BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 6903773 · Received September 29, 2017

    Report

    Report Number
    9617229-2017-02899
    Event Type
    Injury
    Date Received
    September 29, 2017
    Report Date
    October 27, 2017
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 DEFLATION EVENT WAS RECEIVED ON (B)(6) 2017, WITH LOT NUMBER: 1201805. VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: FLUIDS INSIDE DEVICE AND CRACKED VALVE SEAT DIAPHRAGM VALVE. A LEAK TEST WAS PERFORMED WHICH NOT IDENTIFY OPENINGS ON THE SHELL. MICROSCOPIC ANALYSIS WAS PERFORMED WHICH IDENTIFIED: CRACKED VALVE SEAT DIAPHRAGM VALVE AND LESS THAN 75% OF DIAPHERM FLANGE DISK DELAMINATED, CATALOGED AS ADHESIVE FAILURE. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: CRACKED VALVE SEAT DIAPHRAGM VALVE. ADHESIVE FAILURE.

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

    THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683301 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 1201805

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention