Description of Event or Problem · 1
THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A (B)(6) YEARS OLD FEMALE CONSUMER IN UNITED STATES ON (B)(4) 2014. SHE HAD MIRENA (LEVONORGESTREL) INSERTED AND HAD ONLY 3 PERIODS WHILE ON MIRENA. AFTER THAT SHE HAD HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED DIZZY SPELLS, ITCHING EVERYWHERE "HEAD TO TOE", CONSTANT PELVIC PAIN, RIGHT OVARY WAS CONSTANTLY PAINFUL, SHE HAS NOT HAD A NORMAL PERIOD SINCE ESSURE INSERTED, EXTREMELY HEAVY BLEEDING DURING PERIOD/BLEEDING LIKE SHE WAS DELIVERING A CHILD AND THAT SHE MIGHT BE ALLERGIC TO NICKEL. ADD'L INFO RECEIVED ON (B)(4) 2014. ON INFO GIVEN ON CONSUMER'S HISTORY, PAST DRUGS, CONCURRENT CONDITIONS OR CONCOMITANT MEDICATION. IN (B)(6) 2008, THE CONSUMER HAD MIRENA (LEVONORGESTREL) INSERTED AT 20MCG/24 HR CONTINUOUS INTRAUTERINE. IT WAS NOT CLEAR WHETHER MIRENA WAS USED PREVIOUSLY OR NOT. SHE REPORTED THAT SHE HAD ONLY 3 PERIODS WHILE ON MIRENA. THE IUS WAS REMOVED ON (B)(6) 2013. ON (B)(6) 2013, SHE HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED FOR CONTRACEPTION WITH LOT NUMBER B02261. ABOUT 2 MONTHS AFTER PROCEDURE, SHE STARTED EXPERIENCING DIZZY SPELLS IN PARTICULAR WHEN SHE GOT OUT OF BED; SHE HAD TO HOLD ON BECAUSE SHE FELT LIKE SHE WAS GOING TO FALL. SHE ALSO STATED THAT SHE STARTED ITCHING EVERYWHERE FROM HEAD TO TOE; SHE WOULD WAKE UP AND BE BLEEDING BECAUSE SHE SCRATCHED SO MUCH. SHE WAS IN CONSTANT PELVIC PAIN AND HER RIGHT OVARY WAS CONSTANTLY PAINFUL. SHE HAS NOT HAD A NORMAL PERIOD SINCE ESSURE WAS INSERTED AND COMPLAINED OF EXTREMELY HEAVY BLEEDING DURING PERIOD, CHANGING PADS AND CLOTHES MULTIPLE TIME A DAY, AND STATED THAT SHE WAS BLEEDING LIKE SHE WAS DELIVERING A CHILD. SHE CONSIDERED THAT MIGHT BE ALLERGIC TO NICKEL AND HAD NO PREVIOUS DIAGNOSIS OF NICKEL ALLERGY. SHE WILL HAVE A HYSTERECTOMY TO HAVE ESSURE REMOVED. THE REPORTER'S CAUSALITY WAS NOT PROVIDED. F/U INFO WAS RECEIVED ON (B)(4) 2014. CASE HAS BEEN UPGRADED TO INCIDENT DUE TO A HYSTERECTOMY. IN (B)(6) 2013, AN ULTRASOUND AND HSG (HYSTEROSALPINGOGRAM) WERE PERFORMED AND SHOWED THE COILS WERE IN PLACE. ON (B)(6) 2014, SHE HAD A TOTAL VAGINAL HYSTERECTOMY WHICH WAS MEDICALLY NECESSARY BECAUSE OF ALL THE PROBLEMS SHE WAS HAVING. TVAH WAS REPORTED AS THE PROCEDURE USED FOR THE ESSURE REMOVAL. SHE WAS TOLD THAT THE COILS WERE STICKING OUT OF THE TUBES AND PUNCTURING UTERUS. THERE WERE NO SIGNS AND SYMPTOMS OF INFECTION. AFTER ESSURE REMOVAL PROCEDURE, THE LOW BACK PAIN AND DIZZINESS RESOLVED. SHE WAS FEELING A LOT BETTER. IT WAS REPORTED THAT THE EVENTS WERE CAUSED BY THE ESSURE DEVICES BECAUSE SHE WAS FEELING SO MUCH BETTER EVEN THOUGH SHE DOES NOT HAVE SOME OF HER ORGANS ANYMORE, THE OUTCOME WAS RESOLVING. NO FURTHER INFO WAS PROVIDED.