Description of Event or Problem · 1
CASE STATUS: SERIOUS - UNLISTED - RELATED - INCIDENT. THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (MW5034677) IN UNITED STATES ON (B)(6) 2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE ((B)(4)) (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PELVIC CONGESTION SYNDROME, MIGRAINES, BACK PAIN, HEAVY MENSES, BLOOD CLOTS, PELVIC PAIN, SHARP STABBING PAIN ON MY LEFT SIDE OF MY PELVIC AREA. ENDOMETRIOSIS, YEAST INFECTIONS, VAGINOSIS, PID, INFLAMMATION IN MY LOWER ABDOMEN, AND SEVERAL CYSTS ON MY LEFT OVARY. NO INFO GIVEN ON CONSUMER'S HISTORY, PAST DRUGS AND CONCURRENT CONDITIONS. IT WAS NOT REPORTED WHETHER THE CONSUMER RECEIVED ANY CONCOMITANT MEDICATION. ON (B)(6) 2007 THE CONSUMER HAD ESSURE ((B)(4)) (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AT UNK. IT WAS UNK WHETHER ESSURE ((B)(4)) WAS USED PREVIOUSLY. SHE WAS IMPLANTED WITH ESSURE BIRTH CONTROL IN HER FALLOPIAN TUBES IN 2007. A YEAR LATER SHE WAS SUFFERING WITH A NUMBER OF PAINFUL SYMPTOMS: MIGRAINES, BACK PAIN, HEAVY MENSES, BLOOD CLOTS, PELVIC PAIN, SHARP STABBING PAIN ON MY LEFT SIDE OF MY PELVIC AREA. I HAD A NUMBER OF INFECTIONS THROUGH OUT THE YEARS FROM YEAST INFECTIONS, VAGINOSIS AND PID. I WAS ALSO DIAGNOSED WITH ENDOMETRIOSIS, PELVIC CONGESTION SYNDROME FROM ALL THE INFLAMMATION IN MY LOWER ABDOMEN, AND SEVERAL CYSTS ON MY LEFT OVARY. SHE HAD TO HAVE A HYSTERECTOMY TO FINALLY REMOVE COILS AND FEMALE ORGANS. WAS ONLY LEFT WITH HER RIGHT OVARY. HER PROCEDURE WAS DONE ON (B)(6) 2013.