TMJ Therapy and Sleep Center of Colorado · Dr. Kevin Berry | 1660 S Albion Street, Suite 1008 | Denver, CO 80222

TMJ Implant Adverse Events Remind Us Less Is Best for TMJ

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In TMJ treatment, we have increasingly found that less intervention is best. The less we interfere with the normal functioning of the temporomandibular joint, the better results we are likely to get in the long term. Looking at problems related to the use of temporomandibular joint implants, we are reminded why this is the case: there are serious risks associated with invasive treatments.

At the TMJ Therapy & Sleep Center of Colorado in Denver, we recommend noninvasive and reversible treatments unless there is good evidence additional interventions may be necessary.

Temporomandibular Joint Implant Adverse Events Reported

According to FDA’s MAUDE adverse event reporting system, there were 20 incidents reported in relation to TMJ implants in January, February, and March. Some of these events are actually reporting on multiple devices involved in the same procedure, so there were actually 14 distinct adverse events. The types of events recorded included:

  • Infection: 4 reports
  • Swelling and pain: 2
  • Dislocated jaw: 1
  • Ankylosis: 2
  • Malocclusion: 1
  • Revision surgery (no cause given): 2
  • Anatomical mismatch: 1
  • Implant loosening: 1

In 12 of the events, surgery and/or hospitalization was required. It’s important to note that not all of these events occurred during the months they were reported. Some occurred in December (and doubtless some events occurring in March won’t be reported until late April), and two were consolidated from earlier incidents that had been lost due to poor tracking of patients.

Increased Scrutiny of Implants

TMJ implants have actually been under increased scrutiny for several years. In 2011, FDA released a statement that it was increasing surveillance on this type of implant because it seemed to be failing in a remarkably high number of people, often due to pain and swelling that required revision surgery. It looked like failure rates were clustering around 3 years, when the implants were expected to last up to five years.

Therefore, FDA implemented new rules for postmarket surveillance of temporomandibular joint implants to attempt to determine the severity of the problem and its causes. It has not yet released updated information on the results of these surveillance efforts.

A Complex Joint Is Hard to Replace

Joint replacement is a very successful procedure in many cases for many different joints in the body. However, it works best in joints where the intended movement is relatively restricted, or restricted motion is an acceptable outcome. However, the temporomandibular joint is a very complicated joint and it is hard to replace successfully.

None of this is to say that temporomandibular joint implants are inherently bad or are to be avoided at all costs, just to say that they come with risks and therefore should not be used unnecessarily.

Instead, we should try all minimally-invasive and reversible interventions before moving on to treatments that may have repercussions on this scale.

To see if non-sugical TMJ treatment is right for you, please call (303) 691-0267 at the TMJ Therapy & Sleep Center of Colorado in Denver today.

We Look Forward to Seeing You!

TMJ Therapy & Sleep Center of Colorado
- Dr. Kevin Berry
1660 S Albion Street #1008
Denver, CO 80222

(303) 691-0307

Monday - Wednesday: 8:00 am - 5:00 pm
Thursday: 8:00 am - 1:00 pm