BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9296834 · Received November 8, 2019

    Report

    Report Number
    2951250-2019-11333
    Event Type
    Injury
    Date Received
    November 8, 2019
    Report Date
    November 18, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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: CHO YK, NGUYEN S, HARKINS G, DEIMLING T, BENTON A, AN ANALYSIS OF PATIENTS UNDERGOING SURGICAL REMOVAL OF THE ESSURE DEVICE: A RETROSPECTIVE CASE SERIES, JOURNAL OF GYNECOLOGIC SURGERY, 2019, 35:5:285-288. 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 WAS FOUND TO HAVE BENIGN FALLOPIAN TUBE NEOPLASM ("WALLTHARD-CELL NEST"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND BENIGN FALLOPIAN TUBE NEOPLASM OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR BENIGN FALLOPIAN TUBE NEOPLASM AND MEDICAL DEVICE REMOVAL WITH ESSURE. THE REPORTER COMMENTED: AN ADULT FEMALE PATIENT RECEIVED ESSURE AND UNDERWENT SURGICAL REMOVAL OF ESSURE. DURING THE SURGERY, SHE WAS FOUND TO HAVE A FALLOPIAN TUBE WALLTHARD-CELL NEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST - ON AN UNKNOWN DATE: FALLOPIAN TUBE WALLTHARD-CELL NEST. ABSTRACT: QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. OBJECTIVE: THE AIM OF THIS RESEARCH WAS TO DESCRIBE AND INVESTIGATE CHARACTERISTICS OF PATIENTS WHO UNDERWENT SURGICAL REMOVAL OF THE ESSURE(®) DEVICE (BAYER, (B)(4), NJ). THIS DEVICE WAS THE FIRST TRANSCERVICAL MICRO INSERT DEVICE FOR PERMANENT STERILIZATION. MATERIALS AND METHODS: A RETROSPECTIVE CHART REVIEW WAS CONDUCTED AT AN ACADEMIC HOSPITAL ON PATIENTS UNDERGOING SURGICAL REMOVAL OF THE ESSURE DEVICE FROM 2014 TO 2017. RESULTS: A TOTAL OF 69 PATIENTS UNDERWENT ESSURE REMOVAL-25 VIA LAPAROSCOPIC HYSTERECTOMY, 38 VIA SALPINGECTOMY WITH CORNUAL RESECTION, AND 6 VIA SALPINGECTOMY WITHOUT CORNUAL RESECTION. THE MEAN AGE OF THE SUBJECTS WAS 36.4 YEARS (STANDARD DEVIATION [SD] = 7.2). THE MEAN BODY MASS INDEX WAS 31.7 (SD = 7.3). THE MOST-COMMONLY REPORTED PAST MEDICAL HISTORIES WERE ANXIETY (19/69) AND DEPRESSION (16/69). THIRTY-EIGHT PATIENTS HAD HISTORIES OF PRIOR SURGERIES, WITH CESAREAN SECTION BEING REPORTED MOST COMMONLY (22/38). THE MOST-FREQUENTLY CITED ESSURE-ATTRIBUTED SYMPTOMS WERE PELVIC PAIN (63/69), BLEEDING (34/69), AND BLOATING (15/69). WHEN REMOVAL WAS REQUESTED, 58/69 PATIENTS HAD THE DEVICE IN FOR >1 YEAR AND 44/69 PATIENTS REPORTED ONSET OF SYMPTOMS AT TIME OF PLACEMENT. DURING THE REMOVAL SURGERY, 59/69 PATIENTS HAD ADDITIONAL PELVIC INTRAOPERATIVE FINDINGS; SPECIFICALLY, 43/69 HAD ENDOMETRIOSIS, 24/69 HAD ADHESIONS, 22/69 HAD ADENOMYOSIS, 8/69 HAD FIBROIDS; AND 7/69 HAD MISPLACED COILS. THE MAJORITY OF FALLOPIAN TUBES WERE NORMAL/NO PATHOLOGIC ALTERATIONS (35/69), WITH SMALLER SUBSETS OF PATIENTS HAVING PARATUBAL CYSTS (26/69) AND FIBROSIS (5/69). CONCLUSIONS: PATIENTS SEEKING REMOVAL OF THE ESSURE DEVICE MIGHT HAVE COEXISTING PELVIC PATHOLOGY. PROVIDERS SHOULD BE PREPARED TO ADDRESS ANY INTRAOPERATIVE PATHOLOGY FOUND. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-NOV-2019: QUALITY SAFETY EVALUATION OF PTC. 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-CONFORMANT 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 CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL (ESSURE REMOVAL) IN AN ADULT FEMALE PATIENT WHO RECEIVED ESSURE. THE CASE DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('ESSURE REMOVAL'). THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE: CHO YK, NGUYEN S, HARKINS G, DEIMLING T, BENTON A, AN ANALYSIS OF PATIENTS UNDERGOING SURGICAL REMOVAL OF THE ESSURE DEVICE: A RETROSPECTIVE CASE SERIES, JOURNAL OF GYNECOLOGIC SURGERY, 2019, 35:5:285-288. 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 WAS FOUND TO HAVE BENIGN FALLOPIAN TUBE NEOPLASM ("WALLTHARD-CELL NEST"). THE PATIENT WAS TREATED WITH SURGERY. ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL AND BENIGN FALLOPIAN TUBE NEOPLASM OUTCOME WAS UNKNOWN. THE RELATIONSHIP OF BENIGN FALLOPIAN TUBE NEOPLASM AND MEDICAL DEVICE REMOVAL TO TREATMENT WITH ESSURE WAS NOT REPORTED. THE REPORTER COMMENTED: AN ADULT FEMALE PATIENT RECEIVED ESSURE AND UNDERWENT SURGICAL REMOVAL OF ESSURE. DURING THE SURGERY, SHE WAS FOUND TO HAVE A FALLOPIAN TUBE WALLTHARD-CELL NEST. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): PATHOLOGY TEST ON AN UNKNOWN DATE: FALLOPIAN TUBE WALLTHARD-CELL NEST. OBJECTIVE: THE AIM OF THIS RESEARCH WAS TO DESCRIBE AND INVESTIGATE CHARACTERISTICS OF PATIENTS WHO UNDERWENT SURGICAL REMOVAL OF THE ESSURE(®) DEVICE (BAYER, WHIPPANY, NJ). THIS DEVICE WAS THE FIRST TRANSCERVICAL MICRO INSERT DEVICE FOR PERMANENT STERILIZATION. MATERIALS AND METHODS: A RETROSPECTIVE CHART REVIEW WAS CONDUCTED AT AN ACADEMIC HOSPITAL ON PATIENTS UNDERGOING SURGICAL REMOVAL OF THE ESSURE DEVICE FROM 2014 TO 2017. RESULTS: A TOTAL OF 69 PATIENTS UNDERWENT ESSURE REMOVAL-25 VIA LAPAROSCOPIC HYSTERECTOMY, 38 VIA SALPINGECTOMY WITH CORNUAL RESECTION, AND 6 VIA SALPINGECTOMY WITHOUT CORNUAL RESECTION. THE MEAN AGE OF THE SUBJECTS WAS 36.4 YEARS (STANDARD DEVIATION [SD] = 7.2). THE MEAN BODY MASS INDEX WAS 31.7 (SD = 7.3). THE MOST-COMMONLY REPORTED PAST MEDICAL HISTORIES WERE ANXIETY (19/69) AND DEPRESSION (16/69). THIRTY-EIGHT PATIENTS HAD HISTORIES OF PRIOR SURGERIES, WITH CESAREAN SECTION BEING REPORTED MOST COMMONLY (22/38). THE MOST-FREQUENTLY CITED ESSURE-ATTRIBUTED SYMPTOMS WERE PELVIC PAIN (63/69), BLEEDING (34/69), AND BLOATING (15/69). WHEN REMOVAL WAS REQUESTED, 58/69 PATIENTS HAD THE DEVICE IN FOR >1 YEAR AND 44/69 PATIENTS REPORTED ONSET OF SYMPTOMS AT TIME OF PLACEMENT. DURING THE REMOVAL SURGERY, 59/69 PATIENTS HAD ADDITIONAL PELVIC INTRAOPERATIVE FINDINGS; SPECIFICALLY, 43/69 HAD ENDOMETRIOSIS, 24/69 HAD ADHESIONS, 22/69 HAD ADENOMYOSIS, 8/69 HAD FIBROIDS; AND 7/69 HAD MISPLACED COILS. THE MAJORITY OF FALLOPIAN TUBES WERE NORMAL/NO PATHOLOGIC ALTERATIONS (35/69), WITH SMALLER SUBSETS OF PATIENTS HAVING PARATUBAL CYSTS (26/69) AND FIBROSIS (5/69). CONCLUSIONS: PATIENTS SEEKING REMOVAL OF THE ESSURE DEVICE MIGHT HAVE COEXISTING PELVIC PATHOLOGY. PROVIDERS SHOULD BE PREPARED TO ADDRESS ANY INTRAOPERATIVE PATHOLOGY FOUND. 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
    1090750 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R