BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7838133 · Received August 31, 2018

    Report

    Report Number
    2210968-2018-75566
    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
    AS
    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 PRODUCT 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 : CYSTOCELE RECURRENCE AFTER ANTERIOR COLPORRHAPHY WITH AND WITHOUT MESH USE". AUTHOR: VIVIEN WONG, KA LAI SHEK A, JUDITH GOH B, HANNAH KRAUSE B, ANDREW MARTIN C, HANS PETER DIETZ. 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. THIS RETROSPECTIVE OBSERVATIONAL STUDY AIMED TO EVALUATE THE LONG-TERM SUBJECTIVE AND OBJECTIVE OUTCOMES FOLLOWING ANTERIOR COLPORRHAPHY (AC) WITH AND WITHOUT MESH USE; AND ASSESS WHETHER THE ESTIMATED EFFECT OF MESH WAS MODIFIED BY THE PRESENCE OF MAJOR TRAUMA TO THE LEVATOR ANI MUSCLE (¿AVULSION¿). OF THE 332 PATIENTS WHO UNDERWENT AC, 100 FEMALE PATIENTS (MEAN AGE OF 64.9 YEARS) UNDERWENT AC WITH MESH (BETWEEN MAR2004 AND OCT2008) AND 83 FEMALE PATIENTS (MEAN AGE OF 65.3 YEARS) UNDERWENT AC WITHOUT MESH (BETWEEN JAN2002 AND DEC2005) ATTENDED THE AUDIT FOLLOW-UP. IN AC WITH MESH, MESH USED WAS EITHER PROLIFT (N=49) OR PERIGEE (N=51). IN THE FOLLOW-UP PERIOD, RECURRENT CYSTOCELE OF =STAGE 2 WAS OBSERVED IN 33 PATIENTS IN AC WITH MESH GROUP. AT A MEAN OF FOUR YEARS¿ FOLLOW-UP, MESH AUGMENTATION WAS ASSOCIATED WITH REDUCED CYSTOCELE RECURRENCE, BUT THIS EFFECT WAS LIMITED TO PATIENTS WITH LEVATOR AVULSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680573 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention