dental amalgam

Dental amalgam controversy

The dental amalgam controversy is a debate over the use of mercury amalgam as a dental filling. The concern centers around the long-term health effects of toxicity or allergy which may be associated with constant mercury exposure, particularly as a potential cause of chronic illnesses, autoimmune disorders, neurodegenerative diseases, birth defects, oral lesions, and mental disorders. Scientists agree that mercury amalgam fillings expose the bearers to a daily dose of mercury, but different studies have concluded that this exposure may be as low as 1-3 µg/day (FDA), or as high as 27 µg/day (Patterson). The effects of this exposure are disputed, and currently dental amalgam is approved for use in most countries, although Norway and Sweden are notable exceptions.

A 2006 Zogby International poll of 2,590 US adults found that 72% of respondents were not aware that mercury was the main component of dental amalgam, and 92% of respondents would prefer to be told about mercury in dental amalgam before receiving it as a filling. A 1993 study published in FDA Consumer found that 50% of Americans believed mercury filings caused health problems. Some dentists, including one member of the FDA's Dental Products Panel, have suggested that the factors obligate dentists to apply the doctrine of informed consent by notifying their patients that amalgam contains mercury.

Dentists who advocate the use of amalgam point out that it is durable, cheap, and easy to use. On average, resin composites last only half as long as mercury amalgam, although more recent studies find them comparable to amalgam in durability, and dental porcelain is much more expensive. However, the gap between amalgam and composites may be closing. Further, concerns have been raised about the endocrine disrupting (in particular, estrogen-mimicking) effects of plastic chemicals such as Bisphenol A used in composite resins.

In addition to health and ethics issues, opponents to mercury amalgam fillings point to the negative externalities of water contamination and environmental damage of mercury, especially since its use by dentists goes largely unregulated in many places, including the United States. The WHO reports that mercury from amalgam and laboratory devices accounts for 53% of total mercury emissions. Separators may dramatically decrease the release of mercury into the public sewer system, where dental amalgams contribute one-third of the mercury waste, but they are not required in the United States.

Ethics and awareness

A 1993 study published in FDA Consumer found that 50% of Americans believed mercury filings caused health problems. The broad lack of knowledge among the public was displayed when a December 1990 episode of the CBS news program 60 Minutes covered mercury in amalgam. This resulted in a nationwide amalgam scare, and additional research into mercury release from amalgam. The following month, Consumer Reports published an article criticizing the content of the broadcast, stating that it contained a great deal of false information and that the ADA spokesperson on the program was ill prepared to defend the claims.

Exposure

The World Health Organization (WHO) notes that exposure can be greatly increased by personal habits such as bruxism or gum-chewing, and cites a report which found a 5.3 fold increase in mercury levels after chewing, eating, or toothbrushing. They report that amalgam is estimated to contribute 50% of mercury exposure in adults. In the studies the WHO reviews, daily mercury exposure estimates range from 3 μg/day to 9 μg/day. Separately the World Health Organization reports that "there may be no level of mercury at which some adverse effects do not occur". A study conducted by measuring the intraoral vapor levels over a 24-hour period in patients with at least nine amalgam restorations showed the average daily dose of inhaled mercury vapor was 1.7 µg (range from 0.4 to 4.4 µg), which is approximately only 1% of the threshold limit value of 300 to 500 µg/day established by the World Health Organization, based on a maximum allowable environmental level of 50 µg/day in the workplace.

A Swedish study of autopsies examined the mercury levels in brains and kidneys and found a strong correlation with the number of amalgam fillings. A German study found that mercury urinary excretion was significantly higher in those with mercury amalgam fillings.

Research on monkeys has shown that mercury released from dental amalgam restorations is absorbed and accumulates in various organs such as the kidney, brain, lung, liver, gastro-intestinal tract, the exocrine glands. It was also found to have crossed the placental barrier in pregnant rats and proven to cross the gastrointestinal mucosa when amalgam particles are swallowed after amalgam insertion or after removal of old amalgam fillings.

Various diagnostic methods exist to detect the level of mercury in the body, including blood tests, urine tests, stool tests, saliva tests, DMPS or DMSA chelation urine tests, hair analysis and others. Opinions differ on which of these tests, if any, is the most accurate, although mainstream scientific research tends to place the most weight on chelation urine tests or stool tests when trying to assess chronic levels, or on blood or urine tests when trying to assess recent acute exposure.

The degree of accuracy which can be expected from urine based mercury tests given the observations cited above (outlining the drop in mercury excretion levels, after two years, in children with amalgam fillings despite a constant or increased magnitude in the level of mercury exposure) indicates the possibility of clear limitations in the efficacy of urine based mercury tests as an accurate statistic for the purposes of dental studies.

Further, none of these tests can link mercury levels to dental amalgams for methodological reasons, except (a) on an epidemiological scale; or (b) through measuring levels before and after dental work. Studies have investigated both angles and results have differed, fueling the controversy since the scientific data remains inconclusive and has not yet proven either safety or danger.

Health effects

Peer-reviewed scientific studies have come to opposite conclusions on whether the mercury exposure from amalgam fillings causes health problems. A 2004 systematic review conducted by the Life Sciences Research Office, whose clients include the FDA and NIH, concluded that "the current data are insufficient to support an association between mercury release from dental amalgam and the various complaints that have been attributed to this restoration material". Another review published in 2005 by the Freiburg University Institute for Environmental Medicine found that "mercury from dental amalgam may lead to nephrotoxicity, neurobehavioural changes, autoimmunity, oxidative stress, autism, skin and mucosa alterations or non-specific symptoms and complaints", that "Alzheimer's disease or multiple sclerosis has also been linked to low-dose mercury exposure", and that "removal of dental amalgam leads to permanent improvement of various chronic complaints in a relevant number of patients in various trials."

Potential amalgam-induced health risks which have been studied by researchers include those related to allergy as well as toxicity. In 2002, the Food and Drug Administration issued a statement on dental amalgam which asserted that "no valid scientific evidence has shown that amalgams cause harm to patients with dental restorations, except in the rare case of allergy". A 1991-1997 study of 3162 patients in Sweden and Germany found that 719 of those with mercury fillings, or 23 percent, tested positive for systemic allergic sensitivity to inorganic mercury on the MELISA lymphocyte proliferation test. In a smaller group of 85 patients who suffered from symptoms resembling Chronic Fatigue Syndrome and had their amalgams replaced with composites and metal-free ceramics, "over 78 percent reported improvement in health status as compared to the period prior to metal removal." A paper published as part of a 1991 National Institutes of Health conference on side-effects of dental restorative materials reported a 22.53% incidence of allergy in subjects who had amalgam fillings for more than five years. Despite these findings, the ADA claimed as recently as 2004 that there had been less than 100 reported cases of allergic reactions to amalgam filings.

The Fédération Dentaire Internationale performed a meta-analysis of the literature on mercury toxicity and concluded that there is no documented scientific evidence to show adverse effects from mercury in amalgam restorations except in extremely rare cases of mercury hypersensitivity.

In 2001, the United States National Health and Nutrition Examination Survey of 31,000 adult Americans, NHANES III covering 1988-94, which cost $120 Million, is owned by the Centers for Disease Control (CDC) and published by the National Center for Health Statistics (NCHS) and is statistically valid for all 180,000,000 adult Americans found that the number of dental fillings was significantly correlated to incidence of cancer, thyroid conditions, mental conditions, diseases of the nervous system including MS, diseases of the respiratory and genito-urinary systems, and disorders of the eye, circulatory and respiratory systems. At the time of the survey (1988-94), the vast majority of dental fillings placed were silver amalgam. However, the United States FDA, various supreme court judges and others have determined that correlation does not sufficiently demonstrate causation.

Ten years earlier, unrelated to NHANES III and before the NHANES/Dental Filling correlations, in 1991 the United States Food and Drug Administration concluded that “none of the data presented show a direct hazard to humans from dental amalgams.”. The Food and Drug Administration in 2008 subsequently issued an advisory warning pregnant women and children about dental amalgam containing mercury, and posted this warning on their website. Again unrelated to NHANES III, on February 18, 2003, the New York Supreme Court dismissed two amalgam-related lawsuits against organized dentistry, stating the plaintiffs had “failed to show a 'cognizable cause of action'.” The plaintiffs blamed the ADA, the New York Dental Association and the Fifth District Dental Society for deceiving the “public about health risks allegedly associated with dental amalgam. A 2003 monograph on mercury toxicity from the World Health Organization concluded that:

  • Studies on humans and animals have demonstrated that dental amalgam contributes significantly to mercury body burden in humans with amalgam fillings.
  • Dental amalgam is the most common form of exposure to elemental mercury in the general population, constituting a potentially significant source of exposure to elemental mercury, with estimates of daily intake from amalgam restorations ranging from 1 to 27 μg/day, the majority of dental amalgam holders being exposed to less than 5 μg mercury/day.
  • Intestinal absorption varies greatly among the various forms of mercury, with elemental mercury (as found in amalgam) being the least absorbed form (<0.01%)
  • Absorption also varies according to individual factors such as gum chewing and bruxism (tooth grinding).
  • The number of restorations - amalgam or otherwise - is declining, largely due to improved dental hygiene, in all industrialised countries examined declining by 38% since the 1970s in the USA and over 65% in the ten years from 1986 in the UK
  • Although several studies have demonstrated that some mercury from amalgam fillings is absorbed, no relationship was observed between the mercury release from amalgam fillings and the mercury concentration in basal brain.
  • However, in the same report it was concluded that "...even at very low mercury levels, subtle changes in visual system function can be measured."
  • In multiple sclerosis patients with amalgam fillings, red blood cells, haemoglobin, hematocrit, thyroxine (T4), T-lymphocytes and T-8 (CD8) suppressors cells levels are significantly lower, while blood urea nitrogen and hair mercury levels are significantly higher.
  • The report also notes that regarding elemental mercury exposure, the main form of exposure from dental amalgam," most studies rely on assessment of exposure at the time of study, which may not be fully informative, as mercury has a long half-life in the body and thus accumulates in continuous exposure ", making the evaluation of effects on health uncertain.

Other lesser findings were reported, including a cross-sectional study in which cognitive function was not related to the number or surface area of occlusal dental amalgams, a case-control study in which patients with numerous amalgam fillings exhibited higher levels of neurological symptoms than the controls, and a study of self-referred patients who believed they were suffering ill-effects from dental amalgams which found no correlation between number of dental fillings and symptomatology, but higher mean neuroticism than two comparison groups (the authors concluded that self-referred patients with health complaints attributed to dental amalgam are a heterogeneous group of patients who suffer multiple symptoms and frequently have mental disorders).

Two recent randomized clinical trials in children discovered no statistically significant differences in adverse neuropsychological or renal effects observed over the five-year period in children whose caries were restored using dental amalgam or composite materials, although one study could not rule out the possibility of a small adverse effect on IQ in children with amalgam. In contrast, one study showed a trend of higher dental treatment need later in children with composite dental fillings, and thus, claimed that amalgam fillings are more durable. However, a subsequent study published in JAMA cites increased mercury blood levels in children with amalgam fillings. The study states, "during follow-up [blood mercury levels were] 1.0 to 1.5 μg higher in the amalgam group than in the composite group." EPA considers high blood mercury levels to be harmful to fetus, and also states that "exposure at high levels can harm the brain, heart, kidneys, lungs, and immune system of people of all ages." Currently, EPA has set the "safe" mercury exposure level to be at 5.8 micrograms of mercury per one liter of blood. While mercury fillings themselves do not increase mercury levels above "safe" levels, they been shown to contribute to such increase. However, such studies were unable to find any negative neurobehavioral effects.

The American Dental Association (ADA) has asserted that dental amalgam is safe since its foundation in 1859. In its advisory opinion to Rule 5.A. of the ADA Code of Ethics, it has also held that, "the removal of amalgam restorations from the non-allergic patient for the alleged purpose of removing toxic substances from the body, when such treatment is performed solely at the recommendation of suggestion of the dentist, is improper and unethical". According to the Boston College Law School study, "A dentist who is found guilty of violating the ADA Code of Ethics can be sentenced, censured, suspended, or expelled from the ADA" and the "ADA forbids its dentists from suggesting mercury removal under threat of license suspension". The same study pointed out that state dental associations and disciplinary boards have "not only adopted the ADA's position as a matter of routine" in proceedings which have sanctioned anti-amalgam dentists or stripped them of their licenses in California, Maryland, Arizona, Colorado, and Minnesota, but in many cases "the board members themselves often belonged to the ADA as well". A 2002 article in the Atlanta Journal and Constitution reported allegations by anti-amalgamists that the ADA had effectively imposed gag rules which forbade them from discussing their positions with patients. The Boston College Law School study also cites proceedings in which an Arizona dentist, "is facing sanctions for advocating alternative materials", a California dentist lost his license, "for running an advertisement entitled: "Mercury Emission from Silver Filings Unsafe by Government Standards", and a Maryland dentist, "was sanctioned for writing an article on mercury amalgam removal". More recently, the ADA has entered into litigation "aimed at defending its reputation and discouraging further lawsuits by patient-plaintiffs against mercury amalgam".

In response to studies which assert amalgam safety, anti-amalgam groups, such as the International Academy of Oral Medicine and Toxicology (IAOMT), state that these studies are poorly designed and raise ethical questions. An analysis of the data collected during the studies showed that the authors of the studies ignored the drop in mercury excretion, after two years, in the urine in the children with amalgam fillings, even though the mercury exposure from amalgam remained the same or increased. This is explained in a response by Dr. Boyd Haley, to the 2006 publication, in JAMA, of the NIDCR-funded children's amalgam study. According to Haley, this is evidence that these children are losing the ability to excrete mercury with increased exposure. This observation points to a strong limitation in the use of mercury concentrations within urine as an indicator of mercury exposure from amalgam (and, potentially, as an indicator of mercury concentration within the bloodstream).

Better dental health overall coupled with increased demand for more modern alternatives such as resin composite fillings (which match the tooth color), as well as public concern about the mercury content of dental amalgam, have resulted in a steady decline in dental amalgam in developed countries, though overall amalgam use continues to rise worldwide. Given its superior strength, durability and long life relative to the more expensive composite fillings, it will likely be around for many more years to come.

Some practitioners may also recommend that patients with amalgam fillings have them removed and replaced, particularly if the patient is experiencing the symptoms that they attribute to the use of amalgam. These professionals recommend that unprotected amalgam removal should be avoided even in routine dental procedures to avoid exposure to mercury vapor and amalgam particulate matter.

Organizations opposed to amalgam use, such as Consumers for Dental Choice, claim to have over 65,000 studies on file implicating amalgam fillings as the cause of a diversity of health disorders. These studies have been used in various lawsuits, and were the main contributing factor to the passage of Californian legislation concerning the issuing of warnings to patients about mercury, and to the federal bill introduced in 2002 proposing that amalgam fillings be made illegal after 2006. That has not happened.

Consumer Reports magazine, among others, claims that the connection between many of these diseases and amalgam fillings is solely revenue generating propaganda. Consumer Reports told its readers on several occasions that “if a dentist wants to remove your fillings because they contain mercury, watch your wallet.”

Autoimmune disorders

Dental amalgam has been found to be a frequent contributor to oral lichenoid lesions (PMID 15529127) and a possible contributor to other autoimmune conditions such as mutiple sclerosis, lupus, thyroiditis and eczema.

Health effects for dentists

Among modern dentists who are exposed to mercury amalgam and vapor on a daily basis, no evidence of mercury poisoning has been demonstrated. Some studies have indicated that mercury from amalgams affects some dentists mildly. Dentists in several large-scale studies performed multiple cognitive and behavioural tests and, compared to a normal population, lagged behind in many areas. In one study this included 14% worse scores in memory, co-ordination, motor speed and concentration. The study did not demonstrate any link between mercury exposure and these lagging scores, however. A newer study also found a link between cognitive impairment (including mood) and dental work, even though "exposure among these dental personnel are not much greater than exposures to the general population through the dental amalgam in their fillings" as shown by urinary studies. Twelve of 13 symptoms were correlated with greater mercury exposure.

A study examining the health effects of mercury on dentists in the UK published in the Occupational and Environmental Medicine Journal concluded that 180 dentists had on average 4 times the urinary mercury excretion levels of 180 people in a control group. Dentists were significantly more likely than control subjects to have had disorders of the kidney or memory disturbance. No direct correlation between urinary mercury levels and the disability, however, was found. Urine testing is unreliable for showing lifetime mercury accumulation rather than recent exposure.

In the 2005 lawsuit Barnes vs. Kerr, the dentist David Barnes brought action against the Kerr Corporation, a major manufacturer of dental amalgams. This suit was originally decided in the Circuit Court for Bedford County and reviewed by Sixth Circuit of the United States Court of Appeals. Barnes argued that his alleged mercury poisoning was caused by exposure to toxic mercury vapors, and that Kerr Corporation's amalgams were the major source of this poisoning.

Barnes' suit alleged that his exposure came from three sources. The first was "mercury vapor and mercury contained in amalgam particulate inhaled when removing existing amalgam from the teeth of patients". The second was "contaminated office air due to a variety of sources, including mercury released during trituration of capsules, opening of triturated capsules, free mercury that may have leaked during transport, and particulate released into the office air during amalgam removal". The third source was "was mercury vapor and mercury particulate generated during the placement of new amalgams".

Barnes' office was found to be contaminated with mercury by the Tennessee Occupational Health and Safety Administration (TOHSA) , even after it had been thoroughly cleaned, and mercury droplets were found in the machine he had used to mix amalgam capsules. An industrial hygienist found that "89% of the surfaces in Barnes’s office still showed traces of mercury", even after two intensive cleanings.

Kerr Corporation argued that they had not manufactured a majority of the amalgams Barnes had removed, that the contamination of Barnes' office, "could have come from sources other than leaking capsules", and that Barnes could not have been exposed to mercury during the placement of amalgams because of the methods he used.

Kerr Corporation's amalgam capsules bore prominent warning labels in capital letters stating that they "CONTAIN[ED] METALLIC MERCURY" and featured a skull and crossbones next to the word "POISON". A detailed warning enclosed with the amalgam capsule described mercury as a "hazardous ingredient" and listed potential health hazards associated with exposure including nervous irritability, weakness, tremors, gingivitis, erethism, greying of the lens of the eye, nephrotoxic effects, and aggravation of kidney disorders. This full text of the warning read, "WARNING ... Alloy amalgam capsule products contain mercury. Since mercury is a potentially hazardous substance, proper care should be taken to prevent exposure to mercury. These preventative measures include the wearing of gloves, good ventilation, the use of an enclosed amalgamator, proper disposal of capsules once they have been activated and used, and the use of HGX or similar-type mercury absorbing chemicals in the event of spillage. Infrequently capsules may leak mercury and, as a consequence, the above precautionary measures should always be utilized".

The district court held that the testimony of Barnes' expert witnesses in support of "a strong minority view that dental amalgam containing mercury is both unreasonably dangerous and hazardous to human health" was admissible. The district court decided in favor of Kerr Corporation because Barnes had "not demonstrated that his injuries would have occurred ‘but for’ exposure to Kerr’s dental amalgam product". They also ruled that the numerous warnings provided by Kerr "more than adequate [because] ...[r]easonable minds could not differ as to their sufficiency". Barnes' suit against Kerr Corporation was dismissed because he had been warned that amalgam was poisonous and that its use could result in the contamination of his office, and because he could not prove that the majority of the amalgam which had contaminated his office had been manufactured by the Kerr Corporation.

Environmental impact

The WHO reports that mercury from amalgam and laboratory devices accounts for 53% of total mercury emissions, and that one-third of the mercury in the sewage system comes from dental amalgam flushed down the drain. Mercury is an environmental toxin and the World Health Organization, OSHA, and NIOSH have established specific occupational exposure limits. Amalgam removed from teeth is classified as toxic waste in various countries, but in many countries it is not regulated, including the United States. Crematoria are to establish recovery of mercury from flue gases as soon as reasonable since mercury from amalgam is released into air during cremation of cadavers with amalgam fillings. The environmental pollution of mercury imposes health risks upon the surrounding population; in economics this pollution is considered an external cost not factored into the private costs of using dental amalgam. Separators may dramatically decrease the release of mercury into the public sewer system, but they are not required in the United States.

Environmental risks are mitigated provided that amalgams are disposed of properly. ISO has issued standards regarding the proper handling and disposal of amalgam waste, and legislation to enforce these standards is being adopted in some US states.

The Association of Metropolitan Sewerage Agencies (AMSA)studied seven major waste-water treatment plants and found that dental uses were "by far" the greatest contributors of mercury load, on average contributing 40%, over 3 times the next greatest contributor. The EPA recognizes mercury amalgam as a major source of the mercury in the water. The Western Lake Superior Sanitary District that dentists emit .1 grams of mercury per day per dentist. Based on this, mercury amalgam contributes 14% of the mercury in Seattle and 12% of the mercury in San Francisco. 4% of the mercury in Lake Superior is believed to originate from amalgam. The National Association of Clean Water Agencies noted in a report that purification of mercury from waste water will impose a significant financial burden upon municipal treatment plants. Several other groups have analyzed mercury in waste water and concluded that it is a serious problem. Other studies have shown this to be a gross exaggeration. With respect to pollution in the United States, a study done in 1992 showed that batteries “accounted for 86 percent of discarded mercury and dental amalgam a mere 0.56 percent”.

Available alternatives

According to the Consumers for Dental Choice, fully one third of the dentists in the US are currently 'mercury free'. Alternatives include composite resin (or "white") fillings, gold, porcelain, and glass ionomers. However, amalgams are stronger, more durable, and less expensive than most of the available alternatives, though some newer composite materials have demonstrated durability on par with amalgam. Most of these materials, with the notable exception of gold, have not been used as long as amalgam, and some are known to contain other potentially hazardous compounds. This is why biocompatibility testing is recommended for all dental materials as per ADA/ANSA or ISO standards, and can be performed by specialized laboratories. Some experts also caution against a too-sudden shift towards composite resin to allow time for dentists to acquire the skills needed to properly place resin fillings since " clinical studies on the longevity of amalgam and resin composite restorations placed by dental students and dentists who are experienced in both composite resin and amalgam placement show a comparable and acceptable annual failure rate for those restorations". Teaching of amalgam techniques to dental students is declining in some schools in favor of composite resin, and at least one school, University of Nijmegen in the Netherlands, had eliminated dental amalgam from the curriculum entirely in 2001.

History

In 1840, the American Society of Dental Surgeons was founded by a group of dentists who met in New York city. It was the only national organization of dentists in existence at the time. Chapin A. Harris, the co-founder of the ASDS and the first dental school in the US, the Baltimore College of Dental Surgery, spoke of dental amalgam in his opening address: "It is one of the most objectionable articles for filling teeth that can be employed, and yet from the wonderful virtues ascribed to this pernicious compound by those who used it, thousands were induced to try its efficacy". In 1845, the ASDS had members sign a mandatory pledge promising not to use mercury fillings because of fear of mercury poisoning in patients and dentists (at the time, dentists made amalgam by mixing liquid mercury and the other components of amalgam themselves in their office, a practice which continued until pre-filled amalgam capsules became generally available in the 1960s). During the next decade some members of the society were suspended for the use of amalgam. Because of its stance against dental amalgam, membership in the American Society of Dental Surgeons declined, and due to the loss of members, the organization disbanded in 1856.

In 1859, the American Dental Association (ADA) was founded by twenty-six delegates representing various dental societies in the United States at a meeting in Niagara Falls, New York. The ADA did not forbid use of amalgams. The ADA position on the safety of amalgam has remained consistent since its foundation. As of 2006, the ADA has over 152,000 members and is the largest and longest-standing professional association of dentists in the world.

Amalgam formulations and properties were gradually improved, notably by Dr. G.V. Black in 1895. Despite these changes, debate over the use of amalgams persisted in the dental profession. The ADA maintained until 1984 that mercury was bound in amalgam and did not release mercury vapor. In the 1970s studies demonstrated that a small amount of mercury vapor was constantly being released from amalgam, corroborating the first such study published in 1882 in the Ohio State Journal of Dental Science by Dr. Eugene S. Talbot.

Regulation by country

Some legislators have introduced legislation to prohibit or restrict use of amalgam fillings.

Asia

Japan regulates the use of amalgam fillings.

Europe

In most European countries (for example, the United Kingdom, France, and Italy), amalgam use is unrestricted. Some other countries, such as Sweden, have banned or regulated the use of mercury in dental amalgams, citing health or environmental concerns. The Swedish Chemicals Inspectorate (KemI) maintains a web site containing a report on the investigation for a general ban on mercury on which it states, "KemI judges that there are strong grounds for banning amalgam for environmental reasons. From a health point of view there is every reason to apply a precautionary approach." Some countries, notably Austria and Germany, have some restrictions on dental amalgam, such as permitting its use for the general population, but not for children, pregnant women, people with kidney problems, when in contact with other metals, such as braces, and in people with mercury sensitivity.

Norway

Amalgam use is illegal in Norway as of January 01, 2008.

Sewers from Norwegian dental clinics older than 1994 (or if there is other reason to believe amalgam have ended up in the sewers instead of the patients mouth) shall be cleaned by experienced personnel to properly remove any residual mercury. The detailed procedure to do so is available from SFT free of charge

United States

In the United States, amalgams are classified as a "device," not a "substance," by the Food and Drug Administration (FDA). Under the U.S. Code of Federal Regulations, amalgams are a prosthetic device:

Amalgam Alloy, (a) Identification. An amalgam alloy is a device that consists of a metallic substance intended to be mixed with mercury to form filling material for treatment of dental caries. (b) Classification. Class II. (21 CFR 872.3050 (2001))

As a result of this classification, amalgams have not been subject to official government testing in the United States such as is required for medicines. However, the FDA maintains a web page on the use of amalgam, last updated in December 2002, on which it states, "no valid scientific evidence has shown that amalgams cause harm to patients with dental restorations, except in the rare case of allergy. The FDA's assertion that there is no scientific evidence of health risks associated with amalgam is based on periodic reviews of scientific literature it has published in so-called "white papers". But in September 2006, a joint meeting of three FDA committees voted that the most recent FDA white paper was limited in scope, had gaps in knowledge regarding exposure limits, included contradictory evidence, did not include data from other countries, and did not provide a rationale for excluding some studies. According to the meeting summary posted on the FDA's web site, "To the question of whether the white paper 'objectively and clearly presented the current state of knowledge about the exposure and health effects related to dental amalgam,' the panel voted 'no' by a 13-7 margin." Prior to the joint meeting, some scientists and consumer advocates had raised questions about the fairness of this process, as planned by the FDA.

In 2001 in a lawsuit involving California Proposition 65 and amalgams, a California Superior Court judge ruled that all dental offices with more than nine employees must provide notices on the contents of dental fillings. The mandated notice reads:

Notice to Patients, Proposition 65: Warning on dental amalgams, used in many dental fillings, causes exposure to mercury, a chemical known to the state of California to cause birth defects or other reproductive harm. Root canal treatments and restorations including fillings, crowns and bridges, use chemicals known to the state of California to cause cancer. The U.S. Food and Drug Administration has studied the situation and approved for use all dental restorative materials. Consult your dentist to determine which materials are appropriate for your treatment.

In 2002, eight members of the U.S. House of Representatives introduced the Mercury in Dental Filling Disclosure and Prohibition Act (H.R. 4163, 107th Congress, 2nd Session, April 10th 2002), which would have prohibited any mercury in dental fillings starting in 2007. In an interim period between July 1, 2002 and 2007, the bill would have required labeling of amalgam with a warning. The bill was referred to a subcommittee, which tabled it. It has since been re-introduced as bill HR-4011 by congresswoman Diane Watson, who issued a public statement after the September 2006 decision of the FDA Review panel on dental amalgam.

Following the meeting of the joint committees on 6-7 September 2006, when the panel of outside advisers that the FDA had asked to assess the conclusions of its report on amalgam safety rejected the FDA report in a 13-7 vote, they stated the report's conclusions were "unreasonable", given the quantity and quality of information currently available. Panelists said remaining uncertainties about the risk of so-called silver fillings demanded further research, in particular, on the effects of mercury-laden fillings on children and the fetuses of pregnant women with fillings and the release of mercury vapor on insertion and removal of mercury fillings. Michael Aschner, a professor of pediatrics and pharmacology at Vanderbilt University and a panel consultant said "There are too many things we don't know, too many things that were excluded.

Shortly after the decision of the joint advisory panel, the president of the International Academy of Oral Medicine and Toxicology (IAOMT) wrote to the FDA to ask for an expanded review of current science on dental mercury amalgams, a definitive date for such a hearing, and a format that will assure that the full breadth of health effects is assessed. In a press release the ADA wrote that it " welcomes the call by a U.S. Food and Drug Administration (FDA) panel for additional review of scientific studies on the safety of dental amalgam fillings." and reiterated that "the overwhelming weight of scientific evidence supports the safety and efficacy of dental amalgam, and it should continue to be made available to dentists and their patients " and " dental amalgam contains elemental mercury combined with other metals such as silver, copper, tin and zinc to form a safe, stable alloy.

External links

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