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 2016-03-31 for DENTAL AMALGAM manufactured by Unknown.

Event Text Entries

[41568044] (b)(4). After i graduated college and got a job, i had to go to a different dentists. I already had 3 existing cavities that had been filled with amalgam when i was a child, but the new dentist found i had 5 more cavities that had to be filled. After that was done (though i didn't connect the dots until many years later), i started having issues with excess salivation all day but was especially problematic at night because i would drool very heavily in my sleep. It interfered with my sleep because i would drool on my pillow until there was a big drool spot the size of my head on my pillow, and it would wake me up because the pillow was wet and uncomfortable on my face. Then i'd flip the pillow over to the other side but i'd eventually drool a huge wet spot onto that side of the pillow too. Then the wetness would wake me up again and i would switch to a new pillow, and eventually flip that one over too.... And the pattern continued throughout the night. Before you write this off as inconsequential, please remember it was very harmful to the quality of my sleep and this affected my daytime functioning and work performance. I got all sorts of medical tests done like esophageal endoscopy and esophageal manometry and barium swallow, and i tried medications like stomach acid medications and anxiety medications, and they never found anything with the tests and the medications never did anything either. I also thought it might be postnasal drip, so i went down the allergies path, with no success. It would take me all day to describe everything i tried and all the paths i went down, so i'll just leave it at that. I spent all my money and i'm in debt, even with medical insurance paying for most of it. It sounds stupid to go into debt, but there's no point being debt-free if you can't enjoy your life because your body doesn't work right. Sometimes i even taped my mouth shut before bed but then i would wake up choking on saliva, so i stopped using tape. I also had tons of saliva during the daytime but i was able to consciously swallow it every 5-7 seconds, but i think swallowing so often for so many years caused certain muscles to become way too strong from overuse and now according to my physical therapist i have muscular imbalances in my neck. I have chronic neck pain at the age of (b)(6). Sometimes, swallowing would strain my neck muscles so much that i would just spit my saliva in a cup to avoid swallowing it. Not to mention, it makes it really hard to carry on a conversation when you have to stop talking and swallow every few seconds. My relationship with my longtime partner ended because he wanted to have children but i thought there was something wrong with my body and although i wanted a family, i thought it would be cruel to pass on my genes. I got the last amalgam filling removed 9 days ago. It was a stab in the dark that i wasn't sure would help much as the half life of mercury in the body is so long, but miraculously i have slept so incredibly well and not woken up with any wetness on my pillow at all since then. My daytime swallowing has decreased, too. Sometimes i can go almost a whole minute without swallowing. My neck pain isn't bothering me as much either. It seems like a miracle, until i remember how toxic mercury vapor is, and then it makes sense that symptoms would disappear when the source of the toxin is removed. I almost didn't get the fillings in the first place because of the rumors about them being harmful and i almost had them removed years ago for the same reason, but every time i considered it i felt reassured in the end by the ada's emphatic position on amalgam being safe. Now i'm just sad i wasted so much of my twenties being poisoned. I know some people who have amalgam fillings who enjoy good health (so far), so i don't think it's necessarily harmful for everyone, but i do think some people must have biological differences that make them vulnerable. I think an effort needs to be made to somehow test patients' blood or dna to determine whether amalgam will be harmful to them, before a dentist puts amalgam into the patient's mouth. I think putting amalgam in peoples' mouths without doing careful testing to ensure they won't suffer from it is a crime against humanity. Or maybe it would just be easier to stop using amalgam altogether, especially since it's so toxic to the environment. All i know is that whatever money my dental insurance company saved on me by covering amalgam but not composite fillings was negated exponentially by what my medical insurance company had to dish out on me since then. Then again, i suppose the dental insurance company doesn't care about the medical insurance company's bottom line. However, no man is an island. We are all connected, and one person's poor health has cascading effects on those close them and thereby the rest of the country and world. There must be many people like me out there who haven't yet realized they're amalgam-sensitive and who are on government healthcare and the government is paying for most of their medical bills, which really means that we the taxpayers are subsidizing these costs. It's very backwards.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5061380
MDR Report Key5538011
Date Received2016-03-31
Date of Report2016-03-26
Date of Event2011-01-15
Date Added to Maude2016-03-31
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 Report3

Device Details

Brand NameDENTAL AMALGAM
Product CodeEKH
Date Received2016-03-31
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-03-31

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