BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH

    MDR report key: 25121833 · Received May 8, 2026

    Report

    Report Number
    2210968-2026-05032
    Event Type
    Injury
    Date Received
    May 8, 2026
    Date of Event
    September 15, 2025
    Report Date
    May 8, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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. 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. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: HERNIA. 2025 SEP 17;29(1):275. HTTPS://DOI.ORG/10.1007/S10029-025-03469-7. PMID: 40960703.

    Description of Event or Problem · 0

    TITLE: CHRONIC GROIN PAIN AFTER LICHTENSTEIN INGUINAL HERNIA REPAIR: PARTIALLY ABSORBABLE LIGHT-WEIGHT MESH VERSUS CONVENTIONAL LIGHT-WEIGHT VERSUS HEAVY-WEIGHT MESH. THIS RETROSPECTIVE STUDY AIMS TO COMPARE THE RATES OF CPIP BETWEEN PARTIALLY ABSORBABLE LIGHT WEIGHT MESH (PA-LWM), LIGHT-WEIGHT MESH (LWM, AND HEAVY-WEIGHT MESH (HWM, >70 G/M2) AFTER LICHTENSTEIN INGUINAL HERNIA REPAIR. BETWEEN (B)(6) 2014 TO (B)(6) 2024, A TOTAL OF N=319 PATIENTS MET INCLUSION CRITERIA, CONSISTING OF 53 PATIENTS WHO RECEIVED PA-LWM USING ULTRAPRO (ETHICON INC.); N=122 WHO RECEIVED LWM USING EITHER BARD SOFT (BARD/DAVOL INC.), PROLENE SOFT (ETHICON INC.), OR PARIETENE (MEDTRONIC); AND N=144 PATIENTS WHO RECEIVED HWM USING EITHER BARD (BARD/DAVOL INC.), MARLEX (BARD/DAVOL INC.), PARIETEX PROGRIP SELF-FIXATING MESH (MEDTRONIC), OR PROLENE (ETHICON INC.). REPORTED COMPLICATIONS ARE: ULTRAPRO (ETHICON INC.) N=2 COMPLICATIONS SUCH AS SURGICAL SITE INFECTIONS, HEMATOMAS, OR SEROMAS (UNSPECIFIED) TREATMENT: NOT REPORTED N=2 CLINICAL RECURRENCE (1 YEAR) TREATMENT: NOT REPORTED N=5 PATIENT REPORTED RECURRENCE (6 MONTHS) TREATMENT: NOT REPORTED N=3 PATIENT REPORTED RECURRENCE (1 YEAR) TREATMENT: NOT REPORTED. PROLENE SOFT (ETHICON INC.) N=? COMPLICATIONS SUCH AS SURGICAL SITE INFECTIONS, HEMATOMAS, OR SEROMAS (UNSPECIFIED) TREATMENT: NOT REPORTED N=? READMISSIONS TREATMENT: NOT REPORTED N=? CLINICAL RECURRENCE (6 MONTHS) TREATMENT: NOT REPORTED N=? PATIENT REPORTED RECURRENCE (6 MONTHS) TREATMENT: NOT REPORTED N=? PATIENT REPORTED RECURRENCE (1 YEAR) TREATMENT: NOT REPORTED PROLENE (ETHICON INC.) N=? COMPLICATIONS SUCH AS SURGICAL SITE INFECTIONS, HEMATOMAS, OR SEROMAS (UNSPECIFIED) TREATMENT: NOT REPORTED N=? PATIENT REPORTED RECURRENCE (6 MONTHS) TREATMENT: NOT REPORTED N=? PATIENT REPORTED RECURRENCE (1 YEAR) TREATMENT: NOT REPORTED. IN CONCLUSION, CHRONIC POST-OPERATIVE INGUINAL PAIN AFTER LICHTENSTEIN INGUINAL HERNIA REPAIR IS MULTI-FACTORIAL. THIS STUDY FOUND THAT REGARDLESS OF MESH WEIGHT, ROUGHLY 20% OF PATIENTS EXPERIENCE CHRONIC PAIN AT 6 MONTHS, EMPHASIZING THE IMPORTANCE OF SETTING REALISTIC EXPECTATIONS OF OUTCOMES WITH PATIENTS PRE-OPERATIVELY. WHILE A PARTIALLY ABSORBABLE LIGHT WEIGHT MESH MAY DECREASE CPIP IN THE LONG-TERM, THIS MAY BE ACCOMPANIED WITH A HIGHER CLINICAL-RECURRENCE RATE WHICH SHOULD BE TAKEN INTO CONSIDERATION DURING MESH SELECTION. MORE RESEARCH AND COMPREHENSIVE LONG-TERM FOLLOW-UP ARE NEEDED REGARDING THE IMPACT OF MESH WEIGHT AND PARTIALLY RESORBABLE COMPONENTS ON CPIP BEFORE FORMAL CONCLUSIONS CAN BE MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305239 PROLENE POLYPROPYLENE MESH MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other