Encapsulated amalgam, a filling made from a combination of mercury with silver, copper or tin, has been listed as safe and effective material by the FDA (Food and Drug Administration), located in the same category of class II medical device that have gold fillings and composite resin for use in dental restorations.
Dr. Susan Runner, head of the FDA, said that “patients with dental amalgam fillings are not endangered by the adverse health effects associated with mercury. As stated by “prolonged trials in adults and children six years and older with dental amalgam fillings, have not established a causal connection between it and adverse health effects.
Runner explained that some patients “suffer from allergies or sensitivity to mercury or other metals used in dental amalgams” so that such patients may develop “Contact reactions” within the oral cavity.
To address the needs of these patients, Dr. Runner indicated that “the FDA is organizing special controls for dental amalgam to help provide reasonable assurance on its safety and effectiveness.”
In this sense, the U.S. agency advised caution against the use of amalgam in patients with mercury allergy, use ventilation when handling this material and present clearly and succinctly the benefits and risks of the technique before applying it to the patient.