BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 20340373 · Received September 30, 2024

    Report

    Report Number
    2210968-2024-10420
    Event Type
    Injury
    Date Received
    September 30, 2024
    Date of Event
    January 1, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. AN ATTEMPT HAS BEEN 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. H6 CLINICAL CODE: E2402 ¿ GRAFT-RELATED COMPLICATIONS. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: OBSTET GYNECOL 2023; 141: 189¿98. DOI: 10.1097/AOG.0000000000005021.

    Description of Event or Problem · 0

    TITLE: LONG-TERM DATA ON GRAFT-RELATED COMPLICATIONS AFTER SACROCOLPOPEXY WITH LIGHTWEIGHT COMPARED WITH HEAVIER-WEIGHT MESH. THE AIM OF THIS SINGLE-CENTER STUDY IS TO ESTIMATE THE LONG-TERM INCIDENCE AND CHARACTERISTICS OF GRAFT-RELATED COMPLICATIONS, RATE OF REINTERVENTION FOR GRAFT-RELATED COMPLICATIONS AND PROLAPSE, AND SUBJECTIVE AND ANATOMICAL OUTCOMES AFTER LAPAROSCOPIC SACROCOLPOPEXY WITH HEAVIER-WEIGHT (MORE THAN 44 G/M2) COMPARED WITH LIGHTWEIGHT (28 G/M2) POLYPROPYLENE MESH, THE LATTER WITH RESORBABLE POLIGLECAPRONE COMPONENT. A TOTAL OF (B)(4) PATIENTS WHO UNDERWENT LAPAROSCOPIC SACROCOLPOPEXY FOR SYMPTOMATIC STAGE 2 OR GREATER CERVICAL OR VAULT PROLAPSE WERE IDENTIFIED WITH (B)(4) PATIENTS WHO WERE IMPLANTED WITH HEAVIER-WEIGHT POLYPROPYLENE, AND (B)(4) PATIENT WERE IMPLANTED WITH LIGHTWEIGHT POLYPROPYLENE; ALL WERE AUDITED AT COMPARABLE FOLLOW-UP TIMES (HEAVIER-WEIGHT MESH: 97 MONTHS [INTERQUARTILE RANGE 16 MONTHS]; LIGHT-WEIGHT MESH: 92.5 MONTHS [INTERQUARTILE RANGE 58 MONTHS]). HEAVIER-WEIGHT MESHES USED WERE AS FOLLOWS: MARLEX (N=19), PROLENE (N=42), AND GYNEMESH (N=40). LIGHTWEIGHT MESHES USED WERE AS FOLLOWS: ULTRAPRO (N=180) AND ARTISYN (N=58). REPORTED COMPLICATIONS INCLUDE GRAFT-RELATED COMPLICATIONS AND RECURRENT PROLAPSE. IN CONCLUSION, IN TWO CONSECUTIVE COHORTS, THE NUMBER OF GRAFT-RELATED COMPLICATIONS, SYMPTOMATIC GRAFT-RELATED COMPLICATIONS, AND REINTERVENTIONS FOR GRAFT-RELATED COMPLICATIONS WERE HIGHER IN PATIENTS IMPLANTED WITH HEAVIER-WEIGHT POLYPROPYLENE THAN WHEN LIGHTWEIGHT POLYPROPYLENE WAS USED. THERE WERE NO DIFFERENCES IN SUBJECTIVE, OBJECTIVE OUTCOMES, AND REOPERATION RATES FOR PROLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948027 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention