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."