BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 10152706 · Received June 15, 2020

    Report

    Report Number
    2951250-2020-08706
    Event Type
    Injury
    Date Received
    June 15, 2020
    Report Date
    June 17, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE: FRANCINI S, DURAES M, CHARAVIL A, MANNA F, DUFLOS C, COMPAN C, ET. AL., ESSURE REMOVAL FOR DEVICE-ATTRIBUTED SYMPTOMS: QUALITY OF LIFE EVALUATION BEFORE AND AFTER SURGICAL REMOVAL, JOURNAL OF GYNECOLOGY OBSTETRICS AND HUMAN REPRODUCTION, 2020:101772. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED ADVERSE REACTION ("DEVICE-ATTRIBUTED ONLY GYNECOLOGIC SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND ADVERSE REACTION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADVERSE REACTION AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE REFERS TO ONE PATIENT WHO HAD ONLY GYNECOLOGIC SYMPTOMS AND HAD ESSURE REMOVAL FOR DEVICE-ATTRIBUTED SYMPTOMS. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. ABSTRACT INTRODUCTION: INCREASING REPORTS OF ADVERSE EFFECTS HAVE RAISED CONCERNS ABOUT THE ESSURE HYSTEROSCOPIC STERILIZATION METHOD. WOMEN SUFFERING ALLEGED COMPLICATIONS OF THE ESSURE DEVICE OFTEN SEEK SURGICAL REMOVAL. THIS STUDY EVALUATED THE QUALITY OF LIFE (QOL) AND POSTOPERATIVE OUTCOMES IN WOMEN UNDERGOING ESSURE REMOVAL. MATERIAL AND METHODS: THIS OBSERVATIONAL CASE SERIES INCLUDED 95 WOMEN. REMOVAL WAS PERFORMED BY LAPAROSCOPIC SALPINGECTOMY-CORNUECTOMY, OR HYSTERECTOMY WITH BILATERAL SALPINGECTOMY. QOL WAS ASSESSED PREOPERATIVELY AND THREE MONTHS POSTOPERATIVELY BY SF-36 QUESTIONNAIRES [CORRELATED PHYSICAL HEALTH SCORE (PCS) AND MENTAL HEALTH SCORES (MCS)]. SYMPTOMS EVOLUTION WAS COLLECTED AT THREE MONTHS, AND COMPLICATIONS AT ONE MONTH. RESULTS: 64 LAPAROSCOPIC SALPINGECTOMY-CORNUECTOMIES, 33 LAPAROSCOPIC HYSTERECTOMIES, AND EIGHT VAGINAL HYSTERECTOMIES WERE PERFORMED. FOUR INTRAOPERATIVE COMPLICATIONS OCCURRED (ONE CONVERSION FROM CORNUECTOMY TO LAPAROSCOPIC HYSTERECTOMY, ONE SKIN BURN, TWO BLADDER INJURIES). SEVEN POSTOPERATIVE COMPLICATIONS OCCURRED (CLAVIEN DINDO, GRADE 1 OR 2). ALL COMPONENTS OF THE PREOPERATIVE QOL SCORES WERE LOWER THAN THOSE OF THE GENERAL POPULATION. PCS SCORES WERE LOWER PREOPERATIVELY THAN POSTOPERATIVELY. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUN-2020: QUALITY-SAFETY EVALUATION OF PTC. 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.

    Description of Event or Problem · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE: FRANCINI S, DURAES M, CHARAVIL A, MANNA F, DUFLOS C, COMPAN C, ET. AL., ESSURE REMOVAL FOR DEVICE-ATTRIBUTED SYMPTOMS: QUALITY OF LIFE EVALUATION BEFORE AND AFTER SURGICAL REMOVAL, JOURNAL OF GYNECOLOGY OBSTETRICS AND HUMAN REPRODUCTION, 2020:101772. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND EXPERIENCED ADVERSE EVENT ("DEVICE-ATTRIBUTED ONLY GYNECOLOGIC SYMPTOMS"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND ADVERSE EVENT OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ADVERSE EVENT AND MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THIS CASE REFERS TO ONE PATIENT WHO HAD ONLY GYNECOLOGIC SYMPTOMS AND HAD ESSURE REMOVAL FOR DEVICE-ATTRIBUTED SYMPTOMS. ABSTRACT INTRODUCTION: INCREASING REPORTS OF ADVERSE EFFECTS HAVE RAISED CONCERNS ABOUT THE ESSURE HYSTEROSCOPIC STERILIZATION METHOD. WOMEN SUFFERING ALLEGED COMPLICATIONS OF THE ESSURE DEVICE OFTEN SEEK SURGICAL REMOVAL. THIS STUDY EVALUATED THE QUALITY OF LIFE (QOL) AND POSTOPERATIVE OUTCOMES IN WOMEN UNDERGOING ESSURE REMOVAL. MATERIAL AND METHODS: THIS OBSERVATIONAL CASE SERIES INCLUDED 95 WOMEN. REMOVAL WAS PERFORMED BY LAPAROSCOPIC SALPINGECTOMY-CORNUECTOMY, OR HYSTERECTOMY WITH BILATERAL SALPINGECTOMY. QOL WAS ASSESSED PREOPERATIVELY AND THREE MONTHS POSTOPERATIVELY BY SF-36 QUESTIONNAIRES [CORRELATED PHYSICAL HEALTH SCORE (PCS) AND MENTAL HEALTH SCORES (MCS)]. SYMPTOMS EVOLUTION WAS COLLECTED AT THREE MONTHS, AND COMPLICATIONS AT ONE MONTH. RESULTS: 64 LAPAROSCOPIC SALPINGECTOMY-CORNUECTOMIES, 33 LAPAROSCOPIC HYSTERECTOMIES, AND EIGHT VAGINAL HYSTERECTOMIES WERE PERFORMED. FOUR INTRAOPERATIVE COMPLICATIONS OCCURRED (ONE CONVERSION FROM CORNUECTOMY TO LAPAROSCOPIC HYSTERECTOMY, ONE SKIN BURN, TWO BLADDER INJURIES). SEVEN POSTOPERATIVE COMPLICATIONS OCCURRED (CLAVIEN DINDO, GRADE 1 OR 2). ALL COMPONENTS OF THE PREOPERATIVE QOL SCORES WERE LOWER THAN THOSE OF THE GENERAL POPULATION. PCS SCORES WERE LOWER PREOPERATIVELY THAN POSTOPERATIVELY. 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
    617977 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R