Some patients who have complications from a Total Knee Replacement Surgery actually may be suffering due to the type of bone cement used in the surgery. Bone cement is an epoxy cement that is commonly used to attach the knee replacement device to the femur and tibia bones.
Studies and surgery outcomes indicate that the high-viscosity cement (HVC) used in some surgeries is not as effective as other types of bone cement. HVC may cause early failures in the knee replacement because the bone cement fails to remain attached to the bone. These failures will commonly require that patients undergo a revision surgery to remove and replace the knee device.
What Are the Side Effects of Bone Cement?
The medical device manufacturers marketed the use of the high viscosity cement (HVC) to the medical community, specifically the benefit that HVC has a quicker mixing time and a quicker setting time than the other types of bone cement on the market, such as low-viscosity cement and medium-viscosity cement.
However, study results indicate that doctors need to use caution when using HVC because of the possibilities of aseptic loosening. Aseptic loosening occurs when the bone cement splinters or becomes detached from the bone.
Symptoms of aseptic loosening include:
- Knee instability
- Knee joint swelling
- Decreased range of motion
- Persistent or new onset chronic pain
Patients experiencing any of the symptoms listed above should contact their doctor. A doctor can help identify the source of the complications.
Is HVC FDA Approved?
Manufacturers of high viscosity bone cement were able to get their HVC products approved by the FDA by using a “fast track” approval process. The “fast track” approval does not require that a product demonstrate safety and efficacy. Instead, it relies on the claims of the manufacturer seeking approval that the new product is “substantially equivalent” to other products on the market. In this case, the manufacturers claimed that HVC was “substantially equivalent” to low and medium-viscosity cement.
Bone Cement Lawsuits
Knee replacement revision surgeries are costly and painful. If you have had a knee replacement device replaced within the first few years of the initial implant, or if your doctor is recommending an early revision surgery, you may want to contact an attorney and find out more about lawsuits involving (HVC) bone cement.
Our dedicated attorney, Brett Oppenheimer, has successfully helped clients who have suffered physical, emotional, and financial injury from medical devices such as HVC. Stop by our law office to discuss your potential case free of charge. You can call us at (502) 242-8899, or fill out our contact form to set up your consultation.