BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7902295 · Received September 24, 2018

    Report

    Report Number
    2210968-2018-75942
    Event Type
    Injury
    Date Received
    September 24, 2018
    Report Date
    August 29, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    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? 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: OBSTET GYNECOL. 2013; 122: 770¿7. DOI: 10.1097/AOG.0B013E3182A49DAC. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "THREE-YEAR OUTCOMES OF VAGINAL MESH FOR PROLAPSE." AUTHORS: ROBERT E. GUTMAN, MD, PATRICK A. NOSTI, MD, ANDREW I. SOKOL, MD, ERIC R. SOKOL, MD, JOANNA L. PETERSON, RN, HONG WANG, PMD, MS, AND CHERYL B. IGLESIA, MD. CITATION: OBSTET GYNECOL. 2013; 122: 770¿7. DOI: 10.1097/AOG.0B013E3182A49DAC. THE OBJECTIVES OF THE STUDY WAS TO PRESENT THE 3-YEAR OUTCOME OF A DOUBLE-BLIND, MULTICENTER, RANDOMIZED TRIAL COMPARING VAGINAL PROLAPSE REPAIR WITH AND WITHOUT MESH. THIS WAS A PLANNED FINAL ANALYSIS OF 51 WOMEN WITH PELVIC ORGAN PROLAPSE QUANTIFICATION (POP-Q) STAGE 2 TO 4 PROLAPSE RANDOMIZED TO TRADITIONAL VAGINAL PROLAPSE SURGERY WITHOUT MESH (26 PATIENTS; AGE: 63.1 ± 9.0 YEARS; BMI: 28.2 ± 6.4) AND VAGINAL COLPOPEXY REPAIR WITH MESH (25 PATIENTS; AGE: 62.6 ± 10.6; BMI: 27.6 ± 5.5). EITHER TRADITIONAL VAGINAL PROLAPSE SURGERY WITHOUT MESH OR VAGINAL COLPOPEXY REPAIR WITH PROLIFT SYNTHETIC MESH (ETHICON) USING ANTERIOR PROLIFT, MODIFIED ANTERIOR PROLIFT WITH APICAL ARMS, OR TOTAL PROLIFT. IN THE MESH GROUP, REPORTED COMPLICATIONS INCLUDED A FEMALE PATIENT WITH VOIDING DYSFUNCTION, URINARY RETENTION, VAGINAL VAULT PROLAPSE, AND A POSTERIOR ENTEROCELE WHICH REQUIRED SLING REVISION AND CYSTOTOMY REPAIR, RECURRENT PROLAPSE (N-3) WHICH REQUIRED RE-OPERATION, MESH EXPOSURE (N-5) WHICH REQUIRED SURGICAL EXCISION (N-3), DYSPAREUNIA (N-9), DE NOVO DYSPAREUNIA (N-2), AND DE NOVO STRESS URINARY INCONTINENCE (N-3) WHICH REQUIRED SLING PROCEDURE AND THE EVENTS WERE RESOLVED. THE AUTHORS ARE REASSURED BY THE FACT THAT OVERALL QUALITY-OF-LIFE IMPROVEMENT WAS HIGH IN BOTH GROUPS DESPITE THE FACT THAT THERE WAS NO OBSERVED ANATOMIC BENEFIT WITH THE ADDITION OF MESH AND A GREATER THAN 15% MESH EXPOSURE RATE. THE STUDY HIGHLIGHTED THE NEED FOR A BALANCED APPROACH TO THE USE OF VAGINAL MESH THAT INCLUDES A THOROUGH PATIENT CONSENT PROCESS BEFORE ITS USE IN PROLAPSE REPAIRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745262 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention