacle Hip Implant (with a metal liner)
- Wright Profemur Hip Implant Systems
- Wright Conserve Hip Implant
- Stryker MITCH TRH Hip Replacement
- Smith & Nephew Birmingham Hip Replacement
If you or someone you know had a metal-on-metal hip replacement device implanted and has since experienced adverse local tissue reactions, cobalt or chromium poisoning, pseudotumors, premature implant failure or metallosis, we urge you to contact a metal hip lawyer at Parker Waichman today for a free, no obligation metal-on-metal hip replacement lawsuit evaluation.
UK Issues Medical Alert for Patients Implanted With Metal-on-Metal Hips
In June 2017, the British Medicines and Healthcare Products Regulatory Agency issued an alert urging that patients who had received metal-on-metal (MoM) hip replacements be monitored carefully in order to catch any adverse soft-tissue reactions. Follow-up care may include MRI or ultrasound scans as well as isolated fluid collection, according to the agency. The Medicines and Healthcare Products Regulatory Agency is an executive agency of the Department of Health in the United Kingdom, similar to the U.S. Food and Drug Administration (FDA), which is responsible for ensuring that medicines and medical devices are safe and effective.
The British agency cautioned that in both asymptomatic and symptomatic metal-on-metal patients, soft tissue necrosis was a possibility, according to the Chartered Society of Physiotherapy.
“The majority of patients with MoM hip replacements currently have well-functioning hips. However, some patients will develop progressive soft tissue reactions to the wear debris associated with MoM articulations,” the agency stated.
FDA Clamps Down on MoM Hip Devices
Meanwhile, the FDA issued a Safety Alert shedding light on the risks associated with metal hip devices and put new guidelines in place for all-metal hip patients. The FDA urged that anyone with an all-metal device receive diagnostic imaging, physical exams, and metal-ion testing as necessary.
In that alert, the FDA outlined stricter guidelines mandating that manufacturers put their devices through clinical testing in order to prove that they are both safe and effective. This is known as “premarket approval.”
Metal-on-Metal Hip Implant Side Effects, Reactions, Failures, and Complaints
Metal hip replacement devices are constructed using metal ball and socket components. Due to the durability of the material, metal-on-metal hip replacements were designed with the expectation that they would outlast other models made from ceramic and plastic components. An estimated 500,000 Americans have had metal-on-metal hip devices surgically implanted. Yet before they went on the market, most metal-on-metal hip replacement devices went through little, if any, human testing. Most of these implants were approved under the FDA’s 510(k) approval protocols, which do not require manufacturers to conduct human clinical trials if they can show that a device is similar in design to another approved device already on the market.
With the promise of providing more durability and greater longevity, metal-on-metal hips were developed to be superior to their ceramic- or plastic-based counterparts. But metal-on-metal implant recipients allege that the faulty design of these hip devices have caused serious health complications. Due to the relatively high failure rates, litigation, and high-profile recalls, MoM hip replacements have come under scrutiny. In recent years, numerous metal hip makers have had to face lawsuits filed by victims of metal-on-metal hip implant injuries, and those cases are still moving forward.
The problems associated with metal-on-metal hip replacement devices first came to worldwide attention in August 2010, when DePuy Orthopaedics, a division of Johnson & Johnson, issued a global recall of its DePuy ASR hip replacement line because of an unexpectedly high rate of premature failure. Since then, studies have found that among other issues, metal-on-metal hip replacement devices may shed dangerous amounts of microscopic metal particles into the blood, leading to myriad health woes, including:
- Cobalt and chromium poisoning, forms of metallosis (metal poisoning) characterized by increased blood metal ion levels
- Pseudotumors
- Difficulty walking, rising, standing, and balancing
- Dislocation of the hip
- Cancer
- Cardiomyopathy (degenerative heart muscle disease)
- Loss of bone
- Inflammatory reactions
- Noise emanating from the joint
- Need for early device replacement (revision surgery)
- Fracture
- Pain
- Death of surrounding tissue
In February 2012, a BBC and British Medical Journal investigation discovered that there may be hundreds of thousands of people fitted with metal-on-metal hip implants who have been exposed to toxic metals.
In March 2012, a study published in The Lancet found that metal-on-metal hip implants were significantly more likely to fail when compared to other types of hip implants.
The FDA launched a safety review of metal-on-metal hip implants in 2011, as evidence of their dangers piled up. The agency ordered the manufacturers of these devices to conduct post-market safety studies to determine if the metal-on-metal devices were leeching dangerous levels of metal debris into patients’ bloodstreams. In July 2012, a panel of FDA advisors determined that there are few, if any, reasons to continue using metal-on-metal implants due to the serious health risks they pose to patients. The panel also stated that patients experiencing pain or other symptoms should undergo regular X-rays and blood testing to monitor their metal levels.
Cobalt and Chromium Poisoning From Metal-on-Metal Hip Replacements
All-metal surfaces are used in MoM hip replacement devices. When those all-metal surfaces continually rub against one another from walking or other daily activities, debris can be shaved off, which can result in numerous complications. If the complications cause an implant to fail, patients will typically need to have revision surgery in order to remove and replace the device.
The ailments that many metal-on-metal hip replacement patients suffer from are thought to be due to the debris that is shaved off of the devices during routine use. When chromium and cobalt debris is dispersed in the body, these particles can find their way into the bloodstream and surrounding tissue. From there, they can find their way to the lymph nodes and other organs.
Metal-on-metal hip devices have been linked to inflammation, pain radiating from the site of the implant to the back and groin, tissue necrosis, swelling, high failure rates, metal poisoning, osteolysis, and pseudotumors (solid masses or collections of fluid that build up near the hip joint).
Research has also found that cobalt and chromium poisoning from metal-on-metal hip implants may result in serious, long-term health consequences, including:
- Vision loss
- Cardiomyopathy
- Cognitive impairment
- Deafness
- Dizziness
- Hypothyroidism
- Peripheral neuropathy
- Cancer
- Tinnitus (noise or ringing in the ear)
The European Union’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) recommended caution when considering MoM hip implant devices, stating that it found that the use of such devices should be “carefully considered on a case-by-case basis due to the potential adverse effects of released metal.” For example, metal hip implants are not recommended for women of childbearing age or patients with a smaller than normal femoral head size. In addition, SCENIHR urged patients with large-head devices implanted to do annual follow-ups for the lift of the joint.
A blood test is needed to determine if a metal-on-metal hip implant patient is suffering from cobalt and chromium poisoning. If an initial blood test indicates elevated levels of chromium or cobalt, the test will be repeated within three months. Should the follow-up blood test reveal levels of cobalt or chromium still above a safe level, a doctor will likely recommend a MARS MR imaging test to determine the condition of the metal-on-metal hip replacement as well as surrounding tissue and bone.
Revision Surgery
Revision surgeries to remove and replace a metal-on-metal hip device are more complex and expensive than the original surgeries. Not only are they riskier, but they require longer healing times. Despite this, a revision surgery is usually deemed necessary in order to remove a faulty device, and the costs are borne by patients and their insurers, not the manufacturer of the device. But through a metal-on-metal hip replacement lawsuit, you could be able to recover these costs from the company responsible for making your defective implant.
Frequently Asked Questions About Metal-on-Metal Hip Replacement Lawsuits
Is Cobalt Still Used in Hip Replacements?
All-metal hip replacement devices are no longer used in the United States, but cobalt may still be contained in the metal part of a ceramic-on-metal or metal-on-polyethylene implant. In addition, all-metal components are still used in some other hip-related surgeries.
Can You Get Cobalt Poisoning From a Hip Replacement?
Yes. If you had an all-metal hip replacement device implanted, then there is a chance that you could experience cobalt poisoning. Should you notice any symptoms, you should contact your doctor right away.
What Happens When You Have Too Much Cobalt in Your Body?
When your body is in contact with too much cobalt, you can be affected by cobalt poisoning. If this happens, you can suffer from symptoms such as vision or hearing loss, cardiomyopathy, cognitive impairment, vertigo, hypothyroidism, peripheral neuropathy, tinnitus or even cancer.
What Are The Signs and Symptoms of Metallosis?
Symptoms of metallosis include swelling, weakness, pain in the hip or groin, numbness, and/or difficulty walking.
Has There Been a Cobalt and Chromium Hip Replacement Recall?
Metal hip replacement devices that have been recalled include the DePuy ASR TM XL Acetabular System, Johnson & Johnson Adept Hip System, Smith & Nephew R3 metal liners of the R3 Acetabular System, Zimmer Durom Acetabular Component, and the Stryker Rejuvenate and ABG II modular neck hip systems. If you have had one of these devices implanted and have suffered injury as a result, contact an attorney at Parker Waichman for a free consultation.
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