Hip replacement patients who have been implanted with metal-on-metal hip replacement devices may be at risk for serious health problems, including cobalt and chromium poisoning, adverse local tissue reactions, pseudotumor formation, metallosis (metal poisoning), device fracture. These conditions may cause a metal-on-metal hip replacement to fail within just a few years of surgery and may lead to risky revision surgery to remove and replace a failing metal-on-metal hip replacement device. According to recent research, as many as 14 percent of patients who have been implanted with a metal-on-metal hip device replacement may require revision surgery within just seven years of their initial procedures. The rate for other types of hip implants is just three percent.
- Biomet M2a Hip Replacement System
- DePuy ASR XL Acetabular System(Johnson & Johnson)
- DePuy Pinnacle Hip Implant(with a metal liner)
- Wright Conserve Hip Implant
- Wright Profemur Hip Implant Systems
- Smith & Nephew Birmingham Hip Replacement
- Stryker MITCHTRH Hip Replacement
Parker Waichman LLP offers free legal evaluations to victims of metal-on-metal hip implant device injuries. If you or someone you know received a metal-on-metal hip replacement device and suffered cobalt and chromium poisoning, adverse local tissue reactions, metallosis, pseudotumors or premature implant failure, we urge you to contact Parker Waichman LLP today for a free, no obligation metal-on-metal Hip replacement lawsuit evaluation.
UK Warns in Medical Alert to Follow-Up on Patients Implanted with Metal-on-Metal Hips
The Medicines and Healthcare Products Regulatory Agency has indicated that patients who have been implanted with metal-on-metal (MoM) hip replacements should receive follow-up appointments to detect adverse soft tissue reactions. The advice was published by the Agency on June 29, 2017. Follow-up investigations may include MRI or ultrasound scan, as well as isolated fluid collection, according to the Medicines and Healthcare Products Regulatory Agency.
The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health in the United Kingdom, which is similar to the U.S. Food and Drug Administration (FDA), which is responsible for ensuring medicines and medical devices are safe and effective,
The Medicines and Healthcare Products Regulatory Agency warned that soft tissue necrosis may occur in both asymptomatic and symptomatic metal-on-metal patients, 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,” according to the Medicines and Healthcare Products Regulatory Agency.
FDA Issues Safety Alert Over MoM Hip Devices
The FDA issued a Safety Alert acknowledging the risks associated with metal hip devices and issued new guidelines for all-metal hip patients. The agency advised that people implanted with all-metal devices undergo physical exams, diagnostics imaging, and metal-ion testing, when necessary.
In that same alert, the FDA also proposed new, stricter guidelines mandating manufacturers prove their devices are safe and effective through clinical testing, a method known as “premarket approval.”
Metal-on-Metal Hip Implant Side Effects, Reactions, Failures, and Complaints
Metal-on-metal hip replacement devices consist of ball and socket components that are made of metal. Because of metal’s durability, metal-on-metal devices were expected to last longer than other hip implants. An estimated 500,000 Americans have been fitted with metal-on-metal hip implants. Yet, before the devices came on the market, most metal-on-metal hip replacement devices underwent little, if any, human testing. Most of these implants were approved under the U.S. Food & Drug Administration’s (FDA) 510(k) approval protocols, which do not require manufacturers to conduct human clinical trials if they can show a device is similar in design to another approved device already on the market.
Metal-on-metal hips were developed for the promise of greater durability and longevity and with the objective that the purportedly stronger parts would be far superior when compared to their more traditional counterparts constructed with plastic or ceramic elements. Metal-on-metal device recipients allege that metal hip devices led to serious health complications due to their faulty design. These devices have come under scrutiny in light of high-profile recalls and litigation, as well as reports of high failure rates. Numerous lawsuits have also been filed against various metal hip makers over the past few years, and those cases continue to proceed.
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, increased blood metal ion levels
- Metallosis (metal poisoning)
- Difficulty ambulating, rising, standing, and balancing
- Dislocation of the hip
- Cardiomyopathy (degenerative heart muscle disease)
- Loss of bone
- Inflammatory reactions causing pain
- Noise emanating from the joint
- Early device replacement (revision surgey)\
- 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 models of hip implants.
The FDA launched a safety review of metal-on-metal hip implants in 2011, as evidence of their dangers continued to mount. 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’ blood streams. 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 for metal levels.
Cobalt and Chromium Poisoning from Metal on Metal Hip Replacements
Metal-on-metal hip implant devices use all-metal surfaces. When the implants’ metal surfaces rub together, even during normal activities such as walking, the devices may release metal debris, which leads to complications. When an implant fails due to these complications, patients typically undergo a revision surgery to remove the device. In fact, the metal debris shed by metal-on-metal hip implants is thought to be responsible for many of the ailments suffered by metal-on-metal hip replacement patients. If chromium and cobalt are shed by a metal-on-metal device, the particles may leach into the surrounding tissue and blood stream, eventually making their way into the lymph nodes and organ systems.
Research has tied metal-on-metal hip devices to adverse events that include tissue necrosis, pain at the implant site that may spread to the groin and back, inflammation, swelling, metal poisoning, high failure rates, osteolysis (bone loss), and pseudotumors (fluid collection/solid masses around the hip joint). The issue with these devices appears to be with the metal used in these implants, which were touted to last for at least two decades.
- Vision or hearing loss
- Cognitive impairment
- Dizziness, vertigo
- Peripheral neuropathy
- Tinnitus (noise or ringing in the ear)
- Visual changes, visual loss
The European Union’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENHIR) urged caution with metal-on-metal hip implant devices indicating that it found that use of the 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 contraindicated in women of childbearing age and in women with small femoral head size. SCENHIR also advised annual follow-upz for the lift of the joint in patients who have been implanted with large-head devices.
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. If the second blood test shows a concentration of cobalt and 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 surgeries to remove and replace a metal-on-metal hip device are more complex, more expensive procedures than the original surgeries. Revision surgeries are riskier and require longer healing times and, as Consumers Union has previously pointed out, involve longer hospital stays. Despite that revision surgeries are typically performed to remove a device maker’s faulty device, the costs are generally assumed, not by the device maker, but by consumers and insurers, such as Medicare.
Legal Help for Victims of Metal-on-Metal Hip Replacement Victims
If you or a someone you know suffered serious injuries, including cobalt and chromium poisoning, or premature failure of your metal-on-metal hip replacement device, you may have valuable legal rights. For a free, no obligation evaluation of your metal-on-metal hip replacement lawsuit, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) today.
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