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 2012-10-10 for DENTAL AMALGAM manufactured by .

Event Text Entries

[3035544] I became increasingly ill between (b)(6) 2011 and (b)(6) 2012, with multi-systemic problems onset (b)(6) 2011, when a parasite infection became systemic and led to escalating dermatological disease over six months that became severe. I finally got rid of the parasites, but also developed itchy rashes and sensations of movement. I got third opinion consults from numerous specialists at leading (b)(6) hospitals and health networks, all of whom were at a loss. I became anxious as i could no longer concentrate enough to work, or even socialize and visit aging family members without fear of potential contagion. Saw an integrative doctor who had diagnosed my fibromyalgia 20 years ago, who also did not know the cause and was unable to offer fully effective treatment, beyond an anti-fungal and suggesting i stop acid-producing foods, which helped the awful sensations of something swimming under my skin. Previously i had been strong and vigorous, in fact, i was the first woman (b)(6). Since getting fibromyalgia about 18 months after my son was born i had achy joints and tendon pain, tight trigger points, short-term memory deficits, word recall problems, difficulty organizing info, and balance issues, and could tolerate only walking and light swimming or bicycling. By (b)(6) 2011, my immune markers were falling. Three iv ig treatments raised the levels, but did not help alleviate symptoms. At this point i gave up hope, was severely depressed, and barely made it through the days. By (b)(6), i noticed fine tremors developing in my fingers, and my balance and memory were getting even worse, as was my skin. I then gave up wheat and gluten, which helped a bit. Later, reacted to corn and soy, developed lichen planus on trunk and systemic candida. In (b)(6), the integrative doctor told me he had heard a presentation in (b)(6) at a conference in (b)(6) by a parasitologist, (b)(6), phd, on how reactivity to dental materials can cause unexplained dermatopathy, and how to resolve it. I spoke with people whose health care teams had worked with him, located and interviewed biologic dentists, and worked with my doctors to follow a protocol to gradually clear heavy metals and other toxins that my systems were reacting to. The finger tremors were more evident, and i had numbness and peripheral neuropathy in my legs. I got an appointment with a neurologist, who did heavy metals testing and found an elevated blood mercury level of 14. A biologic dentist said i was grinding my teeth at night on amalgam fillings in my upper bicuspids (one older filling and one from 2005); my skin symptoms were always worse at night. He replaced the fillings with a more inert material per a biocompatibility blood test, gave prescriptions for some hidden dental and jaw infections, and i began lymph drainage massage as part of the protocol. I had rapid improvement in all of my dermatological symptoms, and my memory, mood, and energy levels improved greatly as well. I am still a bit hyperactive, and have a slightly low thyroid and some insomnia, with difficulty staying asleep past the middle of the night. It turns out my fibromyalgia of 20 years onset soon after i stopped breastfeeding, and had a bunch of deferred dental work done that involved drilling out amalgam and putting in crowns. They also left mixed metals under crowns and over three root canaled teeth. Twice in the last decade, soon after having a gold crown put in, the one next to it fell off and needed to be replaced. As my fillings and my immune and hormone systems aged, i succumbed to mercury poisoning from my dental fillings, to premature aging with a host of escalating, systemic and costly chronic diseases. I suspect i have the apoe4 gene type, which i have learned does not clear mercury well. I am fortunate to have figured it out, because i kept working the problem as my parents taught us to do, and to have recovered in large part, most people do not. For the past six months i have learned as much as i can about this problem, with an eye to fixing it. Because the fda tragically continues to maintain the safety of this device, rather than follow the recommendations of its 2010 scientific advisory panel, my dental plan will not pay more than the cost of putting more amalgam back in the back of my mouth, and will not pay to redo molars that were redone incorrectly in the past five years, despite appeals with a doctor's letter, and lab results of elevated mercury levels and other abnormal lab markers, and appeals by (b)(6) university benefits office, my husband's employer, and my state rep. I asked my doctors and dentists to report this to the fda, but i finally figured out they do not do so, because it is not mandatory, nor billable. Pts do not report and it is not easy to find out how. I meant to report this sooner, but my mom took ill, i was out of state with her during her last days in hospice, and then had my dad with me for several weeks. During the last four years she was in a memory unit, i learned from my sister that her fillings had basically disintegrated, vaporized, dissolved and fallen out. This may explain her rapid decline from the energetic jogger and beloved math teacher she had been. I tried to get an autopsy and her fillings removed prior to cremation in (b)(4), but i was not successful, as it was not my home state and there was limited time to act. If you want to promote health, and lower chronic diseases, unemployment, sick days, disability leaves, and health care and long term care costs, please stop use of mercury dental amalgam now.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5027229
MDR Report Key2792414
Date Received2012-10-10
Date of Report2012-10-10
Date of Event2012-03-10
Date Added to Maude2012-10-18
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameDENTAL AMALGAM
Generic NameDENTAL AMALGAM "SILVER FILLINGS"
Product CodeEJJ
Date Received2012-10-10
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No1
Device Event Key0

Device Sequence Number: 2

Brand NameDENTAL AMALGAM
Generic NameDENTAL AMALGAM "SILVER FILLINGS"
Product CodeEJJ
Date Received2012-10-10
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Sequence No2
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2012-10-10

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