BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 15 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14452793 · Received May 20, 2022

    Report

    Report Number
    9617229-2022-08056
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    January 1, 2018
    Report Date
    November 28, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. THE EVENT OF INFECTION (UNKNOWN ONSET) 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: RUPTURE, INFECTION (UNKNOWN ONSET).

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: "THE DEVICE RELATED TO THE REPORTED EVENT OF RUPTURE, INFECTION, EDEMA, ANXIETY-PRODUCT/PROCEDURE, SKIN RASH/DERMATITIS, NAUSEA, PAIN, FEVER-NDR, OTHER MEDICAL-NDR, CARDIAC COMPLICATION-NDR, INFECTION (UNKNOWN ONSET)-NDR, DEPRESSION-NDR, HEADACHE-NDR, VARIED INJURIES-NDR, MALAISE-NDR AND PAIN-NDR WAS RECEIVED ON OCTOBER 18, 2022, WITH LOT NUMBER 2461836. BASED ON THE DEVICE ANALYSIS GRID, THE ASSESSMENTS OF THE COMPLAINT ARE: RUPTURE: OBSERVED, BROKEN DEVICE IN THE RADIUS SIDE ASSESSED AS SURGICAL DAMAGE. INFECTION: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. EDEMA: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. ANXIETY-PRODUCT/PROCEDURE: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. SKIN RASH/DERMATITIS: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. NAUSEA: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. PAIN: UNABLE TO CONFIRM AS IT IS A MEDICAL EVENT NOT RELATED TO THE DEVICE. FEVER-NDR, OTHER MEDICAL-NDR, CARDIAC COMPLICATION-NDR, INFECTION (UNKNOWN ONSET)-NDR, DEPRESSION-NDR, HEADACHE-NDR, VARIED INJURIES-NDR, MALAISE-NDR, PAIN-NDR: NOT APPLICABLE AS THE EVENT IS NOT RELATED TO THE DEVICE. ADDITIONAL OBSERVATIONS: NO OTHER OBSERVATION OBSERVED. NO FURTHER ACTIONS ARE REQUIRED AS THE DEVICE WAS IMPLANTED." FURTHER INVESTIGATION: "WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE WORK ORDER (B)(4) WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ALLERGAN PROCEDURES. SEAL STRENGTH RESULTS WERE ACCEPTABLE. ENVIRONMENTAL MONITORING RESULTS WERE FOUND TO BE ACCEPTABLE AND THEY CONFIRMED THAT THERE WAS NOT AN ADVERSE IMPACT ON ENVIRONMENTAL CONDITIONS, DEVICE QUALITY OR PERFORMANCE. THE STERILIZATION RUNS ARE NOT RELATED TO ANY ADDITIONAL COMPLAINT INFECTION RECORD REPORTED AS OF TODAY. DURING THE TREND REVIEW OF ALL INFECTION COMPLAINTS FOR THE PERIOD OF (B)(6) 2020 THROUGH (B)(6) 2022, NO ADVERSE TREND WAS NOTED. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO THE MANUFACTURING PROCESS, AND THERE IS NOT AN ADVERSE TREND FOR THIS TYPE OF EVENT NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME."

    Description of Event or Problem · 0

    PATIENT REPORTED "RIGHT RUPTURE, BREAST IMPLANT ILLNESS, BILATERAL INFECTION AND BILATERAL REMOVAL." PATIENT LEGAL REPRESENTATIVE REPORTED "JOINT PAIN, SWELLING, STIFFNESS, AND OTHER RANDOM PAIN, CHRONIC FATIGUE, BRAIN FOG, WASN'T PRODUCING HORMONES, HAVING CONSTANT PERIODS, STOMACH ISSUES, WEIGHT BECAME DIFFICULT TO MANAGE, HEADACHES, HOT FLASHES, (HANDS, FEET, BACK AND/OR HIPS WOULD BURN AND THROB,) DEPRESSED, ANXIOUS,UNABLE TO GO THE BATHROOM, INFECTIONS IN KIDNEYS, HEADACHES, HEART RACING, HIGH BLOOD PRESSURE, FEVER, APPENDIX WAS ABOUT TO RUPTURE, RIGHT IMPLANT WAS RUPTURED, BII (BREAST IMPLANT ILLNESS) NON-SPECIFIC CONSTITUTIONAL SYMPTOMS, GENERALIZED PAIN, MALAISE, SKIN ATOPY, TACHYCARDIA, UNEXPLAINED EPISODES OF RIGHT-SIDE PAIN EXTENDING TO THE RIGHT CHEST, BACK AND ABDOMEN, DEVICE EXPLANTED. RIGHT SIDE.

    Description of Event or Problem · 0

    PATIENT ADDITIONALLY REPORTED "STARTED GETTING SICK IN 2018/2019."

    Description of Event or Problem · 0

    PATIENT REPORTED RIGHT RUPTURE, BREAST IMPLANT ILLNESS, BILATERAL INFECTION AND BILATERAL REMOVAL. DEVICE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346113 STYLE 15 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 2461836

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Required Intervention