BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 6929242 · Received October 9, 2017

    Report

    Report Number
    9617229-2017-03388
    Event Type
    Injury
    Date Received
    October 9, 2017
    Report Date
    October 9, 2017
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH ASR. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT WAS RECEIVED ON SEPTEMBER 20, 2017 WITH LOT NUMBER 1855178. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: OPENING, WEAR ABRASION, CREASE FOLD. LEAK TEST WAS PERFORMED AND FOUND OPENING ON ANTERIOR AND RADIUS. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFY CREASE SMOOTH OPENING ON RADIUS AND SHARP OPENING IN THE ANTERIOR SIDE. A DIMENSION MEASUREMENT IN THE SHELL WAS PERFORMED WHICH IDENTIFY THE THICKNESS WITHIN SPECIFICATION. THE FILL TEST INSPECTION WAS PERFORMED, THE RESULT IS NO BLOCKAGE BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: -A CREASE SMOOTH OPENING ON RADIUS DUE TO AN FOLD FLAW OPENING. -A SHARP OPENING ON ANTERIOR DUE TO AN UNIDENTIFIED (TEAR) OPENING. DEVICE LABELING: POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH SALINE-FILLED BREAST IMPLANT SURGERY INCLUDE: REOPERATION, PAIN, WRINKLING, ASYMMETRY, IMPLANT PALPABILITY/VISIBILITY, IMPLANT REMOVAL, CAPSULAR CONTRACTURE, CHANGES IN NIPPLE AND BREAST SENSATION, IMPLANT DISPLACEMENT/MIGRATION, IMPLANT DEFLATION, SCARRING, INFECTION, HEMATOMA/SEROMA, BREASTFEEDING COMPLICATIONS, IMPLANT EXTRUSION, NECROSIS, DELAYED WOUND HEALING, BREAST TISSUE ATROPHY/CHEST WALL DEFORMITY, CALCIUM DEPOSITS, AND LYMPHADENOPATHY. DEFLATION ¿ BREAST IMPLANTS ARE NOT LIFETIME DEVICES. SALINE BREAST IMPLANTS DEFLATE WHEN THE SHELL DEVELOPS A TEAR OR HOLE. DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION, BUT THEY ARE MORE LIKELY TO OCCUR THE LONGER THE IMPLANT IS IMPLANTED. THE FOLLOWING THINGS MAY CAUSE IMPLANTS TO DEFLATE: DAMAGE BY SURGICAL INSTRUMENTS; FOLDING OR WRINKLING OF THE IMPLANT SHELL; EXCESSIVE FORCE TO THE CHEST (E.G., DURING CLOSED CAPSULOTOMY, WHICH IS CONTRAINDICATED); TRAUMA; COMPRESSION DURING MAMMOGRAPHIC IMAGING; AND SEVERE CAPSULAR CONTRACTURE. BREAST IMPLANTS MAY ALSO SIMPLY WEAR OUT OVER TIME. LABORATORY STUDIES HAVE IDENTIFIED SOME OF THE CAUSES OF DEFLATION FOR ALLERGAN¿S PRODUCT; HOWEVER, IT IS NOT CONCLUSIVELY KNOWN WHETHER THESE TESTS HAVE IDENTIFIED ALL CAUSES OF DEFLATION.

    Description of Event or Problem · 1

    PATIENT REPORTED A RIGHT SIDE DEFLATION. DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711097 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1855178

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention