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Epidemiological Evidence on the Adverse Health Effects Reported in Relation to Mercury from Dental Amalgam: Systematic Literature Review (2010-Present)

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Epidemiological Evidence on the Adverse Health Effects Reported in Relation to Mercury from Dental Amalgam: Systematic Literature Review (2010-Present) Epidemiological Evidence on the Adverse Health Effects Reported in Relation to Mercury from Dental Amalgam: Systematic Literature Review (2010-Present) Office of Clinical Evidence and Analysis, and the Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Office of Science and Engineering Laboratory Center for Devices and Radiological Health U.S. Food and Drug Administration [date] Note: This scientific assessment is in draft format for peer review. Contents Executive Summary ....................................................................................................................................................... ii Background .................................................................................................................................................................... 1 Evidence Assessment ..................................................................................................................................................... 8 Purpose ...................................................................................................................................................... 8 Methodology ............................................................................................................................................... 8 Overview of Studies ..................................................................................................................................... 9 Summary of Evidence ................................................................................................................................. 12 Increased Mercury Levels as a Single or Combined Outcome of Interest ......................................................... 12 Self-assessed Health Complaints and Other Health-related Measures ............................................................. 16 Oral Mucosa and Cutaneous Outcomes ............................................................................................................ 18 Systemic Inflammation and Autoimmunity Related Outcomes ......................................................................... 23 Neurological and Neuropsychological Outcomes .............................................................................................. 25 Pregnancy and Physical Development Related Outcomes ................................................................................ 31 Cardiovascular Outcomes .................................................................................................................................. 33 Renal Function and Other Subclinical Outcomes ............................................................................................... 34 Putative Effect Modifiers of Amalgam-related Mercury Toxicity ...................................................................... 38 Genetic Markers with Possible Modifying Effects on Mercury Toxicity ............................................................. 38 Sex as Possible Effect Modifier in Mercury Toxicity ........................................................................................... 40 Country/Residence Area and Ethnicity as Possible Effect Modifiers in Mercury Toxicity ................................. 42 Other Applicable Safety Studies ......................................................................................................................... 43 Evidence Critique and Assessment .............................................................................................................. 45 Discussion of Overall Findings ..................................................................................................................................... 46 Findings from the Main Review of the Literature Published between 2010 and Sep 2018 ................................ 46 Cross-Cutting Study Limitations and Identified Knowledge Gaps ...................................................................... 49 Addendum: Update to Main Review of the Literature Published between Sep 2018 and Aug 2019 .................. 52 References ................................................................................................................................................................... 58 Main Review of the Literature Published between 2010 and Sep 2018 (pg. 7-47) ............................................ 58 Addendum: Updated Review of the Literature Published between Sep 2018 and Aug 2019 (pg. 53-56) ............ 70 Appendices .................................................................................................................................................................. 82 Appendix 1: 2010 FDA Systematic Assessment of Peer Reviewed Epidemiologic Literature .............................. 50 Appendix 2: 2012 and 2014 FDA Updates to the Systematic Assessment of Peer Reviewed Epidemiologic Literature ................................................................................................................................................ 110 Abbreviations ............................................................................................................................................................. 143 pg. i www.fda.gov Executive Summary Mercury (Hg) is a naturally-occurring substance with known toxicities. Most people have some exposure to elemental mercury (Hg0) / inorganic mercury (Hg2+) and/or organic methylmercury (MeHg) distributed throughout the environment. Elemental mercury vapors released from dental amalgam, a dental restorative material containing approximately 50% elemental mercury are a source of non-occupational exposure among patients as well as occupational exposure among dental personnel, especially in dental clinics with sub-optimal mercury handling practices, e.g., use of non-encapsulated amalgam, inadequate ventilation, lack of personal protective equipment, and improper recycling of amalgam waste. Mercury from dental amalgam can be released into the environment in various ways, such as from improper dental waste management practices and from crematoria, which along with other sources of inorganic mercury that contaminate air, land, and groundwater, can be biomagnified throughout the food chain as methylmercury. To address public concerns resulting in the ongoing discussion on whether to ban, phase-out, or continue use of dental amalgam in the United States (US), FDA has continued to monitor and review published studies on the potential adverse health effects associated with exposure to dental amalgam mercury. Previous literature reviews conducted by FDA addressed assessment of amalgam-attributed health outcomes in the general population and vulnerable subpopulations, such as pregnant women and their developing fetuses, breastfed infants, and children under the age of six. As a result of these reviews, exposure to dental amalgam was shown to correlate with mercury levels in biofluids, primarily urine and blood; however, no conclusive evidence was found in relation to clinically-manifested adverse outcomes in the general population and listed subpopulations. In 2019, FDA conducted a more comprehensive literature review of the risks of dental amalgam to the general population that was not limited to specific adverse outcomes or subpopulations presumed at higher risk. The current review included clinical/ epidemiological evidence on adverse outcomes attributed to the elemental/inorganic form of mercury from dental amalgam as well as the biomedical evidence on the likelihood of transformation within the body of inorganic mercury to organic mercury and its possible consequences. As a subject related to the FDA’s efforts to evaluate safety questions related to medical device materials including metals, the safety of mercury exposure from dental amalgam will be further addressed at an upcoming Advisory Committee meeting. pg. ii www.fda.gov The currently available evidence derived from studies from the US and other developed countries and based on the actual mercury measurements in large study populations reveals possible mercury increases in biofluids due to either occupational (dental professionals) or non-occupational exposure to dental amalgam; however, the corresponding evidence on clinically-manifested adverse outcomes is less consistent. The available reports on mercury-attributed manifestations such as tremor or other neurological conditions did not demonstrate convincingly that the outcomes under question have been caused by the mercury from dental amalgam. As a result, no increased risks of adverse systemic effects (e.g. neurologic, renal) have been clearly established in the general population or among dental professionals. The evidence linking dental amalgam exposure to local adverse outcomes (e.g., lichenoid and allergic lesions of oral mucosa) is stronger, and removal of amalgam fillings does not always result in complete healing. There were also rare reports indicating possible enhanced susceptibility to mercury (and/or other dental amalgam metallic constituents) with subsequent exaggerated immune and inflammatory responses, which may bear resemblance to similar responses to other implantable/insertable devices with metallic components, and the underlying reasons of which are similarly poorly understood. Despite the reasonable assumption that genetic factors such as gene polymorphisms affecting mercury kinetics and excretion may modify individual responses to mercury exposure,
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