BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    MDR report key: 8897223 · Received August 15, 2019

    Report

    Report Number
    2210968-2019-85609
    Event Type
    Injury
    Date Received
    August 15, 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
    GM
    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: SURG ENDOSC (2008) 22:1790¿1797; DOI 10.1007/S00464-008-9863-6. (B)(4).

    Description of Event or Problem · 1

    TITLE: SIXTY-MONTH FOLLOW-UP AFTER ENDOSCOPIC INGUINAL HERNIA REPAIR WITH THREE TYPES OF MESH: A PROSPECTIVE RANDOMIZED TRIAL. THIS PROSPECTIVE, CLINICAL, RANDOMIZED, DOUBLE-BLIND STUDY AIMED TO INVESTIGATE THE IMPACT OF THE STRUCTURE AND THE AMOUNT OF POLYPROPYLENE (PP) MESH USED IN LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL HERNIOPLASTIC (TAPP) ON PHYSICAL FUNCTION AND LIFE QUALITY. BETWEEN 1999 AND 2001, 180 MALE PATIENTS WITH PRIMARY INGUINAL HERNIA UNDERGOING TAPP WERE RANDOMIZED FOR USING A HEAVYWEIGHT (108 G/M2), DOUBLE-FILAMENT PP MESH (PROLENE, 10 X 15 CM, GROUP A) (N=60, MEAN AGE 61.5±3.4 YEARS); A MULTIFILAMENT, HEAVYWEIGHT VARIANT (116 G/M2) OF PP MESH (SERAPREN, 10 X 15 CM, GROUP B) (N=60, MEAN AGE 62.3±4.3 YEARS), OR A COMPOSITE MESH (POLYGLACTIN AND PP) (VYPRO II, 10 X 15 CM, GROUP C) (N=60, MEAN AGE 63.3±3.8 YEARS). WE DID NOT CUT ANY SLITS IN THE MESHES. WE TRIED TO USE THE MINIMUM NUMBER OF CLIPS ON COOPER¿S LIGAMENT, MEDIAL AND LATERAL TO THE EPIGASTRIC VESSELS WITH STRAIGHT ENDOSTAPLER, (ETHICON, (B)(6)). THE PERITONEUM WAS ALSO CLOSED WITH A RESORBABLE SUTURE (ETHICON, VYCRYL 3/0). COMPLICATIONS IN GROUP A (PROLENE GROUP) INCLUDED SCROTAL HEMATOMA (N=3), ABDOMINAL WALL SEROMA (N=8) AND TESTICULAR CONTACT PAIN (N=3) IN POST-OPERATIVE DAY 1; SCROTAL HEMATOMA (N=12), ABDOMINAL WALL SEROMA (N=10) AND TESTICULAR CONTACT PAIN (N=8) IN POST-OPERATIVE DAY 2; SCROTAL HEMATOMA (N=12), ABDOMINAL WALL SEROMA (N=8) AND TESTICULAR CONTACT PAIN (N=4), PAIN WITH EJACULATION (N=5), DISCOMFORT WITH URINATION (N=8) IN POST-OPERATIVE WEEK 1; SCROTAL HEMATOMA (N=12), ABDOMINAL WALL SEROMA (N=8) AND TESTICULAR CONTACT PAIN (N=7), PAIN WITH EJACULATION (N=10), DISCOMFORT WITH URINATION (N=7) IN POST-OPERATIVE WEEK 2; SCROTAL HEMATOMA (N=8), ABDOMINAL WALL SEROMA (N=6) AND TESTICULAR CONTACT PAIN (N=7), PAIN WITH EJACULATION (N=12), DISCOMFORT WITH URINATION (N=7) IN POST-OPERATIVE WEEK 4; TESTICULAR CONTACT PAIN (N=8), PAIN WITH EJACULATION (N=12), DISCOMFORT WITH URINATION (N=7) IN POST-OPERATIVE WEEK 12; PAIN WITH EJACULATION (N=2), DISCOMFORT WITH URINATION (N=2) AND RECURRENCE RATE (N=1) IN POST-OPERATIVE MONTH 24 AND PAIN WITH EJACULATION (N=1), DISCOMFORT WITH URINATION (N=1) AND RECURRENCE RATE (N=1) IN POST-OPERATIVE MONTH 60. COMPLICATIONS IN GROUP B (SERAPREN GROUP) INCLUDED SCROTAL HEMATOMA (N=2), ABDOMINAL WALL SEROMA (N=6) AND TESTICULAR CONTACT PAIN (N=4) IN POST-OPERATIVE DAY 1; SCROTAL HEMATOMA (N=10), ABDOMINAL WALL SEROMA (N=8) AND TESTICULAR CONTACT PAIN (N=6) IN POST-OPERATIVE DAY 2; SCROTAL HEMATOMA (N=10), ABDOMINAL WALL SEROMA (N=7) AND TESTICULAR CONTACT PAIN (N=4), PAIN WITH EJACULATION (N=6), DISCOMFORT WITH URINATION (N=5) IN POST-OPERATIVE WEEK 1; SCROTAL HEMATOMA (N=10), ABDOMINAL WALL SEROMA (N=6) AND TESTICULAR CONTACT PAIN (N=3), PAIN WITH EJACULATION (N=6), DISCOMFORT WITH URINATION (N=3) IN POST-OPERATIVE WEEK 2; SCROTAL HEMATOMA (N=6), ABDOMINAL WALL SEROMA (N=4) AND TESTICULAR CONTACT PAIN (N=2), PAIN WITH EJACULATION (N=4), DISCOMFORT WITH URINATION (N=2) IN POST-OPERATIVE WEEK 4; TESTICULAR CONTACT PAIN (N=1), PAIN WITH EJACULATION (N=2), DISCOMFORT WITH URINATION (N=1) IN POST-OPERATIVE WEEK 12; DISCOMFORT WITH URINATION (N=1) IN POST-OPERATIVE MONTH 24. COMPLICATIONS IN GROUP C (VYPRO II GROUP) INCLUDED SCROTAL HEMATOMA (N=2), ABDOMINAL WALL SEROMA (N=6) AND TESTICULAR CONTACT PAIN (N=4) IN POST-OPERATIVE DAY 1; SCROTAL HEMATOMA (N=10), ABDOMINAL WALL SEROMA (N=8) AND TESTICULAR CONTACT PAIN (N=7) IN POST-OPERATIVE DAY 2; SCROTAL HEMATOMA (N=10), ABDOMINAL WALL SEROMA (N=8) AND TESTICULAR CONTACT PAIN (N=4), PAIN WITH EJACULATION (N=4), DISCOMFORT WITH URINATION (N=4) IN POST-OPERATIVE WEEK 1; SCROTAL HEMATOMA (N=10), ABDOMINAL WALL SEROMA (N=7) AND TESTICULAR CONTACT PAIN (N=2), PAIN WITH EJACULATION (N=4), DISCOMFORT WITH URINATION (N=4) IN POST-OPERATIVE WEEK 2; SCROTAL HEMATOMA (N=6), ABDOMINAL WALL SEROMA (N=2) AND TESTICULAR CONTACT PAIN (N=2), PAIN WITH EJACULATION (N=4), DISCOMFORT WITH URINATION (N=3) IN POST-OPERATIVE WEEK 4; TESTICULAR CONTACT PAIN (N=2), PAIN WITH EJACULATION (N=2), DISCOMFORT WITH URINATION (N=2) IN POST-OPERATIVE WEEK 12; PAIN WITH EJACULATION (N=1), DISCOMFORT WITH URINATION (N=1) AND RECURRENCE RATE (N=1) IN POST-OPERATIVE MONTH 24 AND RECURRENCE RATE (N=1) IN POST-OPERATIVE MONTH 60. IN CONCLUSION, THE COMPOSITE MESH DOES NOT PROVIDE AN ADVANTAGE CONCERNING PHYSICAL FUNCTION OR PAIN DEVELOPMENT IN COMPARISON TO THE MULTIFILAMENT, HEAVYWEIGHT, PURE POLYPROPYLENE MESH. INDEPENDENTLY OF WHICH MESH WAS IMPLANTED 5% OF PATIENTS ARE STILL SUFFERING FROM DISCOMFORT AFTER 5 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692338 PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention