BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VYPRO MESH UNKNOWN PRODUCT

    MDR report key: 13895003 · Received March 24, 2022

    Report

    Report Number
    2210968-2022-02158
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    March 18, 2021
    Report Date
    March 24, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K002672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 CITE: EUR SURG (2021) 53:231¿239 HTTPS://DOI.ORG/10.1007/S10353-021-00695-Y. 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 ETHICON PRODUCT (VYPRO MESH) 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 · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: FUNCTIONAL AND SEXUAL OUTCOME OF LAPAROSCOPIC VENTRAL MESH RECTOPEXY VS TRANSPERINEAL MESH REPAIR IN THE TREATMENT OF RECTOCELE: A RETROSPECTIVE ANALYSIS. THE AIM OF THIS STUDY IS TO COMPARE FUNCTIONAL OUTCOMES AND QUALITY OF LIFE, BETWEEN TRANSPERINEAL MESH REPAIR (TPMR) AND LAPAROSCOPIC VENTRAL MESH RECTOPEXY (LVMR) IN THE TREATMENT OF RECTOCELE. CONSECUTIVE WOMEN WITH SYMPTOMATIC RECTOCELE WITHOUT ASSOCIATED INTERNAL RECTAL PROLAPSE OR ENTEROCELE WHO UNDERWENT TPMR (N= 15) OR LVMR (N= 20) FROM JANUARY 2013 TO FEBRUARY 2019 WERE INCLUDED. THIS STUDY WAS A RETROSPECTIVE REVIEW OF A PROSPECTIVELY MAINTAINED DATABASE. THE PROCEDURE WAS PERFORMED UNDER SPINAL ANESTHESIA IN THE LITHOTOMY POSITION. A TRANSVERSE PERINEAL INCISION WAS MADE AT THE MUCOCUTANEOUS JUNCTION OF THE POSTERIOR VAGINAL WALL. ADRENALINE (EPINEPHRINE) SOLUTION WAS INFILTRATED INTO THE POSTERIOR VAGINAL WALL ALONG THE ENTIRE LENGTH OF THE RECTOCELE TO FACILITATE DISSECTION AND HEMOSTASIS. THE PLANE BETWEEN THE EXTERNAL ANAL SPHINCTER AND THE POSTERIOR VAGINAL WALL WAS CREATED, AND DISSECTION CARRIED OUT IN THE RECTOVAGINAL SEPTUM UNTIL REACHING THE APEX OF THE RECTOCELE. NO INCISION OR EXCISION MADE AT THE POSTERIOR VAGINAL WALL. THE LATERAL EDGES OF VYPRO II¿ (ETHICON¿JOHNSON AND JOHNSON, EDINBURGH, SCOTLAND, UK) MESH (8× 4CM) WERE SECURED TO BOTH SIDES OF THE LEVATOR ARC. REPORTED COMPLICATION INCLUDED ONE PATIENT FROM THE TPMR GROUP EXPERIENCED MESH EROSION 13 MONTHS AFTER SURGERY. NO COMPLETE MESH REMOVAL WAS REQUIRED. THE EXCESSIVE PART OF THE MESH WAS TRIMMED FROM THE PERINEAL INCISION AND INCISION WAS RE-SUTURED. IN CONCLUSION THE RESULTS OF THE PRESENT STUDY SHOW THAT BOTH TECHNIQUES ACHIEVED IMPROVEMENT IN DEFECATION REVEALED BY A SIGNIFICANT DECREASE IN ALTOMARE¿S ODS SCORES AT 3 AND 12 MONTHS AFTER SURGERY. THE IMPROVEMENT IN DEFECATION WAS ASSOCIATED WITH A SIMILAR IMPROVEMENT IN PAC-QOL AND SF-36 QOL IN BOTH GROUPS. AN IMPROVEMENT IN THE SEXUAL-RELATED QOL WAS OBSERVED IN BOTH GROUPS, BUT DYSPAREUNIA EVALUATED BY THE FSFI WORSENED ONLY AFTER TPMR. WELL-POWERED RANDOMIZED CONTROLLED TRIALS ARE REQUIRED TO ELIMINATE SELECTION BIAS AND EVALUATE THE EFFECTS OF DIFFERENT SURGICAL TECHNIQUES ON FUNCTIONAL AND SEXUAL OUTCOME IN RECTOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022052 VYPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention