Docket Management
Docket: 00N-1665 - Consumer Roundtable; Notice of Meeting
Comment Number: EC -7

Accepted - Volume 1

Comment Record
Commentor Mr. Bernard Windham Date/Time 2001-01-16 13:24:57
Organization Mr. Bernard Windham
Category Individual

Comments for FDA General
Questions
1. General Comments Oral Galvanic Action of Amalgam Fillings and Other Metals: Oral Effects Having dissimilar metals in the teeth(e.g.-amalgam, or gold and mercury) causes galvanic action, electrical currents, and much higher mercury vapor levels and levels in oral tissues. (1-11,30) Average mercury levels in gum tissue near amalgam fillings are about 200 ppm, and are the result of flow of mercury into the mucous membrane because of galvanic currents with the mucous membrane serving as cathode and amalgam metals as anode(1-4). Concentrations of mercury in oral mucosa for a population of patients with 6 or more amalgam fillings taken during oral surgery were 20 times the level of controls(14), and levels in root tips of 41 ppm(5). Amalgam also releases significant amounts of silver, tin, and copper which also have toxic effects, with organic tin compounds formed in the body being even more neurotoxic than inorganic mercury. Mercury and other metals accumulate in the oral cavity in fibroblasts, macrophages, and multinuclear giant cells of connective tissue, in blood vessel walls, along nerve sheath fibres, in basement-membranes of mucosal epithelium, striated muscle fibres, along collagen bundles and elastic tissue, in acini of salivary glands, and in tooth roots and jaw bones(5,11). Such mercury including that in the commonly formed amalgam tattoos moves to other parts of the body over time in significant amounts and more rapidly than the other metals. Macrophages remove mercury by phagocytosis and the mercury moves to other parts of the body through the blood and along nerves(5). Amalgam fillings produce electrical currents which increase mercury vapor release and may have other harmful effects(1-14,38). These currents are measured in micro amps, with some measured at over 4 micro amps. The central nervous system operates on signals in the range of nano-amps, which is 1000 times less than a micro amp(38). Negatively charged fillings or crowns push electrons into the oral cavity since saliva is a good electrolyte and cause higher mercury vapor losses(11,1-6). Patients with autoimmune condtions like MS, or epilepsy, depression, etc. are often found to have a lot of high negative current fillings(11). The Huggins total dental revision(TDR) protocol calls for teeth with the highest negative charge to be replaced first(11). Other protocols for amalgam removal are available from international dental associations like IAOMT(39) and mercury poisoned patients organizations like DAMS(40). For these reasons it is important that no new gold dental work be placed in the mouth until at least 6 months after replacement. Some studies have also found persons with chronic exposure to electromagnetic fields(EMF) to have higher levels of mercury exposure and excretion(38). Some of the oral effects include gingivitis, oral lesions, pain and discomfort, burning mouth, metal mouth, chronic inflamatory response, lichen planus, autoimmune response, oral cancer, etc.(4,5,11,15,19,22,23,25,26,30-35) Studies have shown that mercury in the gums such as from root caps for root canaled teeth or result in chronic inflammation, in addtion to migration to other parts of the body(5,10,15). Mercury, tin, and silver from amalgam fillings can be seen in the tissues as amalgam tattoos, which have been found to accumulate in the oral mucosa as granules along collagen bundles, blood vessels, nerve sheaths, elastic fibers, membranes, striated muscle fibers, and acini of minor salivary glands(5,10). Dark granules are also present intracellularly within macrophasges, multinucleated giant cells, endothelial cells, and fibroblasts. There is in most cases chronic inflammatory response or macrophagic reaction the the metals(5,30), usually in the form of a foreign body granuloma with multinucleated giant cells of the foreign body and Langhans types. Mercury levels are often over 1000 ppm near a gold cap on an amalgam filling due to higher currents when gold is in contact with amalgam (8,9,11,12,13). Similar levels as high as 5000 ppm have been found by German oral surgeons in jaw bone under large fillings or gold crowns(37). These levels are among the highest levels ever measured in tissues of living organisms, exceeding the highest levels found in chronically exposed chloralkali workers, those who died in Minamata, or animals that died from mercury poisoning(29). The FDA/EPA Action Level for mercury in fish or food is 1 ppm. Warnings are given at 0.5 ppm. The component mix in amalgams has also been found to be an important factor in mercury vapor emissions. The level of mercury and copper released from high copper amalgam is as much as 50 times that of low copper amalgams(16). Studies have consistently found modern high copper non gamma-two amalgams have greater release of mercury vapor than conventional silver amalgams (17-21). While the non gamma-two amalgams were developed to be less corrosive and less prone to marginal fractures than conventional silver amalgams, they have been found to be unstable in a different mechanism when subjected to wear/polishing/ chewing/ brushing: they form droplets of mercury on the surface of the amalgams(3,23,24). This has been found to be a factor in the much higher release of mercury vapor by the modern non gamma-two amalgams. Recent studies have concluded that because of the high mercury release levels of modern amalgams, mercury levels higher than Government health guidelines are being transferred to the lungs, blood, brain, CNS, kidneys, liver, etc. of large numbers of people with amalgam fillings and widespread neurological, immune system, and endocrine system effects are occuring(25,26,27,28). References (1) N.Nogi, Electric current around dental metals as a factor producing allergic metal ions in the oral cavity, Nippon Hifuka Gakkai Zasshi, 1989, 99(12):1243-54; (2) A.J.Certosimo et al, National Naval Dental Center, Oral Electricity, Gen Dent, 1996, 44(4):324-6; & B.M.Owens et al, Localized galvanic shock after insertion of an amalgam restoration, Compenium, 1993, 14(10),1302,1304,1306-7. (3) R.H.Ogletree et al, School of Materials Science, GIT, Atlanta,Effect of mercury on corrosion of etaĆ Cu-Sn phase in dental amalgams, Dent Mater, 1995, 11(5):332-6 (4) R.D.Meyer et al, Intraoral galvanic corrosion,Prosthet Dent, 1993,69(2):141-3; (5) A. Buchner et al, Amalgam tattoo of the oral mucosa: a clinicopatholigic study of 268 cases, Surg Oral Med Oral Pathol, 1980, 49(2):139-47;& M. Forsell et al, Mercury content in amalgam tattoos of human oral mucosa and its relation to local tissue reactions. Euro J Oral Sci 1998; 106(1):582-7; & J.D. Harrison et al, Amalgam tattoos: light and microscopy and electron-probe micro-analysis; & T. Kanzaki et al, Electron microscopic X-ray microanalysis of metals deposited in oral mucosa. J Dermatol 1992; 19(8):487-92; & K. Nilner et al, In vitro testing of dental materials by means of macrophage cultures. J Biomed Mater Res 1986;20(8):1125-38. (6) M.D.Rose et al, Eastman Dental Institute, The tarnished history of a posteria restoration, Br Dent J 1998;185(9):436; & Johansson E, Liliefors T, Heavy elements in root tips from teeth with amalgam fillings, Department of Radiation Sciences, Division of Physical Biology, Box 535, 751 21 Uppsala, Sweden (7) Matts Hanson. Amalgam hazards in your teeth,. Dept of Zoophysiology., University of Lund, Sweden.J. Orthomolecular Psychiatry, Vo12 No 3 Sept 1983, 194-201;& Lorscheider & Vimy, Mercury Exposure from silver fillings,The Lancet Vol 337; may 4, 1991. (8) T.Till et al, Mercury Release from Amalgam Fillings and Oral Dysbacteriosis as a Cause of Resorption Phenomena Zahnarztl Welt/Reform(ZWR), 1978:87;1130-1134. & S. Olsson et al, Release of elements due to electrochemical corrosion of dental amalgam J of Dental Research, 1994, 73:33-43. (9) K.Arvidson,Corrosion studies of dental gold alloy in contact with amalgam, Swed. Dent. J 68: 135-139,1984; & Skinner, EW, The Science of Dental Materials, 4th Ed.revised, W.B.Saunders Co., Philadelphia, p284-285,1957. (10) B.M Eley, S.W. Cox. Influence of levels of selenium on renal pathology from mercury released by experimental amalgam tattoos. Biomaterials 1988; 9(4): 339-44; & Effects of particle size and amount of implanted amalgam tattoos, Biomaterials 1987; 8(5):401-3; & The release, tissue distribution and excretion of mercury from experimental amalgam tattoos, Br J Exp Pathol, 1986; 67(6):925-35; & Biomaterials 1983, 4(2): 73-80. (11) Hal Huggins, Its All in Your Head, 1997; & Proceedeings: ICBM Conf. Colorado, 1988; & S.Ziff,Dentistry without Mercury, 8th Edition, 1996, Bio-Probe, Inc., ISBN 0-941011- 04-6 (12) H.Freden et al, Mercury in gingival tissues adjacent to amalgam fillings, Odontal Revy,1974, 25(2): 207-210;& H Reden,Odontal Revy, 25,1971,207-210 (13) C.Malmstrom, M.Hansson,M. Nylander, Conference on Trace Elements in Health and disease. Stockholm May 25-1992; (14) B.Willershausen et al, Mercury in the mouth mucosa of patients with amalgam fillings, Dtsch Med Wochenschr, 1992, 117:46, 1743-7. (15) V.Nadarajah et al, Localized cellular inflamatory response to subcutaneously implanted dental mercury, J Toxicol Environ Health, Oct 11: 49(2):113-25. (16) D.Brune et al, Scand J Dent Res, 1983,19:66-71 & Sci Tot Envir,1985,44:...; & Metal release from dental materials, Biomaterials, 1986, 7, 163-175. (17) C. Toomvali, Studies of mercury vapor emission from different dental amalgam alloys, LIU-IFM-Kemi-EX 150, 1988; & D.B.Boyer, Mercury vaporization from corroded dental amalgam Dental Materials, 1988, 4:89-93 (18) A.Berglund,A study of the release of mercury vapor from different types of amalgam alloys, J Dent Res, 1993, 72:939-946; (19) H. Lichtenberg, Mercury vapor in the oral cavity in relation to the number of amalgam fillings and chronic mercury poisoning, Journal of Orthomolecular Medicine, 1996, 11:2, 87-94. (20) V.Psarras et al, Effect of selenium on mercury vapour released from dental amalgams, Swed Dent J, 1994, 18:15-23; (21) L.E.Moberg, Long term corrosion studies of amalgams and Casting alloys in contact, Acta Odontal Scand 1985, 43:163-177; & L.E. Moberg, Corrosion products from dental alloys, Published Dissertation, Stockholm, 1985. (22) T. Weaver et al, An amalgam tattoo causing local and systemic disease; Oral Surg Oral Med Oral Pathol 1987; 63(1):137-40; & J.P.McGinnis et al, Amalgam tattoo: use of energy dispersive X-ray analysis as an aid in diagnosis; J Amer Dent Assoc 1985; 110(1): 52-4. (23) J Pleva, J Orthomol Psych, Vol 12, No.3, 1983 & J. Of Orthomol. Medicine 1989, 4:141- 148. (24) P.E.Schneider et al, Mercury release from Dispersalloy amalgam, IADR Abstrats, #630, 1982; & N.Sarkar, Amalgamtion reaction of Dispersalloy Reexamined, IADR Abstracts #217, 1991; & N.K. Sarkar et al, IADR Abstracts # 895, 1976; & R.S.Mateer et al, IADR Abstracts #240, 1977; & N.K.Sarkar et al, IADR Abstracts, #358, 1978; & N.W. Rupp et al, IADR Abstracts # 356, 1979. (25) H.J.Lichtenberg, Elimination of symptoms by removal of dental amalgam from mercury poisoned patients, J Orthomol Med 8:145-148, 1993; & Symptoms before and after removal of amalgam,J of Orth Med,1996,11(4):195- (26) Dr. P.Kraub & M.Deyhle, Universitat Tubingen- Institut fur Organische Chemie, Field Study on the Mercury Content of Saliva, 1997 http://www.uni-tuebingen.de/KRAUSS/amalgam.html; (20,000 people tested for mercury level in saliva and health status/symptoms compiled) (27) Public Statement: BBC Panorama Program on Dental Amalgam:The Poison in Your Mouth, June 1994. by World Health Organizaition Scientific Panel Members: Dr. Lars Friburg- chairman, Dr. Fritz Lorscheider, Professor of Medical Physiology, Univ. Of Calgary; Dr. Murray Vimy, Professor of Oral Biology and Dental Medicine, Univ. Of Calgary Medical School. Dr. Vasken Aposhian, Dept. Head, Molecular and Cellular Biology, Univ. Of Arizona; Dr. David Eggleston, Univ. Of Califoria, researcher on mercury in the brain; Dr. Boyd Haley, Univ. Of Kentucky reasearcher on mercury in the brain and Alzheimer's Disease Dr. Gustav Drasch, Univ. Of Munich, reaearcher on mercury in brains of dead infants and fetuses; Dr. D. Echeverria, Neuro-Toxicologist, researcher on reproductive problems and birth defects in dental workers; Batelle Center for Public Health Reseach, Seattle, Wash. (28) B. Windham, Annotated Bibliography: Health Effects Related to Mercury and Amagam and Clincal Results of Amalgam Replacement;1999. (over 500 medical study references and 60,000 clinical cases followed by doctors) (29) C.F.Facemire et al, Reproductive impairment in the Florida Panther, Health Perspect,1995, 103 (Supp4):79-86. (30) Forsell M, Larsson B, et al. Reactions of the oral mucosa related to silver amalgam: a review. Eur J Oral Sci, 1998 Feb, 106:1, 582-7 (31) E.R.Smart et al, Resolution of lichen planus following removal of amalgam restorations, Br Dent J 178(3):108-112,1995(12 cases); & H.Markow, Regression from orticaria following dental filling removal:,New York State J Med, 1943: 1648-1652; & G. Sasaki et al, Three cases of oral lichenosis caused by metallic fillings, J. Dermatol, 23 Dec, 1996; 12:890-892; & J.Bratel et al, Effect of Replacement of Dental Amalgam on OLR, Journal of Dentistry, 1996, 24(1-2):41-45(161 cases). (32) A. Skoglund, Scand J Dent Res 102(4): 216-222, 1994; and 99(4):320-9,1991(40 cases); & P.O.Ostman et al, Clinical & histologic changes after removal of amalgma, Oral Surgery, Oral Medicine, and Endodontics, 1996, 81(4):459-465; & S.H.Ibbotson et al, The relevance of amalgam replacement on oral lichenoid reactions, British Journal of Dermatology, 134(3):420-3, 1996; (270 cases) (33) Y.Omura et al, Heart Disease Research Foundation, NY,NY, Role of mercury in resistant infections and recovery after Hg detox with cilantro, Acupuncture & Electro-Theraputics Research, 20(3):195-229, 1995; & Mercury exposure from silver fillings, Acupunture & Electrotherapy Res, 1996, 133- (34) R.L.Siblerud, Relationship between dental amalgam and health, Toxic Substances Journal, 1990b. 10:425-444; & Effects on health following removal of dental amalgams, J Orthomolecular Med,5(2): 95-106, & Relationship betweem amalgam fillings and oral cavity health Ann Dent, 1990, 49(2): 6-10, (86 cured) (35) Redhe,O. Sick From Amalgam R-Dental Ab, Frejavagen 33, S-79133 Falun, Sweden(in Swedish)(100 cases). (36) M. Daunderer, Handbuch der Amalgamvergiftung, Ecomed Verlag, Landsberg 1998, I SBN 3-609-71750-5 (in German) (37) Schiwara, H.-W. (Medical Laboratory) Arzte fur Laboratoriumsmedizen, D-28357 Bremen; & Heavy Metal Bulletin, 1999, No. 1, p28. (38) F.Schmidt et al, Mercury in urine of employees exposed to magnetic fields, Tidsskr Nor Laegeforen, 1997, 117(2): 199-202; & Sheppard AR and EisenbudM., Biological Effects of electric and magnetic fields of extremely low frequency. New York university press. 1977; & Ortendahl T W, Hogstedt P, Holland RP, Mercury vapor release from dental amalgam in vitro caused by magnetic fields generated by CRT's, Swed Dent J 1991 p 31 Abstract 22 (39) International Acadamy of oral Medicine and Toxicology, A Scientific Response to the American Dental Association Special Report and Statement of Confidence in Dental Amalgam, IAOMT, POB 608531, Orlando,32860-8531, http://emporium.turnpike.net/P/PDHA/mercury/asr.htm; & IAOMT, Protocol for Mercury/Silver Filling Removal, http://emporium.turnpike.net/P/PDHA/mercury/iaomt.htm (40) Amalgam/mercury poisoned patients organizations, DAMS: Assoc. Of Dental Mercury Patients-U.S., http://www.amalgam.org;




EC -7