As your patient’s partner, Cochlear believes it is important to convey not only the benefits, but also the potential risks associated with a Cochlear™ Vistafix® procedure.
Vistafix is contraindicated in patients with inadequate bone quality or quantity to provide stability and support for the implant, or in patients who will be unable to maintain and clean the skin around the abutment. In the U.S., use of the implanted fixture is also contraindicated in children under age 5 years.
All surgical procedures include an element of risk, and it is impossible to guarantee success. The device may fail to osseointegrate for a number of reasons, including physiological and surgical issues as well as traumatic impact to the implant site. On rare occasions, the skin around the abutment may become inflamed from a mild infection or the skin may grow back toward its original thickness. For complete information regarding the risks and benefits of a Vistafix procedure, please refer to the Instructions for use for the Vistafix implant.