BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11423517 · Received March 5, 2021

    Report

    Report Number
    2951250-2021-00634
    Event Type
    Injury
    Date Received
    March 5, 2021
    Report Date
    December 8, 2023
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('ESSURE MIGRATION') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910509) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED DYSPAREUNIA ON (B)(6) 2003, MULTIGRAVIDA (4 GRAVIDA), PARITY 4 AND PELVIC PAIN FEMALE. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: DIFFERENT PILL NOS AND IUD. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("LOCALISED PAIN/PAIN"), DYSPAREUNIA ("DYSPAREUNIA,") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, DYSPAREUNIA AND GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: AS PER FOLLOW UP OF (B)(6) 2021: DISCREPANCY WITH REMOVAL DATE OF ESSURE ( B)(6) 2019 - (B)(6) 2019), AND PATIENTS INITIALS (GD - GLD) REMOVAL DETAILS: DIAGNOSIS: CHRONIC PELVIC PAIN OPERATION: LAPAROSCOPIC BILATERAL SALPINGECTOMY, REMOVAL OF BILATERAL ESSURE COILS, HYSTEROSCOPY. BILATERAL SALPINGECTOMY WITH BIPOLAR FORCEPS AND SCISSORS. ESSURE COILS IDENTIFIED ON BOTH SIDES AND REMOVED COMPLETELY. SPECIMENS (BOTH TUBES AND BOTH COILS) REMOVED AND SENT FOR PATHOLOGY. COMPLICATIONS: EBL 10MLS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE DISLOCATION, PELVIC PAIN , DYSPAREUNIA DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): ULTRASOUND PELVIS - ON (B)(6) 2013: CLINICAL INDICATION: RECURRENT RIGHT-SIDED PELVIC PAIN? PALPABLE FINDINGS: THE UTERUS APPEARED RETROVERTED AND HETEROGENEOUS IN ECHO TEXTURE.ESSURE DEVICES SEEN IN SITU. THERE IS A 9 MM SIZE NABOTHIAN CYST AT THE CERVIX.; ON (B)(6) 2018: TRANSABDOMINAL AND TRANSVAGINAL PELVIC ULTRASOUND EXAMINATION CLINICAL INDICATIONS: DIAGNOSIS PELVIC PAIN HEAVY PERIODS IRREGULAR SEVERAI WEEKS CAUSE FIBROIDS POLYPS?? CONCLUSION: THERE ARE TWO ECHOGENIC LINEAR REGIONS IN THE UTERINE CORNUA. APPEARANCES ARE MOST LIKELY MECHANICAL TUBAL OCCLUSION DEVICE. SONOGRAPHIC FEATURES OF RIGHT POLYCYSTIC OVARY. NORMAL ULTRASOUND EXAMINATION OF THE UTERUS, ENDOMETRIUM, AND LEFT OVARY. NO FOCAL ADNEXAL MASSES OR FREE FLUID NOTED. TECHNICAL FINDINGS: THE UTERUS IS ANTEVERTED AND APPEARS NORMAL IN SIZE, SHAPE AND ECHO PATTERN MEASURING 75 X 51 X 54 MM. NO FOCAL FIBROIDS SEEN. THERE ARE TWO ECHOGENIC LINEAR REGIONS IN THE UTERINE CORNUA. APPEARANCES ARE MOST LIKELY MECHANICAL TUBAL OCCLUSION DEVICE.; ON (B)(6) 2018: INCONCLUSIVE AS TO WHETHER A COIL HAS MIGRATED AND MAY BE THE CAUSE OF HER PAIN. QUALITY-SAFETY EVALUATION OF PTC: 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. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-NOV-2021: 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.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("ESSURE MIGRATION") AND PELVIC PAIN ("CHRONIC PELVIC PAIN") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED (LOT NO. 910509). ADDITIONAL NON-SERIOUS EVENTS ARE DETAILED BELOW. THE PATIENT HAD A MEDICAL HISTORY OF DYSPAREUNIA IN 2003 AND TONSILLECTOMY, SEPTIC SPOTS, DEPRESSION, BIOPSY ENDOMETRIUM, DISCOMFORT, ACNE, INFECTION, POST COITAL BLEEDING, MIGRAINE, PALPITATION, VAGINAL INFECTION, UTERINE CERVICAL EROSION, PELVIC PAIN FEMALE, PARITY 4 AND MULTIGRAVIDA (4 GRAVIDA). PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED: IUD NOS, CONTRACEPTIVES, FLUCONAZOLE, NAPROXEN, ZAPAIN AND ACICLOVIR. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ESSURE WAS REMOVED ON (B)(6) 019. AN UNKNOWN TIME LATER SHE EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERION MEDICALLY IMPORTANT), DYSPAREUNIA ("DYSPAREUNIA"), GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING"), DEVICE INTOLERANCE ("INABILITY TO TOLERATE THE DEVICE") AND MENTAL DISORDER ("PSYCHOLOGICAL ISSUES"). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY HYSTEROSCOPY). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, DYSPAREUNIA AND GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, DEVICE INTOLERANCE, DYSPAREUNIA, GENITAL HAEMORRHAGE, MENTAL DISORDER AND PELVIC PAIN TO BE RELATED TO ESSURE ADMINISTRATION. THE REPORTER COMMENTED: AS PER FOLLOW UP OF (B)(6) 2021: DISCREPANCY WITH REMOVAL DATE OF ESSURE ( (B)(6) 2019 - (B)(6) 2019), AND PATIENTS INITIALS (GD - GLD) REMOVAL DETAILS: DIAGNOSIS: CHRONIC PELVIC PAIN OPERATION: LAPAROSCOPIC BILATERAL SALPINGECTOMY, REMOVAL OF BILATERAL ESSURE COILS, HYSTEROSCOPY. BILATERAL SALPINGECTOMY WITH BIPOLAR FORCEPS AND SCISSORS. ESSURE COILS IDENTIFIED ON BOTH SIDES AND REMOVED COMPLETELY. SPECIMENS (BOTH TUBES AND BOTH COILS) REMOVED AND SENT FOR PATHOLOGY. COMPLICATIONS: EBL 10MLS. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONE/ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE DISLOCATION, PELVIC PAIN , DYSPAREUNIA RIGHT SIDE- 3 COILS LEFT SIDE-2 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [ULTRASOUND PELVIS] ON (B)(6) 2013: CLINICAL INDICATION: RECURRENT RIGHT-SIDED PELVIC PAIN? PALPABLE FINDINGS: THE UTERUS APPEARED RETROVERTED AND HETEROGENEOUS IN ECHO TEXTURE.ESSURE DEVICES SEEN IN SITU. THERE IS A 9 MM SIZE NABOTHIAN CYST AT THE CERVIX.; ON (B)(6) 2018: TRANSABDOMINAL AND TRANSVAGINAL PELVIC ULTRASOUND EXAMINATION CLINICAL INDICATIONS: DIAGNOSIS PELVIC PAIN HEAVY PERIODS IRREGULAR SEVERAI WEEKS CAUSE FIBROIDS POLYPS?? CONCLUSION: THERE ARE TWO ECHOGENIC LINEAR REGIONS IN THE UTERINE CORNUA. APPEARANCES ARE MOST LIKELY MECHANICAL TUBAL OCCLUSION DEVICE. SONOGRAPHIC FEATURES OF RIGHT POLYCYSTIC OVARY. NORMAL ULTRASOUND EXAMINATION OF THE UTERUS, ENDOMETRIUM, AND LEFT OVARY. NO FOCAL ADNEXAL MASSES OR FREE FLUID NOTED. TECHNICAL FINDINGS: THE UTERUS IS ANTEVERTED AND APPEARS NORMAL IN SIZE, SHAPE AND ECHO PATTERN MEASURING 75 X 51 X 54 MM. NO FOCAL FIBROIDS SEEN. THERE ARE TWO ECHOGENIC LINEAR REGIONS IN THE UTERINE CORNUA. APPEARANCES ARE MOST LIKELY MECHANICAL TUBAL OCCLUSION DEVICE.; ON (B)(6) 2018: INCONCLUSIVE AS TO WHETHER A COIL HAS MIGRATED AND MAY BE THE CAUSE OF HER PAIN [ULTRASOUND SCAN VAGINA] ON (B)(6) 2013: ESSURE DEVICES SEEN IN SITU 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: (B)(6) 2023: EVENT - PSYCHOLOGICAL DISORDER NOS, INTOLERANCE TO ESSURE MICRO-INSERT WERE ADDED, REPORTERS INFORMATION PATIENT MEDICAL HISTORY AND LAB DATA, ADDED RCC UPDATED. 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 DEVICE DISLOCATION ('ESSURE MIGRATION') IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 910509) 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 DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("LOCALISED PAIN"), DYSPAREUNIA ("DYSPAREUNIA,") AND GENITAL HAEMORRHAGE ("HEAVY ABNORMAL BLEEDING"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, DYSPAREUNIA AND GENITAL HAEMORRHAGE HAD RESOLVED. THE REPORTER CONSIDERED DEVICE DISLOCATION, DYSPAREUNIA, GENITAL HAEMORRHAGE AND PELVIC PAIN TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: PATIENT'S INFORMATION WAS UPDATED. LOT NUMBER, EVENT OUTCOME AND REMOVAL DATE WERE ADDED. NEW EVENTS ADDED: DYSPAREUNIA, HEAVY/ABNORMAL BLEEDING. WE RECEIVED A LOT NUMBER. 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
    319205 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 910509 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| O