BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4512620 · Received February 12, 2015

    Report

    Report Number
    2951250-2015-00088
    Event Type
    Injury
    Date Received
    February 12, 2015
    Date of Event
    September 1, 2010
    Report Date
    March 21, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION RECEIVED ON 02-APR-2015: ESSURE WAS INSERTED ON (B)(6) 2010 AND IT WAS REMOVED ON (B)(6) 2013. FOLLOW UP INFORMATION ON 26-MAY-2015 FROM CONSUMER: CONSUMER'S DEMOGRAPHIC INFORMATION WAS PROVIDED, SHE WAS A (B)(6) OBESE FEMALE. HER MEDICAL HISTORY INCLUDED MIGRAINES. SHE WAS ALLERGIC TO NICKEL AND CERTAIN METALS TOO. AT THE TIME OF ESSURE INSERTION, SHE WAS 3-4 MONTHS POST-PARTUM. DEPO SHOT WAS USED AS BACK UP CONTRACEPTION. CONSUMER STATED HER BODY REJECTED ESSURE. ABOUT THREE WEEKS AFTER PLACEMENT, SHE WENT TO EMERGENCY ROOM (ER) WITH MASSIVE CRAMPING. SHE WAS DIAGNOSED WITH PID INFECTION (PELVIC INFLAMMATORY DISEASE) FROM THE IMPLANTATION OF COILS. SHE EXPERIENCED PERIODS EVERY TWO WEEKS (EXCESSIVE MENSTRUAL BLEEDING - HEAVY AND PAINFUL) OR SKIPPED PERIODS, EXCESSIVE PAIN IN LEFT SIDE LIKE A KNIFE STICKING HER, CRAMPS SO BAD SHE COULD NOT STAND UP, CLOTS OR TISSUE IN MENSTRUAL BLEEDING, FAINTING, BLACK OUT SPELLS, FATIGUE, INCREASED MIGRAINES, BLURRY VISION, FLOATERS, WEIGHT GAIN, CONSTIPATION, BLOATING, DIARRHEA, NAUSEA, DIZZY SPELLS, FOGGY BRAIN, BACK PAIN, INCREASED UTI'S (URINARY TRACT INFECTIONS) AND RANDOM RASHES\HIVES. SHE WENT TO NEUROLOGIST AND HAD TESTS DONE. HER MIGRAINES INCREASED IN SEVERITY, DURATION, AND NUMBERS OF HEADACHES PER MONTH DOUBLED. SHE WAS EXPERIENCING CONFUSION WITH THE HEADACHES. ALL OF HER MEDICATIONS INCREASED BECAUSE OF THE NEUROLOGICAL DIFFICULTIES INCREASING. SHE WAS SENT TO A GASTROENTEROLOGIST WHO ALSO PERFORMED A LOT OF TESTS TO TRY AND EXPLAIN THE BLOATING, CONSTIPATION, DIARRHEA, LEFT SIDE PAIN. THEY ALSO HAD NO ANSWERS. HER REGULAR DOCTOR PUT HER ON PREVENTATIVE ANTIBIOTICS TO TRY AND GET THE UTI INFECTIONS UNDER CONTROL. THERE WAS NO EXPLANATION FOR THE RANDOM RASHES THAT STARTED WITH THE COIL PLACEMENT. LAB WORK SHOWED SHE WAS NOT PREMENOPAUSAL. SHE BECAME SO SICK AND FINALLY FILED FOR DISABILITY. THE NEUROLOGICAL ISSUES AND PAIN ISSUES FROM INTERNAL FEMALE ORGANS BECAME TOO MUCH FOR HER TO WORK. IN 2012, COILS WERE REMOVED. A TUBAL LIGATION WAS PERFORMED TO REMOVE THEM AND SHE WAS ASSURED ALL PARTS OF THE COILS WERE GONE. SOME OF HER SYMPTOMS GOT BETTER. HER HEADACHES WERE A LESS AND PERIOD WENT BACK TO BEING EVERY 28 DAYS. HER PERIODS BECAME PRETTY NORMAL WITH AN OCCASIONAL HEAVY ONE. SHE STOPPED FAINTING AND HAVING BLACK OUT SPELLS. SHE STILL COULD NOT LOSE WEIGHT AND WAS EXPERIENCING BLOATING, HIVES/RASHES AND LEFT SIDE PAIN. THE BACK PAIN AND LEFT SIDE PAIN WERE STILL INTENSE AND SHE WAS STILL EXPERIENCING CHRONIC UTI SYMPTOMS, FATIGUE, FOGGY BRAIN, FLOATERS DIZZY SPELLS, HIVES/RASHES, NAUSEA, CONSTIPATION, DIARRHEA AND PAIN IN UTERUS AND LEFT SIDE PAIN. IN 2013 SHE KEPT GETTING TREATED FOR URINARY SYMPTOMS, PRESSURE, WOMEN INFECTIONS, AND LEFT SIDE PAIN WITH EXTREME BACK PAIN. SHE GOT HIVES SO BAD SHE HAD TO GO TO ER AND GET MEDS. DOCTOR ALSO SAID SOMETHING AUTO IMMUNE WAS GOING ON. THE HIVES CLEARED UP AND SHE WAS EXPERIENCING A RANDOM RASH ALL OVER HER BACK, WHICH COMES AND GOES. ON ONE ER VISIT IN 2014 FOR THE PAIN AND ALL THESE SYMPTOMS THEY THOUGHT SHE WAS PASSING A KIDNEY STONE AND DID A CT SCAN. THEY FOUND THAT IN HER LEFT SIDE OF WOMB THAT A PIECE OF THE COIL WAS LEFT INSIDE OF HER AFTER THE COILS WERE SUPPOSED TO BE REMOVED. LT WAS THE EXACTLY LEFT SIDE PAIN SPOT THAT WAS HURTING FROM SINCE THE COIL PLACEMENT. SHE STATED THAT ESSURE COILS ARE DEFECTIVE AND UNSAFE AND THAT SHE FILED A COMPLAINT WITH THE FDA IN 2012. ON (B)(6) 2015 SHE HAD CONSULTATIONS FOR HYSTERECTOMY FOR THE LEFT FRAGMENTS. ON (B)(6) 2015, SHE WENT TO THE ER DUE TO PELVIC PAIN AND BLEEDING. ON (B)(6) 2015, HYSTERECTOMY WAS PERFORMED. ESSURE WAS REMOVED. CONSUMER RELATED EVENTS TO ESSURE. FOLLOW UP INFORMATION RECEIVED ON 02-JUN-2015: THE PTC ASSESSMENT WAS UPDATED WITHOUT MAJOR CHANGES. FOLLOW-UP RECEIVED ON 12-JUN-2015: INFORMATION RECEIVED FROM CONSUMER STATES THAT SHE STILL HAS LEFT SIDE PAIN. REPORTER ALSO INFORMED THAT SHE CRASHED AFTER HER RECENT SURGERY AND SHE JUST FINISHED TWO WEEKS ON OXYGEN. THE MAGNETIC RESONANCE IMAGE SHOWED A PIECE OF METAL SO SHE HAD A HYSTERECTOMY A COUPLE OF WEEKS AGO AT UROGYNECOLOGY. SHE HAD INFECTIONS TOO AND POSSIBLE ENDOMETRIOSIS. IN ADDITION, CONSUMER STATES THAT SHE WENT FROM A LADIES SIZE 12 TO A SIZE 2X AND THEN BACK DOWN. NOW SHE HAS NO INSIDE MUSCLES AND HER BLADDER COLLAPSED. ACCORDING TO REPORTER, BEFORE THE ESSURE INSERTION, SHE TOLD DOCTOR THAT SHE WAS ALLERGIC TO NICKEL AND STATES THAT SHE SWELLS FROM NICKEL. DOCTOR TOLD HER NOT TO WORRY ABOUT THE AMOUNT OF NICKEL. AFTER ESSURE, SHE HAD BAD MIGRAINES, WORSE THAN PREVIOUSLY. HER NEUROLOGIST ASKED HER WHAT HAS CHANGED AND HE IS THE ONE WHO SUGGESTED CONSUMER'S WORSENING MIGRAINES COULD BE FROM THE ESSURE SINCE THAT IS THE ONLY THING THAT HAD CHANGED. CONSUMER REPORTED THAT THE SAME PHYSICIAN DID THE ESSURE INSERTION AND THE REMOVAL. NO MRI WAS DONE (SHE WAS DENIED BY HER INSURANCE). ACCORDING TO CONSUMER, THE FIRST TWO WEEKS AFTER THE ESSURE INSERTION, SHE WAS IN THE EMERGENCY ROOM. HER SYMPTOMS THEN KEPT WORSENING FOR 4 YEARS AND SHE IS STILL BLOATING AND STILL HAS LEFT SIDE PAIN. CONSUMER NEVER PASSED OUT BEFORE THE ESSURE AND STATES THAT IT HAS CALMED DOWN SINCE THE ESSURE REMOVAL. SHE IS NOT PASSING OUT ANYMORE FROM THE MIGRAINES. SHE HAD A PREVIOUS HISTORY OF MIGRAINES BUT NOTHING LIKE THE HEADACHES AFTER ESSURE INSERTION. SHE NEEDS TO HAVE PELVIC PHYSICAL THERAPY FOR THE NEXT 8 WEEKS. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD PID (PELVIC INFLAMMATORY DISEASE) INFECTION 3 WEEKS AFTER ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION. ADDITIONALLY, SHE WAS SUBMITTED TO DEVICES REMOVAL. LATER, IT WAS DISCOVERED THAT ESSURE BROKE APART AND METAL WAS LEFT IN HER UTERUS (INTERPRETED AS DEVICE BREAKAGE). SHE WAS SUBMITTED TO A HYSTERECTOMY. ALL EVENTS ARE SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE AND ACCORDING TO PRODUCT TECHNICAL ANALYSIS (PTC). UPPER GENITAL TRACT INFECTIONS, ALSO REFERRED TO AS PELVIC INFLAMMATORY DISEASES (PIDS), OCCUR WHEN MICROORGANISMS ASCEND FROM THE LOWER GENITAL TRACT, INFECTING THE UTERUS, FALLOPIAN TUBES AND OVARIES. WHILE ESSURE SYSTEM IS STERILE IT MAY, DUE TO A BACTERIAL CONTAMINATION DURING INSERTION, BECOME A VEHICLE FOR MICROBIAL TRANSPORT IN THE UPPER GENITAL TRACT. THIS MAY EXPLAIN AN INCREASED RISK FOR PELVIC INFECTIONS AFTER INSERTION PROCEDURE. IN THIS CASE, CONSUMER WAS DIAGNOSED WITH PID ABOUT 3 WEEKS AFTER ESSURE INSERTION. THEREFORE, A CAUSAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. WITH REGARDS TO THE DEVICE BREAKAGE, SINCE IT OCCURRED DURING ESSURE REMOVAL, A CAUSAL RELATIONSHIP CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT DUE TO THE REQUIRED MEDICAL AND SURGICAL INTERVENTIONS FOR DEVICES/FRAGMENTS REMOVAL AND FOR PID'S TREATMENT. ADDITIONALLY, OTHER SERIOUS EVENTS BLACK OUT SPELLS, CRASHED AFTER MY RECENT SURGERY AND JUST FINISHED 2 WEEKS ON OXYGEN, POSSIBLE ENDOMETRIOSIS AND INFECTIONS (UNRELATED TO ESSURE) WERE REPORTED WITH SEVERAL NON-SERIOUS EVENTS. THE PTC ANALYSIS CONCLUDED THAT, BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT. NO FURTHER INFORMATION IS EXPECTED.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A FEMALE CONSUMER OF UNSPECIFIED AGE VIA REGULATORY AUTHORITY (CASE# (B)(4)) IN UNITED STATES ON (B)(4) 2015 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. SHE STATED HER STORY STARTED IN 2010, AFTER HER THIRD CHILD WAS BORN. SHE DECIDED TO GET AN ESSURE PLACEMENT FOR BIRTH CONTROL. HER BODY IMMEDIATELY REJECTED IT. SHE NEVER HAD WOMEN ISSUES LIKE THIS UNTIL THE ESSURE PLACEMENT. BEFORE PREGNANCY AND PLACEMENT OF COILS, SHE WAS A HEALTHY WOMAN RUNNING 2 MILES A DAY. ABOUT 3 WEEKS AFTER PLACEMENT, SHE WENT TO THE EMERGENCY ROOM WITH MASSIVE CRAMPING AND WAS DIAGNOSED WITH A PID (PELVIC INFLAMMATORY DISEASE) INFECTION FROM THE IMPLANTATION OF THE COILS. SHE HAS NOT BEEN OUT OF PAIN SINCE; ESPECIALLY THE LEFT SIDE PAIN. SHE STARTED EXPERIENCING THE FOLLOWING: PERIODS EVERY TWO WEEKS OF SKIPPED PERIODS, EXCESSIVE PAIN IN THE LEFT SIDE (LIKE A KNIFE STICKING INTO YOU), CRAMPS SO BAD SHE COULD NOT STAND UP, EXCESSIVE MENSTRUAL BLEEDING, CLOTS OR TISSUE IN MENSTRUAL BLEEDING, FAINTING, BLACK OUT SPELLS, FATIGUE, INCREASED MIGRAINES, BLURRY VISION, FLOATERS, WEIGHT GAIN, CONSTIPATION, BLOATING, DIARRHEA, NAUSEA, DIZZY SPELLS, FOGGY BRAIN, BACK PAIN, INCREASED UTI (URINARY TRACT INFECTION) AND RANDOM RASHES/HIVES. SHE HAD THE COILS REMOVED AND TUBES REMOVED IN 2013 AND DISCOVERED IN 2014, THEY BROKE APART AND METAL WAS LEFT IN HER UTERUS. SHE STATED MAY NEED A HYSTERECTOMY NOW. THE PRODUCT TECHNICAL COMPLAINT (PTC) INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED ON (B)(4) 2015. THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4). FINAL ASSESSMENT: THIS IS REPORT FROM AN UNKNOWN PATIENT WITH NO CONTACT INFORMATION TO CONDUCT A FOLLOW-UP. THE SYMPTOMS REPORTED COULD NOT BE CONFIRMED. NO DEVICE BREAKAGE COULD BE CONFIRMED. SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. MEDICAL ASSESSMENT: THIS PTC WAS INITIATED DUE TO A PRODUCT QUALITY ISSUE AND A USABILITY ISSUE. IN THIS PARTICULAR CASE A BREAKAGE WAS REPORTED IN THE CONTEXT OF A COMPLICATED DEVICE REMOVAL. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED UNCONFIRMED QUALITY DEFECT. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NO BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. THE REPORTED ADVERSE EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PID (PELVIC INFLAMMATORY DISEASE) INFECTION. AFTER ESSURE REMOVAL, IT WAS DISCOVERED THAT ESSURE BROKE APART AND METAL WAS LEFT IN HER UTERUS (INTERPRETED AS DEVICE BREAKAGE). PID (PELVIC INFLAMMATORY DISEASE) INFECTION IS SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. BROKE APART AND METAL WAS LEFT IN HER UTERUS IS NON-SERIOUS AND LISTED. UPPER GENITAL TRACT INFECTIONS, ALSO REFERRED TO AS PELVIC INFLAMMATORY DISEASES (PIDS), OCCUR WHEN MICROORGANISMS ASCEND FROM THE LOWER GENITAL TRACT, INFECTING THE UTERUS, FALLOPIAN TUBES AND OVARIES. WHILE ESSURE SYSTEM IS STERILE IT MAY, DUE TO A BACTERIAL CONTAMINATION DURING INSERTION, BECOME A VEHICLE FOR MICROBIAL TRANSPORT IN THE UPPER GENITAL TRACT. THIS MAY EXPLAIN AN INCREASED RISK FOR PELVIC INFECTIONS AFTER INSERTION PROCEDURE. IN THIS CASE, CONSUMER WAS DIAGNOSED WITH PID ABOUT 3 WEEKS AFTER ESSURE INSERTION. THEREFORE, GIVEN A COMPATIBLE TEMPORAL RELATIONSHIP BETWEEN THIS EVENT AND SUSPECT INSERT, A CAUSAL RELATIONSHIP CANNOT BE EXCLUDED. WITH REGARDS TO THE DEVICE BREAKAGE, SINCE IT OCCURRED DURING ESSURE REMOVAL, A CAUSAL RELATIONSHIP CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE THE COILS AND TUBES WERE REMOVED. ADDITIONALLY, OTHER SERIOUS EVENT BLACK OUT SPELLS (UNRELATED TO ESSURE) WAS ADDED AND SEVERAL NON-SERIOUS EVENTS WERE ADDED. PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT (NO BATCH NUMBER WAS PROVIDED). MEDICAL PTC ASSESSMENT CONSIDERED THAT, BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT. NO FURTHER INFORMATION IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104434 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 689934(VALID)/ 646623(INVALID)

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other| R DEPO PROVERA| DEPO PROVERA| DEPO PROVERA (MEDROXYPROGESTERONE)