BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3952334 · Received July 17, 2014

    Report

    Report Number
    2951250-2014-00238
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    May 21, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON 02-MAR-2016 CONSUMER STATED THAT SHE WAS VICTIM OF ESSURE FOR 5 YEARS AND SHE IS FINALLY ESSURE FREE (2 YEARS). FOLLOW UP INFORMATION RECEIVED ON 04-MAR-2016: CONSUMER REPORTED THAT SHE COULD FEEL THE COILS POKING HER INSIDES. FOLLOW-UP RECEIVED ON 15-MAR-2016 SHE STATED SHE WAS IN PAIN, TAKING 3 - 4 NAPS A DAY. 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 PELVIC PAIN, BLEEDING, DAMAGES TISSUE AND INFLAMMATION RESPONSE ON FALLOPIAN TUBES AND LIVER. PELVIC PAIN, BLEEDING, INFLAMMATION RESPONSE ON FALLOPIAN TUBES (INTERPRETED AS SALPINGITIS) ARE SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED FOR ESSURE ACCORDING TO THE REFERENCE SAFETY INFORMATION. DAMAGES TISSUE ON FALLOPIAN TUBES (INTERPRETED AS PELVIC ORGAN INJURY), INFLAMMATION RESPONSE AND DAMAGES TISSUE ON LIVER ARE SERIOUS DUE TO MEDICAL IMPORTANCE AND UNLISTED. 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 PARTICULAR CASE, IT WAS NOT REPORTED WHETHER DAMAGES TISSUE AND INFLAMMATION RESPONSE ON FALLOPIAN TUBES OCCURRED UP TO 4 WEEKS POST INSERTION. ALSO, THE TIME FROM ESSURE INSERTION AND THE OCCURRENCE OF PELVIC PAIN AND BLEEDING IS UNKNOWN. ALTHOUGH TEMPORAL RELATIONSHIP IS UNKNOWN, A CAUSAL RELATIONSHIP BETWEEN THESE EVENTS AND SUSPECT INSERT CANNOT BE TOTALLY EXCLUDED. WITH REGARDS TO THE EVENT INFLAMMATION RESPONSE AND DAMAGES TISSUE ON LIVER, SINCE LIMITED INFORMATION WAS PROVIDED AND GIVEN ESSURE'S LOCAL ACTION AT FALLOPIAN TUBES, CAUSALITY CAN BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE ESSURE WAS REMOVED. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED THAT THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. NO FURTHER INFORMATION IS EXPECTED.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    CASE CONSIDERED CLOSED ON 28-APR-2015. 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 PELVIC PAIN, BLEEDING, DAMAGES TISSUE AND INFLAMMATION RESPONSE ON FALLOPIAN TUBES AND LIVER. PELVIC PAIN, BLEEDING, INFLAMMATION RESPONSE ON FALLOPIAN TUBES (INTERPRETED AS SALPINGITIS) ARE SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED FOR ESSURE ACCORDING TO THE REFERENCE SAFETY INFORMATION. DAMAGES TISSUE ON FALLOPIAN TUBES (INTERPRETED AS PELVIC ORGAN INJURY), INFLAMMATION RESPONSE AND DAMAGES TISSUE ON LIVER ARE SERIOUS DUE TO MEDICAL IMPORTANCE AND UNLISTED. 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 PARTICULAR CASE, IT WAS NOT REPORTED WHETHER DAMAGES TISSUE AND INFLAMMATION RESPONSE ON FALLOPIAN TUBES OCCURRED UP TO 4 WEEKS POST INSERTION. ALSO, THE TIME FROM ESSURE INSERTION AND THE OCCURRENCE OF PELVIC PAIN AND BLEEDING IS UNKNOWN. ALTHOUGH TEMPORAL RELATIONSHIP IS UNKNOWN, A CAUSAL RELATIONSHIP BETWEEN THESE EVENTS AND SUSPECT INSERT CANNOT BE TOTALLY EXCLUDED. WITH REGARDS TO THE EVENT INFLAMMATION RESPONSE AND DAMAGES TISSUE ON LIVER, SINCE LIMITED INFORMATION WAS PROVIDED AND GIVEN ESSURE'S LOCAL ACTION AT FALLOPIAN TUBES, CAUSALITY CAN BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE ESSURE WAS REMOVED. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED THAT THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. NO FURTHER INFORMATION IS EXPECTED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON 31-JAN-2015: INFORMATION RECEIVED FROM CONSUMER STATES THAT DAMAGE TISSUE AND THE INFLAMMATION RESPONSE NEVER STOPS (FALLOPIAN TUBES AND LIVER). 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 PELVIC PAIN, BLEEDING, DAMAGES TISSUE AND INFLAMMATION RESPONSE ON FALLOPIAN TUBES AND LIVER. PELVIC PAIN, BLEEDING, INFLAMMATION RESPONSE ON FALLOPIAN TUBES (INTERPRETED AS SALPINGITIS) ARE SERIOUS DUE TO MEDICAL IMPORTANCE AND LISTED FOR ESSURE ACCORDING TO THE REFERENCE SAFETY INFORMATION. DAMAGES TISSUE ON FALLOPIAN TUBES (INTERPRETED AS PELVIC ORGAN INJURY), INFLAMMATION RESPONSE AND DAMAGES TISSUE ON LIVER ARE SERIOUS DUE TO MEDICAL IMPORTANCE AND UNLISTED. 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 PARTICULAR CASE, IT WAS NOT REPORTED WHETHER DAMAGES TISSUE AND INFLAMMATION RESPONSE ON FALLOPIAN TUBES OCCURRED UP TO 4 WEEKS POST INSERTION. ALSO, THE TIME FROM ESSURE INSERTION AND THE OCCURRENCE OF PELVIC PAIN AND BLEEDING IS UNKNOWN. ALTHOUGH TEMPORAL RELATIONSHIP IS UNKNOWN, A CAUSAL RELATIONSHIP BETWEEN THESE EVENTS AND SUSPECT INSERT CANNOT BE TOTALLY EXCLUDED. WITH REGARDS TO THE EVENT INFLAMMATION RESPONSE AND DAMAGES TISSUE ON LIVER, SINCE LIMITED INFORMATION WAS PROVIDED AND GIVEN ESSURE'S LOCAL ACTION AT FALLOPIAN TUBES, CAUSALITY CAN BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE ESSURE WAS REMOVED. A PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS WAS PERFORMED AND CONCLUDED THAT THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT (LACK OF COMPLAINT SAMPLE AND ANY VALID BATCH INFORMATION). ADDITIONALLY, NON-SERIOUS EVENTS WERE REPORTED. NEW PTC ANALYSIS IS EXPECTED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION WAS RECEIVED ON (B)(4) 2014: CONSUMER STATED THAT SHE HAS BEEN ADVISED BY HER LAWYER NOT TO SPEAK TO ANYONE FROM THE COMPANY. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UP INFORMATION RECEIVED ON (B)(4) 2014 FROM CONSUMER: SHE STATED THAT ESSURE WAS REMOVED LAST MONTH ((B)(6) 2014) AND THAT SHE RECOVERED FROM PELVIC PAIN AND SHE DID NOT PRESENT PAIN SHOOTING DOWN HER LEGS ANYMORE. NO FURTHER INFORMATION WAS PROVIDED. PTC INVESTIGATION RESULT RECEIVED ON (B)(4) 2014: FINAL ASSESSMENT: 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 CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE 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 AT THIS TIME. NO CAPA INVESTIGATION IS REQUIRED AT THIS TIME PER CRITERIA ESTABLISHED IN WI-03635, "PROCESSING ESSURE CASES IN DEV@COM." MEDICAL ASSESSMENT: THE REPORTED EVENTS ARE NOT INDICATIVE OF A QUALITY DEFECT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFORMATION NEITHER A TECHNICAL BATCH EVALUATION NOR A BATCH SIGNAL CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE. NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. DUE TO LACK OF SAMPLE RETURN AND ANY VALID BATCH INFORMATION THE RQU WAS UNABLE TO CONFIRM ANY QUALITY DEFECT AND THEREFORE CONCLUDED "UNCONFIRMED QUALITY DEFECT." IN SUMMARY, THERE IS NO SUSPICION OF A QUALITY DEFECT BASED ON THIS REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE REPORT WAS RECEIVED FROM A CONSUMER IN THE UNITED STATES ON (B)(4)2014 . THE REPORT REFERS TO THE REPORTING FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT ) IMPLANTED AND EXPERIENCED BLEEDING, CRAMPING, AND FEELS SHE HAS A NICKEL ALLERGY. NO INFORMATION WAS GIVEN ON CONSUMER'S HISTORY, PAST DRUGS, CONCOMITANT MEDICATION AND CONCURRENT CONDITIONS. IN 2009, THE CONSUMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) IMPLANTED. THE CONSUMER REPORTED SHE HAD EXPERIENCED SEVERE BLEEDING, CRAMPING, AND HAD BEEN TO THE ER (EMERGENCY ROOM). CONSUMER FEELS SHE HAS A NICKEL ALLERGY . SHE GETS GREEN COLOR WHEN SHE WEARS RINGS AND HER EAR LOBES GET ITCHES WITH CHEAP METALS . THE CONSUMER REPORTED HER DOCTOR SAID HE WOULD NOT REMOVE THE ESSURE AND CONSUMER WANTS TO HAVE THE COILS REMOVED WITHOUT HAVING A HYSTERECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420167 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 628436

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CONTRACEPTIVES| CONTRACEPTIVES NOS| CONTRACEPTIVES NOS| CONTRACEPTIVES NOS| INTRAVAGINAL CONTRACEPTIVES| INTRAVAGINAL CONTRACEPTIVES| INTRAVAGINAL CONTRACEPTIVES| INTRAVAGINAL CONTRACEPTIVES| INTRAVAGINAL CONTRACEPTIVES| INTRAVAGINAL CONTRACEPTIVES| INTRAVAGINAL CONTRACEPTIVES| INTRAVAGINAL CONTRACEPTIVES| INTRAVAGINAL CONTRACEPTIVES| INTRAVAGINAL CONTRACEPTIVES| INTRAVAGINAL CONTRACEPTIVES