Metallosis is a condition that occurs when metallic debris is released and deposited into soft tissues of the body. In many cases, metallosis is a direct result of metals being shed from artificial hip devices after a joint replacement procedure has been done. It can also occur after other joint replacement procedures such as elbow or knee surgeries as well.
About Hip Replacements
Hip replacements are performed to remove and replace hip joints that have become injured or degraded through aging processes such as arthritis. Depending on the specific needs of the patient, all or part of the bone tissue may be removed and replaced or in some cases, the available bone may be resurfaced. In most patients, this provides a significant relief of pain and increased mobility. Unfortunately, some patients may experience a number of side effects from the procedure, caused by faulty implant devices.
Side Effects of Hip Replacement
There are a number of common side effects that may be caused by artificial hip replacement. Most of these side effects are mild to moderate but some may be serious and product permanent injury. Side effects of hip joint replacement devices are often caused by metallosis.
Metallosis is poisoning of the tissues of the body, caused by release of metallic debris and metal ions into areas surrounding the hip replacement device. Implant devices that have a metal component may shed metal fragments and those devices which are made from all metal parts, known as metal-on-metal (MoM) are the worst offenders.
All of the medical devices for hip replacement available on the market today were approved under an exemption pathway known as the Food and Drug Administration (FDA) 510(k) process. The 510(k) pathway allows manufacturers to forgo long and costly clinical trials in humans by claiming the device is similar to a device already approved for use. None of these devices had been required to be tested in humans before being sold to the public.
Metallosis may cause local effects, some of which are mild or moderate but some of which may be severe and permanently damaging. Adverse reactions that may be a result of metal toxicity in local tissues may include:
- Pain and inflammation
- Joint instability
- Muscle loss
- Necrosis – death of bone and other tissue
- Osteolysis –dissolution of bone tissue
- Pseudotumors – formation of tumor-like growths surrounding affected joint
- Bone fractures – caused by weakened and dissolved bone
- Joint dislocation causing instability
- Revision Surgery or Reconstructive Surgery – may be required to replace faulty device and repair damage caused by complications of metallosis
In some cases, metallosis may by systemic when metal ions are absorbed into the bloodstream. Patients may experience:
- Body aches
- Flu-like symptoms
Hundreds of hip implant devices are currently available and some of those have caused serious injuries. Thousands of patients have filed lawsuits against major manufactures such as:
- DePuy Orthopaedics and Johnson & Johnson - for the Pinnacle and ASR systems
- Stryker Orthopaedics - for the Rejuvenate and ABG systems
- Zimmer Holdings Inc. with Biomet – for the Durom and M2a Magnum devices
- Smith & Nephew - for the R3 Acetabular System
- Wright Medical Technology Inc. – for the Conserve and Profemure devices
Other manufacturers may also be facing additional lawsuits as well. In addition to personal injury, some of the companies have faced legal action due to marketing and manufacturing issues including violations and accusations of payoffs to physicians for using the devices.
Patients who have been injured by a hip device failure because of metallosis may be awarded compensation for medical damages, lost wages and other costs. Some victims may also be eligible for punitive damages, depending on the individual case. Thousands of lawsuits have already reached settlements that reach into the $billions but many more have yet to be settled and more are expected.