BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 16899132 · Received May 9, 2023

    Report

    Report Number
    2951250-2023-01879
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    September 19, 2022
    Report Date
    July 29, 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

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2022, 1967 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. 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 REPORTED COMPLAINT REASON. 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: 17-MAY-2023: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    BAYER CASE NUMBER: (B)(4). MEDICAL DEVICE REMOVAL [MEDICAL DEVICE REMOVAL]. CASE NARRATIVE: THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF PARITY 3, MULTIGRAVIDA AND MORBID OBESITY. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: DEPO PROVERA. CONCURRENT CONDITIONS WERE LISTED AS PELVIC PAIN FEMALE, LATEX ALLERGY, ASTHMA, ANXIETY, LOWER ABDOMINAL PAIN, DYSPAREUNIA AND DYSMENORRHEA. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2022, 1925 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH NSAIDS (UNKNOWN) AS WELL AS SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: POST PROCEDURE, THE ESSURE COILS WERE VISUALIZED WITH THE DEEP PLACEMENT ON THE LEFT WITH THE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [GYNAECOLOGICAL EXAMINATION] ON (B)(6) 2022: NORMAL APPEARING UTERUS, FALLOPIAN TUBES AND OVARIES. NO EVIDENCE OF PERFORATION OF THE UTERUS OR FALLOPIAN TUBES BY THE ESSURE COILS. HYPERVASCULAR ERYTHEMATOUS VESSELS. PELVIC CONGESTION, NO EVIDENCE OF ENDOMETRIOSIS OR PELVIC ADHESIONS [HYSTEROSALPINGOGRAM] ON (B)(6) 2017: IMPRESSION: 1. NORMAL UTERINE CONTOUR. 2. SUCCESSFUL ESSURE OCCLUSION OF BILATERAL FALLOPIAN TUBES. THE LEFT ESSURE DEVICE IS PLACED WITH ITS MEDIAL END BEYOND TO THE ISTHMIC PORTION OF THE TUBE AND THERE IS CONTRAST OPACIFICATION OF THE FIRST FEW MILLIMETERS OF THE LEFT FALLOPIAN TUBE. HOWEVER, THERE IS NO SPILL OF CONTRAST FROM THIS TUBE [PATHOLOGY TEST] ON (B)(6) 2022: SPECIMEN: UTERUS, CERVIX, FALLOPIAN TUBES, BILATERAL FINAL DIAGNOSIS: RESULT: UTERUS, CERVIX, AND BILATERAL FALLOPIAN TUBES; LAPAROSCOPIC TOTAL HYSTERECTOMY AND BILATERAL SALPINGECTOMY UTERUS AND CERVIX (123 G): HISTOLOGICALLY UNREMARKABLE PERITONEAL REFLECTION AND SEROSA CERVIX WITH MARKED MIXED INFLAMMATION AND CHANGES CONSISTENT WITH PRIOR BIOPSY SMALL FOCUS OF RESIDUAL MILD DYSPLASIA (LSIL/CIN-I) INVOLVING TRANSITION ZONE IN 9:00 TO 12:00 QUADRANT PROLIFERATIVE ENDOMETRIUM WITH FOCI OF TUBAL METAPLASIA HISTOLOGICALLY UNREMARKABLE MYOMETRIUM BILATERAL FALLOPIAN TUBES WITH NO SIGNIFICANT HISTOPATHOLOGIC CHANGE NEGATIVE FOR MALIGNANCY. OPERATIVE PROCEDURE: 1. HYSTERECTOMY TOTAL LAPAROSCOPIC 2. SALPINGECTOMY LAPAROSCOPIC 3. CYSTOURETHROSCOPY [ULTRASOUND PELVIS] ON (B)(6) 2022: FINDINGS: UTERUS: THE UTERUS MEASURES 7.5 X 4.2 X 5.5 CM. THE ENDOMETRIAL THICKNESS MEASURES 3 MM AND EMBOLIZATION COILS ARE PARTIALLY IMAGED WITHIN THE FALLOPIAN TUBES. THE MYOMETRIUM IS DIFFUSELY HETEROGENEOUS. NO DISCRETE MASS. RIGHT OVARY/ADNEXA: THE OVARY MEASURES 2.5 X 2.1 X 2.0 CM. NO ADNEXAL MASS. LEFT OVARY/ADNEXA: THE OVARY MEASURES 2.4 X 2.1 X 1.8 CM. NO ADNEXAL MASS. BLADDER: NORMAL PERITONEUM: NO FLUID IN THE CUL-DE-SAC. IMPRESSION: DIFFUSELY HETEROGENEOUS MYOMETRIUM SUGGESTING ADENOMYOSIS. BILATERAL FALLOPIAN TUBE EMBOLIZATION COILS REMAIN IN SITU. 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 REPORTED COMPLAINT REASON. 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: 16-JUL-2025: MEDICAL RECORD RECEIVED. LAB DATA INCLUDING SURGICAL PATHOLOGY REPORT WERE ADDED. MEDICAL HISTORY & CONCOMITANT CONDITIONS WERE ADDED. ESSURE INSERTION DATE UPDATED. ADDITIONAL REPORTERS WERE ADDED. 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 SAMPLE IF REQUIRED TO PERFORM A PROPER ANALYSIS.

    Description of Event or Problem · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("MEDICAL DEVICE REMOVAL") IN A 31 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. THERE WAS NO INFORMATION ON THE PATIENT'S MEDICAL HISTORY OR CONCURRENT CONDITIONS. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2022, 1967 DAYS AFTER ESSURE INSERTION, SHE UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERION INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE ADMINISTRATION. 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 REPORTED COMPLAINT REASON. 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227539 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female Required Intervention