BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3955150 · Received July 10, 2014

    Report

    Report Number
    2951250-2014-00267
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    February 1, 2010
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP RECEIVED ON 10-AUG-2015: CONSUMER REPORTED NOW THAT ESSURE WAS INSERTED ON (B)(6) 2010 AND REMOVED ON (B)(6) 2012 (DISCREPANT WITH INFORMATION INITIALLY PROVIDED). 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 SEVERE PAIN, UTI'S AND STREP THROAT. THE REPORTED EVENTS WERE CONSIDERED SERIOUS, AS MEDICALLY SIGNIFICANT; THE FIRST IS LISTED WHILE THE REMAINING EVENTS ARE UNLISTED ACCORDING TO THE REFERENCE SAFETY INFORMATION FOR ESSURE. AFTER ESSURE INSERTION ABDOMINAL, PELVIC AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS PARTICULAR CASE, THE CONSUMER STATED THAT SHE EXPERIENCED SEVERE PAIN SINCE ESSURE INSERTION; WHICH IMPROVED AFTER THE DEVICE REMOVAL BY PARTIAL HYSTERECTOMY. ALTHOUGH THE REASON FOR THIS SURGICAL PROCEDURE WAS NOT PROVIDED, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND ESSURE CANNOT BE EXCLUDED. URINARY TRACT INFECTION (UTI) PATHOGENESIS IN WOMEN BEGINS WITH COLONIZATION OF THE VAGINAL INTROITUS BY UROPATHOGENS FROM THE FECAL FLORA, FOLLOWED BY ASCENSION VIA THE URETHRA INTO THE BLADDER. IN THIS PARTICULAR CASE THE CONSUMER REPORTED UTI'S, NO FURTHER INFORMATION WAS PROVIDED, GIVEN THE LIMITED DATA A CAUSAL RELATIONSHIP BETWEEN THIS EVENT AND ESSURE CANNOT BE ASSESSED BY NOW. CONCERNING STREP THROAT (STREPTOCOCCAL SORE THROAT), IT IS A CONTAGIOUS INFECTION, WHICH SPREADS THROUGH CLOSE CONTACT WITH AN INFECTED INDIVIDUAL. GIVEN THIS INFORMATION AND CONSIDERING ESSURE LOCAL ACTION AT FALLOPIAN TUBES, THE REPORTED EVENT WAS CONSIDERED AS UNRELATED TO ESSURE. DUE TO THE SURGICAL INTERVENTION, THIS CASE WAS REGARDED AS AN INCIDENT. IN ADDITION, THE NON-SERIOUS EVENTS PELVIC PAIN, DIARRHEA, VOMITING, RASHES, NEPHROPATHY, HIGH BLOOD PRESSURE, WEIGHT GAIN, SEVERE INFECTION, CONSTANT MIGRAINES, FIBROMYALGIA AND SEVERE ARTHRITIS WERE REPORTED. NO FURTHER INFORMATION IS EXPECTED (NO CONTACT INFORMATION PROVIDED). ACCORDING TO THE PTC INVESTIGATION RESULT, THERE IS NO SUSPICION OF A QUALITY DEFECT BASED ON THIS REPORT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A REGULATOR AUTHORITY (CASE# MW5029557) IN UNITED STATES ON (B)(6) 2014 WHICH REFERS TO A FEMALE CONSUMER OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED THE FOLLOWING EVENTS. ON (B)(6) 2010 SHE HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. SHE STATED THAT SHE EXPERIENCED MANY ADVERSE REACTIONS SINCE THE DATE OF IMPLANT INCLUDING SEVERE PAIN, UTI'S, PELVIC PAIN, FEVERS, DIARRHEA, VOMITING, RASHES, NEPHROPATHY, HIGH BLOOD PRESSURE, WEIGHT GAIN, STREP THROAT, SEVERE INFECTION, CONSTANT MIGRAINES AND FIBROMYALGIA. SHE SAID SHE WAS NEVER TOLD THAT A HYSTERECTOMY WAS THE ONLY WAY OF REMOVAL OF THE DEVICE. SHE SAID SHE WAS IN PAIN MEDICATION AND ALSO HAD TO GO TO PAIN MANAGEMENT AND EXPERIENCED SEVERE ARTHRITIS. A PARTIAL HYSTERECTOMY WAS DONE IN 2012, WHICH REMOVED THE DEVICE AND SHE INSTANTLY FELT A LOT BETTER. SHE STATED THAT SINCE THE REMOVAL OF THE DEVICE, HER PAIN HAS DRASTICALLY IMPROVED AND HER BLOOD PRESSURE HAS GONE BACK DOWN. SHE WAS EXTREMELY UNHAPPY WITH DEVICE. PTC INVESTIGATION RESULT WAS RECEIVED ON (B)(6) 2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REF NUMBER FOR THE PTC REPORT IS: PTC LOCAL NUMBER (B)(4) AND PTC GLOBAL NUMBER(B)(4). 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 DEFICIENCIESES. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE WERE UNABLE TO CONFIRM ANY QUALITY DEFECT AT THIS TIME. MEDICAL ASSESSMENT: THE REPORTED EVENTS ARE NOT INDICATIVE OF A QUALITY DEFECT PER SE. NO BATCH NUMBER WAS REPORTED. WITHOUT THIS INFO 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 INFO THE RQU WAS UNABLE TO CONFIRM ANY QUALITY DEFECT AND THEREFORE CONCLUDE "UNCONFIRMED QUALITY DEFECT". IN SUMMARY, THERE IS NO SUSPICION OF A QUALITY DEFECT BASED ON THIS REPORT. COMPANY CAUSALITY COMMENT: THIS NOT MEDICALLY-CONFIRMED, SPONTANEOUS CASE REFERS TO A FEMALE CONSUMER WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED SEVERE PAIN, UTI'S AND STREP THROAT. THE REPORTED EVENTS WERE CONSIDERED SERIOUS, AS MEDICALLY SIGNIFICANT; THE FIRST IS LISTED WHILE THE REMAINING EVENTS ARE UNLISTED ACCORDING TO THE REF SAFETY INFO FOR ESSURE. AFTER ESSURE INSERTION ABDOMINAL, PELVIC, AND UNCHARACTERIZED PAIN MAY OCCUR. IN THIS PARTICULAR CASE, THE CONSUMER STATED THAT SHE EXPERIENCED SEVERE PAIN SINCE ESSURE INSERTION; WHICH IMPROVED AFTER THE DEVICE REMOVAL BY PARTIAL HYSTERECTOMY. ALTHOUGH THE REASON FOR THIS SURGICAL PROCEDURE WAS NOT PROVIDED, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND ESSURE CANNOT BE EXCLUDED, AND DUE TO THE SURGICAL INTERVENTION IT WAS REGARDED AS IN INCIDENT. UTI PATHOGENESIS IN WOMEN BEGINS WITH COLONIZATION OF THE VAGINAL INTROITUS BY UROPATHOGENS FROM THE FECAL FLORA, FOLLOWED BY ASCENSION VIA THE URETHRA INTO THE BLADDER. IN THIS PARTICULAR CASE THE CONSUMER REPORTED UTI'S, NO FURTHER INFO WAS PROVIDED, GIVEN THE LIMITED DATA, A CAUSAL RELATIONSHIP BETWEEN THIS EVENT AND ESSURE CANNOT BE ASSESSED BY NOW, AND IT WAS THUS, REGARDED AS NON-INCIDENT. CONCERNING STREP THROAT (STREPTOCOCCAL SORE THROAT), IT IS A CONTAGIOUS INFECTION, WHICH SPREADS THROUGH CLOSE CONTACT WITH AN INFECTED INDIVIDUAL. GIVEN THIS INFO AND CONSIDERING ESSURE LOCAL ACTION AT FALLOPIAN TUBES, THE REPORTED EVENT WAS CONSIDERED AS UNRELATED TO ESSURE AND THUS NON-INCIDENT. IN ADDITION, THE NON-SERIOUS EVENTS PELVIC PAIN, DIARRHEA, VOMITING, RASHES, NEPHROPATHY, HIGH BLOOD PRESSURE, WEIGHT GAIN, SEVERE INFECTION, CONSTANT MIGRAINES, FIBROMYALGIA, AND SEVERE ARTHRITIS WERE REPORTED. NO FURTHER INFO IS EXPECTED (NO CONTACT INFO PROVIDED). ACCORDING TO THE PTC INVESTIGATION RESULT, THERE IS NO SUSPICION OF A QUALITY DEFECT BASED ON THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404057 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ES305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other