TMJ Disorders - Implants
 History of TMJ Implants Types of TMJ Prosthetics TMJ Implants & Their Manufacturers TMJ Implant Problems TMJ Implant Congressional Hearings |
The following is an excerpt from "TMJ Technology Gone Awry", a presentation by Terrie Cowley at the Gorham Intertech Conference on October 23, 1994.
HISTORY OF TMJ IMPLANTS
Various materials have been used to replace all or part of the temporomandibular joint. Sometimes, surgeons replace the disc with an interpositional implant (IPI). In other cases, the condyle (the head of the mandible, or lower jaw), fossa (the skull or socket of the jaw joint), or both, are replaced with manufactured prosthetic devices.
The total number of implant recipients is unknown as a national TMJ implant registry does not exist. It is estimated that between 60,000 and 150,000 Americans have received biomaterial jaw joint parts. Many more have undergone autogenous graft surgery utilizing other parts of the body for reconstruction of the jaw joint. Such parts include rib, cartilage (usually femur or ear), temporalis muscle flap, or fat. Some surgeons use cadaver cartilage.
Most biomaterials for jaw joint reconstruction were released into the medical market before the 1976 Medical Devices Amendment Act was passed. This Act requires manufacturers to provide evidence that their devices are safe and effective. Because the TMJ implant material was already on the market, no testing was required. They were simply "grandfathered" under the Act or, in other words, were allowed to remain available for surgical use. Manufacturers of new products only had to show that their devices were "substantially equivalent" to something already on the market to circumvent the Act.
ADDITIONAL RESOURCES:
- The 2007 TMJ Implant Government Accountability Office (GAO) Report
- Sept. 2002 Medical Implant Information Performance & Policies Workshop Final Report
- The FDA TMJ Implant Informational Consumer Update Booklet is available on-line. Some of our information may be similar to the material they present.
- Orthopedic Network News dedicated its feature article in the April 1995 issue to TMJ implants and is a good informational resource. Another resource is the FDA Federal Register which describes the regulatory history and classification of TMJ implant devices.
- Dr. Louis G. Mercuri wrote the article "Historical Perspectives on Prosthetic TMJ Reconstruction" specifically for The TMJ Association Web site. Dr. Mercuri is Professor and Chief, Division of Oral and Maxillofacial Surgery and Dental Medicine at Loyola University Medical Center, Chicago, IL. Dr. Mercuri is also the Chief Clinician for TMJ Concepts. Dr. Mercuri has researched the history of TMJ devices and has authored several articles and a book chapter on the subject. Our appreciation goes to Dr. Mercuri for his contribution to this Web site.
- Long-term Imaging Changes Associated with Temporomandibular Joint Implants:Preliminary Findings. H. Shimohira, J.O Look, J.R. Friction.(School of Dentistry, University of Minnesota, Minneapolis, MN, USA).
- Long-term Mandibular Dysfunction Associated with Temporomandibular Joint Implants: Preliminary Findings.
J.R. Friction, J.O. Look, E.L. Schiffman, P. YU, B.T. Lowry , P.L. Carlson. (School of Dentistry, University of Minnesota, Minneapolis, MN, USA).
- IDE Regulations and Clinical Studies
- Premarket Approval 510(k)'s for Temporomandibular Joint Implants