BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH MESH

    MDR report key: 24782749 · Received April 3, 2026

    Report

    Report Number
    2210968-2026-03512
    Event Type
    Injury
    Date Received
    April 3, 2026
    Date of Event
    November 19, 2025
    Report Date
    April 3, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAL
    PMA / PMN Number
    K082216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) 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. 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS 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. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: EUR J OBSTET GYNECOL REPROD BIOL. 2026 JAN; 316:114841. HTTPS://DOI.ORG/10.1016/J.EJOGRB.2025.114841 EPUB 2025 NOV 19. PMID: 41270538.

    Description of Event or Problem · 0

    TITLE: LONG-TERM COMPLICATIONS AND REOPERATION AFTER LAPAROSCOPIC APICAL MESH FIXATION: SACROCOLPOPEXY AND SACROHYSTEROPEXY. THIS STUDY AIMED TO EVALUATE PELVIC ORGAN PROLAPSE (POP) RECURRENCE THAT REQUIRED REOPERATION, MESH- RELATED COMPLICATIONS THAT REQUIRED REOPERATION, AND STRESS URINARY INCONTINENCE (SUI) THAT REQUIRED MID-URETHRAL SLING (MUS) SURGERY. IT ALSO AIMED TO IDENTIFY RISK FACTORS FOR REOPERATION AFTER LAPAROSCOPIC SACROCOLPOPEXY (SCP). BETWEEN AUGUST 2015 AND SEPTEMBER 2021, THIS RETROSPECTIVE STUDY ANALYZED 484 PATIENTS WITH SYMPTOMATIC POP WHO UNDERWENT SCP AT A SINGLE INSTITUTION BETWEEN 2015 AND 2021. DATA REGARDING POP SEVERITY AND SURGICAL TECHNIQUES WERE COLLECTED. A COX REGRESSION ANALYSIS WAS PERFORMED TO ASSESS ASSOCIATIONS BETWEEN POTENTIAL RISK FACTORS AND REOPERATION FOR POP RECURRENCE. COMPLICATIONS CLASSIFIED AS GRADE III BASED ON THE CLAVIEN-DINDO CLASSIFICATION, SUCH AS POP RECURRENCE, MESH-RELATED COMPLICATIONS, AND SUI, WERE THE PRIMARY OUTCOMES. THE MEAN AGE AT THE TIME OF SCP WAS 71.6 YEARS (PLUS OR MINUS 7.4 YEARS). ALL PATIENTS HAD STAGE III OR WORSE POP ACCORDING TO THE POP QUANTIFICATION (POP-Q) CLASSIFICATION. THE MEDIAN FOLLOW-UP DURATION WAS 46.0 MONTHS. THE VAGINAL WALL WAS DISSECTED ANTERIORLY TO THE BLADDER NECK, AND THE BLADDER PILLARS FORMED THE LATERAL BOUNDARIES. POSTERIORLY, DISSECTION WAS EXTENDED BILATERALLY TO THE LEVATOR ANI MUSCLE AND PERINEAL BODY. TWO POLYPROPYLENE MESH SHEETS (GYNEMESH; ETHICON, SOMERVILLE, NJ, USA) WERE SECURED AT THE CENTER AND RIGHT AND LEFT DISTAL ENDS OF THE ANTERIOR VAGINAL WALL USING 3¿0 NONABSORBABLE BRAIDED POLYESTER SUTURES (TEFDESSER II; KONO SEISAKUSHO, CHIBA, JAPAN). THEN, LAVH WAS COMPLETED VAGINALLY WITHOUT USING MONOPOLAR ELECTRICITY, AND THE VAGINAL CUFF WAS CLOSED WITH MULTIPLE SINGLE-KNOT SUTURES USING 2¿0 ABSORBABLE BRAIDED SUTURES (VICRYL; ETHICON INC.). FINALLY, PERITONEALIZATION OF THE MESH WAS PERFORMED USING ABSORBABLE 2¿0 BARBED SUTURES (STRATAFIX SPIRAL MONOCRYL PLUS A KNOTLESS TISSUE CONTROL DEVICE; ETHICON INC.). REPORTED COMPLICATIONS INCLUDE: GYNEMESH (ETHICON) MESH EXPOSURE AND SUTURE EXPOSURE (N=11) TREATMENT: REOPERATION. STRANGULATION OF THE SMALL INTESTINE (N=3) TREATMENT: REOPERATION. SPONDYLITIS (N=1) TREATMENT: REOPERATION . URETHRAL EROSION (N=1) TREATMENT: REOPERATION . PERSISTENT SUI (N=19) TREATMENT: MUS OCCULT SUI (N=10) TREATMENT: MUS DE NOVO SUI (N=7) TREATMENT: MUS. VICRYL (ETHICON) MESH EXPOSURE AND SUTURE EXPOSURE (N=11) TREATMENT: REOPERATION STRANGULATION OF THE SMALL INTESTINE (N=3) TREATMENT: REOPERATION. SPONDYLITIS (N=1) TREATMENT: REOPERATION . URETHRAL EROSION (N=1) TREATMENT: REOPERATION . PERSISTENT SUI (N=19) TREATMENT: MUS OCCULT SUI (N=10) TREATMENT: MUS DE NOVO SUI (N=7) TREATMENT: MUS. STRATAFIX (ETHICON) MESH EXPOSURE AND SUTURE EXPOSURE (N=11) TREATMENT: REOPERATION. STRANGULATION OF THE SMALL INTESTINE (N=3) TREATMENT: REOPERATION. SPONDYLITIS (N=1) TREATMENT: REOPERATION . URETHRAL EROSION (N=1) TREATMENT: REOPERATION . PERSISTENT SUI (N=19) TREATMENT: MUS OCCULT SUI (N=10) TREATMENT: MUS DE NOVO SUI (N=7) TREATMENT: MUS. IN CONCLUSION, LOWER BMI AT THE TIME OF THE INITIAL SURGERY MAY BE ASSOCIATED WITH A REDUCED RISK OF REOPERATION FOR PROLAPSE RECURRENCE. THESE FINDINGS UNDERSCORE THE IMPORTANCE OF INDIVIDUALIZED RISK ASSESSMENT AND LONG-TERM SURVEILLANCE AFTER SCP. RESEARCH SHOULD AIM TO CLARIFY THE MECHANISMS UNDERLYING RECURRENCE AND EVALUATE WHETHER PATIENT-TAILORED PERIOPERATIVE STRATEGIES¿SUCH AS WEIGHT MANAGEMENT OR MODIFIED SUTURE TECHNIQUES¿CAN FURTHER IMPROVE SURGICAL DURABILITY AND LONG-TERM QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836744 GYNECARE GYNEMESH MESH MESH, SURGICAL, POLYMERIC GAL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention