BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7764187 · Received August 8, 2018

    Report

    Report Number
    2210968-2018-75013
    Event Type
    Injury
    Date Received
    August 8, 2018
    Report Date
    July 31, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: FEMALE PELVIC MEDICINE & RECONSTRUCTIVE SURGERY & VOLUME 17, NUMBER 5, SUPPLEMENT 2, SEPTEMBER/OCTOBER 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : GRANULATION TISSUE FORMATION AT THE VAGINAL CUFF AFTER TOTAL LAPAROSCOPIC HYSTERECTOMY OR DAVINCI ASSISTED TOTAL HYSTERECTOMY WITH UTEROSACRAL LIGAMENT COLPOPEXY FOR SURGICAL CORRECTION OF PELVIC ORGAN PROLAPSE" AUTHOR: A. AZADI1, L. LIPETSKAIA1, T. YEGANEH2, S. TATE2, S. DIAZ1. CITATION: FEMALE PELVIC MEDICINE & RECONSTRUCTIVE SURGERY & VOLUME 17, NUMBER 5, SUPPLEMENT 2, SEPTEMBER/OCTOBER 2011. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO LOOK AT THE PREVALENCE OF VAGINAL CUFF GRANULATION TISSUE FORMATION AFTER TOTAL LAPAROSCOPIC HYSTERECTOMY OR DAVINCI ASSISTED TOTAL HYSTERECTOMY WITH LAPAROSCOPIC UTEROSACRAL LIGAMENT COLPOPEXY. BETWEEN THE PERIODS OF JANUARY 2005 TO DECEMBER 2010, 110 PATIENTS WHO WERE FOUND TO HAVE TOTAL LAPAROSCOPIC HYSTERECTOMY OR DAVINCI ASSISTED TOTAL HYSTERECTOMY WITH UTEROSACRAL LIGAMENT COLPOPEXY WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, ABSORBABLE, BRAIDED SUTURE (VICRYL)\WAS USED FOR VAGINAL CUFF CLOSURE AND NON-ABSORBABLE BRAIDED SUTURE (ETHIBOND)\ WAS USED FOR COLPOPEXY. THERE WERE 7 PATIENTS NOTED TO FORM VAGINAL CUFF SUTURE GRANULOMA, 3 PATIENTS WERE ASYMPTOMATIC AND 1 PATIENT COMPLAINED OF VAGINAL BLEEDING. THERE WERE 3 OTHER PATIENTS COMPLAINED OF BOTH VAGINAL BLEEDING AND DISCHARGE. ONLY 1 PATIENT REQUIRED TREATMENT IN THE OPERATING ROOM FOR EXCISION OF THE LESION AS WELL AS THERMAL COAGULATION AND ALL THE OTHER PATIENTS WERE TREATED AT THE OFFICE BY CHEMICAL COAGULATION BY APPLICATION OF SILVER NITRATE. THERE WERE 3 OUT OF SEVEN PATIENTS WHO DEVELOPED GRANULATION TISSUE HAD DIABETES MELLITUS (42%) COMPARED TO 17% IN PATIENTS WHO DID NOT FORM GRANULATION TISSUE. IN CONCLUSION, VAGINAL CUFF GRANULATION TISSUE IS A COMMON FINDING AFTER LAPAROSCOPIC HYSTERECTOMIES AND LAPAROSCOPIC UTEROSACRAL LIGAMENT COLPOPEXY USING PERMANENT SUTURES (ETHIBOND). THE LOWER INCIDENCE OF FORMING GRANULATION TISSUE COMPARE TO HISTORICAL DATA MAY BE SECONDARY TO THE PLACEMENT OF SUTURE KNOT, WHICH WILL BE PLACED INTRAPERITONEALLY AND THEREFORE CAUSES LESS EXPOSURE OF VAGINAL EPITHELIUM TO THE SUTURE MATERIAL. FURTHER, DIABETES MELLITUS MAY BE A RISK FACTOR FOR FORMING GRANULATION TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606070 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention