BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7897629 · Received September 21, 2018

    Report

    Report Number
    2210968-2018-75918
    Event Type
    Injury
    Date Received
    September 21, 2018
    Report Date
    August 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. ATTEMPTS WERE MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: ARCH GYNECOL OBSTET. 2014; 290: 1151¿1157. DOI: 10.1007/S00404-014-3316-3. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: OUTCOMES AND COMPLICATIONS OF TRANS-VAGINAL MESH REPAIR USING THE PROLIFT¿ KIT FOR PELVIC ORGAN PROLAPSE AT 4 YEARS MEDIAN FOLLOW-UP IN A TERTIARY REFERRAL CENTRE." AUTHORS: ZAINAB A. KHAN, LEE THOMAS, SIMON J. EMERY. CITATION: ARCH GYNECOL OBSTET. 2014; 290: 1151¿1157. DOI: 10.1007/S00404-014-3316-3. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE ANATOMICAL, FUNCTIONAL, AND POSTOPERATIVE OUTCOMES OF PROLIFT POLYPROPYLENE MESH IN THE SURGICAL MANAGEMENT OF PELVIC ORGAN PROLAPSE (POP). A SINGLE-CENTER OBSERVATIONAL STUDY OF 106 SUCCESSIVE PATIENTS (AGE: 61 ± 9.6 YEARS; BMI: 30 ± 4.9), WHO UNDERWENT PROLIFT MESH REPAIR WITH A MEDIAN FOLLOW-UP OF 4 YEARS, WAS PERFORMED AND WERE INCLUDED IN THE STUDY. OF WHICH, 54 PATIENTS UNDERWENT ANTERIOR PROLIFT PROLAPSE SURGERY, 36 PATIENTS UNDERWENT POSTERIOR PROLIFT PROLAPSE SURGERY, AND 16 PATIENTS UNDERWENT TOTAL PROLIFT PROLAPSE SURGERY. DURING THE SURGICAL PROCEDURE, ALL PATIENTS UNDERWENT A STANDARD TRANS-VAGINAL MESH REPAIR USING THE GYNECARE PROLIFT MESH (ETHICON) SYSTEM. THE ANTERIOR PART OF THE MESH WITH ITS TWO LATERAL ARMS ON EITHER SIDE WAS PASSED THROUGH THE OBTURATOR FORAMEN, AT THE LEVEL OF THE ARCUS TENDINEUS FASCIAE PELVIS. THE POSTERIOR PART OF THE PROSTHESIS, WHICH HAS A LATERAL ARM ON EITHER SIDE, WAS ANCHORED TO THE SACRO-SPINOUS LIGAMENTS. AT EARLY FOLLOW-UP (30 TO 90 DAYS POST-OPERATIVELY), REPORTED COMPLICATIONS INCLUDED MESH EXPOSURE (N-6) WHICH WERE MANAGED BY A PARTIAL MESH EXCISION (N-5) AND CONSERVATIVE TREATMENT WITH VAGINAL ESTROGEN (N-1), VAGINAL ADHESIONS (N-2) WHICH REQUIRED DIVISION UNDER GENERAL ANESTHESIA, GROIN OR VAGINAL PAIN (N-6) WHICH WERE INITIALLY MANAGED CONSERVATIVELY WITH A COMBINATION OF ANTI-INFLAMMATORIES AND INFILTRATION WITH TOPICAL STEROIDS. IT WAS REPORTED THAT A PARTIAL EXCISION OF MESH WAS PERFORMED (N-1) WHILST THE OTHER PATIENTS HAD DIVISION OF ONE OF THE ARMS OF THE MESH TO RELEASE THE TENSION (N-2), FLORID GRANULATION TISSUE (N-2) WHICH WAS MANAGED CONSERVATIVELY WITH TOPICAL SILVER NITRATE (N-1) AND SURGICAL EXCISION OF THE GRANULATION TISSUE UNDER GENERAL ANESTHESIA TWICE BEFORE THE SYMPTOMS SUBSEQUENTLY SETTLED (N-1), RECURRENT PROLAPSE IN THE OPERATED COMPARTMENT (N-3) WHICH REQUIRED SACROCOLPOPEXY USING AN ALYTE MESH ATTACHING THE DISTAL END TO THE VAGINAL PROLIFT MESH (N-2) AND THE DISTAL COMPONENT OF THE POSTERIOR LEAF OF MESH HAD RETRACTED LEAVING A DISTAL POSTERIOR DEFECT REPAIRED BY CONVENTIONAL COLPORRHAPHY (N-1), RECURRENT PROLAPSE IN THE NON-OPERATED COMPARTMENT (N-14) WHICH WERE MANAGED BY POSTERIOR PROLIFT (N-6), SACROSPINOUS FIXATION AND ABDOMINAL SACROCOLPOPEXY (N-2), AND ANTERIOR PROLIFT, ANTERIOR COLPORRHAPHY, POSTERIOR COLPORRHAPHY AND A VAGINAL HYSTERECTOMY (N-4), RESPECTIVELY, NEW ONSET STRESS URINARY INCONTINENCE (N-2) WHICH WERE MANAGED WITH BULKING AGENTS DEPENDING ON THE HYPERMOBILITY OF URETHRA, AND WORSENING STRESS URINARY INCONTINENCE (N-4) WHICH REQUIRED MID-URETHRAL SLING INSERTION. AT LONG-TERM FOLLOW-UP (4 YEARS POST-OPERATIVELY), REPORTED COMPLICATIONS INCLUDED RECURRENCE OF PROLAPSE IN THE OPERATED COMPARTMENT (N-6), RECURRENCE OF PROLAPSE IN THE NON-OPERATED COMPARTMENT (N-16), AND SOME DEGREE OF DYSPAREUNIA (N-9). IT WAS CONCLUDED THAT THE PROLIFT MESH IS ASSOCIATED WITH DURABLE LONG-TERM ANATOMICAL CURE RATES. THE AUTHORS FOUND A HIGH RATE OF PROLAPSE DEVELOPMENT IN THE NON-OPERATED COMPARTMENT. THESE RESULTS INDICATE THAT IT WOULD BE UNWISE TO OFFER MESH SURGERY WITHOUT DETAILED INFORMED CONSENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741163 PROLIFT PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention