BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SALINE IMPLANTS SMOOTH

    MDR report key: 15156061 · Received August 3, 2022

    Report

    Report Number
    1645337-2022-08948
    Event Type
    Injury
    Date Received
    August 3, 2022
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 REVIEW COULD BE PERFORMED. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: BREAST PROSTHESIS DEFLATION. 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: DOES OVERFILLING SMOOTH INFLATABLE SALINE-FILLED BREAST IMPLANTS DECREASE THE DEFLATION RATE? EXPERIENCE WITH 4761 AUGMENTATION MAMMAPLASTY PATIENTS. DOI: 10.1007/S00266-021-02380-7. IT WAS REPORTED THAT 210 PATIENTS WHO UNDERWENT AESTHETIC AUGMENTATION MAMMAPLASTY WITH MENTOR STYLE 1600 SALINE BREAST IMPLANT, BETWEEN 2002 AND 2018, EXPERIENCED A BREAST IMPLANT DEFLATION, THE TOTAL NUMBER OF THE AFFECTED DEVICES WERE 224. OBJECTIVE/METHODS/STUDY DATA: THE GOAL OF THIS RETROSPECTIVE COMPARATIVE STUDY WAS TO DETERMINE THE ADVANTAGES OF OVERFILLING SALINE BREAST IMPLANTS. METHODS: A RETROSPECTIVE COMPARATIVE STUDY WAS CONDUCTED FOR 4761 WOMEN WHO UNDERWENT AESTHETIC AUGMENTATION MAMMAPLASTY BY THE AUTHOR. PATIENTS WERE DIVIDED INTO TWO GROUPS: GROUP 1 INCLUDES 2960 PATIENTS WHO HAD BREAST AUGMENTATION BETWEEN 2002 AND 2009 WITH IMPLANTS FILLED WITHIN THE MANUFACTURER¿S RECOMMENDED FILL VOLUMES. GROUP 2 INCLUDES 1801 PATIENTS WHO HAD BREAST AUGMENTATION BETWEEN 2011 AND 2018. THEIR IMPLANTS WERE OVERFILLED WITH AN AVERAGE VOLUME BETWEEN 42 AND 50 CC, OR 10¿13%, RESPECTIVELY. ALL SURGERIES WERE PERFORMED WITH MENTOR STYLE 1600 SALINE BREAST IMPLANTS (SMOOTH, ROUND MODERATE PROFILE) THROUGH AN INFRAMAMMARY INCISION; IMPLANTS WERE PLACED IN THE SUBPECTORAL (DUAL) PLANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544942 UNKNOWN SALINE IMPLANTS SMOOTH PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention