BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 6886574 · Received September 22, 2017

    Report

    Report Number
    9617229-2017-02474
    Event Type
    Injury
    Date Received
    September 22, 2017
    Date of Event
    April 1, 2017
    Report Date
    October 25, 2017
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE RELATED TO THE REPORTED EVENT WAS RECEIVED ON OCTOBER 13, 2017 WITH LOT NUMBER 1770929. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: ONE CURVED OPENING IN THE ANTERIOR, WEAR ABRASION AND FOLD CREASES. A LEAK TEST WAS PERFORMED WHICH IDENTIFIED OPENING. A MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFY: ONE OPENING CURVED STRIATED ASSESSED AS SURGICAL DAMAGE. FILL INSPECTION WAS PERFORMED AND IDENTIFIED NO BLOCKAGE IN THE VALVE. THE CREASES CONDITION THAT WAS INDICATED IN THE COMPLAINT WAS OBSERVED, NEVERTHELESS IS CONSIDERED NON RELATED TO THE MANUFACTURING PROCESS, SINCE THE DEVICE WAS RECEIVED OUT OF THEIR PRIMARY PACKAGING AND IS AN EXPLANTED DEVICE (MULTIPLE HANDLING DURING THE EXPLANTATION SHIPPING PROCESS COULD LEAD A VARIATION ON THE DEVICE CONDITIONS). BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: ONE OPENING CURVED STRIATED ASSESSED AS SURGICAL DAMAGE. CREASES CONDITION WAS OBSERVED, NEVERTHELESS IS NOT RELATED TO THE MANUFACTURING PROCESS.

    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.

    Description of Event or Problem · 1

    THE DEVICE HAS BEEN EXPLANTED. IT WAS NOTED THAT UPON REMOVAL THE DEVICE WAS OBSERVED TO HAVE SEVERAL FOLD FLAWS AND A HOLE IN ONE FOLD FLAW.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED A RIGHT-SIDE DEFLATION. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667555 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1770929

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention