BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7897585 · Received September 21, 2018

    Report

    Report Number
    2210968-2018-75916
    Event Type
    Injury
    Date Received
    September 21, 2018
    Report Date
    August 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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 WERE 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: CAN UROL ASSOC J. 2014; 8 (9-10): E605-9. DOI: HTTP://DX.DOI.ORG/10.5489/CUAJ.2022. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : MORBIDITY AND FUNCTIONAL MID-TERM OUTCOMES USING PROLIFT PELVIC FLOOR REPAIR SYSTEMS." AUTHORS: SÉBASTIEN KOZAL, MD; THOMAS RIPERT, MD; YOUNES BAYOUD, MD; JOHAN MENARD, MD; IOANNIS NICOLACOPOULOS, MD; LAURENCE BEDNARZYCK, MD; FREDERIC STAERMAN, MD; STÉPHANE LARRÉ, MD. CITATION: CAN UROL ASSOC J. 2014; 8 (9-10): E605-9. DOI: HTTP://DX.DOI.ORG/10.5489/CUAJ.2022. THE AUTHORS ASSESS MIDTERM MORBIDITY AND FUNCTIONAL OUTCOMES USING THE GYNECARE PROLIFT MESH SYSTEM (ETHICON) AND IDENTIFY POTENTIAL RELATED RISK FACTORS. THE PROLIFT MESH SYSTEM WAS USED TO TREAT GENITAL PROLAPSE AND WAS INTRODUCED IN 2005. OVER A 7-YEAR PERIOD, THE AUTHORS RETROSPECTIVELY ANALYZED A COHORT OF 112 CONSECUTIVE PATIENTS (AGE RANGE: 40 TO 86 YEARS OLD; BMI: 15 TO 41.5) WHO UNDERWENT THE PROLIFT PROCEDURE SINCE 2006. ALL WOMEN PRESENTING WITH PELVIC ORGAN PROLAPSE (POP) AND TREATED WITH THE PROLIFT MESH SYSTEM WERE INCLUDED. REPORTED COMPLICATIONS INCLUDED BLADDER PERFORATION (N-3) WHICH WERE IMMEDIATELY REPAIRED TRANSVAGINALLY WITH FAVORABLE OUTCOMES, URINARY TRACT INFECTION (N-2), INFECTION (N-2), CHRONIC PAIN SYNDROME (N-2), MESH EXPOSURE (N-5) WHICH REQUIRED SURGICAL RESECTION (N-4) AND ABLATION AFTER A SECONDARY RETRACTION AT 45 MONTHS POST-OPERATIVELY (N-1), MESH RETRACTION (N-2), POP RECURRENCE (N-9), DE NOVO DYSPAREUNIA (N-9), FAILURE OF TREATMENT (N-9), AND DE NOVO PROLAPSE (N-13). DESPITE MARKET WITHDRAWAL, THE PROLIFT MESH SYSTEM WAS ASSOCIATED WITH GOOD MIDTERM ANATOMIC OUTCOMES AND FEW SEVERE COMPLICATIONS. THE MAIN LIMIT WAS THE IMPACT ON SEXUALITY AND THE OCCURRENCE OF DE NOVO POP. BASED ON THE RESULTS, BETTER OUTCOMES WERE OBSERVED IN ELDERLY NON-OBESE WOMEN WITH STAGE 3 OR MORE POP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740331 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention