BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 5270555 · Received December 7, 2015

    Report

    Report Number
    2951250-2015-01869
    Event Type
    Injury
    Date Received
    December 7, 2015
    Report Date
    January 23, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.

    Additional Manufacturer Narrative · 1

    FOLLOWING INTERNAL REVIEW, THIS CASE WAS FOUND TO BE A DUPLICATE OF CASE (B)(4) AND WILL BE DELETED FROM BAYER DATABASE.

    Description of Event or Problem · 1

    INCIDENT. UNANTICIPATED. SERIOUS INJURY. REQUIRED INTERVENTION THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHYSICIAN IN UNITED STATES ON 10-NOV-2015 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (ESS205) (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED IN 2007. THE PATIENT HAD A POST-TUBAL LIGATION SYNDROME. THE REPORTING PHYSICIAN WAS THE ONE WHO DID A SUPRACERVICAL HYSTERECTOMY WITH A MORCELLATOR. HE WAS UNSURE IF THE MORCELLATOR CAUSED THE ESSURE DEVICE TO BREAK. THE PIECES WERE SEEN IN THE ABDOMEN BY ANOTHER PHYSICIAN (UNSURE OF EXACT IMAGING MODALITY) AND IT WERE REMOVED BY ANOTHER SURGEON. THE PATIENT WAS NOW CLAIMING THAT HER PAIN HAS IMPROVED. THE PHYSICIAN WAS UNSURE IF THE PIECES WERE RESPONSIBLE FOR THE PATIENTS PAIN; AND HE WAS ASKING IF THE MORCELLATOR COULD HAVE CAUSED THE DEVICE OR PET FIBERS TO BREAK AND CAUSE THE PATIENT PAIN. THE PHYSICIAN MENTIONED HE MAY BE GETTING SUED BY THIS PATIENT. COMPANY CAUSALITY COMMENT THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD A POST TUBAL LIGATION SYNDROME AFTER ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTION. SHE WAS SUBMITTED TO A SUPRACERVICAL HYSTERECTOMY WITH A MORCELLATOR. AN UNSPECIFIED TIME AFTER THIS PROCEDURE, PIECES OF ESSURE WERE FOUND AND REMOVED FROM HER ABDOMEN. THE REPORTER WAS UNSURE IF THE MORCELLATOR CAUSED ESSURE TO BREAK. THESE EVENTS ARE UNLISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. HEAVIER AND MORE PROLONGED MENSTRUAL BLEEDING AND INCREASED DYSMENORRHEA HAVE BEEN REPORTED AFTER FEMALE STERILIZATION AND ATTRIBUTED, BY SOME AUTHORS, TO A POST TUBAL LIGATION SYNDROME. IN THIS PARTICULAR CASE, CONSUMER WAS DIAGNOSED WITH POST TUBAL LIGATION SYNDROME AND SUBMITTED TO A HYSTERECTOMY WITH A MORCELLATOR. THE TERM MORCELLATION ENCOMPASSES A VARIETY OF SURGICAL TECHNIQUES, SOME USED IN CONCERT WITH SPECIFIC DEVICES, TO FRAGMENT TISSUE SPECIMENS FACILITATING THEIR REMOVAL. IF UTERINE MORCELLATION IS PERFORMED, DISSEMINATION OF UTERINE FRAGMENTS THROUGHOUT THE INTRAPERITONEAL CAVITY MAY OCCUR. IF ESSURE REMOVAL IS REQUIRED, IT IS RECOMMENDED TO PERFORM A SALPINGECTOMY OR SALPINGOTOMY WITH CORNUAL RESECTION (IF REQUIRED) BY A TRANSABDOMINAL APPROACH (LAPAROTOMY OR LAPAROSCOPY). IN THIS CASE, IT SEEMS PATIENT HAD THE ESSURE DEVICE IN PLACE AT THE TIME OF THE MORCELLATION; THUS IT IS POSSIBLE THAT THE REPORTED DEVICE BREAKAGE WAS A CONSEQUENCE OF THE SURGICAL TECHNIQUE APPLIED FOR THE HYSTERECTOMY. NEVERTHELESS, SINCE NO DETAILS ABOUT THE EXACT PROCEDURE FOR ESSURE REMOVAL WERE PROVIDED (UNCLEAR IF THE MORCELLATOR WAS APPLIED DIRECTLY TO THE FALLOPIAN TUBES/ESSURE) CAUSALITY WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS CONSIDERED AN INCIDENT, SINCE SURGICAL INTERVENTIONS WERE REQUIRED FOR EVENTS TREATMENT. A PRODUCT TECHNICAL ANALYSIS AND FOLLOW-UP INFORMATION ARE BEING SOUGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802251 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R