BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 110 SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 13343630 · Received January 25, 2022

    Report

    Report Number
    9617229-2022-01017
    Event Type
    Injury
    Date Received
    January 25, 2022
    Date of Event
    January 1, 2011
    Report Date
    January 25, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION CONTAINED IN THIS REPORT WAS PREVIOUSLY SUBMITTED THROUGH PSR ON (B)(6) 2016. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. THE EVENTS OF INFECTION AND CAPSULAR CONTRACTURE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. 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: "INFECTED;" CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN. FURTHER INVESTIGATION RESULTS: WITH THE INFORMATION COLLECTED DURING THE INVESTIGATION, THERE IS ENOUGH EVIDENCE TO SUPPORT THAT DEVICE SERIAL NUMBER (B)(4) WAS MANUFACTURED UNDER CONTROLLED CONDITIONS IN ACCORDANCE WITH ALLERGAN MEDICAL 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 RUN 110326 IS 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) 2014 THROUGH (B)(6) 2016, ONE POINT WAS FOUND OUT OF THE UPPER LIMIT ON (B)(6) 2014, BASED ON THE ADDITIONAL ANALYSIS PERFORMED FOR THE FIS INVOLVED IN THE (B)(6) 2014, THERE ARE NO SIMILARITIES OR PATTERNS WITH DATA FROM THIS ANALYSIS RELATED TO THIS SPECIFIC MONTH AND ALL THE CORRESPONDENT INVESTIGATIONS FOUND NO ISSUES ASSOCIATED TO EITHER EVENTS. GIVEN THE FACT THAT THE CAUSE OF THE INFECTION CANNOT BE SPECIFICALLY ASSOCIATED TO (B)(6) 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 FOR THEIR LEFT SIDE IMPLANT, IT BECAME "INFECTED AND HARD", "RED," "SWOLLEN," AND "HOT TO THE TOUCH" THE PATIENT STATED THIS HAPPENED "A COUPLE YEARS" AFTER THE IMPLANT SURGERY, AND THE INFECTION, REDNESS, SWELLING, AND "HOT TO THE TOUCH" RESOLVED WITH ANTIBIOTICS. THE PATIENT DID NOT HAVE SPECIFIC INFORMATION ON THE INFECTION ITSELF. THE PATIENT INDICATED THEY STILL HAVE HARDNESS ON THEIR LEFT SIDE. PATIENT REPRESENTATIVE REPORTED "CAPSULAR CONTRACTURE, [BAKER GRADE UNKNOWN] REQUIRING CAPSULECTOMY AND INCREASED RISK OF ALCL. PLAINTIFF HAS NOT BEEN DIAGNOSED WITH BIA-ALCL." THIS RECORD IS FOR THE LEFT SIDE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624168 STYLE 110 SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) 1544247

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention