BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 6799609 · Received August 16, 2017

    Report

    Report Number
    9617229-2017-00920
    Event Type
    Injury
    Date Received
    August 16, 2017
    Date of Event
    July 9, 2017
    Report Date
    September 13, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF DEFLATION WAS RECEIVED ON AGO 10, 2017 WITH LOT NUMBER 1864552. VISUAL ANALYSIS WAS PERFORMED WHICH IDENTIFIED FOLD CREASES, WEAR ABRASION, BROWN PARTICLES IN FILL CHANNEL, AN OPENING ON ANTERIOR AND AN OPENING ON RADIUS. LEAK TEST WAS PERFORMED WHICH IDENTIFIED TWO OPENINGS ON SHELL. MICROANALYSIS IDENTIFIED ONE SMOOTH OPENING ON CREASE ASSESSED AS FOLD FLAW OPENING AND AN OPENING STRIATED ON ANTERIOR ASSESSED AS SURGICAL DAMAGE. FILL INSPECTION WAS PERFORMED AND IDENTIFIED NO BLOCKAGE IN THE VALVE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: CREASE SMOOTH ASSESSED AS FOLD FLAW OPENING. OPENING DUE TO SURGICAL DAMAGE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REGARDING THE EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED OF THE REPORTER BY ALLERGAN; NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. 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 OR 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

    PHYSICIAN REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED RIGHT SIDE DEFLATION. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578449 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1864552

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention