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Agency Promises to Make a Decision Next Year
The Food and Drug Administration (FDA) has long avoided taking a public stand on the safety or danger of mercury in silver dental fillings. However, with a recent settlement in a lawsuit brought by the organization Moms Against Mercury, the governmental health agency has finally agreed to take a stand on the issue. Eventually.
The agreement calls for the FDA to complete its reclassification of dental amalgam by July of 2009. (The agency began that process in 2002.)
Some news articles have heralded this as a major change in the FDA’s attitude toward amalgam, with headlines making grand proclamations about a new post-amalgam era.
Can you guess which of the following is not a genuine headline?
- Mercury Fillings Shattered! FDA, ADA Conspiracy to Poison Children with Toxic Mercury Fillings Exposed in Groundbreaking Lawsuit
- FDA Calls Silver Mercury Dental Fillings Harmful
- Dental Amalgams Dangerous to Pregnant Women and Children
- FDA Says Silver Dental Fillings Containing Mercury Dangerous For Pregnant Women
- Mercury In Dental Fillings Dangerous For Pregnant Women
- Oh No, We Are All Going to Die: Let's Panic!
These are attention-grabbing headlines, to be sure! The problem is, they're not necessarily true per se. (And okay, I made the last one up.)
In the ADA’s response to news of the decision, the dental organization disputes these suggestions. “As far as the ADA is aware, the FDA has in no way changed its approach to, or position on, dental amalgam,” reads the statement.
As part of the agreement, the FDA has updated the consumer information provided by its website on the subject of mercury and dental amalgam.
“Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses. When amalgam fillings are placed in teeth or removed from teeth, they release mercury vapor. Mercury vapor is also released during chewing. FDA’s rulemaking will examine evidence concerning whether release of mercury vapor can cause health problems, including neurological disorders, in children and fetuses.”
– Questions and Answers on Dental Amalgam (FDA Consumer Information)
What do you think? Is this a new era, or just more of the same?
Post a comment
June 11th, 2008 at 4:02 am
The real concern for mercury should be the tuna, swordfish, etc., that we ingest and passes through our entire system. Why is it that this is not an issue? My wife’s OB told her she was not allowed to eat those fish, or shrimp, and a few others while she was pregnant.
June 11th, 2008 at 4:55 am
Jim: It’s about time. As a dentist who has been before the FDA panel and saw them reverse their thinking in September of 2006, it’s amazing that they’ve waited almost 2 years to start rewriting policy and that happened only as a negotiation to make the lawsuits go away. That the ADA still stands behind amalgam is expected, but they will have to change soon.
According to Boyd Haley’s research, there are some individuals who do not have the APO e2 allele which is capable of removing mercury from nerve tissue. Until dentists have a definitive test to show who is susceptable, we have to treat everyone as if they are; just like when we treat patients with gloves and sterilized handpieces: we don’t know who’s got Aids, Hep, STD’s, so we’ve got to treat them all as if they’ve got it.
How long before the rank and file get their heads out of the sand and realize that there are two safe places to store amalgam: 1. In a tightly sealed glass jar under a high-specific-gravity liquid, and 2. in an American’s head?
What the FDA is proposing is just the tip of the iceberg. How do you ban it in a 6 year old but not a 7 year old? What makes that age less susceptible? How do you ban it in pregnant women? Shouldn’t it be all women until they’ve gone through menopause, since you usually don’t know when you’re pregnant until a few weeks after. What makes it okay to put it in the head of a woman 2 weeks before conception, 2 months, 2 years? The mercury is still being liberated. Remember, the Vimy study, which was designed to prove amalgam safety showed the radioisotope in the amalgam crossed the placenta 2x faster than it got into other tissues in the body.
June 11th, 2008 at 6:30 am
Hhhmmmm, so we all know that there is abundant evidence that mercury, along with other heavy metals, have high neurotoxicity in adults, associated with Parkinson’s, Alzheimer’s, etc. Hence our need to dispose of it as a toxic waste. Yet the FDA needs to examine the evidence as to whether or not this confirmed neurotoxicity in adults can be extrapolated to the devoloping neurological system? In humans the natural detoxification of Hg is one of the weakest (basically there is none). Should we continue to go on our merry way until the consensus is reached that it is harmful (and that’s a matter of when not if) and then have to deal with the harm we have done? Or, should we not be assuming, until proven otherwise, that at least this potential exists and therefore err on the side of caution and safety until they are proven safe? Something about rule #1 being do no harm??
drmike
June 11th, 2008 at 7:46 am
Why is it that you cannot put the excess amalgam in the trash because it is hazardous waste, but you can put it in a patient’s mouth. I could never understand the rationale.
June 11th, 2008 at 8:28 am
I’m glad to see the FDA start to bend on this subject. Sure, we may not know for certain that mercury causes neural damage, but why take the risk. Now, I just wish the ADA would get a spine and stand up for the health of our children.
June 11th, 2008 at 10:16 am
You fail to differentiate the difference between elemental mercury (like in the photo at the top of your page) and cured dental amalgam.
Elemental mercury is nasty stuff, but pre-packaged capsules has greatly eliminated the risks of that.
Cured amalgam is not elemental mercury, but more like granite. The risks from cured amalgam is extremely small, and likely of similar magnitude to composite resin: both exist, but the benefits far outweigh the risks.
June 11th, 2008 at 11:55 am
Throughout the panel discussion during the 2006 FDA hearing, as well previous reviews of dental amalgam the FDA repeatedly comes up short on providing adequate data. The 2006 hearing highlighted how much critical data is lacking, which arguably was the finding that resulted in a 13:7 vote repudiating the FDA’s position in the white paper.
For the staff member who had oversight of the review to state “I was simply following orders” per the FDA transcript http://www.fda.gov/ohrms/dockets/ac/cdrh06.html#dentalproductspanel
“DR. KIEBURTZ: A question about the documents. You looked at the NGO reviews. Did you look at other Government reviews?
DR. PAULE: No; we did not.
DR. KIEBURTZ: Why not?
DR. PAULE: I was simply following orders, okay, and was given the charge and we took it.”
What authority directed this study?
What is the formula or bases for which the FDA considers dental amlagam safety? More to the point, what is the tolerable collatoral damage by way of expected incidence of harm or adverse reactions? Clearly, reading the transcript one easily learns that it is the critical data void in the study that led the scientific review panel to vote as they did.
Definition of terms is unclear.
Environmental degradation can be linked to dental waste that gets into the food chain increasing mercury levels in fish and water. On this exposure alone the use of dental amlagam should be abolished.
June 11th, 2008 at 1:58 pm
Here’s a copy of a banned video which records mainstream news media telling the public (or alluding to the “fact”) that mercury helps stimulate and improve neurological functions in small children.
http://www.leechvideo.com/video/view455413.html
June 12th, 2008 at 8:38 am
When will dentistry show the same concern for shared, contaminated dental water from built in dental water delivery systems? As Dr. Markus states, the prudent dentist has to
assume all patients can infect one another hence the purpose for gloves and instrument sterilization. The high speed and low speed hand pieces are linked to non sterile dental water lines. The technology has existed for 10 years for the delivery of sterile dental irrigation fluids. Contact me and I’ll explain how.
June 13th, 2008 at 4:37 am
J. Adler – having had neurotoxic effects myself related to the placement of a large amalgam, which were reversed on removal I can tell you that anyone is sensitive AND because the symptoms are myriad, unless you give your patient a list of symptoms to look for, they’ll never make the link between such things as irritability, depression, insomnia, loss of sex drive, etc. — and I’ll bet they’ve never come to you with them…..but they are happening.
If my granite countertops emitted the same amount of mercury vapor per cubic mm as mercury fillings do, my house would be a superfund site. Get your head out of the sand doctor. Why do you suppose the ADA tells you to store scrap in a tightly closed glass jar, under high specific gravity liquid? Is that what you do with your countertops?
June 19th, 2008 at 8:01 am
My symptoms of heart palpitations, anxiety attacks, headaches, digestive problems, and miscarriage all started in dental school. Looking back to 1975-1979, I remember in dental school never wearing masks, squeezing the mercury out of amalgam in squeeze cloths in ungloved hands, burning the amalgam off my instruments in unventilated rooms, and walking on dropped amalgam scraps strewn throughout the clinic floor. When I worked as a nurse prior to dental school, entire rooms were considered hazardous and sectioned off if a thermometer broke!
Years of work exposure to this very toxic element can contribute to severe acute and chronic health problems. Dentists, especially women (and female dental personnel) working in dental offices that place or remove amalgam must be aware that their exposure to mercury is extraordinarily high and must take special precautions to protect themselves and their fetuses. Morally, dentists must take the responsibility to minimize working exposures and protect themselves and their employees with special barriers, ventilation, filters, separators, nutritional supplements, detoxification, and especially education about this poisonous substance. Eliminating placement of amalgams is a start, but dentists must learn to safely remove amalgams so that mercury exposure from drilling is minimized for the at-risk patient and dental workers.