BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 21067318 · Received January 3, 2025

    Report

    Report Number
    2210968-2025-00090
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    February 26, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. CITATION: SCIENCE CHINA LIFE SCIENCES (MAY 2024) VOL.67 NO.5, 1061¿1068. HTTPS://DOI.ORG/10.1007/S11427-023-2508-X.

    Description of Event or Problem · 0

    TITLE: EFFICACY AND SAFETY OF TRANSVAGINAL MESH REPAIR IN A COHORT WITH A MINIMUM OF 10-YEAR FOLLOW-UP. THIS STUDY PRESENTS THE LONG-TERM EFFICACY, COMPLICATIONS, AND SATISFACTION RATES OF A PROSPECTIVE COHORT OF WOMEN IN CHINA WHO UNDERWENT TVM SURGERY AND WERE FOLLOWED FOR A MINIMUM OF 10 YEARS. THIS STUDY INCLUDED 121 PATIENTS WHO UNDERWENT TRANSVAGINAL MESH (TVM) REPAIR BETWEEN JULY 2008 AND DECEMBER 2013. WOMEN WHO PRESENTED TO THE UROGYNECOLOGY CLINIC WITH SYMPTOMATIC STAGE III¿IV (BUMP ET AL.,1996) POP AND UNDERWENT SURGICAL INTERVENTION WITH EITHER PROLIFT (ETHICON, USA) (ZHANG ET AL., 2015) OR A SELF-CUT POLYPROPYLENE MESH (10 CM×15 CM GYNEMESH; ETHICON) (ZHU ET AL., 2011A) WERE INVITED TO PARTICIPATE. BY THE END OF THIS STUDY, 85.1% (N=103) OF PATIENTS HAD COMPLETED AT LEAST 10 YEARS OF FOLLOW-UP, WITH A MEDIAN FOLLOW-UP DURATION OF 11 (10¿13) YEARS. REPORTED COMPLICATIONS INCLUDE SYMPTOMATIC FAILURE AT 2 YEARS (N=2.5%), ANATOMICAL FAILURE AT 5 YEARS (N=5.1%) AND AT 11 YEARS (N= 8.8%), AND RECURRENCE (N=5.2%), MESH EXPOSURE (N=35) WITH INTERMITTENT VAGINAL BLEEDING (N=16), ABNORMAL DISCHARGE (N=5), PAIN DURING INTERCOURSE (N=2), SPONTANEOUS PAIN (N=1), DE NOVO URINARY INCONTINENCE (N=7), OVERACTIVE BLADDER SYMPTOMS (N=4), VOIDING DIFFICULTY (N=1), AND RECURRENT URINARY TRACT INFECTIONS (N=3). IN CONCLUSION, COMPARED WITH RESULTS AT 5 YEARS, AT A MEDIAN FOLLOW-UP OF 11 YEARS, OUR PROSPECTIVE COHORT OF WOMEN UNDERGOING TVM SURGERY SHOWED INCREASED SYMPTOMATIC FAILURE AND VAGINAL MESH EXPOSURE RATES BUT RELATIVELY STABLE ANATOMIC FAILURE RATES. NO PATIENTS WITH ONLY SYMPTOMATIC FAILURE OPTED FOR REOPERATION. IN THIS STUDY, 80% OF THE VAGINAL MESH EXPOSURE CASES WERE MANAGED IN THE OFFICE SETTING, AND THESE PATIENTS REMAINED SATISFIED WITH THEIR SURGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639620 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention