BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN GEL IMPLANTS SMOOTH

    MDR report key: 16454302 · Received February 28, 2023

    Report

    Report Number
    1645337-2023-02230
    Event Type
    Injury
    Date Received
    February 28, 2023
    Manufacturer
    MENTOR TEXAS
    Product Code
    FTR
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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: HEMATOMA, SCARRING, SKIN REACTION (B)(4). MENTOR IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH MENTOR HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, MENTOR, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MENTOR, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF CERTAIN INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SPLIT INFERIOR PEDICLE: THE 1-STAGE AUGMENTATION MASTOPEXY FOR GRADE 3 PTOSIS PMID: 35619670 PMCID:(B)(4) DOI: 10.1093/ASJOF/OJAC017 OBJECTIVE/METHODS/STUDY DATA: THE AUTHORS DESCRIBE THE 1-STAGE SURGICAL TECHNIQUE FOR PRIMARY GRADE 2 AND GRADE 3 AUGMENTATION-MASTOPEXIES. METHODS: A TOTAL OF 78 PATIENTS WERE REVIEWED. THE AGE RANGE WAS 26-62 YEARS OLD; THE RANGE OF IMPLANT VOLUME WAS 150-375 CC; AND THE FOLLOW-UP TIME PERIOD WAS FROM 1 YEAR TO 22 YEARS. THE KEY POINTS OF THIS TECHNIQUE ARE SIMPLE PREOPERATIVE MARKINGS; THE AUGMENTATION IS PERFORMED WITH A TRUE SUBMUSCULAR PLACEMENT OF SMOOTH IMPLANTS; AND THE MASTOPEXY IS PERFORMED WITH AN INFERIOR PEDICLE TECHNIQUE WITH UNLIMITED SKIN FLAP UNDERMINING AND NO LIMITATION OF NIPPLE ELEVATION. A TOTAL OF 78 PATIENTS WERE REVIEWED. FROM 1990 TO 1999, ANOTHER 52 PATIENTS WERE LOST TO FOLLOW-UP DUE TO THE RELOCATION OF OUR PRACTICE FROM FLORIDA TO GREECE AND WERE NOT INCLUDED IN THE STUDY. THE AGE RANGE WAS 26-62 YEARS OLD; THE RANGE OF IMPLANT VOLUME WAS 150-375 CC; AND THE FOLLOW-UP TIME PERIOD WAS FROM 1 YEAR TO 22 YEARS. THE KEY POINTS OF THIS TECHNIQUE ARE SIMPLE PREOPERATIVE MARKINGS; THE AUGMENTATION IS PERFORMED WITH A TRUE SUBMUSCULAR PLACEMENT OF SMOOTH IMPLANTS; AND THE MASTOPEXY IS PERFORMED WITH AN INFERIOR PEDICLE TECHNIQUE WITH UNLIMITED SKIN FLAP UNDERMINING AND NO LIMITATION OF NIPPLE ELEVATION. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED MENTOR DEVICES POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: SMOOTH ROUND MODERATE, MODERATE PLUS SILICONE IMPLANTS, MENTOR (SANTA BARBARA, CA) IT WAS REPORTED THAT 4 FEMALE PATIENTS WHO UNDERWENT AUGMENTATION MASTOPEXY SURGERY WITH SMOOTH ROUND MODERATE OR MODERATE PLUS SILICONE IMPLANTS DEVELOPED POSTOP HEMATOMA. 4 FEMALE PATIENTS WHO UNDERWENT AUGMENTATION-MASTOPEXY SURGERY WITH SMOOTH ROUND MODERATE OR MODERATE PLUS SILICONE IMPLANTS EXPERIENCED SUPERFICIAL ¿T¿ POINT SLOUGHING AND 6 PATIENTS EXPERIENCED MARGINAL AREOLA SLOUGHING. . 14 FEMALE PATIENTS WHO UNDERWENT AUGMENTATION-MASTOPEXY SURGERY WITH SMOOTH ROUND MODERATE OR MODERATE PLUS SILICONE IMPLANTS EXPERIENCED SCAR REVISIONS UNDER LOCAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753537 UNKNOWN GEL IMPLANTS SMOOTH PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention