FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 4346456 · Received December 19, 2014

Report

Report Number
MW5039651
Event Type
Injury
Date Received
December 19, 2014
Date of Event
October 1, 2011
Report Date
November 14, 2014
Manufacturer
BAYER
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

(B)(4). I STARTED NOTICING VERY HEAVY BLEEDING ( I HAVE TO LINE MY UNDERWEAR WITH 2 TO 3 OF THE OVERNIGHT PADS EACH TIME I HAVE MY MENSTRUATION AND WITH EACH CHANGING OF THOSE PADS I HAVE TO REPLACE THEM WITH 2 TO 3 PADS EACH TIME INCREASING MY FINANCIAL EXPENSES ON FEMININE PRODUCTS), PAINFUL MENSTRUAL CYCLES, EXTENDED MENSTRUAL CYCLES. AS I CONTINUED FOR THE LAST FEW YEARS I HAVE NOTICED ODD ALLERGY REACTIONS TO DIFFERENT THINGS THAT NORMALLY WOULDN'T GIVE ME AN ODD REACTION. HAIR LOSS, SKIN CHANGES, HORMONE CHANGES, AND NOW RECENTLY SEVER BACK PAIN THAT NEVER ENDS. ODD ABDOMINAL PAINS AND TWITCHING THAT FEEL LIKE THERE IS A KICKING BABY INSIDE, BUT THERE ISN'T ONE. I SEEM TO GET SICK MUCH MORE EASILY THAN I HAD IN THE PAST. ODD METALLIC TASTES FROM TIME TO TIME. EASY BRUISING WITH NO REAL CAUSE. I WAS ALSO TOLD THIS PROCEDURE COULD BE REVERSED, AND NOW I HAVE FOUND OUT THAT IT CANNOT BE. WEIGHT GAIN FOR NO REAL APPARENT REASON. MY DIET OR EXERCISE PLANS HAVE CHANGED. DRS TELL ME MY ONLY HOPE TO BE RELIEVED OF A LOT OF MY CONDITIONS THAT I HAVE ACQUIRED DUE TO THIS DEVICE IS TO HAVE A HYSTERECTOMY. I WANTED TO ALSO HAVE ANOTHER BABY, AND NOW I AM ALSO TOLD THAT THAT MAY NOT BE A POSSIBILITY DUE TO THIS DEVICE. THAT I THINK HURTS THE MOST. WHY WASN'T I WARNED THESE THINGS COULD HAPPEN? MY LIFE IS NEVER GOING TO BE THE SAME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
835598 ESSURE HHS BAYER

Patients

Seq Age Sex Outcome Treatment
1 32.000 YR Other| S