BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 17577086 · Received August 18, 2023

    Report

    Report Number
    9617229-2023-13579
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    January 1, 2014
    Report Date
    September 15, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    05060191601566
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTO ANALYSIS: VISUAL ANALYSIS OF THE PHOTOGRAPHS IDENTIFIED: ¿ MALAISE-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ HEADACHE-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ VARIED INJURIES-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ OTHER-MEDICAL-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ AUTOIMMUNE/CONNECTIVE TISSUE DISORDERS-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ CAPSULAR CONTRACTURE: UNABLE TO OBSERVE SINCE IT IS NOT RELATED TO THE DEVICE. ¿ RUPTURE: OBSERVED BUT CANNOT PERFORM AN ASSESSMENT OF THE OPENING AS NO MICROSCOPIC ANALYSIS CAN BE PERFORMED. ¿ PAIN-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ NAUSEA-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ DEPRESSION-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ RAYNAUDS PHENOMENOM-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ SENSATION INCREASE/DECREASE-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ EDEMA-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ¿ INFECTION (UNKNOW ONSET)-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. NO ADDITIONAL OBSERVATIONS WERE CARRIED OUT. NO FURTHER ACTIONS ARE REQUIRED AS NO MANUFACTURING ISSUES ARE OBSERVED. CLARIFICATION TO D.9. RETURNED TO MFG ON: THE DEVICE HAS NOT BEEN RETURNED. SEE PHOTO ANALYSIS IN H.10.

    Additional Manufacturer Narrative · 0

    CONT. H.6. HEALTH EFFECT F2203 IMAGING REQUIRED. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF CAPSULAR CONTRACTURE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: CAPSULAR CONTRACTURE BAKER GRADE III/IV, "GEL HAS PARTIALLY LEAKED".

    Description of Event or Problem · 0

    PATIENT REPRESENTATIVE REPORTED RIGHT SIDE RUPTURE, "GEL HAS PARTIALLY LEAKED", CAPSULAR CONTRACTURE BAKER GRADE III-IV, ¿TENSION IN THE CHEST¿, ¿BREAST PAIN¿, ¿FEELING THAT THE DEVICES WERE ATTACHED TO THE PECTORAL MUSCLE¿, AND ¿ULTRASOUND SHOWED THAT THE DEVICES WERE KINKED AT THE TOP¿. PATIENT REPRESENTATIVE ADDITIONALLY REPORTED THE FOLLOWING EVENTS, WHICH ARE ALL NOT DEVICE-RELATED: ¿BACK PAIN¿, ¿EXTREME PAIN IN THE BACK AND SHOULDERS", ¿EXHAUSTION¿, ¿FREQUENT FATIGUE¿, ¿HEADACHES THAT TURNED INTO MIGRAINES¿, ¿DIAGNOSED WITH AUTO IMMUNE DISEASE 'MORBUS BASEDOW'", ¿DIFFICULTY CONCENTRATING ", ¿FOOD INTOLERANCE WITH STOMACH ACHE¿, ¿GASTROINTESTINAL PROBLEMS¿, ¿DIGESTIVE PROBLEMS¿, ¿DYSREGULATION OF THE THYROID¿, ¿FORGETFULNESS¿, ¿RESTRICTIONS IN THE PROVISION OF SERVICES (SUCH AS HOUSEHOLD)¿, ¿HIGH EYE PRESSURE¿, ¿SENSITIVITY TO LIGHT AND BURNING AND TEARING EYES¿, ¿REPRESENTATIVE HAS ADVISED THAT THESE ARE SYMPTOMS OF BREAST IMPLANT ILLNESS (BII)¿, ¿SLEEP DISORDER¿, ¿ANXIETY¿, ¿PANIC ATTACKS WITH HEART RACE¿, ¿NAUSEA¿, ¿DEPRESSION¿, ¿RAYNAUD SYNDROME¿, ¿SPONTANEOUS TINGLING IN THE FINGERS UP TO STIFFNESS AND NUMBNESS¿, ¿FREQUENT SWELLING OF HANDS, FEET AND LEGS¿, ¿FREQUENT BLADDER INFECTIONS¿. RUPTURE WAS CONFIRMED INTRAOPERATIVELY AND CAPSULECTOMY WAS PERFORMED. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.

    Description of Event or Problem · 0

    PATIENT REPRESENTATIVE REPORTED ¿RIGHT SIDE RUPTURE¿, ¿GEL HAS PARTIALLY LEAKED¿, ¿EXHAUSTION¿, ¿SLEEP DISORDER¿, ¿DIFFICULTY CONCENTRATING ", ¿HEADACHES THAT TURNED INTO MIGRAINES¿, ¿BACK PAIN¿, ¿FOOD INTOLERANCE WITH STOMACH ACHE¿, ¿GASTROINTESTINAL PROBLEMS¿, ¿NAUSEA¿, ¿DIGESTIVE PROBLEMS¿, ¿DIAGNOSED WITH AUTO IMMUNE DISEASE "MORBUS BASEDOW", ¿DEPRESSION AND ANXIETY¿, ¿DYSREGULATION OF THE THYROID¿,¿ FORGETFULNESS¿, ¿RESTRICTIONS IN THE PROVISION OF SERVICES (SUCH AS HOUSEHOLD)¿, ¿HIGH EYE PRESSURE¿, ¿FREQUENT BLADDER INFECTIONS¿, ¿SPONTANEOUS TINGLING IN THE FINGERS UP TO STIFFNESS AND NUMBNESS¿, ¿RAYNAUD SYNDROME¿, ¿TENSION IN THE CHEST¿, ¿EXTREME PAIN IN THE BACK AND SHOULDERS¿, ¿FREQUENT FATIGUE¿, ¿PANIC ATTACKS WITH HEART RACE¿, ¿BREAST PAIN¿, ¿FREQUENT SWELLING OF HANDS, FEET AND LEGS¿, ¿SENSITIVITY TO LIGHT AND BURNING AND TEARING EYES¿, ¿REPRESENTATIVE HAS ADVISED THAT THESE ARE SYMPTOMS OF BREAST IMPLANT ILLNESS (BII)¿, ¿FEELING THAT THE DEVICES WERE ATTACHED TO THE PECTORAL MUSCLE¿, ¿ULTRASOUND SHOWED THAT THE DEVICES WERE KINKED AT THE TOP¿, AND ¿BILATERAL CAPSULAR CONTRACTURE BAKER GRADE III-IV¿. DEVICE HAS BEEN EXPLANTED AND REPLACED WITH A NON-ALLERGAN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330679 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2169972 05060191601566

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention