TMJ Disorders - Implants
 History of TMJ Implants Types of TMJ Prosthetics TMJ Implants & Their Manufacturers TMJ Implant Problems TMJ Implant Congressional Hearings |
TMJ Implant Problems
If you believe that you have experienced a serious adverse reaction related to your TMJ implant, you should report to the FDA. Although we encourage consumers to report their problem through their health care providers, you may report directly to FDA through the MedWatch voluntary reporting system. For more information on MedWatch and how to file a report, please visit the MedWatch homepage - The FDA Safety Information and Adverse Event Reporting Program. For information on how to use Medwatch the FDA has created: FDA 101: How to Use the Consumer Complaint System and MedWatch. You may also report your problem to Dr. Susan Runner, FDA Office of Device Evaluation, HFZ/410, 9200 Corporate Blvd., Rockville, MD. 20850. Please note your implant problem will only be documented when you file a form with MedWatch.
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To view TMJ implant MDR's filed, go to the FDA's Maude Report Web site.
As an advocacy group for TMJ patients, we constantly receive phone calls and letters from people who are desperate for help. Over the last few years, The TMJ Association has heard from many people who have had, or still have, Proplast-Teflon and/or Silastic implants. We must state that our information is strictly anecdotal or, in other words, based on what patients have told us. Most of them are experiencing a wide range of symptoms - both craniofacially and systemically. It is important to understand than an implant may be failing and destruction to the joint occurring even if there are no symptoms. The systemic symptoms people are experiencing may be totally unrelated to TMJ implants, they may be a component part of the complex TMJ diseases/disorders, they may reflect an entirely different disease, or indeed be caused by the TMJ implants...we simply don't know.
According to the FDA, problems seem to be related to length of time the implant is in place; however, from what we are hearing, problems are unpredictable and don't follow a distinct pattern. People are responding in differing ways and severity to these devices perhaps depending upon their immune reactions to the implanted materials. We talk with people who have had an implant for only 1-3 months and are having tremendous problems. On the other hand, we have heard from some who have had their implants as long as 10 years and are experiencing few symptoms.
Many implant victims we hear from can no longer work, function on a daily basis, or lead normal, productive lives. They are, in many cases, facing a lifetime of chronic pain and disability. Some cannot afford or find a surgeon to remove failed implants and perform subsequent multiple revision surgeries. Regardless of the options they choose, all are expensive and without guarantee of success.
The majority of our phone calls from patients center primarily around two concerns:
- I am getting worse and nobody knows what is wrong or will help me. We are experiencing the destruction of our jaw joints and do not have safe, reliable, and effective treatment options. We have systemic problems that doctors are unable to deal with. We are left without any answers. The scientific community has not researched the disease processes that seem common to many TMJ implant patients. The clinical community lacks knowledge and experience in treating our suffering.
- My oral surgeon abandoned me. No other will take me on as a patient. I can't even find a dentist to clean my teeth. Everyone seems to blame me for my condition. Since we have not heard from every implant patient in the country, we are hesitant to say that what we are hearing about treatment and health care professionals is the norm. Some people are pleased with the care they are receiving. However, the overwhelming majority of TMJ patients are not.
Another serious and all-too-common problem is that of pain management. Implant patients experience pain ranging from mild, to severe and unrelenting. An obvious fact is that many people who need pain medication are not getting it. Others are being under medicated, and some people are on medications that require regular kidney or liver monitoring. In some cases, they are not being monitored and, as a result, are experiencing kidney and/or liver damage.
TMJ implants were claimed to be a "cure" for TMJ sufferers. Yet, for many, the result has been a never-ending nightmare. This "Great American Medical Disaster," as one scientist called it, should motivate all of us to demand accountability and responsible action from our professional providers, governmental agencies and everyone who contributed to this disaster. The Orthopedic Network News dedicated its feature article in the April 1995 issue to TMJ implants and is a good informational resource. Orthopedic Network News
As TMJ implant patients ourselves who have talked with thousands of other implant recipients, we fully understand the dilemma faced by people with TMJ diseases/disorders - with or without implants. What is happening to TMJ implant patients is in the infant stage of scientific knowledge. We, the patients, with the help of scientists, will ultimately put the pieces of the puzzle together. We need to find out what is happening to people with TMJ implants, why it is happening, and what can be done to stop it.
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