What should I watch out for?
Metallosis, or metal poisoning, is a medical condition involving the build-up of toxic levels of metal debris in the soft tissue of the human body. Metallosis is linked to artificial joint replacement devices with metal components, such as metal-on-metal hip and knee implants. The U.S. Food and Drug Administration (“FDA”) has warned of and is investigating serious injuries caused by these metal-on-metal hip implants that can shed toxic amounts of metal particles into patients’ bloodstreams or surrounding tissue.
Tell me about Metallosis.
Metallosis is a type of metal poisoning resulting from alarmingly high levels of metal ions in the bloodstream. The FDA has linked metallosis to metal-on-metal hip implants and some knee devices. When the metal components of the artificial devices grind against each other during daily movement such as walking, they release microscopic metal particles into the patient’s blood and surrounding tissues.
This buildup of metal ions in the body leads to metal poisoning, causing major damage to the nervous system, surrounding tissue and bone. In severe cases, metallosis can cause heart damage, heart failure, blindness, deafness, permanent disability or death.
Any patient who receives a metal-on-metal artificial hip system is at risk of developing metallosis. According to the FDA, the following patients have an increased risk of suffering complications from metal ions:
- Patients with bilateral implants, or implants on both hip joints
- Patients with femoral heads of 44mm or smaller
- Female patients
- Patients with high doses of corticosteroids
- Patients with kidney problems or renal insufficiency
- Patients with compromised immune system
- Patients with misaligned device components
- Patients with metal sensitivity to nickel, cobalt or chromium
- Severely overweight patients
- Active patients with high levels of physical activity
What complications may result from Metallosis?
Metal blood poisoning varies from person to person because each person reacts differently to high levels of metal in the bloodstream. Generally, a patient suffering from metallosis can experience symptoms such as:
- Pain around the hip implant
- Tumor-like growths filled with fluid
- Inflammation and swelling
- Loosening or dislocation of the implant
- Bone damage
- Hip replacement failure
- Metal toxicity from metal components rubbing together
- Necessity for a second, or revision, surgery
When the metal-on-metal components grind against each other, tiny metal ions are introduced into the bloodstream as the implant wears down. Additional complications include:
- Vision impairment that may lead to blindness
- Auditory impairment (deafness)
- Thyroid problems
- Tissue death
- Damage to the central nervous system
- Cardiomyopathy (heart problems that can lead to heart failure)
- Cobalt poisoning
- Noise from the hip implant
Orthopedic surgeons test for metallosis by performing soft tissue imaging, using a needle to remove fluid from around the joint, and metal ion testing. Once a patient has been diagnosed with metallosis caused by a metal-on-metal hip implant, a second removal surgery is needed to remove the defective hip implant and replace it with another implant.
What medical devices might cause Metallosis?
Metallosis, known as metal blood poisoning, is a side effect of metal-on-metal hip implants. In hip replacement devices, each device contains a ball and socket component. Metal-on-metal hip replacement devices have a metal ball and metal cup that slide against each other during everyday activities, which causes wear to the surface of the device. Wear at the connection between the metal ball and taper of the stem may also occur.
The metal used in joint replacement devices include chromium, cobalt, titanium, molybdenum and nickel. The surface wear of these metals rubbing against each other can eventually lead to tiny metal particles flaking off around the joint and into the blood and surrounding tissues. Metal poisoning occurs when high, toxic levels of metal debris builds up in the body.
Some metal-on metal hip implants have a metal ball and a metal cup, such as the DePuy ASR replacement system. Other hip implants use a metal neck and stem, like the Stryker Rejuvenate hip implant and the Stryker ABG II system.
In the last several years, hip replacement recalls have been made on popular models of artificial hip devices linked to metallosis, including:
- DePuy ASR Acetabular & Resurfacing System
- Smith & Newphew Modular Redapt Femoral hip systems
- Smith & Nephew R3 Acetabular
- Smith & Nephew Modular SMF
- Stryker Rejuvenate hips
- Stryker ABG II hips
- Wright Conserve Plus
- Wright Profemur Z hip stem
- Zimmer Durom Acetabular Component
Who makes medical devices that might cause this Metallosis?
There are numerous manufacturers that market and sell metal-on-metal hip implants. The most common are:
- DePuy Ortopaedics
- Smith & Nephew
- Wright Medical
How common is Metallosis?
Metallosis has been observed in an estimated 5% of metal-on-metal hip implant devices over the last decades. Metallosis can cause significant damage to a patient’s body, including bone damage, cobalt poisoning, loosening of the joint, and painful revision surgery.
Tell me about Metallosis and the FDA.
The FDA commonly refers to metallosis as “adverse local tissue reaction” (“ALTR”) or “adverse reaction to metal debris” (“ARMD”). The FDA have issued numerous safety communications and alerts related to metal-on-metal hip implants.
The FDA’s Orthopedic and Rehabilitation Devices Advisory Panel held a meeting in June 2012 to discuss the numerous adverse event reports received regarding metal-on-metal hip devices. The adverse events indicated that approximately 95% of patients with an artificial hip system did not need revision surgery for seven years after the initial implant. However, patients with metal-on-metal hip replacements required more revision surgeries than the average patient. In order to obtain additional information, the FDA started asking U.S. metal-on-metal hip manufacturers to conduct long-term, post-market surveillance studies of more than 100 metal-on-metal hips in the U.S. market.
That 2012 meeting came after thousands of adverse event reports noted metal-on-metal hip implant injuries. The main complaint was that as patients performed everyday activities, metal particles were released into the body causing severe complications, including metallosis.
Many manufacturers recalled or discontinued manufacturing metal-on-metal hip implants products due to its dangerous link to injuries like metal poisoning. However, the FDA has not banned metal-on-metal devices despite the perilous complications associated with them.
Be on Watch.
Metallosis is a serious side effect of metal-on-metal hip implants and occurs when metal particles leak into the patient’s bloodstream or nearby tissue. The FDA has found a direct link to metallosis in several patients with metal-on-metal hip device implants.
If you or a loved one developed complications from metallosis after implant of an artificial hip device or knee implant, you may qualify for financial compensation for medical expenses, loss of income, and injuries suffered.
Call us at (888) 458-6825 or send us an email inquiry to discuss your legal options.
The consultation is free and confidential.
- FDA Information about Metallosis and Metal-on-Metal Hips https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/MetalonMetalHipImplants/ucm331971.htm
- Wikipedia definition of Metallosis https://en.wikipedia.org/wiki/Metallosis
- FDA Metal-on-Metal Hip Implant Safety Communication http://www.strykerimplantrecall.com/wp-content/uploads/2013/01/FDA-Safety-Communication_Metal-on-Metal-Hip-implants.pdf