BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 11898133 · Received May 27, 2021

    Report

    Report Number
    2210968-2021-05053
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    July 20, 2020
    Report Date
    April 28, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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.  THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS.  CITATION: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY. 2020; 253: 15¿20. DOI: HTTPS://DOI.ORG/10.1016/J.EJOGRB.2020.07.033LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE COMPLETED.   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 THE ETHICON PRODUCT (PROLIFT PELVIC FLOOR REPAIR) 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? PATIENT DEMOGRAPHICS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: PREDICTORS FOR DE NOVO STRESS URINARY INCONTINENCE FOLLOWING PELVIC RECONSTRUCTIVE SURGERY WITH MESH. THE AIM OF THIS RETROSPECTIVE COHORT STUDY IS TO EVALUATE THE INCIDENCE OF AND PREDICTIVE PREOPERATIVE FACTORS FOR THE EMERGENCE OF DE NOVO SUI IN WOMEN UNDERGOING SURGICAL CORRECTION OF ANTERIOR VAGINAL WALL PROLAPSE WITH A SYNTHETIC MESH. BETWEEN 2007 TO 2017, A TOTAL OF 146 FEMALE PATIENTS (MEAN AGE = 61.2±7.0 YEARS; MEAN BMI = 27.4±3.8) DIAGNOSED WITH ANTERIOR VAGINAL WALL PROLAPSE STAGE II OR HIGHER ACCORDING TO THE PELVIC ORGAN PROLAPSE QUANTIFICATION SYSTEM (POP-Q) WERE INCLUDED AND UNDERWENT SURGICAL CORRECTION OF POP WITH A SYNTHETIC MESH. SURGERY WAS PERFORMED USING A PROLIFT ANTERIOR (GYNECARE/ETHICON) IN 72 PATIENTS, WHILE THE REST WERE FROM COMPETITORS. REPORTED COMPLICATIONS INCLUDED DE NOVO STRESS URINARY INCONTINENCE (N=13), WHICH REQUIRED NEW SURGICAL TREATMENT IN AN UNKNOWN NUMBER OF PATIENTS; OBJECTIVE POP RECURRENCE (N=?), WHICH REQUIRED NEW SURGICAL PROCEDURE IN AN UNKNOWN NUMBER OF PATIENTS, AS THEY HAD RECURRENCE-RELATED COMPLAINTS THAT IMPAIRED THEIR QUALITY OF LIFE (SUBJECTIVE RECURRENCE). IN CONCLUSION, THE INCIDENCE OF DE NOVO SUI AFTER THE SURGICAL CORRECTION OF ANTERIOR VAGINAL WALL PROLAPSE WITH SYNTHETIC MESH IN THIS POPULATION WAS 15.8 % AND 20.5 % AT 3 AND 12 MONTHS OF FOLLOW-UP, RESPECTIVELY. CONTINENT WOMEN WHO UNDERWENT THIS SURGICAL PROCEDURE AND WHO HAD A HIGHER BMI, DIABETES AND POP-Q STAGE =3 HAD A HIGHER RISK OF PRESENTING DE NOVO SUI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788459 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention