BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7838242 · Received August 31, 2018

    Report

    Report Number
    2210968-2018-75567
    Event Type
    Injury
    Date Received
    August 31, 2018
    Report Date
    August 15, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT ( PROLIFT MESH) 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 INVOLVED? CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 172 (2014) 131¿135; DOI: HTTP://DX.DOI.ORG/10.1016/J.EJOGRB.2013.11.001. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : THE IMPROVEMENT OF PELVIC FLOOR MUSCLE FUNCTION IN POP PATIENTS AFTER THE PROLIFT PROCEDURE: RESULTS FROM SURFACE ELECTROMYOGRAPHY." AUTHOR: LIHUA WANG & XINLIANG CHEN & XIAOCUI LI & YAO GONG &HUAIFANG LI & XIAOWEN TONG. CITATION: INT UROGYNECOL J. 2013; 24: 1703 1708. DOI: 10.1007/S00192-013-2094-Y. PATIENTS WITH PELVIC ORGAN PROLAPSE (POP) HAVE LOWER PELVIC FLOOR MUSCLE (PFM) FUNCTION. THE AUTHORS HYPOTHESIZED THAT PELVIC RECONSTRUCTIVE SURGERY COULD IMPROVE PFM FUNCTION AND STRENGTH. THIS CONTROLLED, NON-RANDOMIZED STUDY RECRUITED 37 POP PATIENTS (AGE: 67.95 ± 8.75; BMI: 24.29 ± 2.33) IN THE PROLIFT GROUP AND 30 NON-POP PATIENTS (AGE: 67.37 ± 5.56; BMI: 23.94 ± 3.06) IN THE CONTROL GROUP. DURING THE SURGICAL PROCEDURE, ALL PATIENTS RECEIVED THE PROLIFT PROCEDURE. A TOTAL OF 20 PATIENTS RECEIVED TOTAL PROLIFT (ETHICON), 10 PATIENTS RECEIVED PROLIFT-A (ETHICON), AND 7 PATIENTS RECEIVED PROLIFT-P (ETHICON). REPORTED COMPLICATIONS INCLUDED VAGINAL WALL PERFORATION (N-3), STAGE II PROLAPSE SYMPTOMS (¿FAILED¿; N-1) IN WHICH THE PATIENT REFUSED REOPERATION AND CHOSE BIOFEEDBACK THERAPY, AND DE NOVO STRESS URINARY INCONTINENCE (N-4) IN WHICH THE PATIENTS WERE NOT TREATED DUE TO THE MINOR SYMPTOMS. THE PFM FUNCTION COULD BE IMPROVED 3 MONTHS AFTER THE PROLIFT PROCEDURE BASED ON THE EVALUATION OF SURFACE ELECTROMYOGRAPHY (SEMG) IN POP PATIENTS. THE RESTORATION OF PELVIC ANATOMY MAY ACCOUNT FOR A BETTER PFM FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678909 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention