BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCEED MESH

    MDR report key: 8869761 · Received August 7, 2019

    Report

    Report Number
    2210968-2019-85257
    Event Type
    Injury
    Date Received
    August 7, 2019
    Report Date
    July 9, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K060713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADVERSE EVENTS INVOLVING THE 50-YEAR-OLD MALE IS SUBMITTED VIA MWR# 2210968-2019-85256. 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: HERNIA (2014) 18:57¿63 / DOI 10.1007/S10029-013-1051-5. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE THE CASES (INCLUDING 67-YEAR-OLD FEMALE) DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PROCEED MESH) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS EXPERIENCED BY THE 67-YEAR-OLD FEMALE, AND OTHER PATIENT ADVERSE EVENTS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS INVOLVED? (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: MULTI-STAGED REPAIR OF CONTAMINATED PRIMARY AND RECURRENT GIANT INCISIONAL HERNIAE IN THE SAME HOSPITAL ADMISSION: A PROPOSAL FOR A NEW APPROACH. THE PURPOSE OF THIS RETROSPECTIVE ANALYSIS OF A PROSPECTIVE STUDY WAS TO DISCUSS THE MULTI-STAGED APPROACH OF PRIMARY AND RECURRENT GIANT INCISIONAL HERNIAE. BETWEEN 2009 AND 2012, A TOTAL OF 5 PATIENTS [N=3 MEN, N=2 WOMEN, MEAN AGE 58 YEARS (45-74 YEARS), BMI 35 (30-46)] WHO UNDERWENT SURGICAL MANAGEMENT OF PRIMARY AND RECURRENT CONTAMINATED GIANT INCISIONAL HERNIAE. A 50- YEAR OLD MALE WHO UNDERWENT INCISIONAL HERNIA REPAIR WITH VYPRO MESH. HE HAD PAINFUL IRREDUCIBLE SWELLING AND CT SCAN SHOWED RECURRENT INCISIONAL HERNIA (GRADE 4). HE UNDERWENT FIRST STAGE OF HERNIA REPAIR, ADHESIOLYSIS, INFECTED VYPRO MESH INCORPORATED INTO JEJUNUM REMOVED, JEJUNAL RESECTION, ANASTOMOSES, WASH OUT AND SINGLE LAYER PDS MASS CLOSURE. A 67-YEAR OLD FEMALE WHO UNDERWENT INCISIONAL HERNIA REPAIR WITH PROCEED MESH. SHE HAD FOUR QUADRANT PERITONITIS ON 2ND POSTOPERATIVE DAY AND CT SCAN REVEALED FREE GAS AND FLUID (ABDOMEN). HE UNDERWENT FIRST STAGE OF HERNIA REPAIR, JEJUNAL AND ILEAL PERFORATION WITH EXTENSIVE CONTAMINATION MESH REMOVED AND EXTENSIVE ADHESIOLYSIS. TWO SMALL BOWEL RESECTIONS, ANASTOMOSES, WASH OUT, INTRA-ABDOMINAL DRAINS (4) AND LAPAROSTOMY WITH INLAY VICRYL MESH PLACEMENT AND LAPAROSTOMY. IN THE FIRST STAGE, OPEN PARTIAL EXCISION OF HERNIA SAC AND CLOSURE WITH VICRYL SUTURES AND ONE LAYER MASS ABDOMINAL WALL CLOSURE WITH LOOPED PDS IN THREE PATIENTS WAS PERFORMED. FOR CLOSURE, THE FOURTH PATIENT UNDERWENT OPEN INLAY VICRYL MESH PLACED INTRA-ABDOMINALLY FOLLOWED BY BOGOTA BAG PLACEMENT AS A LAPAROSTOMY. THE SECOND STAGE INVOLVED EITHER OPEN RETRO-RECTUS SUBLAY MESH PLACEMENT WITH BILATERAL COMPONENT SEPARATION TO ALLOW TENSION-FREE CLOSURE OF THE ANTERIOR SHEATH WITH PDS OR LAPAROSCOPIC MESH PLACEMENT WITH TRANSFASCIAL STITCHES (PROLENE) AND DOUBLE CROWN FIXATION. TWO PATIENTS HAD PROCEED COMPOSITE MESH AND THE REMAINING THREE HAD PHYSIO COMPOSITE MESH IMPLANTED FOR THEIR HERNIA REPAIR. MULTI-STAGED APPROACH IN THE SAME HOSPITAL ADMISSION (FOR THE REPAIR OF CONTAMINATED PRIMARY AND RECURRENT GIANT INCISIONAL HERNIAE), EXCLUDES THE DISADVANTAGES OF A TRUE MULTI-STAGED APPROACH AND SIMULTANEOUSLY MINIMISES THE RISKS AND COMPLICATIONS ASSOCIATED WITH A SINGLE-STAGED REPAIR, CAN BE ADOPTED FOR THESE CHALLENGING PATIENTS FOR A SUCCESSFUL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662913 PROCEED MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention