BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 11701740 · Received April 21, 2021

    Report

    Report Number
    2210968-2021-03581
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    September 25, 2018
    Report Date
    April 13, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 05/05/2021. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS RECEIVED: THE SURGEON DOES NOT BELIEVE THAT ANY OF THE ETHICON PRODUCTS (PDS II SUTURE, GYNECARE GYNEMESH PS, OR PROLENE SUTURE) INVOLVED CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE. THE CASES DISCUSSED IN THE ARTICLE WERE NOT REPORTED TO ETHICON AS IT WAS NOT DETECTED ANY PROBLEM WITH THE ETHICON PRODUCTS. THE TWO WOMEN THAT UNDERWENT A POSTERIOR COLPORRHAPHY HAD A LOWER RECTOCELE (BELOW THE MESH). THE REPORTED COMPLICATIONS ARE VERY COMMON IN WOMEN WITH SEVERE VAGINAL WALL AND/OR UTERINE PROLAPSE. MOREOVER WE HAD A VERY LOW RATE OF RECURRENCE AND OF MESH EXTRUSION. EVENTS RELATED TO PDS II POLYDIOXANONE SUTURE CAPTURED VIA 2210968-2021-03579. EVENTS RELATED TO GYNECARE GYNEMESH PS CAPTURED VIA 2210968-2021-03580. EVENTS RELATED TO PROLENE SUTURES CAPTURED VIA 2210968-2021-03581.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO CLARIFY 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS (PDS II SUTURE, GYNECARE GYNEMESH PS, OR PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS (PDS II SUTURE, GYNECARE GYNEMESH PS, OR PROLENE SUTURE) USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CAN YOU PROVIDE THE INDICATION FOR THE TWO WOMEN WHO UNDERWENT POSTERIOR COLPORRHAPHY 6 AND 12 MONTHS AFTER PRIMARY SURGERY (REOPERATION)? PATIENT DEMOGRAPHICS? 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. EVENTS RELATED TO PDS II POLYDIOXANONE SUTURE CAPTURED VIA 2210968-2021-03579. EVENTS RELATED TO GYNECARE GYNEMESH PS CAPTURED VIA 2210968-2021-03580. EVENTS RELATED TO PROLENE SUTURES CAPTURED VIA 2210968-2021-03581. CITATION: INTERNATIONAL UROGYNECOLOGY JOURNAL (2019) 30:1697¿1703/HTTPS://DOI.ORG/10.1007/S00192-018-3775-3.

    Description of Event or Problem · 1

    TITLE: SEVERE PELVIC ORGAN PROLAPSE. IS THERE A LONG-TERM CURE? THE AIM OF THIS SINGLE CENTER PROSPECTIVE STUDY IS TO EVALUATE THE LONG-TERM ANATOMICAL AND FUNCTIONAL OUTCOMES AND REPORT THE LONG-TERM MESH-RELATED COMPLICATIONS. BETWEEN SEP 2007 AND DEC 2014, A TOTAL OF 114 WOMEN WITH MEDIAN AGE OF 56 YEARS (41¿73) AND MEAN BMI OF 24.8 KG/M2 (2.6) WITH ADVANCED PELVIC ORGAN PROLAPSE (POP) UNDERWENT VAGINALLY ASSISTED LAPAROSCOPIC SACROCOLPOPEXY (VALS). DURING TRANSVAGINAL PLACEMENT OF THE MESH ON THE VAGINAL WALLS, A MONOFILAMENT ABSORBABLE 2.0 POLYDIOXANONE SUTURES PDS II (ETHICON) WAS USED. IN ALL CASES A LIGHTWEIGHT POLYPROPYLENE MONOFILAMENT MACROPOROUS NONABSORBABLE MESH GYNECARE GYNEMESH PS (ETHICON) WAS USED. THE NEXT STEP CONSISTS OF A LAPAROSCOPIC APPROACH DURING WHICH THE MESHES ARE SUSPENDED ON THE ANTERIOR LONGITUDINAL SPINAL LIGAMENT ON S1 LEVEL. THE CRANIAL ASPECT OF THE MESH WAS SECURED TO THE SACRAL PROMONTORY WITH 5-MM HELICOIDAL TITANIUM TACKS (PROTACK) OR WITH A SYNTHETIC, MONOFILAMENT, NONABSORBABLE POLYPROPYLENE SUTURE PROLENE (ETHICON). POSTOPERATIVE COMPLICATIONS INCLUDE ANATOMICAL RECURRENCE WITH POSTERIOR VAGINAL WALL BEYOND THE HYMEN (BP: +1) (N=1) AND VAGINAL BULGE SYMPTOMS WITHOUT HAVING ANATOMIC RECURRENCE (N=1). TWO WOMEN UNDERWENT POSTERIOR COLPORRHAPHY 6 AND 12 MONTHS AFTER PRIMARY SURGERY (REOPERATION; REASON UNSPECIFIED) (N=2). AT 1-YEAR FOLLOW UP, TWO PATIENTS WERE TREATED FOR MESH EXTRUSION AT THE VAGINAL CUFF (N=2). BOTH PATIENTS WERE SUCCESSFULLY TREATED BY TRANSVAGINAL SURGICAL REMOVAL OF THE EXTRUDED PART FOLLOWED BY 3-MONTH USE OF VAGINAL ESTROGENS. THE COMBINED VALS TECHNIQUE CAN BE CONSIDERED A SAFE AND EFFECTIVE PROCEDURE FOR THE TREATMENT OF SEVERE POP ALLOWING A LONG-TERM ANATOMICAL RESTORATION OF ALL COMPARTMENTS WITH EXCELLENT FUNCTIONAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600545 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention