• Dr. Jill Ombrello

My Thoughts on the FDA's Updated Recommendations for High-Risk Groups Re: Mercury Amalgam Fillings

First of all, let me tell you how much I enjoy using random photos to explain my dental analogies ;) so thank you for clicking through. I promise that the image will make sense shortly.

In September of 2020, the FDA updated their guidance on mercury amalgam dental fillings, specifically identifying people who are at high-risk for undesired side effects and should avoid getting dental amalgam fillings whenever possible or appropriate. The segments of the population highlighted by the FDA to be at a greater risk for potential harmful health effects include the following:

  • 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 to mercury or other components of dental amalgam.

While I appreciate the FDA catching up in review of the scientific literature that has been exhaustively researched, verified, and implemented by doctors and global organizations, it is unfortunate that it has taken so long for this US-based organization to make these updated recommendations, and in many ways, this guidance is still incomplete. Just to name a few, countries such as Sweden, Denmark, Norway, and Nepal have banned the use of mercury amalgam fillings all together; all 28 member states of the European Union are forbidden from using the material in pregnant and breastfeeding women, and in children under the age of 15; and Ireland, Finland, and Slovakia announced a timetable starting years ago to phase out and eventually have a complete ban on the material as well.

To briefly touch on the reason why such a harmful material isn't so obviously declared as such and banned universally, this short blog summarizes what many have speculated as the reason why there hasn't been immediate and widespread implementation. It states, "Regulators are concerned about any backlash to an outright ban. A sudden announcement that amalgam is unsafe could trigger millions of demands for the removal of dental fillings, and there is also worry that people may sue the authorities if they link neurological problems to their fillings." Insert eyeroll here. From my perspective, an equivalent situation would be a delay in announcing the severity of harm from tobacco products for fear of the backlash in litigation from patients and consumers being misled and being seriously effected. I will admit that meeting the demand would be challenging at this time if everyone was made aware of the concerns, as we are very limited in the number of dental providers who are trained in the Safe Mercury Amalgam Removal Technique, a clinical procedure that protects the patient, the dental staff, and the environment from mercury vapor exposure. However, these are not good reasons to delay widespread patient education, especially when many of these high risk groups are known to be suffering without much improvement in their condition because they have been misguided on the contributing factors to their condition.

To circle back on a previous point to discuss further, here's why I think the updated FDA recommendations are incomplete.

  1. There are far better alternatives to mercury amalgam fillings in the form of resin-based or ceramic restorations that complete negate any risk/benefit analysis of still using mercury amalgam; so to indicate that mercury amalgam fillings should only be advised against for these high risk groups is really doing unnecessary harm to otherwise "healthy" patients or patients that have not been shown to have their chronic illnesses directly linked to this material. Here's another analogy to elucidate this point: for a long time, wood was the chosen material for prosthetic limbs. But once more advanced materials and design features that better served the patient were developed (ie. fully articulated joints, 3D printing, materials optimized for flexion and extension in different environments), people stopped using wood and started using these better materials.

  2. The FDA does not advise removal of amalgam fillings if it is "in good condition and your dentist or healthcare professional says there is no decay beneath the filling". Well that is about as short sighted, overly simplified, and incomplete a stance as I've ever heard of one. Here are all the ways in which a mercury amalgam filling can be compromised that are NOT associated with secondary decay: (a) these fillings can expand, contract, and corrode based on temperature of food, beverage, or air. This change in the material can cause fractures in the surrounding tooth structure and/or can compromise the tooth structure that can inevitably lead to tooth fracture or bacterial infection other issues despite the very best preventive efforts of the most hygienic and healthiest of patients. (b) These metal fillings can cause discomfort associated with electrical flow. Most anyone who has a "silver" filling can attest to a "stinger" or shock of sorts if they accidentally bite on their fork. (c) finally, mercury fillings require the unnecessary removal of healthy tooth structure for placement because they are not bonded in place, but rather require mechanical forces to hold them in place. (d) Even if there is no compromise to the filling itself, a mercury amalgam filling is constantly emitting mercury vapor. While this is a minor amount, and everyone's sensitivity threshold is different, why would you risk actively exposing yourself and ingesting a known carcinogenic, toxic material for an extended period of time (or until the filling "fails") if you could replace it with a far superior solution? **As a caveat to my own argument here, evaluation and prioritization of replacement of mercury amalgam fillings are patient-specific questions that must be taken into consideration with other variables including but not limited to systemic health, other oral health conditions such as periodontal disease, urgent/ emergent care, etc.

  3. In the instance that patient needs or decides to have their mercury amalgam fillings removed, the FDA provides NO no guidance on the safe removal and/or preparation of the patient prior to this procedure. It is especially concerning for these patients that have now been categorized by the FDA as high risk for negative health effects from these fillings, that they may be quickly motivated to have their condition remedied, and if not prepared or well informed, they could risk even MORE exposure to mercury during the procedure. Many US-trained dentists are not educated on these protocols nor are there regulatory bodies that oversee protective guidance on this procedure. It's putting a huge burden on the patient to be self-motivated to be informed and find the right provider with whom to collaborate to ensure their best and healthiest outcome.

So in summary, I appreciate the progress in the right direction that the FDA has made here; however, slow and late this progress may be. But until there is an outright ban with regulations on safe removal, we are far behind those who understand the science and who prioritize public health.

Can't wait to see what kind of pro-mercury, Karen activity I get on the social medias from this one ;)

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