BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7903729 · Received September 24, 2018

    Report

    Report Number
    2210968-2018-75963
    Event Type
    Injury
    Date Received
    September 24, 2018
    Report Date
    August 30, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 165 (2012) 295¿298; DOI: HTTP://DX.DOI.ORG/10.1016/J.EJOGRB.2012.07.011 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: TRANSVAGINAL PROLIFT1 MESH SURGERY DUE TO ADVANCED PELVIC ORGAN PROLAPSE DOES NOT IMPAIR FEMALE SEXUAL FUNCTION: A PROSPECTIVE STUDY" AUTHOR(S): ALEKSANDRA BARTUZI, KONRAD FUTYMA, BEATA KULIK-RECHBERGER, PAWEL SKORUPSKI, TOMASZ RECHBERGER CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY 165 (2012) 295¿298; DOI: HTTP://DX.DOI.ORG/10.1016/J.EJOGRB.2012.07.011. THE PRIMARY AIM OF THE PRESENT STUDY WAS TO EVALUATE SEXUAL FUNCTION IN WOMEN WITH SYMPTOMATIC PELVIC ORGAN PROLAPSE (POP) BEFORE SURGICAL TREATMENT AND THE INFLUENCE OF RECONSTRUCTIVE SURGERY WITH TRANSVAGINAL MESH (PROLIFT, GYNECARE) ON SEXUAL FUNCTION USING THE FEMALE SEXUAL FUNCTION INDEX (FSFI) QUESTIONNAIRE AND TO COMPARE SEXUAL FUNCTION IN PATIENTS WHO UNDERWENT PROLIFT SYSTEM PROLAPSE REPAIR ALONE WITH A GROUP OF WOMEN WHO UNDERWENT PROLAPSE REPAIR COMBINED WITH ADDITIONAL SURGICAL RESTORATION OF PERINEAL BODY DUE TO A WIDE GENITAL HIATUS. BETWEEN JUN2008 AND JAN2010, 59 SEXUALLY ACTIVE FEMALE PATIENTS (MEAN AGE SD OF 52.9 ± 7.6 YEARS) WITH SYMPTOMATIC POP (III & IV) WHO UNDERWENT RECONSTRUCTIVE SURGERY. DURING SURGERY THE GYNECARE PROLIFT PELVIC FLOOR REPAIR SYSTEM WAS USED. IN 49 WOMEN (83%) BOTH ANTERIOR AND POSTERIOR PROLIFT OPERATIONS WERE PERFORMED, IN 5 PATIENTS (8.5%) ONLY THE POSTERIOR PROLIFT1 SYSTEM WAS USED AND IN 5 CASES (8.5%) WITH VAGINAL CUFF PROLAPSE THE TOTAL PROLIFT1 SYSTEM WAS INSERTED. IN 19 PATIENTS (32.2%) MESH REPAIR WAS SUPPLEMENTED BY SURGICAL RESTORATION OF THE PERINEAL BODY USING ABSORBABLE VICRYL NO. 1 SUTURES. AT 12-18 MONTHS AFTER SURGERY, COMPLICATIONS INCLUDED INCREASED SEXUAL PAIN (N=25), MESH EROSION (N=1) SUCCESSFULLY TREATED WITH LOCAL EXCISION, STRESS URINARY INCONTINENCE (N=4; N=2 DE NOVO SYMPTOMS) TREATED WITH SUBURETHRAL SLING, AND DRY OVERACTIVE BLADDER (N=1) TREATED WITH STANDARD ANTIMUSCARINIC THERAPY. CLASSICAL SURGICAL RESTORATION OF THE PERINEAL BODY PERFORMED ADDITIONALLY DUE TO WIDE GENITAL HIATUS DOES NOT APPEAR TO CAUSE POSTOPERATIVE DYSPAREUNIA AND FURTHER DETERIORATION OF SEXUAL FUNCTION. FEMALE SEXUAL BEHAVIOR IS VERY COMPLEX AND THEREFORE IT IS DIFFICULT TO CLEARLY INDICATE ONE CAUSATIVE FACTOR RESPONSIBLE FOR DETERIORATION IN SEXUAL FUNCTIONING BECAUSE IT DEPENDS ON MANY, NOT ONLY ANATOMICAL, ASPECTS. A DECREASE IN QUALITY OF SEXUAL LIFE COULD BE CAUSED BY EXCESSIVE SCARRING, FIBROSIS, AND REDUCTION OF VAGINAL WALL ELASTICITY WHICH CAN LEAD TO DYSPAREUNIA. THE PROLIFT SYSTEM USED IN OUR STUDY APPEARS TO BE AN EFFECTIVE METHOD OF POP TREATMENT, BUT PATIENTS SHOULD NOT EXPECT A SIGNIFICANT IMPROVEMENT IN THEIR SEXUAL QUALITY OF LIFE AFTER THIS TYPE OF OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744972 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention