BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT

    MDR report key: 9531592 · Received December 30, 2019

    Report

    Report Number
    2210968-2019-91398
    Event Type
    Injury
    Date Received
    December 30, 2019
    Report Date
    December 10, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K810428
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. CITATION: JOURNAL OF GASTROINTESTINAL SURGERY / HTTPS://DOI.ORG/10.1007/S11605-018-04095-8. 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 PRODUCT (VICRYL 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 INVOLVED? (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: ABSORBABLE POLYGLACTIN VS. NON-CROSS-LINKED PORCINE BIOLOGICAL MESH FOR THE SURGICAL TREATMENT OF INFECTED INCISIONAL HERNIA. THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO COMPARE THE EFFICACY AND TOLERANCE OF ABSORBABLE AND BIOLOGICAL MESHES FOR THE SURGICAL TREATMENT OF INFECTED IH IN A HOMOGENEOUS SERIES OF PATIENTS, OPERATED ON WITH THE SAME STANDARDIZED TECHNIQUE. BETWEEN JAN 2008 AND JUNE 2015, A TOTAL OF 81 PATIENTS WITH INFECTED INCISIONAL HERNIA UNDERWENT INCISIONAL HERNIA REPAIR. PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE TYPE OF MESH USED: GROUP A, ABSORBABLE (VICRYL) [N=57 (N=27 MALE, MEDIAN AGE 65 YEARS (56-76 YEARS), MEDIAN BMI 29.9 KG/M2 (25.4-36.4 KG/M2))] AND GROUP B, BIOLOGICAL (STRATTICE) [N=24 (N=10 MALE, MEDIAN AGE 63 YEARS (57.5-69.5 YEARS), MEDIAN BMI 30.6 KG/M2 (27.7-36.3 KG/M2))]. ALL PATIENTS INCLUDED BEFORE END OF 2013 WERE OPERATED ON USING AN ABSORBABLE VICRYL MESH (ETHICON) AND ALL PATIENTS OPERATED ON THEREAFTER WITH A BIOLOGICAL MESH (STRATTICE). THE MESH WAS PLACED IN THE INTRAPERITONEAL POSITION AND WAS FIXED UNDER TENSION WITH SUFFICIENT OVERLAP (> 5 CM) ON THE PERIPHERY OF THE DEFECT. POSTOPERATIVE COMPLICATIONS INCLUDED SEROMA (N=1), DEEP INCISIONAL INFECTION (N=11), ORGAN INFECTIONS (N=9), CHRONIC PAIN (N=5), AND RECURRENCE (N=39). BIOLOGICAL MESHES SEEM TO BE SUPERIOR TO ABSORBABLE MESHES IN PATIENTS WITH CONTAMINATED OR INFECTED INCISIONAL HERNIA. THESE RESULTS NEED TO BE CONFIRMED BY PROSPECTIVE RANDOMIZED TRIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327722 VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention