BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8903873 · Received August 16, 2019

    Report

    Report Number
    2210968-2019-85659
    Event Type
    Injury
    Date Received
    August 16, 2019
    Report Date
    July 18, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K962530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 REGARDING THE ADDITIONAL EVENTS. CITATION: BRITISH JOURNAL OF SURGERY 2008; 95: 1226¿1231; DOI: 10.1002/BJS.6325. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: RANDOMIZED CLINICAL TRIAL OF GROIN HERNIA REPAIR WITH TITANIUM- COATED LIGHTWEIGHT MESH COMPARED WITH STANDARD POLYPROPYLENE MESH. THIS RANDOMIZED, CONTROLLED, SINGLE-CENTER CLINICAL TRIAL AIMED TO COMPARE OBJECTIVE AND SUBJECTIVE OUTCOMES AFTER INGUINAL REPAIR USING NON-ABSORBABLE LIGHTWEIGHT OR HEAVYWEIGHT MESH. 317 MALE PATIENTS (MEAN AGE 56 YEARS, RANGE 22-75) WITH UNILATERAL PRIMARY INGUINAL HERNIA WERE INCLUDED IN THE STUDY. 161 PATIENTS (MEAN AGE 57, RANGE 24-75 YEARS) WERE RANDOMIZED IN THE CONTROL GROUP, IN WHICH A 10 × 15-CM STANDARD POLYPROPYLENE MESH WEIGHING MORE THAN 80 G/M2 (PROLENE; ETHICON, NORDERSTEDT, GERMANY) WAS USED. 156 PATIENTS (MEAN AGE 56, RANGE 22-75 YEARS) WHERE RANDOMIZED IN THE STUDY GROUP IN WHICH A 10 × 15-CM TITANIUM-COATED POLYPROPYLENE LIGHTWEIGHT MESH OF 35G/M2 IN WEIGHT (TIMESHTC; GFE MEDIZINTECHNIK, NUREMBERG, GERMANY) WAS EMPLOYED. THE MESH WAS TAILORED TO COVER THE AREA FROM THE INGUINAL LIGAMENT TO THE LATERAL BORDER OF THE RECTUS SHEET, AND FROM THE SUPERIOR PUBIC RAMUS TO 6 CM LATERAL TO THE INTERNAL ORIFICE OF THE INGUINAL CANAL. THE CORNERS WERE CURVED AND 1 CM OF THE MESH WAS DOUBLED AND INCORPORATED INTO THE SUTURE ALONG THE INGUINAL LIGAMENT, IN ORDER TO REINFORCE THE SUTURE LINE AND PREVENT RUPTURE OF THE MESH. COMPLICATIONS INCLUDED NEURALGIA (N=2), INFECTION (N=1), SEROMA (N=1), RECURRENCE (N=3), PAIN WITH STRENUOUS ACTIVITY (N=4), PAIN WITH NORMAL ACTIVITY (N=2), UNSPECIFIED PAIN (N=3) AND DISCOMFORT (N=17). IN CONCLUSION, PATIENTS WITH THE LIGHTWEIGHT MESH HAD A SHORTER CONVALESCENCE THAN THOSE WITH THE STANDARD HEAVYWEIGHT MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694444 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention