FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 3793573 · Received May 6, 2014

Report

Report Number
MW5035920
Event Type
Injury
Date Received
May 6, 2014
Date of Event
April 1, 2011
Report Date
April 15, 2014
Manufacturer
BAYER
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I WAS IMPLANTED WITH A MEDICAL DEVICE IMPLANT CALLED ESSURE IN (B)(6) 2010. THIS MEDICAL DEVICE IMPLANT IS NOW MANUFACTURED BY BAYER, FORMALLY BY CONCEPTUS INC. MY LOT NUMBER FOR THE LEFT SIDE IS #686083 AND THE LOT NUMBER FOR THE RIGHT SIDE IS #12407573. MY MODEL NUMBER FOR THE RIGHT SIDE IS ESS305-R1 AND THE MODEL NUMBER FOR THE LEFT SIDE IS ESS305. THIS DEVICE HAS A THREE YEAR SHELF LIFE, HOWEVER, I DO NOT HAVE THAT EXPIRATION DATE. THE ONSET OF MY COMPLAINTS STARTED IN (B)(6) 2011. THIS IS A LIST OF MY SIDE EFFECTS AND SYMPTOMS THAT I HAVE EXPERIENCED DUE TO ESSURE. NO MENSUS FOR 14 MONTHS AND WHEN IT RETURNED, IT WAS EXTREMELY HEAVY WITH SEVERE CRAMPING AND CLOTTING. GYNO PUT ME ON BIRTH CONTROL TO REGULATE MY CYCLE TO 4X PER YEAR, HOWEVER, MY BODY WILL NOT WAIT THE FULL 12 WEEKS TO MENSTRUATE. I HAVE BREAK THROUGH BLEEDING A LOT. CHRONIC FATIGUE, SEVERE MIGRAINE HEADACHES, 35LB WEIGHT GAIN, MEMORY LOSS, BRAIN FOG AND CONFUSION AT TIMES, CONSTANT LOSS OF HAIR, NO ENERGY, BLOATING FROM JUST UNDER MY BREASTS ALL THE WAY DOWN TO MY HIPS (I LOOK 7 MO PREG), PELVIC PAIN THAT COME AND GOES, JOINT/MUSCLE PAIN, URINARY INCONTINENCE AND CONSTANT PRESSURE ON MY BLADDER THAT I HAVE TO WEAR A MAXI PAD EVERYDAY-ALL DAY, MY DEPRESSION AND ANXIETY HAVE INCREASED SIGNIFICANTLY THAT MY MEDS HAVE BEEN INCREASED, NIGHT SWEATS/HOT FLASHES, RASHES, 4 DIFFERENT BARTHOLIN CYSTS, LOWER BACK PAIN THAT FEELS LIKE LABOR, LEG/FOOT CRAMPS, DIZZINESS, SPOTTING AFTER SEXUAL INTERCOURSE. I HAVE RECENTLY BEEN SEEN BY ONE DOCTOR TO DISCUSS MY ISSUES. WE ARE LOOKING AT SCHEDULING A HYSTERECTOMY IN THE NEAR FUTURE. THE DEVICE IS STILL INSIDE OF ME. I JUST WANT MY LIFE BACK. I HAVE NOT FELT LIKE MYSELF FOR OVER 3 YEARS NOW. I HAVE TRULY BEEN MISERABLE AND MY FAMILY HAS HAD TO WATCH ME SUFFER. (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
272168 ESSURE HHS BAYER

Patients

Seq Age Sex Outcome Treatment
1 41.000 YR Other| S ESSURE