THE UNITED States Food and Drug Administration (US FDA) has issued recommendations for certain high-risk groups regarding dental amalgam containing mercury.
The US FDA statement, issued September 24, came from Dr. Jeffrey E. Shuren MD, Director of the Center for Devices and Radiological Health at the Food and Drug Administration (CDRH).
The CDRH regularly evaluates, monitors and updates scientific evidence on the risks from medical devices. These include issues related to the materials used in devices, such as metals.
In the case of implanted and inserted medical devices, where materials may be in contact with the body for extended periods of time, it evaluates safety issues involved with, among other things, the body’s long-term exposure to certain materials, taking into account that sometimes uncertainties remain and more research is needed.
Its new recommendations concern the potential risks to certain high-risk individuals that may be associated with mercury-containing fillings used to restore the missing structure and surfaces of a decayed tooth.
“The FDA has found that certain groups may be at greater risk for potential harmful health effects of mercury vapor released from the device,” it said.
“As a result, the agency is recommending certain high-risk groups avoid getting dental amalgam whenever possible and appropriate.”
The groups that may be at a greater risk for potential harmful health effects include:
* pregnant women and their developing fetuses
* women who are planning to become pregnant
* nursing women and their newborns and infants
* children, especially those younger than six years of age
* people with pre-existing neurological disease such as multiple sclerosis, Alzheimer’s disease or Parkinson’s disease
* people with impaired kidney function; and
* people with known heightened sensitivity (allergy) to mercury or other components of dental amalgam
For over 20 years, the US FDA has been reviewing scientific literature, monitoring reports and holding public discussions regarding the public health effects of dental amalgam and amalgam-related mercury vapor.
According to the US FDA, dental amalgam is a mixture of mercury and a powdered alloy made up of silver, tin and copper. The amalgam releases small amounts of mercury vapor over time.
Here’s what it has to say about the matter:
“While low-levels of inhaled mercury vapor are generally not harmful to most people, these high-risk individuals may be at increased risk of adverse health outcomes.
“How much vapor is released can also depend on the age of the filling as well as a person’s habits such as teeth grinding.
“These uncertainties in the most vulnerable patients are why today we are recommending people who may be at high risk for adverse health effects of mercury exposure use non-mercury alternatives to dental amalgam, such as composite resins and glass ionomer cement fillings.
“Dental amalgam-related mercury vapor release may be highest during placement or removal of the filling.”
The US FDA is not recommending the removal or replacement of existing amalgam fillings in good condition unless it is considered medically necessary.
This is because, it says, removing intact amalgam fillings can cause a temporary increase in exposure to mercury vapor and the potential loss of healthy tooth structure, “potentially resulting in more risks than benefits.”
***
Dr. Joseph D. Lim is the former Associate Dean of the UE College of Dentistry, former Dean of the College of Dentistry, National University, past president and honorary fellow of the Asian Oral Implant Academy, and honorary fellow of the Japan College of Oral Implantologists. Honorary Life Member of Thai Association of Dental Implantology. For questions on dental health, e-mail jdlim2008@gmail.com or text 0917-8591515./PN
