BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 6861766 · Received September 13, 2017

    Report

    Report Number
    9617229-2017-02172
    Event Type
    Injury
    Date Received
    September 13, 2017
    Date of Event
    August 15, 2017
    Report Date
    October 12, 2017
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT OF CAPSULAR CONTRACTURE WAS RECEIVED ON SEP 26, 2017 WITH LOT NUMBER 2230482. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED OPENING CRACK, CREASE FLAT, WEAR ABRASION, WHITE PARTICLES INSIDE THE DEVICE. THE LEAK TEST WAS PERFORMED AND FOUND OPENING CRACK IN THE VALVE SEAT DIAPHRAGM VALVE. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED OPENING CRACK BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: A CRACK OPENING ON DIAPHRAGM VALVE DUE TO CRACKED VALVE SEAT DIAPHRAGM VALVE.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A LEFT SIDE DEFLATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641362 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 2230482

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention