BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7667851 · Received July 6, 2018

    Report

    Report Number
    2210968-2018-74152
    Event Type
    Injury
    Date Received
    July 6, 2018
    Report Date
    June 13, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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 INVOLVED? CITATION: HERNIA (2016) 20:691¿700; DOI 10.1007/S10029-016-1526-2 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: POLYPROPYLENE-BASED COMPOSITE MESH VERSUS STANDARD POLYPROPYLENE MESH IN THE RECONSTRUCTION OF COMPLICATED LARGE ABDOMINAL WALL HERNIAS: A PROSPECTIVE RANDOMIZED STUDY" AUTHOR(S): M. I. KASSEM ¿ H. M. EL-HADDAD CITATION: HERNIA (2016) 20:691¿700; DOI 10.1007/S10029-016-1526-2 THIS PROSPECTIVE RANDOMIZED STUDY AIMED TO COMPARE POLYPROPYLENE MESH POSITIONED ONLAY SUPPORTED BY OMENTUM AND/OR PERITONEUM VERSUS INLAY IMPLANTATION OF POLYPROPYLENE-BASED COMPOSITE MESH IN PATIENTS WITH COMPLICATED WIDE-DEFECT VENTRAL HERNIAS. DURING A 4-YEAR REVIEW PERIOD FROM JAN2012 TO JAN2016, 60 PATIENTS WITH COMPLICATED LARGE VENTRAL HERNIA DUE TO LARGE ABDOMINAL DEFECT WERE TREATED WITH MESH REPAIR AND WERE RANDOMLY DIVIDED INTO TWO GROUPS ACCORDING TO THE TYPE OF MESH USED TO REINFORCE THE ABDOMINAL WALL: GROUP A (N=30; N=10 MALE AND N=20 FEMALE; MEAN AGE SD OF 46.9 ± 12.7 YEARS) - THE DEFECT WAS CLOSED BY STANDARD PROLENE MESH PLACED OVER A LAYER OF GREATER OMENTUM/PERITONEUM, AND GROUP B (N=30; N=12 MALE AND N=18 FEMALE; MEAN AGE SD OF 46.1 ± 12.3 YEARS) ¿ THE DEFECT WAS CLOSED BY PP-BASED COMPOSITE MESH (PROCEED MESH AND PHYSIOMESH). IN GROUP A, THE DEFECTS WERE MANAGED BY OMENTAL AND/OR PERITONEAL FLAP INTERPOSITION BETWEEN A POLYPROPYLENE MESH INSERTED AS ONLAY MESH ON ABDOMINAL WALL MUSCLE AND THE INTRAPERITONEAL VISCERA. PROLENE 1 SUTURES WERE USED TO NARROW THE OPPOSITE END OF THE DEFECT AND VICRYL 0 WAS USED TO SUTURE THE OMENTUM TO THE EDGES OF THE DEFECT. IN GROUP B, COMPOSITE MESH REINFORCEMENT WAS ACHIEVED BY PROCEED OR PHYSIOMESH AND 2/0 OR 3/0 TRANSFACIAL PROLENE SUTURE WAS USED FOR MESH FIXATION IN BOTH TYPES. IN BOTH GROUPS, THE SUBCUTANEOUS TISSUE WAS CLOSED IN LAYERS FOLLOWED BY SKIN STAPLES. POSTOPERATIVELY, COMPLICATIONS INCLUDED MINOR HEMATOMA (N=11 GROUP A AND N=9 GROUP B) AND GRADE II ABDOMINAL COMPARTMENTAL SYNDROME (N=4 GROUP A AND N=1 GROUP B). IN GROUP A, A (B)(6) FEMALE PATIENT WHO HAD STRANGULATED PARASTOMAL HERNIA PRESENTED WITH DEEP INFECTION EXTENDING TO THE MESH 2 WEEKS AFTER THE OPERATION THAT NECESSITATED ITS REMOVAL TO CONTROL THE INFECTION. DURING THE FOLLOW-UP PERIOD RANGING FROM 2-48 MONTHS, 7 PATIENTS IN GROUP A AND 3 PATIENTS IN GROUP B COMPLAINED OF FOREIGN BODY SENSATION. IN GROUP A, 2 PATIENTS HAD RECURRENCE AT 3 MONTHS AND 8 MONTHS AFTER THE PROCEDURE. THE CAUSE OF RECURRENCE WAS ATTRIBUTED TO WOUND INFECTION AND POSTOPERATIVE ABDOMINAL HYPERTENSION IN THE FIRST CASE AND TO LARGE DEFECTS REACHING TO THE FLANKS THAT A SUFFICIENT PERIPHERAL OVERLAP WAS IMPOSSIBLE. SEROMA CASES WERE ASSOCIATED WITH SUBCUTANEOUS DISSECTION. THE INLAY POSITION HELPED TO REDUCE DISSECTION AND THIS WAS ATTRIBUTED TO THE LOW INCIDENCE OF SEROMA FORMATION BECAUSE THIS MANEUVER CREATES A POTENTIAL SPACE IN WHICH A SEROMA CAN FORM. COMPOSITE MESH DEPLOYMENT PROVIDES, IN ONE SESSION, SATISFACTORY RESULTS IN PATIENTS WITH COMPLICATED LARGE ABDOMINAL WALL HERNIA. THE PROCEDURE IS SAFE AND EFFECTIVE IN LOWERING OPERATIVE TIME WITH A TREND OF LOW WOUND COMPLICATION AND RECURRENCE RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510271 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention