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It's Time to Be Part of the Solution

The National Academy of Medicine (NAM) Study on Temporomandibular Disorders (TMD) is well underway. We strongly encourage everyone affected by TMD to write to the NAM committee letting them know what it is like to live with TMD and your experiences with getting care.

New CME on Chronic Overlapping Pain Conditions

The Chronic Pain Research Alliance, an initiative of The TMJ Association, in partnership with the International Pelvic Pain Society, is pleased to announce the release of our newly developed Continuing Medical Education (CME) program on Chronic Overlapping Pain Conditions.

And the Committee heard from the American Association of Oral and Maxillofacial Surgeons

At the end of the NAM meeting, Dr. Gregory Ness, representing the American Association of Oral and Maxillofacial Surgeons (AAMOS) gave the following comments: “AAMOS welcomes the interest and support of the Academies, the NIH, NIDCR, FDA and The

What Allen Told the Committee

Allen Cowley addressed the second open-to-the-public meeting of the National Institute of Medicine's (NAM) Committee on Temporomandibular Disorders (TMD) held on March 28, 2019 in Washington, DC. No stranger to the world of TMD, Dr. Cowley is the hus

Some Thoughts on Depression

It is hardly surprising that the chronic pain and limitations in function that many long-time TMJ patients experience can be accompanied by a state of depression, a sense of exhaustion and hopelessness.

Need an All Titanium TMJ Implant?

  • Jan 27, 2017

Increasingly over the past several years patients with temporomandibular total joint implants have been telling us that they have become sensitive to a material, or materials in the implants. The most common material they're sensitive to is nickel. The implant companies have responded to this problem by manufacturing the implant without the standard materials, and manufacturing implants of all titanium. Two TMJ device companies have been manufacturing all titanium devices--Biomet Microfixation (recently acquired by Zimmer, Inc.) and TMJ Concepts.

The FDA has approved Biomet Microfixation stock product devices--stock meaning that they are of a specific design and material but made in different sizes. The materials in the stock products are cobalt, chromium, molybdenum and ultra-high molecular weight polyethylene. They also have approval to manufacture all titanium stock products, however they do not have FDA approval to manufacture a custom all titanium device.

TMJ Concepts manufactures custom TMJ implants meaning that they make the devices according to the individual's craniofacial anatomy. TMJ Concepts has FDA approval to manufacture these devices composed of: titanium alloy, cobalt, chromium, molybdenum alloy, titanium mesh and ultra-high molecular weight polyethylene. They do not have FDA approval to distribute an all titanium device in the United States.

Recently the Food and Drug Administration (FDA) has limited the manufacture of non-approved devices to five per year, which is in accordance with the last FDA device reauthorization bill. Naturally, patients with traditional implants experiencing symptoms of sensitivity are concerned that the all titanium implants are not available to them because of this limitation.   

We contacted the FDA about this situation and were told that TMJ Concepts and Biomet Microfixation, after they produced the limited five devices per year, are able to then provide a "small" number of the all titanium custom devices on a Compassionate Use exemption basis. That means the companies will be able to manufacture an implant for a patient with evidence of sensitivity to routinely used materials. There are criteria that the companies will have to fulfill in order to do this.

Mr. Dave Samson, President of TMJ Concepts, stated that "they are exploring the feasibility of addressing the criteria FDA lays out for manufacturing the all-titanium TMJ implant for Compassionate Use."  

TMJ Disorders

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