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Journal of Long-Term Effects of Medical Implants
Abstract of "Ethical Issues When Insurance Companies Falsely Label Certain Surgical Treatments as Experimental and Investigational"
Robert W. Christensen
TMJ Implants, Inc., 17301 W. Colfax Avenue, Suite 135, Golden, CO 80401
In the area of TMJ reconstructive surgery, there can be major ethical issues in treatment selections, treatment failure rates, and patients and surgeons being given false information by insurance companies. As an example, Aetna, in its Clinical Policy Bulletin #0028, alleges TMJ Implants' devices are experimental and investigational. Subsequently, during an approval process for a TMJ implant operation, they steer their insured away from a successful and proper treatment option, i.e., alloplastic hemiarthroplasty of the TMJ using the Christensen partial joint prosthesis. In their bulletin they suggest they will cover multiple autologous grafts (which have a 69%−90% failure rate) for hemiarthroplasty of this joint. They state that the Christensen devices are experimental and investigational, even though they have been implanted successfully for nearly 50 years. These implants have been used around the United States and some other areas of the world for many years, and a premarket approval process for FDA clearance has been successfully completed. TMJ Implants, Inc. was never placed by FDA in its Experimental and Investigational pre-approval category, usually required as a precondition for final FDA approval, since it was grandfathered in at the passage of the Medical Device Act of May 28, 1976. This then becomes an ethical issue for the patient and the surgeons in being able to have a successful treatment, and even in how the medical device company might overcome such a fraudulent directive.
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