FDA Adverse Event Summary report: N

ESSURE

MDR report key: 3170017 · Received June 5, 2013

Report

Report Number
MW5030528
Date Received
June 5, 2013
Date of Event
June 26, 2012
Report Date
June 5, 2013
Manufacturer
CONCEPTUS
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAVE DONE ESSURE PROCEDURE PERMANENT CONTRACEPTION MADE BY CONCEPTUS, INC ON (B)(6) 2011. AFTER THREE MONTHS LATER, (B)(6) 2011 I HAVE DONE MY F/U ON ESSURE DOING HSG PROCEDURE. THE REPORT SAID MY FALLOPIAN TUBES 100% BLOCKED. AS SOON I GOT ESSURE MY PERIODS STARTED ACTING NOT NORMAL SUCH AS HEAVY BLEEDING, ABDOMINAL SHARP PAIN, MISSING PERIODS. DURING THE INTERCOURSE, I DEFINITELY FEEL THE COILS INSIDE OF ME THAT IS VERY UNCOMFORTABLE. IN (B)(6) 2012, I HAVE MISSED MY PERIODS, CAME TO THE DOCTOR COMPLAINING ABOUT ALL OF THIS. I DID AND IT WAS NEGATIVE. NEXT MONTH, I HAVE SOME SPOTTING DURING MY PERIODS. ANOTHER MONTH, I HAVE MISSED MY PERIODS AGAIN. IN (B)(6), I WAS TRAVELING TO ANOTHER COUNTRY, WENT TO THE STORE AND HAVE HAD A HEAVY BLEEDING MISCARRIAGE. I WAS TRANSPORTED TO THE HOSPITAL WHERE THE DOCTOR HAS CONFIRMED A FACT OF MISCARRIAGE. CAME BACK HOME, WENT TO MY OB. HE DID ULTRASOUND AND BLOOD WORK. HE HAS CONFIRMED I WAS ABOUT 3 MONTHS PREGNANT. I WAS VERY FRUSTRATED AND SHOCKED. I HAVE BOUGHT A SOLUTION (ESSURE) THAT DOESN'T WORK AND PUT MY LIFE IN DANGER. NOW, I HAVE TO REMOVE IT DOING A MAJOR SURGERY. ON THE TOP OF IT, I HAVE TO LOSE MY ORGANS DUE TO THE COILS CAN'T BE REMOVED BY ITSELF. YET, I HAVE TO COVER ALL FINANCIAL EXPENSES RELATED TO ESSURE. THIS PRODUCT MUST BE OUT OF MARKET TO PREVENT RUINING WOMEN'S LIVES AND HEALTH. REASON FOR USE: PERMANENT CONTRACEPTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
249986 ESSURE ESSURE HHS CONCEPTUS

Patients

Seq Age Sex Outcome Treatment
1 46 YR Hospitalization| O| R