BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 11478334 · Received March 12, 2021

    Report

    Report Number
    2210968-2021-02328
    Event Type
    Injury
    Date Received
    March 12, 2021
    Date of Event
    January 1, 2009
    Report Date
    March 2, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. 2009 SEP; CONFERENCE: 34TH ANNUAL MEETING OF THE INTERNATIONAL UROGYNECOLOGICAL ASSOCIATION, IUGA. LAGO DI COMO ITALY. CONFERENCE PUBLICATION:(VAR.PAGINGS). 20 (3 SUPPL.): S287. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    TITLE: TECHNICAL TRANSVAGINAL ANTERIOR VAGINAL PROLAPSE REPAIR WITH AN ULTRA-LIGHT POLYPROPYLENE MESH NOVASILK USING A LARGE UNFIXED INTERVESICOVAGINAL MESH: A PROSPECTIVE LONGITUDINAL STUDY. THE AIM OF THIS PROSPECTIVE LONGITUDINAL OBSERVATIONAL STUDY IS TO EVALUATE THE EFFICACY OF A NEW ULTRA-LIGHT POLYPROPYLENE MESH, 22G/M2 (NOVASILK DEGREE COLOPLAST) IN THE TREATMENT OF AT LEAST GRADE 2 CYSTOCELE PELVIC ORGAN PROLAPSE QUANTIFICATIONS (POP-Q) CLASSIFICATION USING A LARGE UNFIXED MESH TECHNIQUE; AND TO ACCESS SHRINKAGE OF THE MESH AND VAGINAL EROSION AND THEIR CONSEQUENCES ON PAIN AND DYSPAREUNIA. BETWEEN 14 JUN 2006 AND 24 APR 2008, 97 CONSECUTIVE FEMALE PATIENTS WITH MEAN AGE OF 66.2 YEARS (RANGE 38-92) UNDERWENT PELVIC RECONSTRUCTIVE SURGERY FOR SYMPTOMATIC PROLAPSE WITH ANTERIOR VAGINAL WALL PROLAPSE AT LEAST GRADE 2, POINT BA POP-Q CLASSIFICATION. DURING THE PROCEDURE, THE ANTERIOR PART OF THE MESH IS ATTACHED TO THE RETRO-PUBIC INSERTION OF THE PUBO-COCCYGEUS MUSCLES WITH A 2/0 PROLENE (ETHICON) SUTURE. POSTOPERATIVE COMPLICATIONS INCLUDE ABNORMAL BLEEDING NEEDING BLOOD TRANSFUSION (N=1), PELVIC HEMATOMAS (N=2), URETERAL DISTENSION NECESSITATING DRAINAGE AND URETERAL JJ STENT (N=1), URINARY RETENTION (N=3) WITH ONE NEEDING SECTIONING OF TRANSOBTURATOR TAPE (TOT), URINARY INFECTION (N=6), AND INTRA VAGINAL PROLAPSE RECURRENCE (N=10) THAT ARE ALL ASYMPTOMATIC AND DID NOT NEED RE-OPERATION, FURTHER COMPLICATIONS INCLUDE VAGINAL MESH EXPOSITION (N=2) IN WHICH THE FIRST ONE OCCURRED 8 MONTHS POST OPERATIVELY AND WAS MANAGED IN THE CLINIC WHILE THE OTHER ONE OCCURRED 30 MONTHS POST OPERATIVELY THAT NEEDED PARTIAL EXPLANTATION OF THE MESH IN SURGERY ROOM BUT BOTH HAD GOOD VAGINAL HEALING. FOUR PATIENTS ADVOCATED WORSENING IN THEIR SEXUAL LIFE (N=4) WITH ONLY ONE HAVING DYSPAREUNIA. A TOTAL OF SIX PATIENTS REPORTED HAVING DYSPAREUNIA (N=6) AND TWO OF THEM SAID IT WAS RELATED TO SURGERY. INTENSE RETRACTION AND VAGINAL EROSION (N=1) OCCURRED IN ONE PATIENT WHO NEEDED EXPLANTATION OF MESH WITH GOOD HEALING OF THE VAGINA. THE AUTHORS RESULTS SUGGEST THAT LARGE POLYPROPYLENE MESH (NOVASILKDEGREE) PUT IN UNFIXED FASHION TO REINFORCE ENDOPELVIC FASCIA MAY GIVE PROMISING RESULTS IN THE CORRECTION OF ANTERIOR VAGINAL WALL PROLAPSE WITH LOW COMPLICATION AND LOW MORBIDITY RATES AT ONE YEAR FOLLOW-UP. PELVIC ORGAN PROLAPSE (POP) SYMPTOMS ARE SIGNIFICANTLY CORRECTED AND SEXUAL LIFE IS RESPECTED. THE UNFIXED TECHNIQUE USED IN THIS SERIES MAY EXPLAIN THE GOOD VAGINAL TOLERANCE, AS THE MESH CAN RETRACT FREELY, THUS REDUCING SHRINKAGE, MESH EXPOSITION AND DYPAREUNIA. LONG-TERM FOLLOW-UP ARE REQUIRED TO CONFIRM THESE PRELIMINARY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370476 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1