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Final Regulation on Dental Amalgam Issued by the FDA

By July 29, 2009

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In a bold move, the FDA issued a controversial, final regulation on Tuesday classifying dental amalgam a class II medical device with moderate risk. According to the official press release, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of dental amalgam. What does this actually mean? Basically, this classification says that even though elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients; therefore the use of amalgam fillings is safe.

Are you confused? Just over a year ago, this press release reveals that a court settlement filed by the Consumers for Dental Choice, required the FDA to withdraw claims of dental amalgams safety from its website and issue an advisory that clearly indicates that " Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses."

The American Dental Association released a statement on Tuesday as well, supporting the FDA's decision. President of the ADA, Dr. John Finderly firmly addresses the decision by stating "The FDA has left the decision about dental treatment right where it needs to be--between the dentist and the patient," adding, "This decision underscores what the ADA has long supported--a discussion between dentists and patients about the full range of treatment options to help patients make educated decisions regarding their dental care."

Believe me when I tell you that this issues is far from over. What has changed since the court decision in June 2008? The ADA says numerous scientific studies conducted over the past several decades, including two large clinical trials published in the April 2006 Journal of the American Medical Association, indicate dental amalgam is a safe, effective cavity-filling material for children and others. And, in its 2009 review of the scientific literature on amalgam safety, the ADA's Council on Scientific Affairs reaffirmed that the scientific evidence continues to support amalgam as a valuable, viable and safe choice for dental patients. On the other hand, the Consumers for Dental Choice have this to say: "FDA broke its contract and broke its word that it would put warnings for children and unborn children for neurological damage," adding "Bowing to the dental products industry, FDA for the first time in its history pulled a warning about neurological harm to children. This contemptuous attitude toward children and the unborn will not go unanswered. We will see FDA in court."

Do you need a place to vent your opinion? Visit the dentistry forum, or comment here. I want to hear what you, the patient, feels about the use of amalgam in dentistry. Before you head to the forum, vote below.

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July 29, 2009 at 9:31 pm
(1) MS Patient says:

Multiple sclerosis is one of the diseases that some have suggested is linked to amalgam fillings. As a multiple sclerosis patient, I have investigated this issue fairly closely and have found no reputable trusted sources validating the connection. Another theory that makes the rounds of the Internet is a connection between diet sodas and MS. I have been known to get upset about the fourteenth time that someone emails me this “information” without doing any fact checking. Blaming diseases such as MS on diet sodas or amalgam fillings just keeps us from making progress with the real science of the disease.

August 3, 2009 at 10:24 pm
(2) Hgfree says:

It is evermore curious that mercury was said to remain fast in dental amalgam. Then the FDA conceded that mercury does vaporize from a filling. States recognize the harm to the environemnt from mercury released from dental offices and human excrement from those with dental amalgam. Many states now mandate that mercury separators be used in dental offices. Sadly, most waste treatment facilites do not remove mercury and it gets sent back to waterways. Check the NY Academy for Science Harbor Report for details on the large amount of mercury from dental offices in the NY/NJ Harbor.
The transcript of the 2006 public hearing on dental amalgam where the scientific advisory panel voted 13:7 against the FDA’s position in its White Paper, citing many gaps in data. Oddly, many of the gaps are the same ones reported in earlier reviews, though the FDA has still not filled-in those gaps with scientific data.
The life-cycle of mercury in fillings is not being considered for the related health care costs associated with the cumulative effect of mercury exposure in people’s teeth. This includes the ongoing body burden as well environmental assault.
A key contraindication of mercury exposure is spontaneous abortion. Mercury is known to cross the placental barrier. Swedish studies have shown that the number of mercury fillings in the mother was more significant to the amount of mercury found in cord blood than the amount of fish in her diet. Does the FDA’s decision to promote drilling and filling mercury fillings in pregnant women truly consider the potential for a spontaneous abortion?
Where are the scientific studies that measure the amount of mercury exposure during the drill and fill exposure while in the dentist’s chair to affirm that the potential for the mercury vapor to the unborn is not affected. Does the FDA have parallel studies of dental and medical records to determine whether a pattern of spontaneous abortion exisits? How does the FDA track medical incidents against dental exposure? Do medical schools teach students to track mercury levels and measure mercury levels according to a patients number of filings? Does the FDA provide guidance on threshold levels of how much mercury from fillings is permissible?
There are more questions unanswered than not and the FDA’s decision falls short on building the public’s confidence that it is doing a thorough job in considering the many exposures and provoked by mercury.

August 5, 2009 at 10:56 am
(3) Local Consumer News says:

Very good article.

August 5, 2009 at 4:45 pm
(4) Stephen Dent says:

I love your article here about this final regulation by the FDA. Very interesting stuff, well done.

There is a new family dentistry website started by Stephen Dent. If you are in the mood, I highly recommend it.

August 6, 2009 at 9:57 am
(5) Linda Brocato says:

PLEASE, PLEASE, PLEASE LISTEN!!! Removal of dental amalgam WILL BENEFIT those MS people that have a genetic predisposition and/or are hypersensitive to “mercury” let alone the other metals in the dental fillings. Denial is rampant with this issue. What happened to common sense?

I was diagnosed with Multiple Sclerosis in 1981. 3 hospitalizations, 8 different medications including oral and intravenous chemotherapy for MS, experimental Plasmaphoresis, bedridden for 10 years, slurred speech and dying. I had my dental amalgam mercury “silver” fillings removed and guess what? All symptoms gradually disappeared, NO medication, NO relapses, NO symptoms, except this left me in a wheelchair! This happened 2 weeks after all amalgam fillings were removed. Prior to mercury dental removal I had 1 to 3 relapses per year and haven’t had 1 relapse since 1989.

I have been in contact with people since 1996 regarding their symptoms of mercury toxicity. The diseases encompass a wide range of symptoms from autoimmunity to heart problems etc. Unfortunately, some symptoms like mine manifest later in life.

According to Dr. Boyd Haley, former Professor and Chair of Chemistry at the University of Kentucky and renowned toxicologist, says there are NO SAFE LEVELS OF MERCURY.

Amalgams contain 50% mercury, a poison and a neuro-toxin. A cross and skull bones with the word poison are on the label when the mercury comes into the dentists’ office. Mercury vapors are released 24/7 every time a person chews, drinks hot liquids, brushs their teeth, etc. See “The Smoking Teeth” at http://www.iaomt.org.

If denial is everywhere let the toxicologists and manufacturers determine if “mercury” is safe for the public (not to mention the environment)and that should end the discussion of safety vs. non-safety! The FDA (Food and Drug Administration) is suppose to PROTECT THE PUBLIC NOT HARM THEM!!!

Linda Brocato

August 7, 2009 at 1:03 am
(6) San Luis Obispo Dental Office says:

I just love your blog and all your articles posted in this blog. This is such a nice blog.Thanks for creating this.

June 26, 2010 at 9:15 pm
(7) Toronto Dentist in Etobicoke says:

If mercury filling were invented today, do you think they would ever even see the light of day?

Not a chance.

One of the reasons they still exist is dental schools keep on teaching the old ways.

Joe Bulger DDS
Visit my Toronto Dentist Smile Blog

June 27, 2010 at 4:25 pm
(8) Toronto Dentist in Etobicoke says:

I can imagine the liability issues could be enormous if bans were suddenly placed on mercury-based restorations.

The reputation of our profession would be in shambles. The stable hierarchy of academics might be disrupted.

Institutions don’t like revolution.

Joe Bulger DDS
Visit my dental blog – Toronto Dentist Smile Blog

August 28, 2010 at 7:33 am
(9) Toronto Dentists Etobicoke says:

Why would our profession still use mercury-based fillings?

They’re cheap, effective and easy to place. These fillings demand less skill from dentists and tend to last far longer than resin fillings in patients with poor oral-hygiene.

Joe :D

September 27, 2010 at 11:18 pm
(10) paul says:

Mercury is tasteless odourless and colorless , if you have these fillings in your mouth you are being slowly poisoned and you dont know it. To all the people out there who have these fillings and say I have never had a problem with them I say “you are the future in dementia”

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