BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 4080478 · Received September 11, 2014

    Report

    Report Number
    2951250-2014-00373
    Event Type
    Injury
    Date Received
    September 11, 2014
    Date of Event
    January 1, 2013
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: 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)(6) 2014 WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) STERILIZATION DEVICE LOT NUMBER 626806 INSERTED ON (B)(6) 2008. CONSUMER STATED IT TOOK ALMOST 3 HOURS TO COMPLETE A 10 MINUTES PROCEDURE. THEN SHE HAD TO HAVE A HSG TESTS DONE, BECAUSE THE PHYSICIANS DIDN'T RECORD THE CORRECT MEASUREMENTS ON THE FIRST TEST. SHE IMMEDIATELY BEGAN HAVING PROBLEMS, AND COMPLAINED OFTEN TO HER PHYSICIAN, WHO REPEATEDLY WROTE HER PROBLEMS OFF AS OTHER DIAGNOSES. SHE THOUGHT MAYBE HE WAS RIGHT, UNTIL 2013 WHEN SHE STARTED HAVING HER PERIOD EVERY TWO WEEKS WITH SEVERE BLEEDING AND MAJOR BLOOD CLOTS. SHE ALSO EXPERIENCED CONSTANT HEADACHES, MOOD SWINGS, IRRITABILITY, SEVERE SKIN RASHES, HAIR LOSS, WEIGHT GAIN, FATIGUE, CHEST PAINS, NIGHTMARES, SEVERE PAIN DURING INTERCOURSE, ALMOST ALL OF HER TEETH HAVE BROKEN AND WERE FALLING OUT, DIZZINESS, WEAKNESS, BRAIN FOG, AND MANY OTHER SYMPTOMS. SHE LOST HER ABILITY TO INTERACT WITH HER CHILDREN AND HUSBAND PHYSICALLY AND MENTALLY. SHE SUFFERED FOR ABOUT HALF OF THE YEAR IN 2013. AFTER EXAMS AND BLOOD TESTS, HER PHYSICIAN AGREED THAT SHE WAS POSSIBLE HAVING A REACTION TO THE ESSURE COILS AND WE SCHEDULED A HYSTERECTOMY FOR 2013 (ESSURE REMOVED ON (B)(6) 2013). SHE LOST ALL OF HER REPRODUCTIVE PARTS EXCEPT FOR OVARIES, AND WAS STILL HAVING SOME ISSUES, BUT AT LEAST SHE WAS NOT BLEEDING SEVERELY ANYMORE. CONSUMER ASSESSED HOSPITALIZATION AND INJURY AS EVENT OUTCOME AND EVENT REPORT TYPE, RESPECTIVELY; HOWEVER, IT WAS NOT SPECIFIED FOR EACH EVENT. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UP INFORMATION FROM (B)(6) 2014: FOLLOW-UP NOT POSSIBLE DUE TO LACK OF CONTACT INFORMATION FOR REPORTER. THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED ON (B)(6) 2014: THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: 2014-021992. 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. IN THIS CASE, 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. MEDICAL ASSESSMENT: THE REPORTED EVENTS ARE NOT INDICATIVE OF A QUALITY DEFECT PER SE. 5 FURTHER AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NO. (B)(4), OF WHICH 3 CASES REFER ALSO TO SIMILAR TYPES OF ADVERSE EVENTS. NO UNUSUAL PATTERN COULD BE IDENTIFIED. THE REVIEW OF THE MANUFACTURING- AND RELEASE DOCUMENTATION OF THE CONCERNED BATCH REVEALED NO REASON TO SUSPECT A QUALITY DEFICIT (SEE TECHNICAL STATEMENT). NO COMPLAINT SAMPLE WAS PROVIDED FOR FURTHER TECHNICAL INVESTIGATION. THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT". IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT. COMPANY CAUSALITY COMMENT: THIS NON-MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED PERIOD EVERY TWO WEEKS WITH SEVERE BLEEDING AND BLOOD CLOTS. THE EVENT PERIOD EVERY TWO WEEKS WITH SEVERE BLEEDING AND BLOOD CLOTS ASSUMED AS POLYMENORRHOEA, IS SERIOUS; DUE TO HOSPITALIZATION REPORTED AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. IN SOME OCCASIONS A BLEEDING AFTER ESSURE INSERTION MAY OCCUR; THEREFORE, THIS EVENT WAS REGARDED AS INCIDENT SINCE THE CONSUMER STATED THAT A HYSTERECTOMY AND BILATERAL SALPINGECTOMY WAS PERFORMED AND WAS CONSIDERED AS RELATED TO ESSURE. ADDITIONALLY NON-SERIOUS EVENTS WERE REPORTED. PRODUCT TECHNICAL COMPLAINT (PTC) ANALYSIS CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT. 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
    561853 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 626806

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization