FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 3880378 · Received June 13, 2014

Report

Report Number
MW5036653
Event Type
Injury
Date Received
June 13, 2014
Date of Event
June 11, 2014
Report Date
June 12, 2014
Manufacturer
BAYER
Product Code
HHS
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

AFTER I HAD MY FOURTH CHILD IN 2009, I WENT FOR MY 6 WEEK CHECK AND AT THAT APPOINTMENT MY DOCTOR AND I TALKED ABOUT PERMANENT STERILIZATION (TUBES TIED) EVEN THOUGH MY HUSBAND HAD ALREADY BEEN FIXED. I CHOSE TO HAVE TUBES TIED, MY DOCTOR TOLD ME ABOUT ESSURE. SHE TOLD ME THAT THERE WERE NO SIDE EFFECTS AND COILS WERE INSERTED INTO MY TUBES AND IN THREE MONTHS THE TUBES CLOSED. NO SURGERY, 10 MINS IN AND OUT, GONE SHOPPING. SHE WAS RIGHT BUT WHAT I DID NOT KNOW IS THAT A YEAR LATER MY BODY WOULD BE SO ITCHY EVERYDAY. MY PERIODS WOULD BE SO IRREGULAR TO ALMOST NONE EXISTENCE. HEADACHES ALMOST EVERYDAY WHERE I HAVE ONLY EVER HAD ONE BEFORE IN MY LIFE. EXTREMELY GASSY TO THE POINT EVERY STEP I TAKE I (B)(4) AND IT'S NOT PLEASANT SMELLING. I HAVE EXTREME BLOATING WHERE I TAKE TUMS EVERY NIGHT. WEIGHT GAIN AND TIRED ALL THE TIME, HAVE GAINED OVER 70 LBS, DIZZINESS AND FAINTNESS. I HAVE ANXIETY DISORDER AND ON MEDICATION SO THAT I CAN SLEEP. I TAKE TYLENOL FOR PAIN IN MY STOMACH AND SOMETIMES IN MY LOWER ABDOMINAL AREA. I HAVE MAJOR LOWER BACK PAIN DAILY, ALSO NECK PAIN DAILY. JOINT PAIN AND NUMBNESS IN EXTREMITIES. MY FEET AND HANDS ARE EXTREMELY TENDER. MY SYMPTOMS ALL STARTED AFTER I GOT ESSURE. I WAS TO DOCTORS TO FIND OUT WHAT WAS WRONG, ALL THEY WOULD SAY IS I'M AS HEALTHY AS A HORSE. I WOULD ASK IF YOU MEANT A DYING HORSE. FINALLY GOT A DOCTOR TO SEEK INTO MORE OF MY MEDICAL ISSUES. SHE SENT ME FOR ULTRASOUNDS AND FOUND NOTHING, WRONG, BUT I AM AS OF RIGHT AWAITING FOR A HYSTERECTOMY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
350055 ESSURE ESSURE HHS BAYER

Patients

Seq Age Sex Outcome Treatment
1 30 YR Required Intervention| S