BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5297899 · Received December 15, 2015

    Report

    Report Number
    2951250-2015-01918
    Event Type
    Injury
    Date Received
    December 15, 2015
    Date of Event
    June 1, 2011
    Report Date
    November 2, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT RECEIVED ON 17-DEC-2015. PTC GLOBAL NUMBER (B)(4). LOT NUMBER 844600 (PRODUCTION DATE MAR-2011; EXPIRATION DATE MAR-2014). FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODEL FOR THE DEVICE. MEDICAL ASSESSMENT: BASED ON THE AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED. THE REPORTED MEDICAL EVENT(S) ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. A REVIEW OF SIMILAR CASES FOR THIS BATCH RESULTED IN NO UNUSUAL PATTERN IDENTIFIED. IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVEN (S) AND A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS AND NON-MEDICALLY CONFIRMED CASE REPORT (RECEIVED VIA REGULATORY AUTHORITY) REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SINCE THEN, HER PERIODS WERE VERY FREQUENT AND HEAVY, EVERY 15-24 DAYS LASTING 7 DAYS AT A TIME. SHE HAD AN ENDOMETRIAL ABLATION DONE TO TRY TO SOLVE THIS PROBLEM. AFTER THE PROCEDURE, SHE WAS BLEEDING HEAVILY 2 WEEKS POST OPERATION. SHE HAD ESSURE REMOVAL SCHEDULED. THESE EVENTS, SEEN AS MENORRHAGIA AND POST PROCEDURAL BLEEDING, ARE SERIOUS DUE TO MEDICAL IMPORTANCE AND REQUIRED INTERVENTION (DISABILITY WAS MENTIONED BUT WAS NOT SPECIFIED NEITHER DESCRIBED). MENORRHAGIA IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE WHILE POST PROCEDURAL BLEEDING RELATED TO ABLATION IS UNLISTED. GENITAL BLEEDING AND MENTRUAL PATTERN CHANGES MAY OCCUR DURING ESSURE USE. IN THIS CASE, SHE HAD INTENSE PERIODS, HAD AN ABLATION AS A THERAPEUTIC MEASURE AND EXPERIENCED A HEAVY BLEEDING FOR TWO WEEKS AFTER THE PROCEDURE. CONSIDERING ITS NATURE AND THE TEMPORAL RELATIONSHIP, A CONTRIBUTORY ROLE FROM ESSURE FOR THIS FIRST EVENT CANNOT BE TOTALLY EXCLUDED AND AS THE ABLATION LED TO A NEW BLEEDING FOR TWO WEEKS, THIS OTHER BLEEDING IS ALSO ASSESSED AS RELATED TO ESSURE. SINCE INTERVENTION WAS REQUIRED (ABLATION) AND OTHER ONE IS SCHEDULED TO REMOVE THE DEVICES THIS CASE IS REGARDED AS INCIDENT. OTHER NON-SERIOUS EVENTS WERE INFORMED. ACCORDING TO PRODUCT TECHNICAL COMPLAINT, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVEN (S) AND A QUALITY DEFECT. NO FURTHER INFORMATION IS EXPECTED.

    Additional Manufacturer Narrative · 1

    MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-DEC-2016: NEW EVENTS WERE PROVIDED WITHIN LEGAL CLAIM. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS AND NON-MEDICALLY CONFIRMED CASE REPORT (RECEIVED VIA REGULATORY AUTHORITY) REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND SINCE THEN, HER PERIODS WERE VERY FREQUENT AND HEAVY, EVERY 15-24 DAYS LASTING 7 DAYS AT A TIME. SHE HAD AN ENDOMETRIAL ABLATION DONE TO TRY TO SOLVE THIS PROBLEM. AFTER THE PROCEDURE, SHE WAS BLEEDING HEAVILY 2 WEEKS POST OPERATION. SHE ALSO EXPERIENCED ABNORMAL, HEAVY BLEEDING. A TOTAL HYSTERECTOMY WAS PERFORMED AND ESSURE WAS REMOVED. THESE EVENTS, SEEN AS POLYMENORRHAGIA, POST PROCEDURAL BLEEDING AND GENITAL BLEEDING, ARE ANTICIPATED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE, EXCEPT FOR POST PROCEDURAL BLEEDING THAT IS RELATED TO ABLATION IS UNANTICIPATED. REQUIRED INTERVENTION (DISABILITY WAS MENTIONED BUT WAS NOT SPECIFIED NEITHER DESCRIBED). GENITAL BLEEDING AND MENTRUAL PATTERN CHANGES MAY OCCUR DURING ESSURE USE. IN THIS CASE, SHE HAD INTENSE PERIODS, HAD AN ABLATION AS A THERAPEUTIC MEASURE AND EXPERIENCED A HEAVY BLEEDING FOR TWO WEEKS AFTER THE PROCEDURE. CONSIDERING THEIR NATURE AND THE TEMPORAL RELATIONSHIP, A CONTRIBUTORY ROLE FROM ESSURE FOR THE EVENTS POLYMENORRHAGIA AND GENITAL BLEEDING CANNOT BE TOTALLY EXCLUDED AND AS THE ABLATION LED TO A NEW BLEEDING FOR TWO WEEKS, THIS OTHER BLEEDING IS ALSO ASSESSED AS RELATED TO ESSURE. THIS CASE WAS REGARDED AS INCIDENT SINCE SURGICAL INTERVENTION WAS PERFORMED AND DEVICE REMOVAL WAS REQUIRED. OTHER NON-SERIOUS EVENTS WERE INFORMED. ACCORDING TO PRODUCT TECHNICAL COMPLAINT, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVEN (S) AND A QUALITY DEFECT. UPON RECEIPT OF FOLLOW-UP INFORMATION, THIS CASE BECAME LEGAL. THEREFORE, FURTHER INFORMATION WILL BE OBTAINED THROUGH THE LITIGATION PROCESS.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION WAS RECEIVED ON 19-JAN-2016 VIA ESSURE HEALTH CARE PROVIDER GENERAL QUESTIONNAIRE. CONSUMER'S WEIGHT AND HEIGHT WERE PROVIDED. MEDICAL HISTORY INCLUDED COLPOSCOPY AND BIOPSY (2013), ELECTIVE CURETTAGE, MIRENA (2006 TO 2011). MYOMECTOMY AND ADNEXAL SURGERY WERE DENIED. SHE WAS NOT ON POSTPARTUM STATE AT THE TIME OF ESSURE INSERTION. ANALGESIA (PROPOFOL, PARACERVICAL) WAS APPLIED DURING INSERTION. CERVICAL DILATATION AND SOUNDING WERE DENIED. ESSURE WAS EASILY IMPLANTED. FLUID LOSS DURING HYSTEROSCOPY WAS LESS THAN 1500CC AND THE PROCEDURE DID NOT TAKE MORE THAN 20 MINUTES. MICRONOR WAS USED AS BACK-UP CONTRACEPTION AFTER ESSURE INSERTION AND BEFORE TOTAL OCCLUSION CONFIRMATION. ON (B)(6) 2011 HSG (HYSTEROSALPINGOGRAM) WAS PERFORMED. PERFORATION, TREATMENT, RELATED DIAGNOSTIC TESTS, PATHOLOGY RESULTS AND HOSPITALIZATION WERE DENIED. IN 2015 SHE UNDERWENT A THERMACHOICE. ESSURE WAS NOT REMOVED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS AND NON-MEDICALLY CONFIRMED CASE REPORT (RECEIVED VIA REGULATORY AUTHORITY) REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPAIN TUBE OCCLUSION INSERT) INSERTED AND SINCE THEN, HER PERIODS WERE VERY FREQUENT AND HEAVY, EVERY 15-24 DAYS LASTING 7 DAYS AT A TIME. SHE HAD AN ENDOMETRIAL ABLATION DONE TO TRY TO SOLVE THIS PROBLEM. AFTER THE PROCEDURE, SHE WAS BLEEDING HEAVILY 2 WEEKS POST OPERATION. SHE HAD ESSURE REMOVAL SCHEDULED. THESE EVENTS, SEEN AS MENORRHAGIA AND POST PROCEDURAL BLEEDING, ARE SERIOUS DUE TO MEDICAL IMPORTANCE AND REQUIRED INTERVENTION (DISABILITY WAS MENTIONED BUT WAS NOT SPECIFIED NEITHER DESCRIBED). MENORRHAGIA IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE WHILE POST PROCEDURAL BLEEDING RELATED TO ABLATION IS UNLISTED. GENITAL BLEEDING AND MENTRUAL PATTERN CHANGES MAY OCCUR DURING ESSUSE USE. IN THIS CASE, SHE HAD INTENSE PERIODS, HAD AN ABLATION AS A THERAPEUTIC MEASURE AND EXPERIENCED A HEAVY BLEEDING FOR TWO WEEKS AFTER THE PROCEDURE. CONSIDERING ITS NATURE AND THE TEMPORAL RELATIONSHIP, A CONTRIBUTORY ROLE FROM ESSURE FOR THIS FIRST EVENT CANNOT BE TOTALLY EXCLUDED AND AS THE ABLATION LED TO A NEW BLEEDING FOR TWO WEEKS, THIS OTHER BLEEDING IS ALSO ASSESSED AS RELATED TO ESSURE. SINCE INTERVENTION WAS REQUIRED (ABLATION) AND OTHER ONE IS SCHEDULED TO REMOVE THE DEVICES THIS CASE IS REGARDED AS INCIDENT. OTHER NON-SERIOUS EVENTS WERE INFORMED. ACCORDING TO PRODUCT TECHNICAL COMPLAINT, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVEN (S) AND A QUALITY DEFECT. NO FURTHER INFORMATION IS EXPECTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A FEMALE CONSUMER OF UNSPECIFIED AGE VIA REGULATORY AUTHORITY (CASE # MW5056302) IN UNITED STATES ON 26-OCT-2015. THE CONSUMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. SHE RECEIVED THE FOLLOWING CONCOMITANT MEDICATION: TECFIDERA (DIMETHYL FUMARATE) FOR MULTIPLE SCLEROSIS, PROZAC (FLUOXETINE HYDROCHLORIDE), WELLBUTRIN (BUPROPION) AND VITAMIN D (COLECALCIFEROL). THE CONSUMER REPORTED THAT SINCE SHE HAD ESSURE HER PERIODS WERE VERY FREQUENT AND HEAVY, EVERY 15-24 DAYS LASTING 7 DAYS AT A TIME. ON 2015 SHE HAD THE ENDOMETRIAL ABLATION DONE TO TRY TO SOLVE THAT PROBLEM. SHE WAS BLEEDING HEAVILY 2 WEEKS POST OPERATION BUT HAD NOT BLED SINCE THEN. HER MEMORY WAS TERRIBLE BOTH PAST AND PRESENT, FOR EXAMPLE ONE DAY SHE TOOK HER MEDICINE TWICE BUT HAD NO RECOLLECTION WHAT SO EVER OF EVEN TAKING IT ONCE. HER HAIR WAS FALLING OUT AND WAS VERY THIN. THE CONSUMER WAS TAKING FOLIC ACID (FOLIC ACID), BIOTIN (BIOTIN) AND USING A PRO-BIOTIC SHAMPOO AND NOTHING SEEMED TO HELP. DISABILITY/PERMANENT DAMAGE WAS MENTIONED BUT NOT SPECIFIED AND/OR ASSIGNED TO ONE OF THE EVENTS. THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION RESULTS WHICH PTC NUMBER IS (B)(4) WAS RECEIVED ON 17-NOV-2015. FINAL ASSESSMENT: FOR CASES WHERE A DEVICE FAILURE DURING INSERTION IS REPORTED, WE CONDUCT AN INVESTIGATION OF ANY RETURNED DEVICE. FOR CASES WHERE AN INSERT IS REMOVED AT A LATER TIME AFTER INSERTION, WE TYPICALLY DO NOT CONDUCT AN INSPECTION OF THE INSERT. IN THIS CASE, NO PRODUCT WAS RETURNED. 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. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. MEDICAL ASSESSMENT: BASED ON AVAILABLE INFORMATION NO PRODUCT QUALITY DEFECT WAS CONFIRMED/IDENTIFIED. MOREOVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. A REVIEW OF SIMILAR CASES IS NOT APPLICABLE AS NO BATCH NUMBER WAS REPORTED. IN SUMMARY, BASED ON AVAILABLE INFORMATION THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP BETWEEN THE REPORTED MEDICAL EVENTS AND A QUALITY DEFECT. FOLLOW-UP INFORMATION WAS RECEIVED ON 24-NOV-2015. CONSUMER'S DATE OF BIRTH WAS PROVIDED. THIS REPORT REFERS TO A (B)(6) FEMALE CONSUMER. ON (B)(6) 2011 ESSURE LOT NUMBER 844600 WAS IMPLANTED. ESSURE REMOVAL WAS SCHEDULED TO (B)(6) 2015. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS AND NON-MEDICALLY CONFIRMED CASE REPORT (RECEIVED VIA REGULATORY AUTHORITY) REFERS TO A (B)(6) FEMALE CONSUMER WHO HAD ESSURE (FALLOPAIN TUBE OCCLUSION INSERT) INSERTED AND SINCE THEN, HER PERIODS WERE VERY FREQUENT AND HEAVY, EVERY 15-24 DAYS LASTING 7 DAYS AT A TIME. SHE HAD AN ENDOMETRIAL ABLATION DONE TO TRY TO SOLVE THIS PROBLEM. AFTER THE PROCEDURE, SHE WAS BLEEDING HEAVILY 2 WEEKS POST OPERATION. SHE HAD ESSURE REMOVAL SCHEDULED. THESE EVENTS, SEEN AS MENORRHAGIA AND POST PROCEDURAL BLEEDING, ARE SERIOUS DUE TO MEDICAL IMPORTANCE AND REQUIRED INTERVENTION (DISABILITY WAS MENTIONED BUT WAS NOT SPECIFIED NEITHER DESCRIBED) . MENORRHAGIA IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE WHILE POST PROCEDURAL BLEEDING RELATED TO ABLATION IS UNLISTED. GENITAL BLEEDING AND MENTRUAL PATTERN CHANGES MAY OCCUR DURING ESSUSE USE. IN THIS CASE, SHE HAD INTENSE PERIODS, HAD AN ABLATION AS A THERAPEUTIC MEASURE AND EXPERIENCED A HEAVY BLEEDING FOR TWO WEEKS AFTER THE PROCEDURE. CONSIDERING ITS NATURE AND THE TEMPORAL RELATIONSHIP, A CONTRIBUTORY ROLE FROM ESSURE FOR THIS FIRST EVENT CANNOT BE TOTALLY EXCLUDED AND AS THE ABLATION LED TO A NEW BLEEDING FOR TWO WEEKS, THIS OTHER BLEEDING IS ALSO ASSESSED AS RELATED TO ESSURE. SINCE INTERVENTION WAS REQUIRED (ABLATION) AND OTHER ONE IS SCHEDULED TO REMOVE THE DEVICES THIS CASE IS REGARDED AS INCIDENT. OTHER NON-SERIOUS EVENTS WERE INFORMED. FURTHER INFORMATION AND A NEW TECHNICAL ANALYSIS (LOT NUMBER PROVIDED) HAVE BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827801 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 844600

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other| R| S ADDERALL| ADDERALL| BETHANECHOL| BETHANECHOL| BETHANECHOL| COPAXONE| COPAXONE| COPAXONE| DEXTROAMPHETAMINE| ESTRACE| ESTRACE| ESTRACE| HYDROCODONE| HYDROCODONE BITARTRATE| HYDROCODONE BITARTRATE| MICRONOR| MICRONOR| MICRONOR| MIRENA| PROZAC| PROZAC| PROZAC| PROZAC (FLUOXETINE HYDROCHLORIDE)| TECFIDERA| TECFIDERA| TECFIDERA| TECFIDERA (DIMETHYL FUMARATE)| VITAMIN D| VITAMIN D| VITAMIN D| WELLBUTRIN| WELLBUTRIN| WELLBUTRIN| XANAX| XANAX| XANAX| ZOLOFT| ZOLOFT| ZOLOFT