BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9952887 · Received April 13, 2020

    Report

    Report Number
    2951250-2020-02801
    Event Type
    Injury
    Date Received
    April 13, 2020
    Report Date
    April 13, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBES)'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT AND RIGHT ADNEXAL REGIONS'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') AND MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852006) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE),"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), UTERINE PAIN ("UTERINE PAIN"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, TOOTH DISORDER, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, ALOPECIA, UTERINE PAIN, BLADDER DISORDER AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE DYSMENORRHOEA AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MENORRHAGIA, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-MAR-2020: QUALITY SAFETY EVALUATION OF PTC. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBES)'), DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT AND RIGHT ADNEXAL REGIONS'), VAGINAL HAEMORRHAGE ('ABNORMAL BLEEDING (VAGINAL)') AND MENORRHAGIA ('MENORRHAGIA') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 852006) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), VAGINAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), MENORRHAGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), TOOTH DISORDER ("DENTAL PROBLEMS"), DYSMENORRHOEA ("DYSMENORRHEA(CRAMPING)"), DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE),"), FATIGUE ("FATIGUE"), ALOPECIA ("HAIR LOSS"), UTERINE PAIN ("UTERINE PAIN"), BLADDER DISORDER ("BLADDER PROBLEMS OR CHANGES"), URINARY TRACT DISORDER ("URINARY PROBLEMS OR CHANGES") AND ABDOMINAL PAIN ("ABDOMINAL PAIN") AND WAS FOUND TO HAVE WEIGHT INCREASED ("WEIGHT GAIN"). THE PATIENT WAS TREATED WITH SURGERY (ABLATION AND HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2018. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, TOOTH DISORDER, DYSPAREUNIA, FATIGUE, WEIGHT INCREASED, ALOPECIA, UTERINE PAIN, BLADDER DISORDER AND URINARY TRACT DISORDER OUTCOME WAS UNKNOWN, THE VAGINAL HAEMORRHAGE AND MENORRHAGIA HAD RESOLVED AND THE DYSMENORRHOEA AND ABDOMINAL PAIN WAS RESOLVING. THE REPORTER CONSIDERED ABDOMINAL PAIN, ALOPECIA, BLADDER DISORDER, DEVICE DISLOCATION, DYSMENORRHOEA, DYSPAREUNIA, FALLOPIAN TUBE PERFORATION, FATIGUE, MENORRHAGIA, TOOTH DISORDER, URINARY TRACT DISORDER, UTERINE PAIN, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM ON (B)(6) 2011: TOTAL BILATERAL OCCLUSION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 5-MAR-2020: PFS AND MR RECEIVED: CASE BECOME INCIDENT INJURY NOS REPLACED WITH NEW EVENTS. LOT NUMBER ADDED. EVENTS:ABLATION, HYSTERECTOMY (FULL), ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), BLADDER OR URINARY PROBLEMS OR CHANGES, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: LEFT AND RIGHT ADNEXAL REGIONS, DENTAL PROBLEMS, DYSMENORRHEA (CRAMPING), DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE), PAIN, PERFORATION (FALLOPIAN TUBES), FATIGUE, WEIGHT GAIN, HAIR LOSS, UTERINE PAIN, ABDOMINAL PAIN WERE ADDED. REPORTERS, PATIENT DEMOGRAPHICS, LAB DATA WERE ADDED. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416481 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 852006 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R