BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 7927084 · Received October 2, 2018

    Report

    Report Number
    2210968-2018-76219
    Event Type
    Injury
    Date Received
    October 2, 2018
    Report Date
    September 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. 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 USED IN THIS PROCEDURE? CITATION: HERNIA (2017) 21: 245¿252; DOI 10.1007/S10029-017-1576-0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "VENTRAL HERNIA REPAIR IN PATIENTS WITH ABDOMINAL LOSS OF DOMAIN: AN OBSERVATIONAL STUDY OF ONE INSTITUTION¿S EXPERIENCE" AUTHORS: F. K. AZAR, T. C. CRAWFORD, K. E. PORUK, N. FARROW, P. CORNELL, O. NADRA, S. C. AZOURY1, K. C. SOARES1, C. M. COONEY, F. E. ECKHAUSER. CITATION: HERNIA (2017) 21: 245¿252; DOI 10.1007/S10029-017-1576-0. THIS SINGLE-INSTITUTION, SINGLE-SURGEON STUDY AIMED TO SUMMARIZES THE OUTCOMES OF ONE SURGEON¿S EXPERIENCE USING A ¿¿SANDWICH¿¿ TECHNIQUE FOR HERNIA REPAIR IN PATIENTS WITH LOSS OF ABDOMINAL DOMAIN. FROM 2008 TO 2015, 21 PATIENTS (N=9 MALE AND N=12 FEMALE; AVERAGE AGE OF 62 ± 13 YEARS) WITH ABDOMINAL LOSS OF DOMAIN (A VENTRAL HERNIA >300CM2) UNDERWENT VENTRAL HERNIA REPAIR. SEVENTEEN OF THESE PATIENT UTILIZED SANDWICH TECHNIQUE USING AN ACELLULAR DERMAL MATRIX BELOW THE FASCIA AND A PROLENE MESH ABOVE THE FASCIA. FOR PATIENTS AMENABLE TO PRIMARY FASCIAL CLOSURE, REINFORCEMENT OF PROLENE MESH ABOVE THE FASCIA (N=3) OR BIOLOGIC MESH BENEATH THE FASCIA WERE PERFORMED. IN ALL PATIENTS, DERMIS WAS APPROXIMATED USING 3-0 VICRYL SUTURES. TWO PATIENTS EXPERIENCED HERNIA RECURRENCE OF WHICH ONE PATIENT PRECEDED BY A SURGICAL SITE INFECTION THAT REQUIRED MULTIPLE DEBRIDEMENTS AND RESECTION OF THE EXPOSED MESH. ONE PATIENT DEVELOPED ABDOMINAL COMPARTMENT SYNDROME WHICH REQUIRED REOPERATION WITH EXCISION OF MESH TO DECOMPRESS THE PERITONEAL CAVITY. FURTHER SURGICAL SITE OCCURENCES INCLUDED SURGICAL SITE INFECTION (N=1; THE OTHER PATIENT WAS WITH RECURRENCE), SEROMA FORMATION (N=6), WOUND DEHISCENCE (N=4), AND ENTEROCUTANEOUS FISTULA FORMATION (N=1). IN TWO OF THESE PATIENTS, UNINCORPORATED MESH HAD TO BE EXCISED AT REOPERATION TO ALLEVIATE A FOREIGN BODY REACTION BY THE HOST IMMUNE SYSTEM AND TO FACILITATE PROPER WOUND HEALING. IN CONCLUSION, PATIENTS WITH VENTRAL HERNIAS AND ASSOCIATED LOSS OF DOMAIN ARE AT INCREASED RISK FOR POSTOPERATIVE COMPLICATIONS INCLUDING HERNIA RECURRENCE AND SURGICAL SITE OCCURRENCES. DESPITE THIS, THE STUDY AFFIRMS THAT VENTRAL HERNIA REPAIR MAY BE SAFELY PERFORMED IN PATIENTS WITH LOSS OF DOMAIN WITH LOW RATES OF RECURRENCE AND INFECTIOUS COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766530 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VICRYL SUTURE