High Viscosity Cement Implant

Commonly used in total knee and hip replacements, bone cement helps attach joint implants to bones. In knee implants, cement is used to prevent loosening and promote binding between metal implants and bones, namely the tibia and femur. Although patients are never asked or given options when it comes to bone cement, these products are not all created equally. The viscosity, or thickness, of the bone cement can be manipulated to influence the outcome of the procedure. High viscosity cement is designed to take a longer time to harden, and less time to prepare. The intention is for the surgeon to have more time to manipulate the implants before they are fastened to bone. However, research has shown the benefits of high viscosity cement have come at a high cost.

Instead of increasing the efficacy of total knee replacements, high viscosity cement has led to:

• Increased risk of failure, even with a well-performing implant
• Failure of the implant to adhere to the bone
• Increased risk of patients having to undergo revision surgery

New Study on High Viscosity Cement

As early as 2013, a study found only 9 out of 3,048 total knee replacements failed, and all 9 of these used high viscosity cement. Additionally, the National Center for Biotechnology Information reported in 2016, researchers evaluated 13 cases where the implant failed to adhere to cement and believed the failure was a result of the high viscosity cement. Manufacturers of high viscosity cement pushed their products through FDA approval using the 510(K) process. The 510(K) process allows manufacturers to claim a product is “substantially equivalent” to other products already on the market, as to avoid the rigorous testing necessary for new products in the FDA’s pre-market approval process.

Contact Us Today

At Rheingold Giuffra Ruffo & Plotkin LLP, our New York product liability attorneys have extensive experience handling cases involving hip and knee implants. We are dedicated to helping individuals achieve financial and emotional relief from the undue physical hardships and overwhelming medical costs they have endured due to defective products. If you or a loved one developed complications from a knee or hip replacement, please contact us today to schedule a free consultation.

Fill out an online evaluation form or call (888) 260-0473 to reach our experienced New York product liability law firm today.