These products have caused patients physical, emotional, and financial distress, and we encourage you to seek legal advice if you believe you may be suffering from joint replacement failure or bone cement complications.
What is Bone Cement?
Orthopedic surgeons use a range of bone cements for different types of surgeries. The cement acts as a glue, adhering to bones and securing components used in a variety of procedures.
The biggest variation among bone cements is the viscosity, meaning how thin or thick it is. In some surgeries, a thin, runny viscosity cement works best while a thicker, peanut-butter-like texture may be more suitable in others.
The cement is often infused with antibiotics to prevent infections, particularly in joint surgeries where bacteria can cause painful and dangerous post-surgery complications. If you’ve had a joint replacement, there’s a good chance your surgeon used a bone cement in the process.
During total knee replacement, the joint is removed and replaced with prosthesis of metal, ceramic or plastic components. The procedure involves attaching the components of the new knee joint to the femur and tibia using an epoxy cement.
Widespread use of high-viscosity cement is a relatively recent development as it offers surgeons shorter mixing and waiting times as well as longer working and hardening phases when compared with low- or medium-viscosity cements.
While high-viscosity cement may be more convenient for the surgeon, research has shown increasing evidence that the bond produced with high-viscosity cement is not as strong and has resulted in an increasing number of early failures due to debonding.
Debonding is when the bone or components held together by the bone cement begin to come apart or break apart completely. This causes additional complications such as instability, pain, and swelling in the affected limbs.
What Complications are Associated With Bone Cement?
Bone cement is classified as a medical device, so these products are subject to review by the Food and Drug Administration (FDA). Some manufacturers of high-viscosity bone-cement fought to gain approval from the Food and Drug Administration (FDA) by claiming there product was “substantially equivalent” to other bone cements on the market. This allowed high-viscosity cement to be cleared under the FDA’s 510(k) fast-track approval process which does not require products to demonstrate their safety and efficacy independently.
But when numerous cases of debonding occur, it’s clear that one of two things has gone wrong: either the cement isn’t holding the way it was supposed to or there’s an issue with the implant components.
Because complications related to debonding are on the rise, Van Wey, Metzler & Williams has been investigating cases involving higher-viscosity bone cement.
There is always a risk of debonding with complex surgeries, and it’s not always clear whether the cement is to blame. Different components, such as knee replacement implants, can have rougher or smoother surface textures that influence the strength of the bond.
Because complications related to debonding are on the rise, Van Wey, Metzler & Williams has been investigating cases involving higher-viscosity bone cement.
However, what makes high-viscosity cement concerning is that the rates of debonding with high-viscosity cement are much higher than with medium- to low-viscosity products, even when they’re used in the same types of procedures with the same components. Research is emerging that shows manufacturers may have overstated the effectiveness of high-viscosity cements, and that over-hyped marketing may have led surgeons to use these products in procedures that would have been better served by more traditional cements.
Common Bone Cement Side Effects
Hiring A Bone Cement Lawsuit Attorney
If you’re experiencing bone cement complications or suspect that debonding may be occurring, we encourage you to contact us as soon as possible. We would encourage you to talk to your doctor to find out what’s going on and get professional medical advise as to your next steps. Our product liability team will want to find out what types of components were used in your surgery so we can determine whether you might have a case.
Joint replacement surgeries are challenging enough the first time but having to experience them twice – or live with the consequences of defective devices – can be excruciating. If you or a loved one have experienced complications from bone cement debonding, including new onset chronic pain, instability, or loosening or debonding, please contact the product liability team at Van Wey, Metzler & Williams as soon as possible to help protect your rights.
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