BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 11602580 · Received April 1, 2021

    Report

    Report Number
    2210968-2021-02938
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    January 1, 2012
    Report Date
    March 2, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT# (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: INTERNATIONAL UROGYNECOLOGY JOURNAL AND PELVIC FLOOR DYSFUNCTION. 2012 SEP. 23 (2 SUPPL. 1): S203-S204. PLEASE SEE ARTICLE ATTACHED.   EVENT RELATED TO PROLIFT DEVICE REPORTED VIA MW # 2210968-2021-02936. EVENT RELATED TO GYNECARE MESH REPORTED VIA MW # 2210968-2021-02937.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: TRANSVAGINAL MESH FOR PELVIC ORGAN PROLAPSE: 10-YEAR EXPERIENCE WITH 627 PROCEDURES. THE OBJECTIVE OF THIS RETROSPECTIVE COHORT STUDY WAS TO EVALUATE AND COMPARE THE OUTCOMES OF THREE DIFFERENT TRANSVAGINAL MESH (TVM) PROCEDURES FOR PELVIC ORGAN PROLAPSE. BETWEEN JANUARY 2002 AND APRIL 2012, A TOTAL OF 672 (AVERAGE AGE=61.2 YEARS, AGE RANGE=31 ¿ 87 YEARS) TVM PROCEDURES WERE PERFORMED. THE PATIENTS WERE DIVIDED INTO THREE GROUPS: 76 WITH GYNEMESH, 299 WITH PROLIFT, AND 248 WITH ELEVATE. DURING THE PROCEDURE, AN ANTERIOR AND/OR POSTERIOR VAGINAL REPAIR WITH A SURGEONFASHIONED INLAY OF GYNEMESH (ETHICON, INC., A KNITTED, LARGE-PORE, MONOFILAMENT POLYPROPYLENE MESH OF 41G/M2 DENSITY), WITH OR WITHOUT CONCURRENT SSF USING 0-PROLENE SUTURE (ETHICON) (REFERRED TO AS THE 'GYNEMESH' GROUP HEREAFTER); AN ANTERIOR, POSTERIOR OR TOTAL PROLIFT, (ETHICON, INC., A KIT UTILIZING GYNEMESH IN A TROCAR-BASED DELIVERY SYSTEM, WITH 4 EXITS ANTERIORLY AND 2 EXITS POSTERIORLY, PROVIDING APICAL SUPPORT VIA BILATERAL SACROSPINOUS LIGAMENT FIXATION (SSF) WITH THE POSTERIOR AND TOTAL SYSTEMS, THE 'PROLIFT' GROUP); OR AN ANTERIOR AND/OR POSTERIOR ELEVATE (AMERICAN MEDICAL SYSTEMS, INC., A KIT USING INTEPRO LITETM MESH, A POLYPROPYLENE MESH OF 25 G/M2 DENSITY, IN A TROCAR-LESS, NO EXIT SYSTEM, DESIGNED WITH SELF-FIXATING TIPS, ALLOWING BILATERAL SSF WITH BOTH THE ANTERIOR AS WELL AS THE POSTERIOR SYSTEMS, THE 'ELEVATE' GROUP). REPORTED COMPLICATIONS IN PROLIFT GROUP INCLUDED LONGER TIME (MEAN DIFFERENCE 15 MINS, P<0.001) AND HAD GREATER NUMBER OF INTRAOPERATIVE BLEEDING COMPLICATIONS (DEFINED AS AN ESTIMATED BLOOD LOSS OF >=500 CC, A HEMOGLOBIN DROP OF >=30 G/L, OR THE NEED FOR BLOOD TRANSFUSION, 15.3% VS 7.4%, P=0.009) COMPARED TO THE OTHER GROUPS (N=?); CYSTOTOMIES (N=4); URINARY TRACT INFECTION AND TRANSIENT VOIDING DYSFUNCTION RESULTED IN 5.1% (N=?); SUFFERED MORE FEBRILE EPISODES (5.4% VS 1.2%, P=0.014) (N=?); EXIT-SITE CELLULITIS (3.0%) (N=?); MESH COMPLICATIONS, SUCH AS EROSION, CONTRACTION CAUSING STENOSIS, AND PROMINENCE (N=?); DE NOVO STRESS URINARY INCONTINENCE, URGE INCONTINENCE, AND DYSPAREUNIA (N=?). REPORTED COMPLICATIONS IN GYNEMESH GROUP INCLUDED INTRAOPERATIVE BLEEDING COMPLICATIONS (DEFINED AS AN ESTIMATED BLOOD LOSS OF >=500 CC, A HEMOGLOBIN DROP OF >=30 G/L, OR THE NEED FOR BLOOD TRANSFUSION, 15.3% VS 7.4%, P=0.009) (N=?); INFECTION (N=?) REQUIRING SURGICAL DEBRIDEMENT AND REMOVAL OF THE MESH IMPLANT; MESH COMPLICATIONS, SUCH AS EROSION, CONTRACTION CAUSING STENOSIS, AND PROMINENCE (N=?); DE NOVO STRESS URINARY INCONTINENCE, URGE INCONTINENCE, AND DYSPAREUNIA (N=?). IN CONCLUSION, THE STUDY SUGGEST THAT WHILE ELEVATE AND PROLIFT TVM KITS ARE ASSOCIATED WITH IMPROVED ANATOMICAL CURE RATES OVER THE SURGEON-FASHIONED GYNEMESH INLAY, - THE TROCAR ¿ BASED SYSTEM, WHICH REQUIRES GREATER DISSECTION AND HAS EXIT SITES, IS ASSOCIATED WITH GREATER OPERATIVE MORBIDITY, AND COMPLICATIONS SUCH AS MESH EROSION AND CONTRACTION APPEAR TO BE RELATED TO THE SPECIFIC MESH USED, INDICATING THAT DIFFERENCES IN MESH PROPERTIES, SUCH AS DENSITY, COULD ACCOUNT FOR DIFFERENCES IN THESE COMPLICATION RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498958 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention