BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT

    MDR report key: 7848428 · Received September 5, 2018

    Report

    Report Number
    2210968-2018-75646
    Event Type
    Injury
    Date Received
    September 5, 2018
    Report Date
    August 20, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    OTP
    PMA / PMN Number
    K071512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING 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: TAIWANESE JOURNAL OF OBSTETRICS & GYNECOLOGY. 2014; 53: 552 558. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "A COMPARATIVE STUDY OF LAPAROSCOPIC SACROCOLPOPEXY AND TOTAL VAGINAL MESH PROCEDURE USING LIGHTWEIGHT POLYPROPYLENE MESHES FOR PROLAPSE REPAIR." AUTHORS: CHIH-KU LIU, CHING-PEI TSAI, MIN-MIN CHOU, PAO-SHENG SHEN, GIN-DEN CHEN, YAO-CHING HUNG, MAN-JUNG HUNG. CITATION: TAIWANESE JOURNAL OF OBSTETRICS & GYNECOLOGY. 2014; 53: 552 558. THE USE OF VAGINAL MESHES FOR TREATMENT OF PELVIC ORGAN PROLAPSE (POP) REMAINS CONTROVERSIAL. A TREND TOWARD ABDOMINAL APPROACHES AND THE DEVELOPMENT OF NEW MESHES HAS BEEN NOTED. THE AUTHORS COMPARED THE 1-YEAR RESULTS OF TWO DIFFERENT APPROACHES USING NEW LIGHTWEIGHT MESHES. A TOTAL OF 69 PATIENTS WITH POP STAGE = 2 WHO UNDERWENT LAPAROSCOPIC SACROCOLPOPEXY (LSC; N-39; AGE RANGE: 33 TO 65 YEARS OLD; BMI: 17.4 29.9) OR A TOTAL VAGINAL MESH (TVM) PROCEDURE (N-30; AGE RANGE: 45 TO 78 YEARS OLD; BMI: 18.9 32.0) USING LIGHTWEIGHT POLYPROPYLENE MESHES WERE STUDIED. DURING THE SURGICAL PROCEDURE IN TVM, THE PARTIALLY ABSORBABLE PROLIFT + M POLYPROPYLENE MESH (ETHICON) WAS USED. CONCOMITANT SURGERIES WERE PERFORMED AS INDICATED; IN THE LSC GROUP, A TVT-O (ETHICON) MID-URETHRAL SLING WAS PERFORMED IN 14 PATIENTS. IN THE TVM GROUP, TVT-O (ETHICON) MID-URETHRAL SLING WAS PERFORMED IN 10 PATIENTS. IN THE LSC GROUP, REPORTED COMPLICATIONS INCLUDED PELVIC INFLAMMATORY DISEASE (N-1), DELAYED FREE VOIDING (N-1), DE NOVO STRESS INCONTINENCE (N-1), DE NOVO URGENCY INCONTINENCE (N-2), CASE 1, A (B)(6) PATIENT WITH ANATOMIC RECURRENCE WHICH REQUIRED OBSERVATION, CASE 2, A (B)(6) PATIENT WITH ANATOMIC RECURRENCE WHICH REQUIRED OBSERVATION, CASE 3, A (B)(6) PATIENT WITH ANATOMIC RECURRENCE WHICH REQUIRED OBSERVATION, CASE 4, A (B)(6) PATIENT WITH ANATOMIC RECURRENCE WHICH REQUIRED OBSERVATION, CASE 5, A (B)(6) PATIENT WITH ANATOMIC RECURRENCE WHICH REQUIRED OBSERVATION, AND CASE 6, A (B)(6) PATIENT WITH ANATOMIC RECURRENCE WHICH REQUIRED OBSERVATION. IN THE TVM GROUP, REPORTED COMPLICATIONS INCLUDED BLOOD LOSS (N-1) WHICH REQUIRED PERIOPERATIVE BLOOD TRANSFUSION, DELAYED FREE VOIDING (N-1), DE NOVO STRESS INCONTINENCE (N-4), DE NOVO URGENCY INCONTINENCE (N-1), VAGINAL MESH EXTRUSION CONCOMITANTLY WITH A STAGE 2 RECURRENT UTERINE PROLAPSE (N-1) WHICH REQUIRED SIMPLE MESH EXCISION AND A VAGINAL TRACHELECTOMY, CASE 7, A (B)(6) PATIENT WITH ANATOMIC RECURRENCE WHICH REQUIRED TRACHELECTOMY, CASE 8, A (B)(6) PATIENT WITH ANATOMIC RECURRENCE WHICH REQUIRED TRACHELECTOMY, CASE 9, A (B)(6) PATIENT WITH ANATOMIC RECURRENCE WHICH REQUIRED TRACHELECTOMY, AND CASE 10, A (B)(6) PATIENT WITH ANATOMIC RECURRENCE WHICH REQUIRED LSC PROCEDURE. IT WAS CONCLUDED THAT THE STUDY RESULTS SUGGESTED THE NEW LIGHTWEIGHT POLYPROPYLENE MESHES WERE SAFE FOR USE IN LSC AND TVM AND RESULTED IN FAVORABLE AND COMPARABLE ANATOMIC AND FUNCTIONAL OUTCOMES. THE LIMITATION IN TREATING SELECTIVE VAGINAL DEFECTS WITH EACH PROCEDURE, NOTED IN THIS STUDY, INDICATES THE IMPORTANCE OF INDIVIDUALIZED TREATMENT. THE INFORMATION OBTAINED MAY BE BENEFICIAL IN CLINICAL COUNSELING FOR MESH-AUGMENTED POP REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690234 PROLIFT +M PELVIC FLOOR REPAIR UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention