BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MENTOR GEL IMPLANTS SMOOTH

    MDR report key: 12636438 · Received October 14, 2021

    Report

    Report Number
    1645337-2021-11478
    Event Type
    Injury
    Date Received
    October 14, 2021
    Date of Event
    July 31, 2021
    Report Date
    September 21, 2021
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NGUYEN HH, TO LT. COMPARISON OF ENDOSCOPIC TRANSAXILLARY AND PERI-AREOLAR APPROACHES IN BREAST AUGMENTATION WITH SMOOTH IMPLANTS. AESTHETIC PLAST SURG. (*DATE REMOVED). DOI: 10.1007/S00266-021-02448-4. EPUB AHEAD OF PRINT. PMID: 34251473. SINCE THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS CAN BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, THE INVESTIGATION WILL BE REOPENED AND CONDUCTED AS APPROPRIATE. SINCE NO LOT NUMBER WAS PROVIDED, NO MANUFACTURING RECORD EVALUATION COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE, HEMORRHAGE, IMPAIRED HEALING, LOCAL REACTION, SCARRING, CUTANEOUS CONTOUR DEFORMITY MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    NGUYEN HH, TO LT. COMPARISON OF ENDOSCOPIC TRANSAXILLARY AND PERI-AREOLAR APPROACHES IN BREAST AUGMENTATION WITH SMOOTH IMPLANTS. AESTHETIC PLAST SURG. (*DATE REMOVED). DOI: 10.1007/S00266-021-02448-4. EPUB AHEAD OF PRINT. PMID: 34251473. OBJECTIVE AND METHODS: THE PURPOSE OF THE STUDY WAS TO COMPARE THE ENDOSCOPIC TRANS AXILLARY APPROACH AND THE PERI-AREOLAR APPROACH IN BREAST AUGMENTATION WITH SMOOTH IMPLANTS. THIS PROSPECTIVE STUDY COMPARED THE OUTCOMES OF 275 WOMEN UNDERGOING PRIMARY BREAST AUGMENTATION (ENDOSCOPIC TRANSAXILLARY N=205, PERI-AREOLAR N=70). ALL PROCEDURES WERE PERFORMED BY A SINGLE SURGEON USING SMOOTH ROUND SILICONE IMPLANTS AND DUAL-PLANE POCKETS FROM APRIL 2013 TO MARCH 2016. ALL IMPLANTS USED WERE SMOOTH, ROUND, SILICONE GEL FROM MENTOR (STYLE 4000, MENTOR, IRVING, TX USA). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED MENTOR DEVICE POSSIBLY ASSOCIATED WITH SMOOTH ROUND SILICONE GEL IMPLANTS (MENTOR WORLDWIDE LLC) OTHER MENTOR DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-MENTOR DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: THE ARTICLE DOES NOT PROVIDE ADEQUATE INFORMATION TO DETERMINE EXACT QUANTITIES OF PRODUCTS INVOLVED. ADVERSE EVENT(S) FOR ALL STUDY GROUPS: QTY-5 LOCALIZED FLUID COLLECTION (LOCAL REACTION), QTY-7 HYPERTROPHIC SCARS OR KELOIDS, QTY-5 AREOLAR AND NIPPLE DEFORMITY (CUTANEOUS CONTOUR DEFORMITY), QTY-UNK DELAYED WOUND HEALING, QTY-2 POSTOPERATIVE BLEEDING, QTY-6 CAPSULAR CONTRACTURES (BG-III-5, BG-IV-1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532111 UNKNOWN MENTOR GEL IMPLANTS SMOOTH PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention