BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 11810399 · Received May 11, 2021

    Report

    Report Number
    2210968-2021-04463
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    October 26, 2020
    Report Date
    April 29, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 05/11/2021. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO CLARIFY 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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OPERATIVE COMPLICATIONS (ANTERIOR VAGINAL WALL PROLAPSE, VAGINAL LAXITY/REDUNDANCY AND DE NOVO URGENCY INCONTINENCE) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (PROLENE SUTURE) USED IN THIS PROCEDURE/STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (ANTERIOR VAGINAL WALL PROLAPSE, VAGINAL LAXITY/REDUNDANCY AND DE NOVO URGENCY INCONTINENCE) AND DETAILS OF EVENTS IF AVAILABLE. WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. WAS THERE ANY SURGICAL/MEDICAL INTERVENTION PERFORMED FOR THE PATIENT WITH ANTERIOR VAGINAL WALL PROLAPSE? PLEASE PROVIDE, IF POSSIBLE, TYPE, PRODUCT CODE OR LOT NUMBER OF ETHICON SUTURE (PROLENE SUTURE) USED IN THIS STUDY. CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL (2020); DOI: HTTPS://DOI.ORG/10.1007/S00192-020-04590-0.

    Description of Event or Problem · 1

    TITLE: PROSPECTIVE ANALYSIS OF TRANSVAGINAL MESH HYSTEROPEXY IN THE TREATMENT OF UTERINE PROLAPSE. THE AIM OF THIS PROSPECTIVE, SINGLE-CENTER OBSERVATIONAL STUDY IS TO ASSESS THE ROLE OF TRANSVAGINAL MESH HYSTEROPEXY FOR THE SURGICAL MANAGEMENT OF SYMPTOMATIC UTERINE PROLAPSE. BETWEEN MARCH 2016 TO JULY 2018, A TOTAL OF 40 FEMALE PATIENTS (MEAN AGE = 68 ± 9 YEARS; AGE RANGE = 50¿86 YEARS) WITH BOTHERSOME UTERINE PROLAPSE WERE TREATED WITH TRANSVAGINAL MESH HYSTEROPEXY. THE APICAL PORTIONS OF THE ANTERIOR AND POSTERIOR MESH WERE SUTURED TO THE FRONT AND BACK OF THE CERVIX, RESPECTIVELY, WITH AT LEAST TWO 2¿0 NONABSORBABLE PROLENE SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED ANTERIOR VAGINAL WALL PROLAPSE (N=1), VAGINAL LAXITY/REDUNDANCY (N=2), AND DE NOVO URGENCY INCONTINENCE (N=2) BASED UPON THEIR MESA URGE SUBSCORE RESPONSES, YET NONE REQUIRED TREATMENT. IN CONCLUSION, THIS STUDY HIGHLIGHTS THE FACT THAT THE UTERUS CAN BE RETAINED WITH MINIMAL SURGICAL COMPLICATIONS AND HIGH COMPOSITE SUCCESS. WE LOOK FORWARD TO FOLLOWING THESE SUBJECTS TO DETERMINE LONGER-TERM SAFETY OF USING SYNTHETIC MESH FOR HYSTEROPEXY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705984 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1