FDA orders review of jaw joint implants

By John Fauber of the Journal Sentinel

The Food and Drug Administration has ordered a review of the performance of artificial jaw joint implants after finding a substantial number of problems with the products in recent years.

The action comes a couple months after a Journal Sentinel investigation found that the agency had approved four such devices beginning in 1999, despite weak and incomplete research clouded by potential conflicts of interest. The artificial joint devices were used in attempt to help patients who failed to respond to conventional TMJ treatments.

In announcing the action, the agency said it found a substantial number of adverse events involving the jaw-joint devices between 2004 and 2010, including patients who had to have devices removed prematurely after they were implanted because of extreme pain.

Many of those patients were forced to undergo surgery to remove the devices in less than three years. That is considerably shorter than the expected five-year minimum, the agency said.

It is not known how many patients have been implanted with the devices since they were approved beginning in 1999 – the year of the FDA’s first such approval – but it is believed to be in the thousands.

The FDA’s latest action involved implants used to treat a condition known as temporomandibular joint disorder, or TMJ – a group of ailments affecting the joint connecting the jaw to the head.

It affects more than 10 million Americans, including a small number who undergo radical surgery to implant an artificial jaw joint.

Among the medical device reports it has reviewed, 52% of the devices that had to be removed were taken out less than three years after they were implanted, the agency said in an e-mail to the Journal Sentinel.

Patient problems included pain, surgical procedure or repeat surgical procedure, additional therapy and nonsurgical treatment or treatment with medication, infection, swelling, hospitalization and headache, it said.