BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7902146 · Received September 24, 2018

    Report

    Report Number
    2210968-2018-75940
    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 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: INT J GYNECOL OBSTET 2017; 139: 192¿196; DOI: 10.1002/IJGO.12267. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE:" A RETROSPECTIVE ANALYSIS OF THE EFFECTIVENESS OF ANTERIOR PELVIC ORGAN PROLAPSE REPAIR WITH PROLIFT VERSUS ELEVATE VAGINAL MESH" AUTHOR: ISABEL BARROS-PEREIRA, ALEXANDRE VALENTIM-LOURENÇO, ANDREIA FONSECA, BRUNA MELO, ALEXANDRA HENRIQUES, ANA RIBEIRINHO. CITATION: INT J GYNECOL OBSTET 2017; 139: 192¿196; DOI: 10.1002/IJGO.12267. THE PRIMARY OBJECTIVE OF THIS RETROSPECTIVE MEDICAL RECORD REVIEW WAS TO COMPARE THE EFFECTIVENESS OF PROLIFT AND ELEVATE FOR ANTERIOR POP SURGERY AT 12 MONTHS OF FOLLOW-UP, AND TO COMPARE COMPLICATIONS AND MORBIDITY IN THE PERIOPERATIVE AND POSTOPERATIVE PERIODS. BETWEEN 02JAN2007 AND 30DEC2009, 50 FEMALE PATIENTS (AGE AT TREATMENT: 64.2 ± 8.9 YEARS) WITH ANTERIOR PELVIC ORGAN PROLAPSE UNDERWENT REPAIR WITH PROLIFT MESH, WHERE THIS WAS COMPARED TO ANOTHER 50 PATIENTS WHO UNDERWENT REPAIR WITH ELEVATE MESH. IN PROLIFT GROUP AT 3-MONTH FOLLOW-UP, COMPLICATIONS INCLUDED VAGINAL BULGE SYMPTOMS (N=1), NEW ONSET OF OVERACTIVE BLADDER (N=5), DYSPAREUNIA (N=1), CONSTIPATION (N=1) AND RECURRENCE (N=8). MOREOVER AT 6 MONTHS, COMPLICATIONS INCLUDED VAGINAL BULGE SYMPTOMS (N=2), PELVIC FLOOR PAIN (N=2), NEW ONSET OF OVERACTIVE BLADDER (N=5), CONSTIPATION (N=3) AND RECURRENCE (N=9). FURTHERMORE AT 12 MONTHS, COMPLICATIONS INCLUDED VAGINAL BULGE SYMPTOMS (N=7), PELVIC FLOOR PAIN (N=1), NEW ONSET OF STRESS URINARY INCONTINENCE (N=1), NEW ONSET OF OVERACTIVE BLADDER (N=4), CONSTIPATION (N=3), AND RECURRENCE (N=19). ONE PATIENT IN THE PROLIFT GROUP EXPERIENCED POSTOPERATIVE VAGINAL MESH EXPOSURE AT 12 MONTHS, WHICH WAS TREATED WITH LOCAL ESTROGEN AND PARTIAL EXCISION OF THE ERODED MESH UNDER LOCAL ANESTHESIA. THE VAGINAL MESH EXPOSURE IN PROLIFT GROUP MIGHT BE RELATED TO LEVEL OF SURGICAL EXPERIENCE AND LARGE SIZE OF PROLIFT RESULTED IN INSUFFICIENT INTRAOPERATIVE MESH SPREADING OR FOLDING IN THE IMMEDIATE POSTOPERATIVE PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745242 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention