FDA Warns High-Risk Population of the Adverse Health Effects Linked to Dental Amalgam Mercury Exposure FDA – October 13, 2020 – According to an FDA Safety Communication regarding dental amalgam, the U.S. Food and Drug Administration (FDA) has released new recommendations concerning the health effects of mercury exposure. The FDA Safety Communication was released on September […]
FDA – October 13, 2020 – According to an FDA Safety Communication regarding dental amalgam, the U.S. Food and Drug Administration (FDA) has released new recommendations concerning the health effects of mercury exposure. The FDA Safety Communication was released on September 24, 2020, and the safety report states that certain groups of people may be at an increased risk of suffering serious adverse health effects when exposed to dental amalgams containing mercury.
The U.S. Food and Drug Administration (FDA) is giving new safety recommendations concerning the use of dental amalgam containing level of mercury in the following specific groups of dental patients:
For more than 20 years, the FDA has been actively studying, reviewing, considering, and conducting public debates concerning scientific research and all other evidence on dental amalgam safety. The most recent key discoveries have been the uncertainties concerning the acceptable level of exposure to mercury vapor (gas) and if the amount of mercury accumulation in the body from dental amalgam can cause adverse health consequences. The FDA also wants to understand if there is a potential for mercury gas to transform into other mercury compounds in the body. In December 2010, the FDA conducted a meeting of its Dental Products Panel of the Medical Devices Advisory Committee to discuss these possibilities. In November of 2019, the FDA had a meeting of our Immunology Devices Panel to review the health risks.
Elemental mercury is often used in certain dental amalgam, and mercury is linked with numerous adverse health effects. Another concern is the theory that when a patient’s amount of mercury exposure is high, the patient may develop a reduced ability to expel mercury from their body.
Even though most research evidence suggests that mercury exposure from dental amalgam will not cause negative health effects in the healthy population, little or no information is known about the negative health consequences of mercury exposure high-risk individuals. Therefore, the FDA has updated its recommendation regarding the use of non-mercury restorations(fillings) like glass ionomer cement and composite resin in patients who are at a higher risk for adverse health effects when exposed to mercury.
At this time, the FDA is not recommending that dental filling patients replace or remove any existing amalgam fillings as long as the fillings are in good condition. High-risk patients should not replace amalgam fillings unless the procedure is medically necessary. Removing pre-existing amalgam fillings could result in a short increase in mercury vapor exposure as the vapor is released during the amalgam removal process.
The FDA also stated that they did not discover any new evidence that would warrant a complete ban on the use of dental amalgam. So far, all research suggests that there is no evidence that shows dental amalgam mercury exposure produces adverse health effects in the general population. Also, any a ban on mercury-containing dental amalgam could result in delayed or no treatment in communities where there is a limit to the availability of alternative dental materials.The DDA’s Recommendations for Dental Amalgam Use in Patients and Caregivers
The following groups of patients are at higher risk for possible negative effects of mercury vapor (gas), which is typically released from dental amalgam fillings:
If you or a loved one are a high-risk patient, as noted above, the FDA recommends that you receive alternative dental filings that are non-mercury options such as glass ionomer types of cement and composite resins.
Dental amalgam is used in restorative dentistry. The amalgam is a mixture of an alloy primarily composed of tin, silver, and copper, with elemental mercury. This mixture is used to fill missing surfaces and structure of decayed teeth. The process of receiving a dental filling using dental amalgam releases tiny amounts of mercury vapor. Mercury gas is also released during the chewing of the food and during teeth grinding.
It is believed that inhaling mercury gas is harmful, especially when the vapor produces doses much higher than those usually experienced during a dental restoration procedure. These mercury vapors are absorbed by the body when the patient inhales the mercury vapor into his or her lungs. The body excretes a portion of the absorbed mercury. However, small traces of mercury enter the bloodstream might collect in specific tissues, such as brain and kidney tissues. In some cases, a pregnant woman may pass the mercury to her baby via the umbilical cord.
Mercury is a recognized nervous system toxicant, and long-term exposure to high amounts of mercury, as in some occupational environments, may be associated with the following side effects:
For more than two decades, the FDA has conducted several scientific data reviews to determine the potential health risks associated with dental amalgam. So far, the reviews have not produced enough evidence to show that mercury exposure from dental amalgam causes adverse health effects in the general population. However, not enough evidence concerning the health effects on high-risk groups has been properly investigated.
If you are experiencing serious side effects linked to mercury exposure, contact Parker Waichman LLP for your free initial case review. Simply call 1-800-YOURLAWYER (1-800-968-7529) for your free consultation.