inforMED
InjuryEJJ

AMALGAM FILING

Received May 18, 2021 · Event occurred Jan 1, 2016

Report MW5101426 · MDR key 11848188

Device

Generic name

Alloy, Amalgam

Manufacturer

Unk

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

34 YR

  • Anxiety
  • Numbness
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Anxiety
  • Numbness
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

Narrative

Description of Event or Problem

I HAD AMALGAM FILLINGS PLACED IN 2007 WHEN I WAS (B)(6) YEARS OLD. I STARTED HAVING NUMBNESS IN MY HANDS AND ARMS, DIGESTIVE ISSUES, ANXIETY, AND BRAIN FOG WITHIN A YEAR OR TWO OF THEIR PLACEMENT. IN 2016, I STARTED TO GO INTO CKD WITH SUDDENLY VERY HIGH NUMBERS (SHOULD BE UNDER 37, SUDDENLY MINE WERE OVER 600) WITH NO OTHER SYMPTOMS OF CKD. EVEN MY DOCTOR WAS CONFUSED. I SPENT 3 YEARS WITH HIGH CREATININE AND ALBUMIN LEVELS WITH NO WORSENING FUNCTION. SUDDENLY, IN 2020 AFTER MY 3RD PREGNANCY WITH THESE FILINGS, MY NUMBERS SHOT UP TO OVER 900. MY DOCTOR WAS STILL CONFUSED. I HAVE HAD TYPE 1 DIABETES FOR 30 YEARS, IN EXCELLENT CONTROL, WITH NO OTHER COMPLICATIONS. I ALSO HAVE MTHFR WHICH MAKES HEAVY METAL DETOXIFICATION DIFFICULT. I'VE HAD INTENSE ANXIETY OVER THE LAST TWO YEARS THAT I HAD NOT EXPERIENCED BEFORE. I'M HAVING THE FILINGS REMOVED. FDA SAFETY REPORT ID #(B)(4).