BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEPRAMESH IP

    MDR report key: 23957615 · Received January 5, 2026

    Report

    Report Number
    1213643-2025-01304
    Event Type
    Injury
    Date Received
    January 5, 2026
    Date of Event
    January 1, 2018
    Report Date
    December 18, 2025
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    FTL
    PMA / PMN Number
    K063739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE ARTICLE, NO DEFINITIVE CONCLUSIONS CAN BE DRAWN. THE INFORMATION IS LIMITED TO WHAT IS REPORTED IN THE ARTICLE. THE ARTICLE DOES NOT REPORT THAT ANY SPECIFIC DEVICE MALFUNCTION OR ALLEGED POST-OP COMPLICATIONS WERE CAUSED OR CONTRIBUTED TO THE USE OF THE SEPRAMESH IP. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. INFECTION, PAIN AND HERNIA RECURRENCE ARE CLINICALLY UNDERSTOOD POTENTIAL COMPLICATIONS OF SURGERY/USE OF THE DEVICE AND ARE IDENTIFIED IN THE INSTRUCTIONS-FOR-USE PROVIDED WITH THE DEVICE, AS POSSIBLE COMPLICATIONS. REGARDING INFECTION THE WARNING SECTION STATES, ¿IF AN INFECTION DEVELOPS, TREAT THE INFECTION AGGRESSIVELY. CONSIDERATION SHOULD BE GIVEN REGARDING THE NEED TO REMOVE THE MESH. AN UNRESOLVED INFECTION MAY REQUIRE REMOVAL OF THE DEVICE." NOTE, THE DATE OF EVENT (01-JAN-2018) IS CONSIDERED TO BE A BEST ESTIMATE. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE: "BOTULINUM TOXIN A FACILITATED LAPAROSCOPIC REPAIR OF COMPLEX VENTRAL HERNIA". THE STUDY AIMED TO EXAMINE THE EFFECTIVENESS OF PREOPERATIVE COMBINED USE OF BOTULINUM TOXIN A (BTA) AND PREOPERATIVE PROGRESSIVE PNEUMOPERITONEUM (PPP) FOR SURGICAL PREPARATION OF PATIENTS WITH COMPLEX VENTRAL HERNIA. A TOTAL OF 22 PATIENTS (12 MALE AND 10 FEMALE) WERE ADMINISTERED BTA INJECTIONS INTO THEIR LATERAL ABDOMINAL MUSCLES AND PPP AS AN INPATIENT PROCEDURE 2¿3 WEEKS PRIOR TO THE ELECTIVE VENTRAL HERNIA SURGICAL REPAIR BETWEEN JANUARY 2018 AND MAY 2021. ALL PATIENTS UNDERWENT LAPAROSCOPIC INTRA-PERITONEAL ONLAY MESH (IPOM) OR LAPAROSCOPIC-OPEN-LAPAROSCOPIC (LOL) HERNIA REPAIR. AFTER THE PRIMARY CLOSURE, MESH REPAIR WAS CARRIED OUT USING A COMPOSITE-POLYPROPYLENE MESH (BARD SEPRAMESH, PARIETEX), A FEW PATIENTS WERE TREATED WITH BIOLOGICAL MESH. ON COMPARING CT IMAGES BEFORE AND AFTER THE ADMINISTRATION OF COMBINED BTA INJECTION AND PPP, INCREASED LATERAL ABDOMINAL MUSCLE LENGTH AND SIMULTANEOUS DECREASED MUSCLE THICKNESS WERE NOTED. THE POSTOPERATIVE COMPLICATIONS INSIDE 30 DAYS INCLUDED ABDOMINAL PAIN (N = 1), ONE PATIENT DEVELOPED MESH INFECTION 4 MONTHS AFTER SURGERY AND UNDERWENT MESH REMOVAL AND INCISION AND DRAINAGE OF ABDOMINAL ABSCESS. TWO PATIENTS HAD INCISIONAL HERNIA RECURRENCE AT 4 MONTHS AND 6 MONTHS AFTER SURGERY. LAPAROSCOPIC INCISIONAL HERNIA REPAIR WAS PERFORMED AGAIN AFTER PPP TREATMENT. CONCLUSION: THE PREOPERATIVE COMBINED USE OF PPP AND BTA INCREASED THE ABDOMINAL VOLUME, LENGTHENED THE LATERALLY RETRACTED ABDOMINAL MUSCLES, AND FACILITATED LAPAROSCOPIC CLOSURE OF LARGE COMPLEX VENTRAL HERNIA. ADDITIONALLY, USING BTA CAN BE MORE CONDUCIVE TO WOUND HEALING DUE TO LESS TENSION. MOREOVER, PPP INDUCES AN INSIGNIFICANT INCREASE IN ABDOMINAL CAVITY VOLUME PRIOR TO SURGERY, WHICH FACILITATES TOTAL REINTEGRATION OF THE BOWEL INTO THE ABDOMEN. ARTICLE DOES NOT PROVIDE CASE/PRODUCT SPECIFIC INFORMATION TO KNOW WHICH PATIENTS WERE IMPLANTED WITH WHAT DEVICE AND EXPERIENCED WHAT COMPLICATIONS. NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND MAY REQUIRE MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29495 SEPRAMESH IP SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention