DENTAL AMALGAM FILLINGS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-15 for DENTAL AMALGAM FILLINGS manufactured by .

Event Text Entries

[2125571] Back in (b)(6) (this yr), i wrote to the fda office in (b)(6) about my experience with amalgam dental fillings. The letter was acknowledged by (b)(6) who recommended that i direct my concerns to medwatch, which is the intent of this letter. Also, she sent copies to me of the fda medical devices summary regarding dental amalgam, and a voluntary reporting form. I was born in (b)(6), am (b)(6) tall, and have weighed in the (b)(6) - range throughout my adult life. Several yrs ago (prior to 1991), 60 minutes on (b)(6), reported a possible link between amalgam fillings and arthritis, and also mentioned some other probable side effects. In 1998, an article appeared in the indianapolis star newspaper addressing a condition i had experienced skin brown spots which cleared up after i had these fillings replaced in 1991. I have attached a copy of the responding letter i wrote to the doctor who provided the article, which details my experience before and after having the seven amalgam fillings replaced. Please review the contents of this letter and consider the info for your study. As a side note, the fda has surmised that the use of glucosamine/chondroitin is ineffective for treating osteoarthritis. Arthritis began to appear in my joints during my (b)(6) and i had tried the glucosamine/chondroitin sometime in my (b)(6) without any improvement. Probably about 1999, several yrs after the amalgam fillings had been removed (1991), i tried the supplement again and the results have been amazing. Arthritic discomfort is no longer apparent anyplace in my body, except in the tmj which has shown only a minor improvement. Could it be that the fda study on this subject should have checked to find out if the participants had amalgam dental fillings? There was a news item on 60 minutes (b)(6) investigating a link between arthritis and mercury-laden tooth fillings. As a side issue, it was mentioned that some people had gotten relief from migraine and other types of headaches when their mercury-laden fillings were replaced with the newer plastic type. I have been plagued with headaches my entire life. In earlier yrs, these were primarily migraine and would occur 10-20 times a yr (usually more during stressful periods). However, in later yrs the headaches were of many different types and only occasionally of the migraine variety - maybe 3-4/yr. At the time of the 60 minutes program i was having 3-5 headaches/week and had not found an effective treatment. These headaches were positively not caused by tension or diet as i lead a very comfortable and happy life, except for headaches. Being somewhat desperate, and when the mercury-laden fillings scenario was mentioned as a cause of headaches, i had my seven metallic fillings replaced with the newer material. This was in 1991 at (b)(6). I have been astonished at the differences which have occurred and will mention several for your review, firstly relating to the brown spot issue. Before the change in fillings, i had a significant number of brown spots on my forearms and balding scalp. I have never had an outdoor job nor did i spend an unusual amount of time in the sun. Within a month of the filling change, the brown spots began to disappear. The lighter ones began to fade away. The darker ones would crust over and could be picked or scraped off. Sometimes there was healthy skin under the spot and other times the skin would be raw which i would treat with an antiseptic and they would clear up in a week or so. Roughly, approximately 75% of the spots have disappeared. I have arthritis throughout my body. Symptoms of this condition appeared when i was in my (b)(6). My mother and father lived to be (b)(6) respectively and neither showed any signs of arthritis until their 70's. They were both toothless and wore dentures most of their adult life. Before the filling change, my ankles and knees would ache when i got up in the morning. With movement, this discomfort would be alleviated. At that time, i was taking lodine 300mg, 2/day, i believe. Now, i still have arthritis and i am not making any 'cured' claims, but my ankles and knees no longer ache and i can go for long periods without medication. When i do use medication, one lodine capsule per day is sufficient. I am inclined to blame the early onset of my arthritis condition on the mercury-laden fillings. As i mentioned, my first metallic fillings were placed in my early teens. When i was about 16, the inside of my upper lip would split open during the night hrs. My doctor said this was caused by sleeping with my mouth open and the thin lip skin would dry out and split open. This occurred in all seasons. My doctor recommended that i coat my lip with vaseline at bedtime and, as long as i remembered to do so, this solved the problem. I had been doing this every night because, even in my adult yrs, if i would forget the lip would split open - and i would forget many times. This was always an annoyance. I continued to apply the vaseline after the filling change but, eventually, i forgot one night. To my surprise, no split! But i did not stop using the vaseline. However, after the second 'forget' occurrence without an associated split, i decided to stop the vaseline and see what would happen. I have not awaken with a split lip since the fillings change. Since my late teens, i have been bothered with sinus problems. Frequently, there would be a lot of drainage during the night and, when i would clear my throat in the morning, often times the thick mucous would be tainted with blood. This condition became more frequent with age. After the filling change, the sinus problem disappeared completely. In the fifteen, or so, yrs before the filling change, about every two weeks a hair follicle in my nose would become infected. I would treat this by finding and pulling out the infected hair then applying an antiseptic (polysporin). Since the filling change, there have been two occurrences of this - both after working in dusty areas and within the first six months after the change. None since! During most of my adult yrs before the filling change, i had to use the softest toothbrush i could find to brush my teeth and still my gums would bleed. I now use a medium bristle brush and my gums never bleed. There have been a few other minor changes which have occurred since the filling change. I had always attributed these and the conditions mentioned above to just getting older. But one thing i want to emphasize is that there have not been any other changes in my lifestyle, diet, etc. , either before or after the filling change. Based on my experience, i can only conclude that the mercury-laden fillings had a significantly detrimental effect on my health. I am aware that the ada has denied that there are any health hazards associated with these mercury-laden fillings. Of course, if they had recognized a negative connection, dentists throughout the world would be besieged with lawsuits. It is my suspicion that some people (maybe most) can tolerate the mercury-laden fillings. However, just like some people are violently allergic to penicillin, maybe others are affected by these metallic fillings. I seem to recall that there is, presently, a study being conducted in (b)(6) regarding this issue, but have not become aware of the results. I would be interested in your response. Oh, yes! Regarding my headaches, my doctor surmised that the arthritis in my tmj was causing irritation to the blood vessel going through that joint which, in turn, causes the vessels in and around my eyes, which is where most headaches occur, to dilate. He suggested cafergot and, after yrs of experimentation, i now cut the cafergot suppository into 5 equal parts and insert one part at bedtime since most of my headaches have their onsets during the night. This has been a fairly successful method of treatment, but it appears that i will be fighting this battle until a cure is found for arthritis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5021473
MDR Report Key2177425
Date Received2011-07-15
Date of Report2011-07-15
Date Added to Maude2011-08-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDENTAL AMALGAM FILLINGS
Generic NameDENTAL AMALGAM FILLINGS
Product CodeEJJ
Date Received2011-07-15
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2011-07-15

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