BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 4770907 · Received May 12, 2015

    Report

    Report Number
    9617229-2015-00039
    Event Type
    Injury
    Date Received
    May 12, 2015
    Date of Event
    December 19, 2009
    Report Date
    July 17, 2010
    Manufacturer
    ALLERGAN
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, CONCERNS HAVE BEEN RAISED REGARDING POTENTIAL DAMAGING EFFECTS ON CHILDREN BORN TO MOTHERS WITH IMPLANTS. TWO STUDIES IN HUMANS HAVE FOUND THAT THE RISK OF BIRTH DEFECTS OVERALL IS NOT INCREASED IN CHILDREN BORN AFTER BREAST IMPLANT SURGERY. ALTHOUGH LOW BIRTH WEIGHT WAS REPORTED IN A THIRD STUDY, OTHER FACTORS (FOR EXAMPLE, LOWER PRE-PREGNANCY WEIGHT) MAY EXPLAIN THIS FINDING. THIS AUTHOR RECOMMENDED FURTHER RESEARCH ON INFANT HEALTH.

    Description of Event or Problem · 1

    PATIENT REPORTED CHILD BEING DIAGNOSED WITH "ADHD". UPON F/U WITH THE DIAGNOSING PHYSICIAN'S OFFICE, THE DOCTOR STATED "UNCERTAIN OF THE CAUSE OF [CHILD'S] ADHD SYMPTOMS." NO INDICATION OF TREATMENT OR SURGICAL REOPERATION. DEVICE REMAINS IMPLANTED. THIS MEDWATCH IS FOR THE RIGHT SIDE. SEE MFR#: 9617229-2015-00038 FOR THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311274 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT FTRFTR FTR ALLERGAN NA 1430396

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other