Section 33.213. Use and replacement of dental amalgams—statement of policy

(a) Background. The safety of dental amalgams, specifically, whether the mercury in amalgams causes or contributes to a variety of health problems, has become a recurring issue in dentistry. The Food and Drug Administration has determined that while elemental mercury has been associated with adverse health effects at high exposures, the levels released by amalgam fillings are not high enough to cause harm in patients. The Board is not aware, however, of conclusive evidence that the use of alternative restorative materials or removal of amalgams will prevent, cure or ameliorate disorders other than those associated with confirmed allergic reactions to mercury. Nonetheless, nonallergic patients may request the use of alternative restorative materials or replacement of amalgam restorations in the belief, or merely the hope, that a medical condition will thereby disappear or improve. Dentists receiving these requests must make ethical and professional decisions compatible with the best interests of their patients.

(b) Purpose. Section 4.1(a)(8) and (9) of the act (63 P. S. § 123.1(a)(8) and (9)) authorizes the Board to take disciplinary action against licensees who engage in unprofessional conduct or commit acts of negligence, incompetence or malpractice. The replacement of amalgams may implicate both provisions by, for example, generating complaints of unnecessary or even harmful treatment. The Board therefore provides the following guidelines to assist its licensees in conforming their behavior to the requirements of the act. In a disciplinary action brought against a dentist for treatment associated with replacing amalgams, the Board will consider whether these guidelines were followed.

(c) Guidelines.

(1) The Board recommends that, before replacing amalgams in a nonallergic patient, the dentist:

(i) Explain to the patient the current status of research on the safety of dental amalgams.

(ii) Provide the patient with information on contraindications and costs associated with removal/replacement of amalgam restorations.

(iii) Advise a patient relying on third-party payment to ascertain whether the insurer will cover removal/replacement procedures.

(iv) Encourage a patient seeking amelioration of a medical condition to consult with a physician and, as appropriate, secure from the physician documentation of recommendations made to the patient.

(v) Memorialize in writing the disclosures made to the patient and the patient’s informed consent.

(2) The Board recognizes the right and duty of dentists to refuse to replace amalgam restorations when, in their professional judgment, this procedure would not be in the best interests of the patient.

The provisions of this § 33.213 adopted January 18, 1965; amended September 12, 1975, effective September 13, 1975, 5 Pa.B. 2397; amended June 23, 1995, effective June 24, 1995, 25 Pa.B. 2492; amended October 25, 2013, effective October 26, 2013, 43 Pa.B. 6385. Immediately preceding text appears at serial pages (311481) to (311482).