BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7857083 · Received September 7, 2018

    Report

    Report Number
    2210968-2018-75724
    Event Type
    Injury
    Date Received
    September 7, 2018
    Report Date
    August 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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 ARE BEING 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: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 2016; 23: 614¿621. DOI: HTTP://DX.DOI.ORG/10.1016/J.JMIG.2016.02.014. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: SYNTHETIC GRAFT AUGMENTATION IN VAGINAL PROLAPSE SURGERY: LONG-TERM OBJECTIVE AND SUBJECTIVE OUTCOMES." AUTHORS: ISUZU MEYER, MD*, GERALD MCGWIN, PHD, THOMAS A. SWAIN, BS, MITCHELL D. ALVAREZ, MD, DAVID R. ELLINGTON, MD, AND HOLLY E. RICHTER, PHD, MD. CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 2016; 23: 614¿621. DOI: HTTP://DX.DOI.ORG/10.1016/J.JMIG.2016.02.014. THE OBJECTIVES OF THE STUDY WAS TO REPORT LONG-TERM OBJECTIVES AND SUBJECTIVE OUTCOMES IN WOMEN WHO UNDERWENT PROLAPSE SURGERY WITH A SYNTHETIC GRAFT AUGMENTATION. A TOTAL OF 70 WOMEN (AGE: 60.3 ± 9.3; BMI: 28.3 ± 5.4) WITH SYMPTOMATIC PELVIC ORGAN PROLAPSE WHO UNDERWENT TRANSVAGINAL GRAFT AUGMENTATION USING THE PROLIFT MESH SYSTEM (ETHICON) BETWEEN JULY 2006 AND DECEMBER 2008 FOR A MINIMUM 5-YEAR FOLLOW-UP WERE INCLUDED IN THE STUDY. REPORTED COMPLICATIONS INCLUDED DYSPAREUNIA (N-25), BLADDER PERFORATION (N-2), SURGICAL SITE INFECTION (N-1), FEVER (N-2), URINARY TRACT INFECTION (N-8), VAGINAL TENDERNESS IN THE DISTAL VAGINAL (N-4), VAGINAL TENDERNESS IN THE MIDDLE VAGINA (N-5), VAGINAL TENDERNESS IN THE PROXIMAL VAGINA (N-12), VAGINAL STRICTURE IN THE PROXIMAL VAGINA (N-1), AND GRAFT EXPOSURE (N-3). ALTHOUGH LIMITED BY A RELATIVELY LOW FOLLOW-UP RATE, THIS STUDY PROVIDES THE LONGEST FOLLOW-UP DATA ASSESSING BOTH SUBJECTIVE AND OBJECTIVE OUTCOMES IN THE CURRENT LITERATURE. SYNTHETIC GRAFT AUGMENTATION IN TRANSVAGINAL PELVIC ORGAN PROLAPSE SURGERY CAN BE A VIABLE OPTION, WITH POSITIVE OUTCOMES AT LONG-TERM FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695148 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention