BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VYPRO MESH UNKNOWN PRODUCT

    MDR report key: 13893963 · Received March 24, 2022

    Report

    Report Number
    2210968-2022-02153
    Event Type
    Injury
    Date Received
    March 24, 2022
    Date of Event
    November 7, 2018
    Report Date
    March 24, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K002672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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.  THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS.  CITATION: HTTPS://DOI.ORG/10.1007/S10029-018-1846-5. 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 (ULTRAPRO MESH, VICRYL MESH) 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 INVOLVED? PATIENT DEMOGRAPHICS? ASSOCIATED EVENTS SUBMITTED VIA MW# 2210968-2022-02152.

    Description of Event or Problem · 0

    IT WAS REPORTED IN A JOURNAL ARTICLE WITH TITLE: LAPAROSCOPIC TRANSPERITONEAL INGUINAL HERNIOPLASTY (TAPP) AFTER RADICAL OPEN RETROPUBIC PROSTATECTOMY: SPECIAL FEATURES AND CLINICAL OUTCOMES. THIS STUDY AIMED TO EVALUATE THE SURGICAL OUTCOME OF PATIENTS WITH INGUINAL HERNIAS AFTER RADICAL PROSTATECTOMY, USING THE TAPP OR TEP PROCEDURE. A TOTAL OF 44 PATIENTS WITH TAPP REPAIR (N = 51 HERNIAS) WERE INVITED TO COMPLETE A COMPREHENSIVE QUESTIONNAIRE AND THE DATA WERE COMPARED IN A PSEUDO-ANONYMIZED FORM WITH THE DATA OF A REPRESENTATIVE CONTROL GROUP OF 1,116 PATIENTS WITH 1,491 TAPP REPAIRS 2, 7, 12 AND 17 YEARS AGO, AND STRUCTURAL EQUALITY WITH ALL OPERATED HERNIAS FROM 1993 TO 2009. SIX PATIENTS WITH 7 HERNIAS AFTER PROSTATECTOMY (13.7%) AND 169 PATIENTS WITH 224 HERNIAS OF THE CONTROL GROUP (11.3%) HAD DIED MEANWHILE. 2 PATIENTS WITH 2 HERNIAS OF THE POSTPROSTATECTOMY GROUP AND 62 PATIENTS WITH 72 HERNIAS OF THE CONTROL GROUP WERE LOST TO FOLLOW-UP. THE COMPLETED QUESTIONNAIRES OF 95.5% OF ALL LIVING PATIENTS (N = 42) WITH TAPP REPAIR AFTER PROSTATECTOMY AND 94.6% OF THE CONTROL GROUP (N = 1,123) COULD BE EVALUATED. (A COMPLETE FOLLOW-UP OF ALL LIVING STUDY PARTICIPANTS 17 YEARS AFTER TAPP [N = 117 HERNIAS] TOOK PLACE IN 91.4%, AFTER 12 YEARS [N = 404 HERNIAS] IN 94.9%, AFTER 7 YEARS [N = 338 HERNIAS] IN 96.5% AND AFTER 2 YEARS [N = 264 HERNIAS] IN 95.9%). PARALLEL TO THE DEVELOPMENT OF NEW POLYPROPYLENE REDUCED MESH TECHNOLOGIES BETWEEN 1993 AND AUGUST 2000, NON-ABSORBABLE HEAVY-WEIGHT MESHES (MARLEX®, N = 17) WERE IMPLANTED IN TAPP AFTER PRIOR RADICAL PROSTATECTOMY, FROM SEPTEMBER 2000 TO AUGUST 2003 PARTLY ABSORBABLE POLYPROPYLENE-REDUCED LIGHTWEIGHT MESHES (VYPRO II®, N = 6), AND FROM SEPTEMBER 2003 POLYPROPYLENE-REDUCED AND PARTLY ABSORBABLE ULTRALIGHTWEIGHT MESHES (ULTRAPRO®, N = 28). 92.2% OF THE TAPP REPAIRS AFTER PRIOR OPEN RADICAL RETROPUBIC PROSTATECTOMY WERE PERFORMED BY THREE SURGEONS WITH MORE THAN 500 PERSONAL TAPP PROCEDURES AND VERY EXPERIENCED IN ENDOSCOPIC LAPAROSCOPIC HERNIA SURGERY AND 7.8% OF TAPP REPAIRS WERE DONE BY SURGICAL RESIDENTS UNDER SUPERVISION AND GUIDANCE OF EXPERIENCED ENDOSCOPIC LAPAROSCOPIC HERNIA SURGEONS. NO INTRAOPERATIVE COMPLICATIONS SUCH AS INJURY OF THE URINARY BLADDER, BOWEL OR LARGE VESSELS WERE OBSERVED IN THE PROSTATECTOMY HERNIA GROUP AND ONLY ONE PATIENT NEEDED 48 H POSTOPERATIVELY A LAPAROSCOPIC DRAINAGE OF A LARGE LOCAL HEMATO-SEROMA. A BLOCK-LIKE SHRINKAGE OF THE IMPLANTED HEAVY-WEIGHT MARLEX® MESHES CAUSED PAIN IN THE PUBIC BONE AT THE INGUINAL LIGAMENT INSERTION IN ONE PATIENT, SUCCESSFULLY TREATED BY A PERIOSTOMY. 2 PATIENTS COMPLAINED OF PAIN OF THE GROIN AND ONE OF TESTICULAR PAIN, LASTING LONGER THAN 4 WEEKS POSTOPERATIVELY. CHRONIC PAIN OF THE THIGH AND NUMBNESS OF THE LATERAL THIGH WERE NOT SPECIFIED. LATE POSTOPERATIVE COMPLICATIONS SUCH AS BOWEL OBSTRUCTION, TROCAR HERNIA, TESTICULAR ATROPHY AND DEVELOPMENT OF A HYDROCELE DID NOT OCCUR. ONE PATIENT WITH BILATERAL INGUINAL HERNIAS (RIGHT-SIDED MEDIAL INGUINAL HERNIA AND LEFT-SIDED HUGE SCROTAL HERNIA) DEVELOPED 2 YEARS POSTOPERATIVELY A LEFT-SIDED LATERAL (INDIRECT) HERNIA RECURRENCE (2.4%), TREATED BY A SECOND TAPP PROCEDURE AND WITHOUT ADDITIONAL HERNIA RELAPSE DURING ANOTHER FOLLOW-UP PERIOD OF 7 YEARS. THE HERNIA RECURRENCE WAS CAUSED BY SLIPPING (ROLLED-UP) THE LATERAL PART OF THE IMPLANTED MESH. REPORTED COMPLICATIONS INCLUDED N=1 TESTICULAR PAIN, N=1 GROIN PAIN AND N=1 HERNIA RECURRENCE. IN CONCLUSION, IN THE HANDS OF SURGEONS WITH LARGE EXPERIENCES IN ENDOSCOPIC LAPAROSCOPIC HERNIA REPAIR, THE LAPAROSCOPIC TRANSPERITONEAL HERNIOPLASTY (TAPP) AFTER PREVIOUS RADICAL OPEN RETROPUBIC PROSTATECTOMY IS SAFE AND EFFECTIVE WITH LOW INTRA- AND POSTOPERATIVE COMPLICATIONS AND LOW HERNIA RECURRENCES (2.4%). A TAPP TECHNIQUE WITH CLOSURE OF HERNIA GAPS LARGER THAN 1 × 1 CM WITH NON-ABSORBABLE SURGICAL SUTURES AND A MESH-SIZE OF 13 × 13¿15 CM IS REQUESTED. A COMPLETE SHARP DISSECTION OF THE RETROPUBIC SCARED TISSUE FOR MESH IMPLANTATION IS NOT MANDATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337844 VYPRO MESH UNKNOWN PRODUCT MESH, SURGICAL, POLYMERIC FTL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male