BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD FLAT MESH

    MDR report key: 7907606 · Received September 25, 2018

    Report

    Report Number
    1213643-2018-03281
    Event Type
    Death
    Date Received
    September 25, 2018
    Date of Event
    May 15, 2018
    Report Date
    September 25, 2018
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDMENT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE PATIENT WAS TREATED WITH BARD/DAVOL MESH PRODUCTS. AT THIS TIME, NO CONCLUSION CAN BE MADE. THE INFORMATION PROVIDED IS LIMITED TO THE MATERIAL EXTRACTED FROM THE ARTICLE. DUE TO EU PATIENT PRIVACY REGULATIONS NO ADDITIONAL PATIENT/CASE DETAILS (INCLUDING DEATH CERTIFICATE, AUTOPSY REPORT) ARE UNOBTAINABLE. BASED ON THE INFORMATION OBTAINED FROM THE ARTICLE THERE IS NO DIRECT CORRELATION THAT CAN BE MADE BETWEEN THE MESH IMPLANTS AND THE PATIENT'S CANCER DIAGNOSIS AND SUBSEQUENT DEATH. POLYPROPYLENE MATERIAL HAS BEEN USED IN MOST SURGICAL SPECIALTIES (INCLUDING GENERAL SURGERY, CARDIOVASCULAR SURGERY, TRANSPLANT SURGERY, OPHTHALMOLOGY, OTOLARYNGOLOGY, GYNECOLOGY, AND UROLOGY) FOR OVER FIVE DECADES, IN MILLIONS OF PATIENTS. THE SAFETY AND EFFECTIVENESS OF PERMANENT IMPLANT SURGICAL MESHES MADE FROM POLYPROPYLENE RESIN HAS BEEN EXTENSIVELY STUDIED WITHIN THE MEDICAL AND SCIENTIFIC COMMUNITIES FOR APPROXIMATELY SIXTY YEARS. PRODUCT IDENTIFIERS WERE NOT PROVIDED; WITHOUT THIS INFORMATION A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE: THE DATE OF DEATH WAS PRESENTED AS MONTH/YEAR; AS SUCH THE DATE OF DEATH AND DATE OF EVENT DOCUMENTED HAVE BEEN ESTIMATED. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED. NOTE: THE INFORMATION PROVIDED BY BARD 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 BARD. NO SAMPLE RETURNED.

    Description of Event or Problem · 1

    REVIEW OF A RECENT ARTICLE PUBLISHED IN THE SUNDAY POST (AUG 12TH), HTTPS://WWW.SUNDAYPOST.COM/FP/MEMOS-REVEAL-MESH-FIRMS-WERE-WARNED-21-YEARS-AGO-THAT-MATERIAL-SHOULD-NOT-BE-USED-ON-HUMANS/, ALLEGES ADVERSE PATIENT OUTCOMES ASSOCIATED WITH MESH IMPLANTS: REVIEW OF THE ARTICLE IDENTIFIED A CONNECTED ARTICLE FROM MAY 7, 2018 TITLED, "BRAVE MUM DYING FROM CANCER SPEAKS OUT AFTER CONTROVERSIAL MESH TREATMENT LEFT HER TOO WEAK FOR CHEMO." THE STORY ALLEGES THAT, "AFTER 20 YEARS OF STRUGGLING WITH THE CRIPPLING SIDE EFFECTS OF SIX HERNIA MESH IMPLANTS IN HER GROIN AND ABDOMEN", THE PATIENT, "WAS DIAGNOSED WITH VAGINAL NEUROENDOCRINE CANCER IN JUNE". "AFTER SO MANY SURGERIES AND MESH COMPLICATIONS, SHE WAS TOLD BY CANCER SPECIALISTS SHE HAS BEEN LEFT TOO WEAKENED FOR CHEMOTHERAPY. PATIENT STATED, "I WAS GIVEN 35 RADIATION THERAPY TREATMENTS, BUT THE CANCER SPREAD TO MY LYMPH NODES AND LUNGS." IT IS REPORTED THAT, AFTER THE OPERATIONS AT (B)(6) INFIRMARY THE PATIENT "BECAME VERY ILL, SUFFERING AGONIZING PAIN. THE MESH APPEARED TO HARDEN ACROSS HER ABDOMEN AS IF IT WAS WRAPPED IN A METAL SHIELD". "THE SPECIALIST TOLD ME THE MESH HAD CALCIFIED". IT IS ALLEGED THAT DOCTORS HAD TO, "REPEATEDLY SNIP MESH FRAGMENTS PROTRUDING THROUGH HER SKIN, CAUSING OPEN WOUNDS". THE PARENT ARTICLE IDENTIFIES THE PATIENT DIED IN (B)(6) 2018. NOTE: THE ARTICLES DO NOT IDENTIFY THE IMPLANTS USED TO TREAT THE PATIENT. THERE IS NO MANUFACTURER, BRAND, NAME OR PRODUCT IDENTIFIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746079 BARD FLAT MESH SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| R