BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7811073 · Received August 23, 2018

    Report

    Report Number
    2210968-2018-75375
    Event Type
    Injury
    Date Received
    August 23, 2018
    Report Date
    August 15, 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE 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 INVOLVED? CITATION: INT UROGYNECOL J (2016) 27:1547¿1555; DOI 10.1007/S00192-016-2996-6. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE TITLE: SEEKING NEW SURGICAL PREDICTORS OF MESH EXPOSURE AFTER TRANSVAGINAL MESH REPAIR. THE OBJECTIVE OF THIS RETROSPECTIVE, OBSERVATIONAL COHORT STUDY WAS TO EXPLORE NEW SURGICAL PREDICTORS FOR MESH EXPOSURE WITH THE AIM TO IMPLEMENT STRATEGIES THAT AVOID MESH-RELATED COMPLICATIONS AND REOPERATIONS AND REPORT THE TIME FRAME AT WHICH MESH EXPOSURE COULD BE DETECTED USING A LONGER SURVEILLANCE PERIOD AND PROVIDE EVIDENCE FOR A LATE (I.E., > 12-MONTH) POSTOPERATIVE OCCURRENCE OF MESH EXPOSURE. BETWEEN JAN 2008 AND JAN 2012, 92 FEMALE PATIENTS (MEAN AGE SD OF 63.5±9.3 YEARS [RANGED 43-74 YEARS) UNDERWENT TRANSVAGINAL MESH (TVM) REPAIR FOR PELVIC ORGAN PROLAPSE (POP) II (N=12), III (N=75) AND IV (N=5). IN THE PROCEDURE, 52 PATIENTS RECEIVED ANTERIOR PROLIFT, 2 POSTERIOR PROLIFT AND 4 TOTAL PROLIFT. IN ALL PATIENTS, THE VAGINAL WALL WAS CLOSED USING 2-0 VICRYL SUTURES ON EITHER WHOLE LAYER INTERMITTENT METHOD OR SUBMUCOSAL RUNNING METHOD. POSTOPERATIVE COMPLICATIONS INCLUDED VOIDING DIFFICULTY (N=28), DE NOVO URGENCY (N=8), WOUND DEHISCENCE (N=10), HEMATOMA (N=6) AND MESH EXPOSURE (N=18; N=16 USING PROLIFT). ALL EXPOSURES WERE LOCATED IN THE AREA OF THE SUTURE LINE. FOURTEEN OF 18 PATIENTS WITH MESH EXPOSURES (77.8 %) WERE TREATED TOPICALLY WITH ESTROGEN ON AN OUTPATIENT BASIS AND REMOVAL OF EXPOSED MESH OR TAPE, WHEREAS REOPERATIONS UNDER ANESTHESIA WERE PERFORMED TO CLOSE THE VAGINAL MUCOSA OF FOUR PATIENTS WHO EXPERIENCED PERSISTENT VAGINAL SPOTTING AND REINFORCEMENT TO REPAIR THE ANTERIOR VAGINAL WALL. SURGEON EXPERIENCE (= 15 PROCEDURES), PROLIFT MESH KIT, AND WHOLE-LAYER INTERRUPTED CLOSURE WERE SIGNIFICANTLY ASSOCIATED WITH MESH EXPOSURE. HEMATOMA FORMATION WAS NOT ASSOCIATED WITH CLOSURE METHOD. HEMATOMA FORMATION WAS ASSOCIATED WITH WOUND DEHISCENCE AND WAS AN IMPORTANT, DIRECT PREDICTOR OF MESH EXPOSURE. THE DEVELOPMENT OF MESH EXPOSURE IS THOUGHT TO BE MULTIFACTORIAL, WITH DOCUMENTED CONTRIBUTING FACTORS DIVIDED INTO THREE MAJOR CATEGORIES: (1) MESH CHARACTERISTICS, (2) PATIENT FACTORS, AND (3) SURGICAL-SITE FACTORS/SURGICAL TECHNIQUE. SURGICAL-SITE FACTORS, SUCH AS SURGEON EXPERIENCE, CONCOMITANT HYSTERECTOMY, AND SUBSEQUENT T-SHAPED COLPOTOMY IN PATIENTS UNDERGOING HYSTERECTOMY OR BLEEDING COMPLICATIONS, ARE ALSO BELIEVED TO CONTRIBUTE TO MESH-RELATED COMPLICATIONS BY REDUCING WOUND HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652821 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention