BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT

    MDR report key: 14265924 · Received May 3, 2022

    Report

    Report Number
    2210968-2022-03181
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    March 9, 2021
    Report Date
    April 30, 2022
    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 · 0

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (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 CITE: HERNIA (2021) 25:1507¿1517 HTTPS://DOI.ORG/10.1007/S10029-021-02387-8. 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? PATIENT DEMOGRAPHICS?

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: ADJUNCT BOTOX TO PREOPERATIVE PROGRESSIVE PNEUMOPERITONEUM FOR INCISIONAL HERNIA WITH LOSS OF DOMAIN: NO ADDITIONAL EFFECT BUT MAY IMPROVE OUTCOMES. THIS STUDY FOCUSES ON THE INTEREST OF ADDING PREOPERATIVE BOTULINUM TOXIN A (BTA) INJECTION TO PREOPERATIVE PROGRESSIVE PNEUMOPERITONEUM (PPP), COMPARED TO PPP ALONE. PATIENTS BETWEEN JANUARY 2015 AND MARCH 2020 WITH IHLD WHO UNDERWENT PRE-OPERATIVE PREPARATION WERE INCLUDED. THEIR BASELINE CHARACTERISTICS WERE RETROSPECTIVELY ANALYZED, ALONG WITH THE CHARACTERISTICS OF THEIR INCISIONAL HERNIA BEFORE AND AFTER PREPARATION INCLUDING CT-SCAN VOLUMETRY. FOUR HUNDRED AND FIFTY (450) PATIENTS WITH INCISIONAL HERNIA WERE OPERATED, INCLUDING 41 PATIENTS (9.1%) WITH IHLD, 13 OF WHICH HAD BOTH BTA AND PPP, WHILE 28 HAD PPP ONLY. IN CASE OF INTRA-OPERATIVE SEPTIC CONDITIONS, ABSORBABLE MESHES OF VICRYL® (ETHICON®, SOMERVILLE, NJ, USA) WAS USED. REPORTED COMPLICATIONS INCLUDED SURGICAL SITE OCCURRENCES (N=17), SUPERFICIAL SURGICAL SITE INFECTION (N=4), HEMATOMA (N=1), SEROMA (N=2), SKIN NECROSIS (N=5), DEEP SURGICAL SITE INFECTION (N=3) AND FISTULA (N=1). IN CONCLUSION BTA AND PPP ARE BOTH USEFUL IN PRE-OPERATIVE PREPARATION FOR IHLD. COMBINING BOTH SIGNIFICANTLY INCREASES THE VOLUME OF ABDOMINAL CAVITY BUT ASSOCIATING BTA TO PPP DOES NOT ADD ANY VOLUMETRIC BENEFIT BUT MAY DECREASE THE POSTOPERATIVE SSO RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118136 VICRYL POLYGLACTIN 910 MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown