FDA Adverse Event Injury Summary report: N

SILMET, INC

MDR report key: 1942105 · Received December 26, 2010

Report

Report Number
MW5018713
Event Type
Injury
Date Received
December 26, 2010
Date of Event
March 9, 1998
Report Date
December 26, 2010
Manufacturer
SILMET INC
Product Code
EMA
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD AN AMALGAM DENTAL FILLING DRILLED OUT AND REPLACED WITH ANOTHER LARGE AMALGAM FILLING ON (B)(6), 1998. SEVEN DAYS LATER, I WAS SUDDENLY STRUCK WITH DOUBLE VISION WHICH CAUSED ME TO BE EXTREMELY LIGHT SENSITIVE AND UNABLE TO SEE A SINGLE IMAGE. THE DOUBLE VISION BECAME WORSE IN THE ENSUING DAYS AND I WAS UNABLE TO NAVIGATE OR DRIVE WITHOUT COVERING ONE EYE WITH AN EYE PATCH. NINE DAYS LATER, I WENT TO SEE MY OPTOMETRIST WHO BECAME EXTREMELY CONCERNED AND INSISTED THAT I NOT LEAVE HER OFFICE UNTIL I HAD AN APPT TO SEE A NEURO-OPHTHALMOLOGIST THE FOLLOWING DAY. SHE THOUGHT I MIGHT HAVE A BRAIN TUMOR OR MULTIPLE SCLEROSIS. AFTER BLOOD TESTS AND A BRAIN MRI, THE NEUROLOGIST DIAGNOSED ME WITH MS OR LUPUS AND CONFIDENTLY SAID I WOULD BE SICK FOR THE REST OF MY LIFE, ALTHOUGH HE SAID THERE WERE NO KNOWN CAUSES OF THESE DISEASES. THE DECISION WAS BASED ON AN ELEVATED ANA TITER, ELEVATED LIVER ENZYMES AND RHEUMATOID FACTOR AND THE CLINICAL SYMPTOMS. WITHIN WEEKS, THE DOUBLE VISION BECAME MORE EXAGGERATED, I DEVELOPED SWOLLEN MANDIBULAR GLANDS, DROOPING EYELIDS AND LOSS OF EQUILIBRIUM. I SAW SEVERAL NEUROLOGISTS WHO ONLY WANTED TO TREAT ME WITH STEROIDS AND OTHER DRUGS TO SUPPRESS THE SYMPTOMS. NOT ONE EXPRESSED AN INTEREST FINDING OUT WHAT MAY HAVE CAUSED THESE SERIOUS NEUROLOGICAL PROBLEMS. IN FACT, I WAS TOLD BY ONE THAT I WOULD BE SICK FOR THE REST OF MY LIFE AND I BETTER GET USED TO IT. WITHIN A MONTH, I WAS DIAGNOSED BY AN ENVIRONMENTAL PHYSICIAN WITH MERCURY POISONING FROM THE DENTAL WORK DONE ON (B)(6), 1998. DR (B)(6) REPORT IS AVAILABLE. THE MERCURY FROM THE DRILLING OUT AND PLACEMENT OF THE FILLINGS CAUSED ME TO INHALE DANGEROUS LEVELS OF MERCURY VAPOR WHICH WERE INHALED AND THEN TRAVELED TO THE BRAIN. THE PRODUCT USED TO FILL MY TOOTH WAS A MIXTURE OF 50% MERCURY LIQUID MIXED WITH AN ALLOY CONTAINING SILVER, TIN, ZINC, AND COPPER MFG BY SILMET, INC. ALTHOUGH MERCURY IS A KNOWN NEUROTOXIN, FDA DOES NOT REQUIRE DENTISTS TO SHARE THE WARNINGS CONTAINED ON THE PRODUCT MSDS, AND THEREFORE, CONSUMERS CANNOT MAKE INFORMED DECISIONS AND CANNOT PROTECT THEMSELVES. I HAD ALL OF MY AMALGAM FILLINGS REMOVED BY A DENTIST WHO WAS TRAINED TO SAFELY AND CAREFULLY REMOVE THEM. IT TOOK 3 1/2 YRS FOR MY EYELIDS TO RETURN TO NORMAL, HOWEVER, I STILL HAVE PERIPHERAL DOUBLE VISION AND AT TIMES HAVE AN EXACERBATION OF THE DOUBLE VISION AND PTOSIS -DROOPING EYELID-. MY ANA TITER, RHEUMATOID FACTOR AND ANTIBODIES TO THE ACETYLCHOLINE RECEPTOR REMAIN ELEVATED, HOWEVER, MY LIVER ENZYMES HAVE RETURNED TO NORMAL. THIRTEEN YRS LATER, I STILL HAVE AN AUTOIMMUNE DISEASE AND PERMANENT NEUROLOGICAL INJURIES. MY CURRENT DIAGNOSIS IS MYASTHENIA GRAVIS, A NEUROMUSCULAR DISEASE, IN WHICH THE ACETYLCHOLINE RECEPTOR IS BLOCKED AT THE GAP JUNCTION PREVENTING THE NERVE TO SPEAK TO THE MUSCLE. IN MY CASE, MERCURY CAUSED THIS TO OCCUR DURING THE REMOVAL AND PLACEMENT OF THE SO CALLED SILVER FILLING. IT IS TIME FOR FDA TO BAN THE USE OF MERCURY IN DENTISTRY AND REQUIRE PHYSICIANS TO CONSIDER MERCURY POISONING FROM FILLINGS FOR SUCH SYMPTOMS ASSOCIATED WITH PARKINSON'S DISEASE, ALS, LUPUS, MULTIPLE SCLEROSIS, ALZHEIMER'S, ALL AUTOIMMUNE DISEASES, THYROID, AND MENTAL ILLNESS INCLUDING DEPRESSION, ANXIETY AND SCHIZOPHRENIA. DOSE OR AMOUNT: ONE LARGE FILLING; FREQUENCY: ONE TIME; ROUTE: DENTAL. DATES OF USE: (B)(6) 1998 -- (B)(6) 1998. DIAGNOSIS OR REASON FOR USE: CAVITY UNDER OLD FILLING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 SILMET, INC NOGAMA II MIXED WITH ONE HALF LIQUID EMA SILMET INC

Patients

Seq Age Sex Outcome Treatment
1 Other| R