FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 5010935 · Received August 18, 2015

Report

Report Number
MW5055453
Event Type
Injury
Date Received
August 18, 2015
Date of Event
June 9, 2010
Report Date
July 28, 2015
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 WAS IMPLANTED WITH A MEDICAL DEVICE IMPLANT CALLED ESSURE ON (B)(6) 2009. THIS MEDICAL DEVICE IMPLANT IS NOW MANUFACTURED BY BAYER, FORMALLY BY CONCEPTUS INC. THE ONSET OF MY COMPLAINT STARTED AROUND (B)(6) 2010. THIS IS A LIST OF MY SIDE EFFECTS AND SYMPTOMS THAT I HAVE EXPERIENCED DUE TO ESSURE OVER THE PAST FIVE YEARS. NOT ALL HAPPENED AT THE SAME TIME SO I DIDN'T CONNECT ALL THE SYMPTOMS UNTIL RECENTLY. SYMPTOMS HAVE INCLUDED: INCREASED HEADACHES/MIGRAINES, BRAIN FOG, JOINT PAIN, BACK PAIN, EXTREME FATIGUE, PAINFUL PERIODS, PROLONGED PERIOD, MASSIVE/SEVERE BLOATING, UNEXPLAINED BLISTERS/LESIONS ON HANDS, HOT FLASHES, STABBING PAIN AT OPENING OF VAGINAL AREA, EXTREME TENDERNESS (SOMETIME PAIN) IN BREAST, LUMPS IN BREAST/ARMPIT THAT ARE PAINFUL AND GO AWAY AFTER A FEW WEEKS, UNCONTROLLABLE PAIN IN LEGS, SWELLING OF FEET, BRUISES OF UNKNOWN ORIGIN, EXTREME FATIGUE, WEIGHT GAIN, BLURRY VISION, NO ENERGY, SEVERE CONSTIPATION (ENEMA, LAXATIVES, SOFTENERS, FIBER, ETC DOESN'T WORK), MAJOR MOOD SWINGS, FORGETFULNESS, BAD TASTE IN MOUTH, SKIN ON BACK ITCHES ALL THE TIME, URGE TO URINATE ALL THE TIME/INABILITY TO HOLD URINE, MARBLE SIZE CYSTS AT VAGINAL OPENING (TWICE), DISCHARGE/ODOR FROM VAGINA, SHARP PAINS IN ABDOMEN (ALWAYS THINK I'M HAVING APPENDICITIS), SEVERE ALLERGIES (NEVER HAD AN ISSUE BEFORE), NUMBNESS/TINGLING ALONG MY SPINE, HAIR GROWTH ON CHIN. I HAVE BEEN SEEN BY MULTIPLE DOCTORS. NO DOCTORS CAN COME UP WITH A REASONABLE EXPLANATION FOR MY SYMPTOMS. THE DEVICE IS STILL INSIDE OF ME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
545821 ESSURE HHS BAYER

Patients

Seq Age Sex Outcome Treatment
1 42.000 YR Other