FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 6890762 · Received September 25, 2017

Report

Report Number
MW5072396
Event Type
Injury
Date Received
September 25, 2017
Date of Event
December 31, 2005
Report Date
July 25, 2017
Manufacturer
BAYER
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

(B)(4). IT'S BEEN 12 YEARS SINCE THIS NIGHTMARE STARTED , TRUSTED A GYNECOLOGIST WHO SWORE THIS DEVICE IMPLANTED IN ME WOULD BE ABSOLUTELY 100% SAFE, HOWEVER I AM BARELY ABLE TO FUNCTION AND ENJOY THE SIMPLEST PARTS OF MY DAY DUE TO THE HORRENDOUS SIDE EFFECTS IT HAS BROUGHT UPON MY LIFE AS WELL AS HUNDREDS OF OTHER WOMEN'S LIVES. NOT TO MENTION THE EXPENSE OF EVERY MEDICAL AND HOSPITAL VISIT AS I TRIED TO FIGURE OUT EXACTLY WHAT WAS DETERIORATING MY HEALTH. IT'S BEEN 12 YEARS NOW AND I SUFFER FROM VERTIGO ATTACKS, NAUSEA, BLOATING AND CRAMPING OF LIMBS, SEVERE PELVIC PAIN, SEVERE MIGRAINES, SPINAL PAIN, DEPRESSION, UNCONTROLLABLE STRESS AND INABILITY TO MAINTAIN A CONSTANT MOOD. ALONG WITH HAIR LOSS, LOSS OF APPETITE, DIFFICULTY USING THE BATHROOM, BURNING SENSATION IN MY LOWER AREA, AND AMONG MANY OTHER EXTREMELY PAINFUL SIDE EFFECTS THAT PREVENT DAILY FUNCTION WHICH ARE REACHING PERMANENT DAMAGE DUE TO THE MIGRAINES SERIOUSLY AFFECTING MY VISION. MY DEVICE WAS PROVIDED BY MY INSURER (B)(6) AND I AM DEMANDING ACTION TO STOP PRODUCTION OF THIS DEVICE AND FOR REPARATIONS TO THE PAIN I HAVE SUFFERED AND AM CURRENTLY SUFFERING IN AN ESCALATED RATE DUE TO NEGLIGENCE ON BEHALF OF THE GYNECOLOGIST AT THE TIME; AND THE COMPANY THAT PRODUCED THE DEVICE FOR NOT WARNING OF THESE SIDE EFFECTS AND CONTINUING TO PUSH IT AMONG WOMEN REGARDLESS OF THE SEVERE DANGERS THAT ARE BEING REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
669523 ESSURE HHS BAYER

Patients

Seq Age Sex Outcome Treatment
1 45.000 YR Hospitalization| L| O| R| S