Cases That Made A Difference

Jaw Implant Devices Taken Off the Market

Between 1983 and 1988, more than 25,000 patients received synthetic jaw implants manufactured by Vitek Inc. These health care consumers suffered from temporo-mandibular joint syndrome (TMJ), a disorder can cause arthritis, jaw and facial pain, headaches, earaches and restricted jaw movements. The joint itself permits the lower jaw, the mandible, to move up and down and side to side, and is critical in allowing a person to bite, chew, speak, laugh and smile.

In 1983, Vitek began marketing its jaw implant, which essentially was two layers of plastic (Teflon FEP and Proplast) laminated together, after convincing the Food and Drug Administration (FDA) that the device was "substantially equivalent" to a product already on the market before enactment of a 1976 law regulating medical devices. The jaw implant was never tested in animals before being marketed. Nor did Vitek perform any human trials.

The jaw implants safety was questioned only after animal testing and implants in humans showed the device could not withstand the wear and tear of the lower jaw sliding on its plastic surface. Products liability suits against the company and medical negligence claims against surgeons who implanted the device began mounting in 1987. These claims, in turn, caused liability-insurance problems for Vitek, which eventually withdrew the jaw implant from the market in 1988. The FDA forced the company, which filed bankruptcy, to issue a safety alert in 1990.

Medical experts now predict that most, if not all, of the devices implanted in unsuspecting health care consumers will fragment, causing a biochemical reaction that erodes the jaw bone and creates other painful complications.