FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 4953225 · Received July 24, 2015

Report

Report Number
MW5044917
Event Type
Injury
Date Received
July 24, 2015
Date of Event
October 1, 2010
Report Date
July 24, 2015
Manufacturer
BAYER CORP
Product Code
HHS
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAD 5 YRS OF PROBLEMS CAUSED BY ESSURE. LAST YEAR HAS BEEN THE WORST OF MY LIFE STRUGGLE OF PAIN, IN TERMS OF ASSET PROBLEMS AND ASSISTANCE TO DRUGS. A YEAR AGO I BEGAN TO HAVE UNIMAGINABLY HARD LOW BACK AND PELVIC PAIN. PAIN "BEAMED" THIGH AND THE BLADDER WAS FEELING THE PRESSURE. IN ADDITION, MY BREASTS WERE SO SORE THAT I COULD NOT EVEN SLEEP AT NIGHT WITHOUT SPORTS JACKETS. SOUGHT MEDICAL ATTENTION SEVERAL TIMES (INTERNAL MEDICINE PHYSICIAN, GENERAL PRACTITIONER, WORK PLACE PHYSICIAN, GYNECOLOGIST). MY BACK WAS FILMED AND THE CAUSE IS NOT FOUND. I HAD TO BE ON SICK LEAVE FOR LONG PERIODS OF TIME. IN (B)(6) 2015, THE ESSURE IMPLANT CAME OUT WITH MENSTRUAL CYCLE. I ORDERED MYSELF LUMBAR SPINE A YEAR AGO, CAPTURED IMAGES AND EVEN A LAYMAN. I NOTICED THAT ALREADY THEN THE SECOND IMPLANT IS NOT INSERTED. IN (B)(6) I WENT SECTION, WHICH WAS INTENDED TO REMOVE THE SECOND ESSURE IMPLANT AND AT THE SAME TIME MAKE ME STERILE. AFTER THE SURGERY, I READ SECURITIES, THAT THE IMPLANT HAS NOT BEEN AWAY, AS IT WAS INTO THE MYOMETRIUM. FOR NOW I DON'T KNOW IF THERE IS ANY PIECES OF OUTGOING IMPLANT OR I DON'T EXACTLY KNOW WHERE THE OTHER ONE IS. PAIN AND MANY OTHER SYMPTOMS ARE STILL EVERYDAY PROBLEMS. SYMPTOMS I HAVE BEFORE ESSURE: SWELLING, ANTIQUE (I DO NOT FEEL REFRESHED), APPETITE (I CANNOT START ANY), SKIN DISORDERS (ACNE PIMPLES), BREAST TENDERNESS, TOOTH BLOOD LEAKAGE, RINGING IN THE EARS, ALLERGY (CONSTANT RUNNY NOSE AND SNEEZING), CYSTS IN BREASTS, GROIN PAIN, HAIR LOSS, VERY PAINFUL MENSTRUATION, LEUKOCYTE VALUES ARE HIGH, GOITER. MANY OF THESE SYMPTOMS WAS DIAGNOSED BY DOCTOR.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
481686 ESSURE ESSURE HHS BAYER CORP ESS305 678817

Patients

Seq Age Sex Outcome Treatment
1 42 YR Hospitalization| S