BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 6575019 · Received May 18, 2017

    Report

    Report Number
    9617229-2017-00167
    Event Type
    Injury
    Date Received
    May 18, 2017
    Date of Event
    May 15, 2016
    Report Date
    May 18, 2017
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION TO AGE/DATE OF BIRTH. TWENTY-TWO (22) PATIENTS RANGING FROM AGE 25-72 YEARS. ARTICLE CITATION: ¿DOUBLE-CHAMBER TISSUE EXPANDERS OPTIMIZE LOWER POLE EXPANSION IN IMMEDIATE BREAST RECONSTRUCTION REQUIRING ADJUVANT RADIATION THERAPY,¿ BY LAUREN HEWELL FISCHER, MD, AND DUNG NGUYEN, MD., PUBLISHED IN ANNALS OF PLASTIC SURGERY, VOL. 76, ISSUE 5, MAY 2016, PP. 171-174. THE EVENT OF INFECTION IS A PHYSIOLOGICAL COMPLAINT, AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE REPORTER REGARDING THE EVENT, PRODUCT, AND/OR PATIENT DETAILS WAS REQUESTED. DEVICE LABELING: ¿POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH SILICONE GEL-FILLED BREAST IMPLANT SURGERY INCLUDE: INFECTION.¿ ¿IN RARE INSTANCES, ACUTE INFECTION MAY OCCUR IN A BREAST WITH IMPLANTS. THE SIGNS OF ACUTE INFECTION INCLUDE ERYTHEMA, TENDERNESS, FLUID ACCUMULATION, PAIN, AND FEVER. VERY RARELY, TOXIC SHOCK SYNDROME, A POTENTIALLY LIFE-THREATENING CONDITION, HAS BEEN REPORTED IN WOMEN AFTER BREAST IMPLANT SURGERY. IT IS CHARACTERIZED BY SYMPTOMS THAT OCCUR SUDDENLY AND INCLUDE HIGH FEVER (102°F, 38.8°C OR HIGHER), VOMITING, DIARRHEA, A SUNBURN-LIKE RASH, RED EYES, DIZZINESS, LIGHTHEADEDNESS, MUSCLE ACHES, AND DROPS IN BLOOD PRESSURE, WHICH MAY CAUSE FAINTING. PATIENTS SHOULD BE ADVISED TO CONTACT A PHYSICIAN IMMEDIATELY FOR DIAGNOSIS AND TREATMENT FOR ANY OF THESE SYMPTOMS.¿

    Description of Event or Problem · 1

    REPORTED EVENT OF UNKNOWN SIDE ¿INFECTION¿ FOR A PATIENT IMPLANTED WITH A ¿NATRELLE STYLE 410¿ IMPLANT WAS NOTED IN ¿DOUBLE-CHAMBER TISSUE EXPANDERS OPTIMIZE LOWER POLE EXPANSION IN IMMEDIATE BREAST RECONSTRUCTION REQUIRING ADJUVANT RADIATION THERAPY,¿ PUBLISHED IN ANNALS OF PLASTIC SURGERY, VOL. 76, ISSUE 5, MAY 2016, PP. 171-174. TREATMENT CONSISTED OF ¿REMOVAL OF IMPLANT¿ AND ¿INTRAVENOUS ANTIBIOTICS.¿ THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355857 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention