BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8479616 · Received April 3, 2019

    Report

    Report Number
    2210968-2019-79987
    Event Type
    Injury
    Date Received
    April 3, 2019
    Report Date
    March 7, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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. CITATION: POLISH JOURNAL OF SURGERY (2003); 75, 8, 741¿757. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE, TITLE: "COMPARATIVE STUDY OF THE EFFICACY OF INGUINAL HERNIA REPAIR WITH THE USE OF SHOULDICE TECHNIQUE AND THE PROLENE HERNIA SYSTEM," AUTHOR: JERZY STANISLAWEK, STANISLAW GLUSZEK, CITATION: POLISH JOURNAL OF SURGERY (2003); 75, 8, 741¿757. THE OBJECTIVE OF THE STUDY WAS TO PERFORM A COMPARATIVE ASSESSMENT OF THE EFFICACY OF THE PRIMARY INGUINAL HERNIA REPAIR WITH THE USE OF SEMI-TENSION-FREE SHOULDICE TECHNIQUE (SH) AND THE TENSION-FREE PROLENE HERNIA SYSTEM (PHS; ETHICON). FROM SEPTEMBER 1999 TO FEBRUARY 2001, 148 PATIENTS WHO WERE ADMITTED TO THE DEPARTMENT TO UNDERGO INGUINAL HERNIA REPAIR, WERE INCLUDED IN THE STUDY. THE PATIENTS WERE RANDOMLY DIVIDED INTO 2 GROUPS: IN THE PHS GROUP (MALE 72 AND FEMALE 1; AGE RANGE: 40-79 YEARS; BMI 20-33), HERNIA WAS REPAIRED VIA TENSION-FREE PHS MESH IMPLANTATION AND IN THE SH GROUP (MALE 72 AND FEMALE 3, AGE RANGE: 40-84 YEARS; BMI 19-32), THE SHOULDICE REPAIR WAS USED. THE DEPARTMENTAL STANDARD FOR SHOULDICE TECHNIQUE WAS TO RECONSTRUCT THE BASE OF THE INGUINAL CANAL IN A WAY THAT PUTS THE LEAST AMOUNT OF TENSION ON THE ANASTOMOSIS. A 2/0 PROLENE (ETHICON) RUNNING SUTURE WAS USED. IN ORDER TO IMPLANT THE PHS MESH, FENESTRATED FORCEPS WERE PLACED AT THE LEVEL OF THE CONNECTOR, AND THE MESH WAS INSERTED DEEP INTO THE RING OF HERNIA. THE TOP MESH LAYER MUST BE PLACED IN SUCH A MANNER THAT ¿ AFTER THE REMOVAL OF THE FORCEPS ¿ ITS LONG AXIS WOULD GO ALONG THE INGUINAL CANAL, TOWARDS THE PUBIC TUBERCLE. NEXT, THE LATERAL PART OF THE TOP MESH LAYER WAS INCISED TO CREATE AN "ARTIFICIAL" DEEP INGUINAL RING. IN THE CASE OF INDIRECT INGUINAL HERNIA, THE CIRCULAR PART OF THE CONNECTOR WAS INCISED IN THE MIDDLE, WHILE FOR DIRECT HERNIAS, THE INCISION WAS MORE LATERAL. THE SURGEON WOULD THREAD THE SPERMATIC CORD THROUGH THE INCISION AND THE MESH WOULD BE SUTURED AGAIN, THIS TIME WITH A STITCH FIXATED TO THE INGUINAL CANAL. THE CONNECTOR LOCATED AT THE RING OF HERNIA WOULD BE SEWN WITH 140 SUTURES TO THE TRANSVERSE ABDOMINAL MUSCLE AND THE ABDOMINAL INTERNAL OBLIQUE MUSCLE OR TO THE CONJOINT TENDON. THE MESH WAS FIXATED WITH THE USE OF A 2/0 VICRYL ABSORBABLE SUTURE (ETHICON). IN PHS GROUP, REPORTED PERIOPERATIVE COMPLICATIONS INCLUDED PAINFUL EDEMA OF THE WOUND (N-2) IN WHICH CONSERVATIVE TREATMENT WAS USED, SUPPURATIVE WOUND (N-2) IN WHICH 1 PATIENT NEEDED A DEEP WOUND INCISION, DRAINAGE OF THE ABSCESS AND CLOSURE BY SECONDARY SUTURE; THE TREATMENT WAS CARRIED OUT IN THE OUTPATIENT CLINIC, INFECTION IN THE SUPERFICIAL LAYERS (N-1) WHICH WAS TREATED IN THE OUTPATIENT CLINIC, SCROTAL EDEMA (N-2) AND URINARY RETENTION (N-2) WHICH REQUIRED CATHETERIZATION, WERE TREATED CONSERVATIVELY AND PROLONGING PATIENT¿S HOSPITALIZATION, EARLY PARESTHESIA (N-1). POSTOPERATIVE COMPLICATIONS INCLUDED PAIN SYMPTOMS ON WEEK 1 (N-57), PAIN SYMPTOMS ON WEEK 2 (N-14), AND PAIN SYMPTOMS ON MONTH 1 (N-2). IN THE FINAL CLINICAL EXAMINATION, REPORTED COMPLICATIONS INCLUDED LOW-LEVEL INTERMITTENT PAIN IN THE GROIN AREA (N-15). IN SH GROUP, REPORTED PERIOPERATIVE COMPLICATIONS INCLUDED PAINFUL EDEMA OF THE WOUND (N-2) IN WHICH CONSERVATIVE TREATMENT WAS USED, SUPPURATIVE WOUND (N-1), INFECTION IN THE SUPERFICIAL LAYERS (N-1) WHICH WAS TREATED IN THE OUTPATIENT CLINIC, SCROTAL EDEMA (N-5), GROIN HEMATOMA (N-2) AND URINARY RETENTION (N-2) WHICH REQUIRED CATHETERIZATION, WERE TREATED CONSERVATIVELY AND PROLONGING PATIENT¿S HOSPITALIZATION, EARLY PARESTHESIA (N-2). POSTOPERATIVE COMPLICATIONS INCLUDED PAIN SYMPTOMS ON WEEK 1 (N-33), PAIN SYMPTOMS ON WEEK 2 (N-19), PAIN SYMPTOMS ON MONTH 1 (N-16), AND PAIN SYMPTOMS FOR MORE THAN 1 MONTH (N-7). IN THE FINAL CLINICAL EXAMINATION, REPORTED COMPLICATIONS INCLUDED LOW-LEVEL INTERMITTENT PAIN IN THE GROIN AREA (N-18) AND HERNIA RECURRENCES (N-4). IN CONCLUSION, THE PHS MESH REPAIR IS MORE EFFECTIVE WITH RESPECT TO THE COURSE OF SURGERY AND CONVALESCENCE WHEN COMPARED WITH SHOULDICE REPAIR, WHICH CONFIRMS THE BENEFITS OF ITS USE IN TENSION-FREE PRIMARY INGUINAL HERNIA REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271021 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention