Osteolysis After Hip Replacement
Thousands of hip replacement lawsuits have been filed by plaintiffs suffering premature device failures, metallosis, and bone loss. Early failure of hip implants is often blamed on osteolysis, or bone tissue destruction, which can make revision surgeries more complex. Many patients have endured multiple surgeries, severe pain, and extended periods of immobility.
Our defective medical device attorneys are representing plaintiffs in hip replacement lawsuits against multiple manufacturers. If you or a loved one have suffered from complications after receiving a hip implant, you may be entitled to compensation for your injuries. Please contact our legal team to schedule a free case evaluation.
Defective Hip Implants
Hip replacement procedures have become increasingly common in recent years, and newer implant products are continually introduced to the U.S. market. Made of ceramics, polyethylene (plastic), and metal, the devices are designed to replace or repair hip bones damaged by injury, arthritis, and other medical conditions.
Many new and “improved” hip replacement models received fast-track approval from the U.S. Food and Drug Administration (FDA), bypassing the standard requirement to conduct extensive safety trials. An FDA loophole known as the 510(k) track allows companies to introduce a new product if they can show the device is similar to existing products that have already been screened. The manufacturers of metal-on-metal hip implants used this strategy, and claimed that the new devices were stronger and more durable than earlier models made from other materials.
Some devices, primarily metal-on-metal implants, are causing more than 10 percent of patients to suffer premature failure, sometimes as early as a year after the initial placement procedure.
Nearly 380,000 U.S. patients undergo total hip replacement each year. In this procedure, a hip stem implant is inserted into the femur for stability, replacing the head of the bone with a new ball. The socket (acetabulum) for the ball is then replaced with a device that resembles a cup. The components work together to provide strength and mobility to patients struggling with a painful or disabled hip.
Doctors also perform partial replacement procedures, treating only the femur or replacing just the acetabulum. Another common, less-invasive procedure is hip resurfacing. In this surgery, the femur is reshaped and capped rather than replaced.
Patients as young as 45 undergo hip implant operations and are seeking a durable product with optimal longevity. Hip implants are intended to last for decades, but unfortunately, many patients have experienced premature hip replacement failure. Some devices, primarily metal-on-metal implants, are causing more than 10 percent of patients to suffer premature failure, sometimes as early as a year after the initial placement procedure. The primary cause of premature implant failure is osteolysis.
Osteolysis is a process that causes the destruction of skeletal bone. For implant patients, this results in loss of bone around the implant, which leads to loosening of the device. According to a Postgraduate Medical Journal article, osteolysis is the most significant adverse effect from total hip replacement, and the catalyst for as many as 75 percent of revision surgeries.
Osteolysis has been shown to occur after particle debris has accumulated in bodily tissue. This debris consists of tiny metal fragments that are produced by the repetitive friction movement of hip replacement components. The bone loss is a biological reaction to the microscopic debris from the implants, which lodge in crevices between the bone and device.
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Chronic inflammation and damage to surrounding tissue can erode the bone to the extent that x-ray imaging studies will reveal noticeable holes in the surface. The bone surrounding the implant begins to deteriorate, leading to migration of the device, which can affect the stability and range-of-motion of the implant.
Some osteolysis patients complain of symptoms, including thigh pain, sciatica, groin pain, and infection at the site. Many patients, however, do not experience symptoms until they become aware of a loosening or instability near the implant.
To diagnose osteolysis, the doctor will perform a physical exam and order radiographic and CT scans. There is no treatment for the condition other than revision surgery.
Revision Surgery After Osteolysis
Bone loss and tissue damage can add further complications to an already complex surgery. Revision procedures are often less successful than initial surgeries, and many patients never recover full range-of-motion. The mortality rate is 1.5 times as high in revision surgery as compared to the original procedure.
In most cases, bone grafting will be required to stabilize and add volume to existing bone. This may mean taking bone from another area of the patient’s body, using donor tissue, or artificial grafting material Bone grafting can also add significantly to the timeline, as the patient will need time to heal and recover before the revision procedure.
Complication rates are extremely high for revision surgeries, and more than 30 percent of patients will need another revision procedure in the future. Unfortunately, the expected longevity of an implant decreases with each successive surgery.
Higher incidences of osteolysis and early device failures are seen in patients implanted with metal-on-metal devices. Studies have confirmed this, showing that ceramic and plastic components last longer and are not as susceptible to corrosion.
Complication rates are extremely high for revision surgeries, and more than 30 percent of patients will need another revision procedure in the future.
Metal-on-metal components can also cause metallosis, a type of metal poisoning seen after long-term exposure to cobalt and chromium in hip replacement systems. Researchers have discovered pseudotumors in some of these patients as well. A study published in the Journal of Bone & Joint Surgery found pseudotumors in 39 percent of patients with metal-on-metal implants, and these patients had elevated serum cobalt levels in their blood. Though benign, these masses may contribute to tissue destruction and osteolysis.
Several metal products have been recalled, and the FDA has issued safety warnings concerning premature implant failure and bone loss. The agency referred to an “adverse local tissue reaction” or an “adverse reaction to metal debris.”
An example is Stryker®‘s Rejuvenate and ABG II Modular products, which were voluntarily recalled in 2012. Plaintiffs in thousands of lawsuits against the company have complained of osteolysis, necrosis (tissue death) and metallosis. In 2014, Stryker® settled 3,000 claims for $1.43 billion, and more claims are pending.
Products Involved in Litigation
There have been several specific brands that have been implicated in serious patient complications, including:
- DePuy PINNACLE® ULTAMET Acetabular Cup System
- DePuy ASR™ XL Acetabular System (Recalled)
- DePuy ASR™ Hip Resurfacing System (Recalled)
- Biomet® M2a Magnum and M2a-38 Hip Implants
- Biomet® Stanmore
- Biomet® Exceed ABT
- Stryker® Rejuvenate Hip System (Recalled)
- Stryker® ABG II Modular Neck Hip Stems (Recalled)
- Smith & Nephew R3 Acetabular System (Recalled)
- Smith & Nephew Birmingham Hip Resurfacing System
- Smith & Nephew Empirion Modular Hip System
- Zimmer Durom Cup Hip Devices
- Wright™ Medical CONSERVE® Plus Hip Devices
- Wright™ Medical PROFEMUR® Z Stem
- OMNI Apex K-2 Modular Hip System
Hip Replacement Lawsuits
Patients from all over the country have filed personal injury lawsuits against many of these manufacturers, who are accused of marketing defective devices and failing to warn patients of potential complications. There have been numerous multi-million-dollar settlements and courtroom verdicts awarding plaintiffs generous compensation for their suffering. Plaintiff awards may include medical costs, loss of income, and punitive damages.
Some of these companies have also settled criminal allegations pertaining to bribery of physicians. Millions in restitution for these crimes have been paid by Biomet®, Smith & Nephew, and Wright™ Medical.
Speak with an Experienced Attorney
If you underwent a hip replacement or hip resurfacing procedure and experienced osteolysis, metallosis, or premature device failure, you may qualify to receive compensation. Statute of limitations laws apply, but some patients have been unaware that their injuries were caused by a faulty device. Our experienced legal team has assisted plaintiffs from all over the country, and we may be able to help you. Please contact our legal team today to speak to a lawyer and schedule a free consultation