Before the Federal Drug Administration enacted the Medical Device Regulation act in 1976, the medical device marketplace was a completely different space than it is today. Prior to this act, manufacturers of medical devices were not required to prove their devices were safe before they were sold to the public, causing many medical injuries.
One example is the case of the Vitek jaw device. The Vitek jaw device was designed to help patients with temporomandibular joint (TMJ) disorder. Made of Teflon and silicone, the Vitek jaw device was implanted into about 10,000 patients with TMJ disorder in the 1970s and ’80s. Unfortunately, the devices were never determined to be safe or even effective – and as it turns out, they were neither of those things. Implant recipients soon began complaining of increased jaw pain due to reactions from the Teflon implants. As the devices became worn with use, they began to break down inside the jaw. Soon the patients began experiencing symptoms like their initial TMJ disorder symptoms – and those were the lucky ones. Many others suffered additional biochemical reactions that caused bone loss, and some devices even shattered, leaving Teflon particles embedded in patients’ brains and muscles. Some victim required multiple surgeries and remain permanently disfigured.
Today, many survivors of the Vitek jaw device disaster work to lobby for greater understanding and treatment options of TMJ disorder. A roundtable of Vitek survivors recently met with TMJ disorder experts to discuss the future of TMJ treatment. Roundtable participants agreed that, among other things, we as a society need improved clinical studies regarding TMJ disorder, more genetic information, more identification of biomarkers, and a “greater understanding of genetic and environmental risk factors, including gender and sex differences.”
“It really goes to show the character of these people. They owe the world nothing, but they are committed to furthering the research of this condition and making treatment better for everyone,” says Dr. Alexandra George, a dentist who specializes in TMJ treatment from Wexford, Pennsylvania. “Their advocacy and experience is making a real difference in the lives of TMJ disorder sufferers everywhere.”
