BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9111899 · Received September 24, 2019

    Report

    Report Number
    2951250-2019-08245
    Event Type
    Injury
    Date Received
    September 24, 2019
    Report Date
    August 25, 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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 822366) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED UTERINE BLEEDING. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSES)"), MENORRHAGIA ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)"), METRORRHAGIA ("METRORRHAGIA(BLEEDING B/W PERIODS)"), ALLERGY TO METALS ("NICKEL ALLERGY"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEMS - UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, MENORRHAGIA, METRORRHAGIA, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED AND THE ALLERGY TO METALS, PSYCHOLOGICAL TRAUMA, FATIGUE, GASTROINTESTINAL DISORDER, HORMONE LEVEL ABNORMAL, MIGRAINE, HEADACHE, ABDOMINAL DISTENSION AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR- DYSMENORRHEA, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, METRORRHAGIA, PSYCH INJURY, UTI, VAGINAL INFECTION, VAGINAL BLEEDING, VAGINAL DISCHARGE, FATIGUE, GI CONDITION, HORMONAL CHANGES,MIGRAINES, HEADACHES AND BLOATING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2011: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) BILATERAL OCCLUSION.. LOT NUMBER: 822366 MANUFACTURING DATE: 2011-01 EXPIRATION DATE: 2014-01. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-AUG-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 PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. 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 PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DYSMENORRHOEA ("DYSMENORRHEA CRAMPING)"), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSPAREUNIA ("DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSES)"), MENORRHAGIA ("MENORRHAGIA(HEAVY MENSTRUAL BLEEDING)"), METRORRHAGIA ("METRORRHAGIA(BLEEDING B/W PERIODS)"), ALLERGY TO METALS ("NICKEL ALLERGY"), PSYCHOLOGICAL TRAUMA ("PSYCH INJURY"), URINARY TRACT INFECTION ("BLADDER/URINARY PROBLEMS - UTI"), VAGINAL INFECTION ("VAGINAL INFECTION"), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE"), GASTROINTESTINAL DISORDER ("GI CONDITIONS"), MIGRAINE ("MIGRAINES"), HEADACHE ("HEADACHES") AND ABDOMINAL DISTENSION ("BLOATING") AND WAS FOUND TO HAVE HORMONE LEVEL ABNORMAL ("HORMONAL CHANGES") AND WEIGHT DECREASED ("WEIGHT LOSS"). THE PATIENT WAS TREATED WITH SURGERY (HYSTERECTOMY (FULL)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, DYSMENORRHOEA, ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA, MENORRHAGIA, METRORRHAGIA, URINARY TRACT INFECTION, VAGINAL INFECTION AND VAGINAL DISCHARGE HAD RESOLVED AND THE ALLERGY TO METALS, PSYCHOLOGICAL TRAUMA, FATIGUE, GASTROINTESTINAL DISORDER, HORMONE LEVEL ABNORMAL, MIGRAINE, HEADACHE, ABDOMINAL DISTENSION AND WEIGHT DECREASED OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA, FATIGUE, GASTROINTESTINAL DISORDER, HEADACHE, HORMONE LEVEL ABNORMAL, MENORRHAGIA, METRORRHAGIA, MIGRAINE, PELVIC PAIN, PSYCHOLOGICAL TRAUMA, URINARY TRACT INFECTION, VAGINAL DISCHARGE, VAGINAL INFECTION AND WEIGHT DECREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR- DYSMENORRHEA, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, MENORRHAGIA, METRORRHAGIA, PSYCH INJURY, UTI, VAGINAL INFECTION, VAGINAL BLEEDING, VAGINAL DISCHARGE, FATIGUE, GI CONDITION, HORMONAL CHANGES,MIGRAINES, HEADACHES AND BLOATING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON (B)(6) 2011: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED- EVENT INJURY TO HERSELF WAS UPDATED WITH NEW EVENTS PELVIC PAIN, DYSMENORRHEA(CRAMPING), ABDOMINAL PAIN, BACK PAIN, DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE), MENORRHAGIA(HEAVY MENSTRUAL BLEEDING), METRORRHAGIA(BLEEDING B/W PERIODS), NICKEL ALLERGY, PSYCHOLOGICAL INJURIES, URINARY TRACT INFECTION, VAGINAL INFECTION, VAGINAL DISCHARGE, FATIGUE, GI CONDITIONS, HORMONAL CHANGES, MIGRAINE, HEADACHE, WEIGHT LOSS AND BLOATING WERE ADDED. PATIENT DEMOGRAPHY UPDATED. LAB DATA WAS ADDED. INCIDENT: NO LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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
    905256 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 822366 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R