DENTAL AMALGAM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-23 for DENTAL AMALGAM manufactured by Unk.

Event Text Entries

[146821116] Healthy until midlife, i developed fibromyalgia and mystery symptoms for two decades which increasingly impacted my life and ability to work. In 2011, i began a year of accelerating neurological problems that were hundreds and left me unable to work. After 3rd opinion consults in many specialties and giving up all hope, a functional md i had been seeing heard a presentation that such problems could be due to mercury accumulation. Incredulous, i heard about biological dentistry, and saw a biological dentist who said this was possible. I had a blood mercury test performed at (b)(6) in (b)(6), which had an elevated reading of 14 mcg/dl (0-10 scale). The neurologist was not concerned as it was only "slightly" elevated. What i learned later - and she did not know - is that people with gene variants who do not methylate (clear toxins) well may have low levels of circulating mercury, but high levels sequestered in cells, organs and tissues, where it bioaccumulates instead of being excreted. The biological dentist removed and replaced the exposed dental amalgam in my bicuspids, using the safe mercury amalgam removal technique (smart) developed by the international academy of oral medicine and toxicology. Those had been done in the last 10 years or so, with a newer formulation of amalgams that off-gases greater amounts of mercury vapor when you chew, drink hot liquids, grind your teeth, or get dental cleanings and polishing. I had rapid resolution of the worst neurological symptoms, and my physical and cognitive health began to improve. The functional md identified and addressed contributing problems, and my fibromyalgia went away. I largely regained the health of my younger days, when i was the first woman to pass the civil service ocean lifeguard test in (b)(6), and the first women civil service lifeguard examiner. I still had short-term memory and sleep problems. A few years later, i had add'l dental work done which removed and replaced amalgam left under white and gold crowns that were installed years ago, this time with fillings for which i was pretested for biocompatibility. I had no idea that my past dentists had left mercury dental amalgam under crowns when they were replaced. I have two low lg levels which may explain why i was prone to cavities as a child, in contrast to my siblings. Each molar (including some baby teeth) had small amalgams, then larger ones, then partially removed and capped by crowns, plus a few in my bicuspids, which adds up to a large exposure over a lifetime for anyone with common gene variants impacting methylation. I still have high mercury levels when measured by provoked challenge tests, and still have short-term memory and sleep problems. I am eagerly awaiting fda approval of a new drug, irminix, which is a safer mercury chelator drug option that boosts glutathione levels being developed by emeramed. I do not still have the product, because keeping mercury fillings would be a significant health hazard. Because there are no labels, info sheets, or written informed consent in february 2019. A man in (b)(6) whose grandfather was a dentist melted down a bag of old fillings he found because he needed money, so wanted to reclaim the "silver". Three days later, he was hospitalized in critical condition. Two weeks later, his partner and her daughter called 911 and said they were increasingly ill and 3 pets had died. Hazmat went out, measured extremely high mercury levels, and sent the women to the hosp. For two weeks, the man had been in the er at (b)(6) hosp, and no dr at this (b)(6) hosp thought to perform a heavy metal test. The entire building was condemned, all the residents of the other units in the building had to move out, and the 4th pet died. The landlord now owns a hazmat site, three people lost their health (and nearly their lives), families are homeless, and animals died. This is what happens when the fda does not accurate label for pts, disclose material content, warn, or require written informed consent for installation of dental devices. Over the years since i recovered my health, i have met hundreds of pts whose lives and health have been impacted or nearly ruined by dental amalgam mercury toxicity, because they lost the gene lottery - and because the fda hangs onto outdated science, flawed risk assessments, and a long history of dental and reaction on a neurotoxin that should no longer be allowed to be used in dentistry. There are safer materials that work in all clinical situations, as proven in the growing number of nations that have banned amalgam, many in (b)(6). As of july 2018, eu nations no longer allow amalgam use in children under 15 or in pregnant / nursing mothers, and are developing phaseout plans. The fda should follow swiftly. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086904
MDR Report Key8640777
Date Received2019-05-23
Date of Report2019-05-21
Date of Event2012-04-30
Date Added to Maude2019-05-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameDENTAL AMALGAM
Generic NameMERCURY
Product CodeELY
Date Received2019-05-23
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-05-23

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