BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 24710840 · Received March 30, 2026

    Report

    Report Number
    2951250-2026-00119
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    November 25, 2016
    Report Date
    April 1, 2026
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BAYER CASE NUMBER: (B)(4) NICKEL ALLERGY [NICKEL ALLERGY] , URTICARIA ERUPTION [RASH URTICARIA-LIKE] , PUNCTIFORM MACULOPAPULAR ERUPTION [MACULO-PAPULAR] , IMPACT ON HER PERSONAL DAILY LIFE [IMPAIRED QUALITY OF LIFE] . CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("NICKEL ALLERGY") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF METRORRHAGIA AND ILIAC FOSSA PAIN ON (B)(6) 2015, POLLEN ALLERGY, CAESAREAN SECTION, FRACTURED THUMB, ELBOW FRACTURE, PARITY 2 (B)(6) 2003 AND (B)(6) 2005) AND BODY MASS INDEX NORMAL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: COPPER IUD AND LUTENYL. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED: SPOTTING WITH COPPER IUD. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 62 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED RASH MACULO-PAPULAR ("PUNCTIFORM MACULOPAPULAR ERUPTION"). ON (B)(6) 2016 SHE EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2017. ON UNKNOWN DATE SHE EXPERIENCED URTICARIA ("URTICARIA ERUPTION") AND IMPAIRED QUALITY OF LIFE ("IMPACT ON HER PERSONAL DAILY LIFE"). THE PATIENT WAS TREATED WITH ANTIHISTAMINICO (CHLORPHENAMINE MALEATE) AND CORTISONE (CORTISONE ACETATE) AS WELL AS SURGERY (TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY (PRESERVED OVARIES)). AT THE TIME OF THE REPORT, THE URTICARIA AND RASH MACULO-PAPULAR HAD NOT RESOLVED. THE OUTCOMES FOR ALLERGY TO METALS AND IMPAIRED QUALITY OF LIFE WERE UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, IMPAIRED QUALITY OF LIFE, RASH MACULO-PAPULAR AND URTICARIA TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: 1 COIL ON THE RIGHT SIDE, 4 COILS ON THE LEFT SIDE. REMOVAL OF ONE POLYP. ON (B)(6) 2019, THE PATIENT EXPERIENCED INTENSE ABDOMINAL AND PELVIC PAIN (FOLLOWED BY DIARRHEA) EVERY MONTH SINCE THE HYSTERECTOMY. ON (B)(6) 2019, A CHRONIC OCCLUSION (PELVIC FLANGE POST-HYSTERECTOMY) WAS DIAGNOSED. AFTER EXPLORING LAPAROSCOPY WITH FLANGE SECTION, NO MORE ABDOMINO-PELVIC PAIN BUT ASTHENIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 22.039 KG/SQM. [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): WITHOUT FINDING (ONLY A RECTOCELE GRADE I) [IMAGING PROCEDURE] ON (B)(6) 2013: RELAPSE OF SIMILAR ABDOMINOPELVIC PAIN, DIGESTIVE STAGNATION WITHOUT SIGN OF OBSTRUCTION. [MAGNETIC RESONANCE IMAGING] (DATE UNKNOWN): WITHOUT FINDING. (ONLY A RECTOCELE GRADE I) QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY; NO SIGNAL WAS OBSERVED WITH REGARD TO THE REASON FOR THE REPORTED COMPLAINT. THE RISK MANAGEMENT FILE WAS REVIEWED, AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 01-APR-2026: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. CASE COMMENTS: BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Description of Event or Problem · 0

    BAYER CASE NUMBER: (B)(4). NICKEL ALLERGY [NICKEL ALLERGY]. URTICARIA ERUPTION [RASH URTICARIA-LIKE]. PUNCTIFORM MACULOPAPULAR ERUPTION [MACULO-PAPULAR]. IMPACT ON HER PERSONAL DAILY LIFE [IMPAIRED QUALITY OF LIFE]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF ALLERGY TO METALS ("NICKEL ALLERGY") IN A 41-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF METRORRHAGIA AND ILIAC FOSSA PAIN ON (B)(6) 2015, POLLEN ALLERGY, CAESAREAN SECTION, FRACTURED THUMB, ELBOW FRACTURE, PARITY 2 (B)(6) 2003 AND (B)(6) 2005) AND BODY MASS INDEX NORMAL. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: COPPER IUD AND LUTENYL. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED: SPOTTING WITH COPPER IUD. ON (B)(6) 2016, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2016, 62 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED RASH MACULO-PAPULAR ("PUNCTIFORM MACULOPAPULAR ERUPTION"). ON (B)(6) 2016 SHE EXPERIENCED ALLERGY TO METALS (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED ON (B)(6) 2017. ON UNKNOWN DATE SHE EXPERIENCED URTICARIA ("URTICARIA ERUPTION") AND IMPAIRED QUALITY OF LIFE ("IMPACT ON HER PERSONAL DAILY LIFE"). THE PATIENT WAS TREATED WITH ANTIHISTAMINICO (CHLORPHENAMINE MALEATE) AND CORTISONE (CORTISONE ACETATE) AS WELL AS SURGERY (TOTAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY (PRESERVED OVARIES)). AT THE TIME OF THE REPORT, THE URTICARIA AND RASH MACULO-PAPULAR HAD NOT RESOLVED. THE OUTCOMES FOR ALLERGY TO METALS AND IMPAIRED QUALITY OF LIFE WERE UNKNOWN. THE REPORTER CONSIDERED ALLERGY TO METALS, IMPAIRED QUALITY OF LIFE, RASH MACULO-PAPULAR AND URTICARIA TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: 1 COIL ON THE RIGHT SIDE, 4 COILS ON THE LEFT SIDE. REMOVAL OF ONE POLYP. ON (B)(6) 2019, THE PATIENT EXPERIENCED INTENSE ABDOMINAL AND PELVIC PAIN (FOLLOWED BY DIARRHEA) EVERY MONTH SINCE THE HYSTERECTOMY. ON (B)(6) 2019, A CHRONIC OCCLUSION (PELVIC FLANGE POST-HYSTERECTOMY) WAS DIAGNOSED. AFTER EXPLORING LAPAROSCOPY WITH FLANGE SECTION, NO MORE ABDOMINO-PELVIC PAIN BUT ASTHENIA. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX: 22.039 KG/SQM. [COMPUTERISED TOMOGRAM] (DATE UNKNOWN): WITHOUT FINDING (ONLY A RECTOCELE GRADE I) [IMAGING PROCEDURE] ON (B)(6) 2013: RELAPSE OF SIMILAR ABDOMINOPELVIC PAIN, DIGESTIVE STAGNATION WITHOUT SIGN OF OBSTRUCTION. [MAGNETIC RESONANCE IMAGING] (DATE UNKNOWN): WITHOUT FINDING (ONLY A RECTOCELE GRADE I). CASE COMMENTS: BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT. IN CASE A SAMPLE IS RECEIVED THE INVESTIGATION MIGHT LEAD TO DESTRUCTION OF THE SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773920 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention