BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7931858 · Received October 3, 2018

    Report

    Report Number
    2210968-2018-76298
    Event Type
    Injury
    Date Received
    October 3, 2018
    Report Date
    September 10, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS 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 PRODUCTS USED IN THIS PROCEDURE? CITATION: INT UROGYNECOL J. 2018; 29: 71¿79. DOI: 10.1007/S00192-017-3405-5 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC SACROHYSTEROPEXY VERSUS VAGINAL HYSTERECTOMY FOR UTEROVAGINAL PROLAPSE USING VALIDATED QUESTIONNAIRES: 2-YEAR PROSPECTIVE STUDY" AUTHORS: FARAH LONE, TAMARA CURNOW, SARAH ANNE THOMAS CITATION: INT UROGYNECOL J. 2018; 29: 71¿79. DOI: 10.1007/S00192-017-3405-5. SURGICAL OPTIONS FOR UTEROVAGINAL PROLAPSE CAN BE CATEGORIZED INTO UTERUS CONSERVATION OR VAGINAL HYSTERECTOMY (VH). THE AIM OF THE STUDY WAS TO COMPARE SUBJECTIVE AND OBJECTIVE OUTCOMES OF LAPAROSCOPIC SACROHYSTEROPEXY (LSHP) AND VH. THE SECONDARY AIM WAS TO RECORD ADVERSE EVENTS, RECURRENT PROLAPSE, AND NEW-ONSET STRESS URINARY INCONTINENCE (SUI) UP TO 2 YEARS. A TOTAL OF 125 WOMEN WITH SYMPTOMATIC UTEROVAGINAL PROLAPSE WHO OPTED FOR EITHER LSHP (N-44; AGE: 60 ± 11.74; BMI: 27.5 ± 3.97) OR VH (N-81; AGE: 66 ± 9.81; BMI: 27 ± 3.36) WERE INCLUDED. IN THE LSHP GROUP, THE MESH WAS SHAPED TO CREATE TWO ARMS AND A TAIL. THE ARMS OF THE MESH WERE INTRODUCED THROUGH THE BROAD LIGAMENT WINDOWS AND SUTURED ANTERIOR TO THE CERVIX USING ETHIBOND 2-0 SUTURES (ETHICON). IN THE VH GROUP, BOTH VAULT SUSPENSION TECHNIQUES WERE PERFORMED USING VICRYL 1-0 REABSORBABLE SUTURES (ETHICON). IN THE LSHP GROUP, REPORTED COMPLICATIONS INCLUDED PORT-SITE HEMATOMA (N-1) WHICH REQUIRED READMISSION, URINARY TRACT INFECTION (N-1) WHICH REQUIRED READMISSION, BOWEL SEROSAL INJURIES (N-2) THAT WERE IDENTIFIED AND WERE SUTURED INTRAOPERATIVELY, NEW-ONSET STRESS URINARY INCONTINENCE (N-3) WHICH REQUIRED A MID-URETHRAL TAPE PROCEDURE, AND SYMPTOMATIC PROLAPSE (N-2) WHICH OPTED FOR VAGINAL SUPPORT PESSARY MANAGEMENT. IN THE VH GROUP, REPORTED COMPLICATIONS INCLUDED BLADDER INJURIES (N-2) WHICH WERE REPAIRED INTRAOPERATIVELY AND URINARY TRACT INFECTION (N-1) WHICH REQUIRED READMISSION. THIS STUDY HIGHLIGHTS THAT BOTH LSHP AND VH ARE EFFECTIVE SURGICAL TREATMENT OPTIONS FOR MANAGING UTEROVAGINAL PROLAPSE. AT 2 YEARS, THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE TWO PROCEDURES IN TERMS OF SYMPTOM DOMAINS, OVERALL SCORES, AE, RECURRENT PROLAPSE, OR NEW-ONSET SUI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770530 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention