BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 7838061 · Received August 31, 2018

    Report

    Report Number
    2210968-2018-75565
    Event Type
    Injury
    Date Received
    August 31, 2018
    Report Date
    August 14, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (VICRYL SUTURE OR GYNECARE MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (VICRYL SUTURE OR GYNECARE MESH) USED IN THIS PROCEDURE? CITATION: INT BRAZ J UROL. 2017; 43: 525-32. DOI: 10.1590/S1677-5538.IBJU.2016.0482. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: ANTERIOR SIX ARMS PROLENE MESH FOR HIGH STAGE VAGINAL PROLAPSE: FIVE YEARS FOLLOW-UP". AUTHORS: LUIS GUSTAVO M. DE TOLEDO, ANDRÉ COSTA-MATOS, SUSANE MEY HWANG, RAQUEL DÓRIA RAMOS RICHETTI, SILVIA S. CARRAMÃO, ANTÔNIO P. F. AUGE. CITATION: INT BRAZ J UROL. 2017; 43: 525-32. DOI: 10.1590/S1677-5538.IBJU.2016.0482. IN HIGH STAGE VAGINAL PROLAPSE, RECURRENCE RISK PATIENTS, ANTERIOR AND APICAL DEFECTS NEED TO BE ADDRESSED IN THE SAME PROCEDURE. THE OBJECTIVES OF THE STUDY WAS TO PRESENT LONG TERM FOLLOW-UP OF PATIENTS TREATED WITH A HOMEMADE MESH SHAPE TO CORRECT HIGH STAGE PROLAPSES. THE AUTHORS PROSPECTIVELY DESCRIBED 18 PATIENTS (AGE RANGE: 53 TO 81 YEARS OLD; BMI: 16.8 33) WITH ANTERIOR AND APICAL VAGINAL PROLAPSES, STAGES III AND IV, REPAIRED USING THIS SPECIFIC DESIGN OF MESH. DURING THE SURGICAL PROCEDURE, MESH POSITIONING WAS DONE WITH AID OF PERMANENT NEEDLES, DELIVERING TWO PRE-PUBIC ARMS PROVIDING SUB URETHRAL SUPPORT AND AVOIDING MESH MIGRATION PROXIMALLY, 2 TRANSOBTURATOR (TO) ARMS AS CLOSE AS POSSIBLE TO THE ISCHIAL SPINE THROUGH THE ARCUS TENDINEUS LIGAMENT, TREATING LATERAL DEFECT, AND 2 ARMS THROUGH THE SACROSPINOUS LIGAMENT, THROUGH TRANS GLUTEUS ACCESS, MEDIAL TO THE ISCHIAL SPINE. FIXATION OF THE PROXIMAL END OF THE MESH TO THE PERICERVICAL RING USED VICRYL 2.0 ABSORBABLE SUTURES (ETHICON). THE MESH USED WAS A GYNECARE GYNEMESH NON-ABSORBABLE MONOFILAMENT SOFT POLYPROPYLENE MESH (ETHICON). REPORTED COMPLICATIONS INCLUDED PELVIC HEMATOMA (N-1) WHICH REQUIRED SURGICAL DRAINAGE BY PFANNENSTIEL INCISION, HEMORRHAGE (N-1) WHICH REQUIRED BLOOD TRANSFUSION, MESH VAGINAL EXTRUSION (N-2) WHICH WAS SUCCESSFULLY TREATED WITH EXTIRPATION OF THE EXTRUDED MESH, APICAL STAGE I OBJECTIVE RELAPSE (N-1), AND POSTERIOR STAGE II OBJECTIVE RELAPSE (N-1). IT WAS CONCLUDED THAT THE SIX ARMS GYNECARE GYNEMESH MESH ALLOWS CONCOMITANT CORRECTION OF ANTERIOR AND APICAL HIGH STAGES PROLAPSES, THROUGH A SINGLE ANTERIOR VAGINAL INCISION, WITH HIGH SUCCESS AND ACCEPTABLE COMPLICATIONS RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678904 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC OTO ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention