BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7740797 · Received August 1, 2018

    Report

    Report Number
    2210968-2018-74826
    Event Type
    Injury
    Date Received
    August 1, 2018
    Report Date
    July 11, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: DIS COLON RECTUM. 2007; 50: 1¿10. DOI: 10.1007/S10350-007-0255-0.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: SURGICAL MANAGEMENT OF PELVIC ORGAN PROLAPSE IN FEMALES: FUNCTIONAL OUTCOME OF MESH SACROCOLPOPEXY AND RECTOPEXY AS A COMBINED PROCEDURE AUTHOR: M. LIM, M.R.C.S.,1 P. M. SAGAR, F.R.C.S.,1 S. GONSALVES, M.R.C.S., D. THEKKINKATTIL, M.R.C.S.,1 C. LANDON, F.R.C.O.G.. CITATION: DIS COLON RECTUM. 2007; 50: 1¿10. DOI: 10.1007/S10350-007-0255-0. THIS STUDY WAS DESIGNED TO EVALUATE THE FUNCTIONAL OUTCOME OF A SERIES OF PATIENTS WHO HAVE UNDERGONE OPEN MESH SACROCOLPORECTOPEXY SURGERY FOR COMBINED VAGINAL AND RECTAL PROLAPSE. A CONSECUTIVE SERIES OF PATIENTS FROM JUNE 2000 TO JUNE 2004 WITH SIGNS AND SYMPTOMS OF PROLAPSE OF MULTIPLE PELVIC ORGANS WERE INCLUDED IN THE STUDY. THERE WERE A TOTAL OF 29 PATIENTS WITH A MEDIAN AGE OF 66 (AGE RANGE: 59 TO 73 YEARS OLD) YEARS. DURING THE PROCEDURE, THE UPPER 4 CM OF THE VAGINA WAS EXPOSED. A SUITABLE LENGTH OF GYNEMESH (ETHICON) WAS CUT AND SHAPED INTO A Y-SHAPE CUT SUCH THAT APPROPRIATE TENSION WOULD BE ACHIEVED WHEN THE MESH WAS FIXED TO THE VAGINA AND SACRAL PROMONTORY TO PERMIT THE VAGINA TO RETURN TO ITS CORRECT ANATOMIC POSITION. THE 2 LIMBS OF THE MESH WERE ATTACHED TO THE VAULT, ANTERIOR, AND POSTERIOR ASPECTS OF THE VAGINA WITH PDS 1-0 SUTURES (ETHICON), AND ETHIBOND 1-0 SUTURES (ETHICON) WERE USED TO FIX THE STALK OF THE Y-SHAPED MESH TO THE SACRAL PROMONTORY BY MEANS OF GENEROUS BITES OF THE PRESACRAL FASCIA. THE PDS 1-0 SUTURES (DISSOLVABLE) WERE CHOSEN FOR VAGINAL ATTACHMENT TO PERMIT SUFFICIENT TIME TO ELAPSE FOR FIXATION TO OCCUR BEFORE THE INTEGRITY OF THE SUTURES WAS LOST AND YET PREVENT EROSION THROUGH THE VAGINAL MUCOSA THAT COULD HAVE OCCURRED WITH A PERMANENT SUTURE. NO SUCH CONCERNS APPLIED TO THE USE OF ETHIBOND 1-0 SUTURES (PERMANENT) ATTACHED TO THE PRESACRAL FASCIA AND THIS PARTICULAR SUTURE AND THE ASSOCIATED J-SHAPED NEEDLE PERMITTED SAFE AND STRONG ATTACHMENT. CARE WAS TAKEN TO AVOID DAMAGING THE PRESACRAL VEINS. THE PREVIOUSLY MOBILIZED RECTUM WAS THEN ATTACHED TO THE MESENTERY BY PLACING IT ON THE HAMMOCK-LIKE MESH AND THEN SUTURING EACH FREE EDGE OF THE RECTUM TO THE FREE EDGES OF THE MESH WITH PROLENE 2-0 SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED MESH EROSION INTO THE VAGINA (N-1) WHICH REQUIRED TRANSVAGINAL PROCEDURE TO TRIM THE EXPOSED MESH AND FURTHER COLLAPSE OF THE VAGINAL VAULT AND RECURRENCES OF THEIR VAGINAL PROLAPSE (N-2) IN WHICH THE PATIENTS UNDERWENT SUCCESSFUL REVISIONAL SURGERY. IT WAS REPORTED THAT BOTH OF THE PATIENTS WERE OBESE AND THE MESH HAD BECOME DETACHED FROM THE VAGINA OR HAD APPARENTLY STRETCHED OR BEEN INSERTED TOO LOOSE. IT WAS CONCLUDED THAT THE COMBINED MESH SACROCOLPORECTOPEXY FOR PELVIC ORGAN AND RECTAL PROLAPSE IS FEASIBLE AND CAN RESULT IN SIGNIFICANT IMPROVEMENT OF FUNCTION AND QUALITY OF LIFE. THE PROCEDURE RESULTED IN SIGNIFICANT IMPROVEMENT IN PELVIC ORGAN PROLAPSE, ANORECTAL, AND URINARY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579674 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention