FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 3820550 · Received May 15, 2014

Report

Report Number
MW5036155
Event Type
Injury
Date Received
May 15, 2014
Date of Event
November 25, 2013
Report Date
May 14, 2014
Manufacturer
BAYER
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

AFTER HAVING THE ESSURE DEVICE PLACED, I STARTED HAVING SEVERE HEADACHES. OTHER SYMPTOMS WERE DIZZINESS, VISUAL DISTURBANCES TO WHERE I WAS SEEING BLACK SPOTS, FEELING FAINT AND A FOGGY HEAD. THEN I STARTED HAVING WEAKNESS AND HAVING TROUBLE REMEMBERING WHAT I HAD DONE. I CURRENTLY HAVE AN 11 MONTH OLD AND FIXED A BOTTLE TWICE. I WENT AND HAD SOME TESTS DONE AND REPORTS SHOWED THAT AI ONLY HAD 2% OF MY SHORT TERM MEMORY LEFT. I HAVE ALSO HAD HEAVY METAL TESTS DONE THAT REVEALED LOW LEVELS OF ARSENIC IN MY BLOOD AS WELL AS LOW POTASSIUM LEVELS AND VITAMIN B12 LEVELS WERE SO LOW THAT I AM NOW TAKING SHOTS TO GET MY LEVEL BACK UP. I WAS NEVER TOLD THAT THE DEVICE HAD NICKEL IN THE DEVICE AND I HAVE NEVER BEEN ABLE TO WEAR NICKEL EARRINGS DUE TO AN ALLERGY TO IT. I HAVE ALSO HAD ABDOMINAL CRAMPING, HEAVY BLEEDING FOR WEEKS AFTER IT WAS PLACED. ALSO, I HAVE HAD LOW GRADE FEVERS EVER SINCE I HAVE HAD THIS DEVICE PLACED INSIDE OF ME. I HAVE HAD A PSYCHOANALYSIS TEST PERFORMED ALONG WITH MRI'S, CAT SCANS AND EEG TESTING. THE PSYCHOANALYSIS THAT WAS PERFORMED ALSO SHOWED THAT MY THINKING LEVEL IS AT A SIXTH TO EIGHTH GRADE LEVEL. I AM CURRENTLY A NURSE AND UNABLE TO WORK AT THIS TIME. I WAS ALWAYS AN A/B STUDENT AND MADE THE DEAN'S LIST IN SCHOOL. THE ANALYSIS REVEALED THAT I HAD TOXIC ENCEPHALOPATHY WHICH COULD POSSIBLY BE COMING FROM A FOREIGN OBJECT IN MY BODY. MY OB-GYN TOLD ME THAT THESE SYMPTOMS COULD NOT BE COMING FROM THE ESSURE PRODUCT, BUT I WAS A COMPLETELY HEALTHY NORMAL PERSON PRIOR TO ITS PLACEMENT. I HAVE READ OTHER'S STORIES THAT HAVE HAD THIS DEVICE PLACED AND HAVE NUMEROUS SYMPTOMS AS THEY DID.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
289695 ESSURE NONE HHS BAYER

Patients

Seq Age Sex Outcome Treatment
1 35 YR Required Intervention| S