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FDA Trial: Metal-on-Metal Hip Replacement Systems Are No Better Than Older Counterparts

Criticism regarding the use of metal-on-metal hip replacement systems has intensified after recent studies have suggested that they demonstrate a larger propensity for failure than their predecessors. Subsequently, newer metal-on-metal hip implants seem to be no more effective than older implants and may often exhibit more problematic adverse events. Data compiled from a number of large national registries indicates that metal-on-metal implants are just as effective as metal-on-polyethylene systems, but are associated with a higher rate of adverse events.

Metal-on-metal hip replacement systems are made up of a series of metallic components in order to promote longevity and dexterity. Unfortunately, recent evidence suggests that metallic components, consisting of cobalt and chromium, may coincide with catastrophic complications. More specifically, the wear and tear that ball and socket components generate may lead to significant deterioration over a seemingly short period of time. This degeneration has a tendency to create minute metal shavings that have the potential to cause significant damage to an individual. As a result, these metal pieces may lead to a concentration of hazardous debris in the fluid of the joint and surrounding muscles that can cause extreme pain and severe infections when leached into the recipient.

Concern regarding the safety and effectiveness of these systems has grown exponentially in the healthcare community. However, recent evidence lends weight to the long-suspected link between metal-on-metal hip replacement systems and a propensity for adverse events. While these metal-on-metal systems were incorporated into the U.S. market to reduce the risk of revision surgeries, an influx of complications have drawn an intense amount of scrutiny from the U.S. Food and Drug Administration (FDA).

As a result, the FDA, in association with Dr. Art Sedrakyan and colleagues, began to review the comparative safety and effectiveness standards for numerous hip replacement systems. The analysis, published in the British Medical Journal (BMJ), included 3,139 patients enrolled in 18 randomized trials or comparative observational studies, and more than 830,000 operations in national registries.

The comparative study indicated that metal-on-metal hip implant systems had no distinct advantage over that of polyethylene hybrid systems. In fact, disease-specific functional outcomes and general quality-of-life scores showed an advantage for metal-on-polyethylene over metal-on-metal implants.

According to the three largest registries involved in the comparative study, revision rates were higher with metal-on-metal implants compared with metal-on-polyethylene. Often times, metal debris was responsible for pain, swelling and infection that required revision surgery. Though metal-on-polyethylene systems did indicate reasons for revision, they were not as significant as the problems witnessed with metal-on-metal systems.

Do I have a Defective Hip Implant Lawsuit?

The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in defective hip implant lawsuits. We are currently accepting new cases in all 50 states.

Again, if you or a loved one has been injured by a defective hip implant, you should contact our lawyers immediately by clicking the link below or calling toll free 1-800-773-0849. You may be entitled to compensation for your injuries and we can help.

Categories: Product Liability
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