wigglytooth

Assistant Wiggle-ator
Moderator Emeritus
10+ Year Member
7+ Year Member
Apr 13, 2006
970
5
Status
Resident [Any Field]
FYI

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm173992.htm

FDA NEWS RELEASE

For Immediate Release: July 28, 2009

Media Inquiries: Peper Long, 301-796-4671, [email protected]
Consumer Inquiries: 888-INFO-FDA
FDA Issues Final Regulation on Dental Amalgam

The U.S. Food and Drug Administration today issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. While 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.

The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, 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 the device.

The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.

Specifically, the FDA recommended that the product labeling include:

* A warning against the use of dental amalgam in patients with mercury allergy;
* A warning that dental professionals use adequate ventilation when handling dental amalgam;
* A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.

Dental amalgam is a “pre-amendment device,” which means that it was in use prior to May 28, 1976, when the FDA was given broad authority to regulate medical devices. That law required the FDA to issue regulations classifying pre-amendment devices according to their risk into class I, II, or III. Although the FDA previously had classified the two separate parts of amalgam – elemental mercury and the metal powder alloy – it had not issued a separate regulation classifying the combination of the two, dental amalgam. During this time, however, dental amalgam has been subject to all applicable provisions of the law.

Today’s regulation also reclassifies the mercury component of dental amalgam from Class I (low risk) to Class II (moderate risk).

Over the past six years, the FDA has taken several steps to assure that the classification of dental amalgam is supported by strong science.

In 2002, the agency issued a proposed rule to classify dental amalgam and identify any special controls necessary for its safe and effective use.

Due to a high number of comments on that rule, the agency held an advisory committee meeting in 2006, inviting dental and neurology experts to review existing scientific data on dental amalgam, especially with regard to its toxicity in pregnant women and children.

The agency drafted a review of recent and relevant peer-reviewed scientific literature on exposure to dental amalgam mercury. The advisory committee asked that the agency conduct an even deeper review of the scientific literature on this topic. In all, the agency considered some 200 scientific studies.

On April 28, 2008, the FDA reopened the comment period on the 2002 proposed classification in order to elicit the most up-to-date comments and information related to classification of dental amalgam. Today’s rule reflects the years of agency review on this topic.

FDA’s Web site on dental amalgam:
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/default.htm
 

NyCzPeter

10+ Year Member
5+ Year Member
Jun 7, 2008
672
3
Status
Dental Student
What does this mean??? Should I be happy? Sad? Angry? :confused:
 

DrJeff

Senior Member
Moderator Emeritus
15+ Year Member
Nov 30, 2000
2,840
385
Brooklyn, ct
Status
Dentist
What does this mean??? Should I be happy? Sad? Angry? :confused:
This means 2 things

1) Business as usual for dentists:clap:

2) The anti-amalgamists will be out in full force once again trying to poke holes in this:beat:

Basically, amalgam is now classified by the FDA in the same category as compsite and gold restorations, and the only warning associated with it is to not use it in persons with known allergies to mercury and/or other metals present in the amalgam:sleep:
 

Lopyswine

10+ Year Member
7+ Year Member
Oct 8, 2007
720
4
Chicago, IL
Status
Dental Student
This means 2 things

1) Business as usual for dentists:clap:

2) The anti-amalgamists will be out in full force once again trying to poke holes in this:beat:

Basically, amalgam is now classified by the FDA in the same category as compsite and gold restorations, and the only warning associated with it is to not use it in persons with known allergies to mercury and/or other metals present in the amalgam:sleep:

hey Jeff,
what % of the time do you do amalgam restorations over composite? How often is this based on your recommendation to the patient that it will last longer/better than a composite? Also, how many inlays and onlays would you say you do in a month?

Do many people choose amalgam because its cheaper?

We just finished our section on inlays and onlays and it felt sort of necessary. So many of our profs told us we won't do many after we graduate. I know many of my classmates have stated they won't have amalgam in their offices (of course they are saying that now.... who knows what will really happen.) I am trying to get a feel for how much of the techniques we are learning are getting phased out but our still part of our curriculum.
 

DrJeff

Senior Member
Moderator Emeritus
15+ Year Member
Nov 30, 2000
2,840
385
Brooklyn, ct
Status
Dentist
hey Jeff,
what % of the time do you do amalgam restorations over composite? How often is this based on your recommendation to the patient that it will last longer/better than a composite? Also, how many inlays and onlays would you say you do in a month?

Do many people choose amalgam because its cheaper?

We just finished our section on inlays and onlays and it felt sort of necessary. So many of our profs told us we won't do many after we graduate. I know many of my classmates have stated they won't have amalgam in their offices (of course they are saying that now.... who knows what will really happen.) I am trying to get a feel for how much of the techniques we are learning are getting phased out but our still part of our curriculum.
I'm probably 80/20 composite to amalgam in my practice these days. Most folks for a number of reasons want composite (esthetics, "mercury fear" :rolleyes:, etc). A few ask for amalgam because of $$. But generally these days when I'm placing an amalgam, it's because I'm telling the patient that because of isolation issues, I NEED to use it! (when someone can show me a way to predictably isolate #31 lingual on an obese person whose tongue is the size of most folks thigh and has a salivary flow rate close to that of the flow rate of water over Niagra Falls, then I'll probably get rid of amalgam in my practice ;))

Inlay/onlay wise, I go in waves. I seem to have a month where I might do 10 to 20 of them and then I may not do another for 4 to 6 months. For me atleast as I'm treatment planning them, so much of it has to do with in my mind if it will look/work correctly. I know it sounds kind of stupid, but there are many times where I might just place a direct composite where I easily could have done an inlay or I might goto a full coverage restoration where I could have done an onlay. Call it clinician's intuition or something like that, but after seeing thousands of my restorations function, wear, succeed and sometimes fail(and yes, ALL of us will have some failures) in my patient's mouths for years and years, I've learned things like a) in the PROPER patient, that MOL direct composite on #30 will last/function as well as an onlay or crown b) Cusp fractures can and do occur adjacent to inlays at about the same rate as a similarly sized direct restoration will see cusp fractures and c) for many a patient, while it may wear as well as a full coverage restoration does, the decay rates around a large onlay are greater than those around a full coverage crown,

The fun thing about dentistry, and it happens to just about all of us as we evolve as clinicians, is for most folks, every 3 to maybe 7 years, you'll tend to make some type of shift in how you treatment plan and/or prep + restore teeth (sometimes it might be some continuing education that causes the change, sometimes a new material will cause the change, and sometimes just your own retrospective analysis of your work overtime will cause the change), and for me atleast seeing the evolution of my work is one of the fun things of my job on a day to day basis, and if you can't be able to step back and take a good critical look at your work overtime, well then you should remain as an associate and plan on changin jobs every 12 to 24 months so you WON'T get to watch your work age;):D
 

gryffindor

15+ Year Member
Feb 2, 2002
2,807
74
Visit site
Status
Dentist
Have physicians been seeing an unusual increase in mad hatter disease lately? Why is there all this focus on amalgam and reclassifying it and what not? If the public pushes and gets rid of the "cheap" way to save a tooth, then they will only be left with the more expensive options to save teeth. CE courses for gold foil might come back in vogue, if any of the guys who know how to do them are still alive.