(Rosemont, IL – June 2, 2009) Foot & Ankle International (FAI), the official journal of the American Orthopaedic Foot & Ankle Society (AOFAS), has recently added a new highlight to its monthly publication. The section is entitled FootForum and is written by AOFAS member Michael S. Pinzur, MD, Professor, Orthopaedic Surgery, Loyola University Medical School, Maywood, IL. In the May issue, the FootForum topic is Experimental Surgery. In it, he discusses who or what are the appropriate bodies to decide that clarification in reference to a medical procedure such as the total ankle replacement (TAR).
Dr. Pinzur states that the regulatory process for the introduction of a new orthopaedic implant (total ankle replacement) is the responsibility of the United States Food & Drug Administration (FDA). Before a new product can enter the commercial market, manufacturers must follow a strict process to receive this approval. The goal behind this process is the protection of the public from unsafe devices. However, it is the insurance companies who often make the final decision as to whether a medical procedure should be reimbursed. This increases the need for proper data being used in these decisions.