BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 23663694 · Received November 27, 2025

    Report

    Report Number
    2951250-2025-00694
    Event Type
    Injury
    Date Received
    November 27, 2025
    Date of Event
    January 1, 2013
    Report Date
    December 12, 2025
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BAYER CASE NUMBER: (B)(4). ONE OF THE COILS MIGRATED/DISPLACED [DEVICE MIGRATION]. PELVIC PAIN [PELVIC PAIN FEMALE]. HEAVY LEGS [HEAVINESS IN LIMBS]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE OF THE COILS MIGRATED/DISPLACED") IN A 53-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 882183) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. CONCOMITANT PRODUCTS INCLUDED PROGESTERONE FOR PRODUCT USED FOR UNKNOWN INDICATION AND ESTROGEN (ESTRADIOL, ESTRADIOL) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON UNKNOWN DATE, AFTER ESSURE INSERTION, SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ON (B)(6) 2025, 4419 DAYS AFTER ESSURE INSERTION, SHE EXPERIENCED PELVIC PAIN ("PELVIC PAIN") AND LIMB DISCOMFORT ("HEAVY LEGS"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL HYSTERECTOMY). ESSURE WAS REMOVED ON (B)(6) 2025. AT THE TIME OF THE REPORT, THE PELVIC PAIN AND LIMB DISCOMFORT WERE RESOLVING AND THE DEVICE DISLOCATION HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, LIMB DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: I AM WRITING TO REPORT A FAILURE OF THE ESSURE DEVICE THAT RESULTED IN SIGNIFICANT MEDICAL COMPLICATIONS. AFTER PLACEMENT IN 2013, ONE OF THE COILS MIGRATED/DISPLACED, LEADING TO ONGOING PAIN AND ULTIMATELY REQUIRING A PARTIAL HYSTERECTOMY FOR SAFE REMOVAL. BATCH NUMBER: 882183, EXPIRY DATE: 31-JUL-2014, MANUFACTURING DATE: 31-JUL-2011. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY; NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED, AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: 09-DEC-2025: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. UPON INTERNAL REVIEW, DATE OF "ONE OF THE COILS MIGRATED/DISPLACED" WAS REMOVED AND ANNEX E CODE UPDATED FOR THE EVENT. EVENT "EMOTIONAL COMPLICATION" (EMOTIONAL DISORDER) DELETED. CASE COMMENTS: A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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). ONE OF THE COILS MIGRATED/DISPLACED [DEVICE MIGRATION]. PELVIC PAIN [PELVIC PAIN FEMALE]. HEAVY LEGS [HEAVINESS IN LIMBS]. EMOTIONAL COMPLICATION [EMOTIONAL DISORDER]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ONE OF THE COILS MIGRATED/DISPLACED") IN A 53 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 882183) FOR FEMALE STERILISATION. ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. CONCOMITANT PRODUCTS INCLUDED PROGESTERONE FOR PRODUCT USED FOR UNKNOWN INDICATION AND ESTROGEN (ESTRADIOL, ESTRADIOL) FOR PRODUCT USED FOR UNKNOWN INDICATION. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN 2013 SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ON (B)(6) 2025 SHE EXPERIENCED PELVIC PAIN ("PELVIC PAIN") AND LIMB DISCOMFORT ("HEAVY LEGS"). ESSURE WAS REMOVED ON (B)(6) 2025. ON UNKNOWN DATE SHE EXPERIENCED EMOTIONAL DISORDER ("EMOTIONAL COMPLICATION"). THE PATIENT WAS TREATED WITH SURGERY (PARTIAL HYSTERECTOMY). AT THE TIME OF THE REPORT, THE PELVIC PAIN AND LIMB DISCOMFORT WERE RESOLVING AND THE DEVICE DISLOCATION HAD RESOLVED. THE OUTCOME OF EMOTIONAL DISORDER WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, EMOTIONAL DISORDER, LIMB DISCOMFORT AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: I AM WRITING TO REPORT A FAILURE OF THE ESSURE DEVICE THAT RESULTED IN SIGNIFICANT MEDICAL COMPLICATIONS. AFTER PLACEMENT IN 2013 ONE OF THE COILS MIGRATED/DISPLACED, LEADING TO ONGOING PAIN AND ULTIMATELY REQUIRING A PARTIAL HYSTERECTOMY FOR SAFE REMOVAL. THIS COMPLICATION HAS CAUSED PHYSICAL, EMOTIONAL, AND FINANCIAL HARDSHIP. I AM REQUESTING INFORMATION ON AVAILABLE OPTIONS FOR COMPENSATION, REIMBURSEMENT, OR SUPPORT RELATED TO THE DEVICE FAILURE AND THE SURGERY THAT FOLLOWED. PLEASE ADVISE ON THE NEXT STEPS NEEDED TO FORMALLY DOCUMENT MY CASE AND DETERMINE ELIGIBILITY FOR COMPENSATION. CASE COMMENTS: A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAIN RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS 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
    2727964 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG 882183 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention ESTROGEN (ESTRADIOL, ESTRADIOL),| PROGESTERONE (PROGESTERONE),