BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 14596798 · Received June 3, 2022

    Report

    Report Number
    9617229-2021-57580
    Event Type
    Injury
    Date Received
    June 3, 2022
    Report Date
    June 3, 2022
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    UDI-DI
    10888628002739
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED DEVICE IDENTIFIED: WEIGHT TO THE SPEC, CREASE FOLD, DEFORMATION, YELLOW PARTICLES. CLOUDY AND BUBBLES WERE OBSERVED AFTER AUTOCLAVE DISINFECTION PROCESS. BASED ON THE DEVICE ANALYSIS THE FINAL ASSESSMENT IS: NO ISSUES FOUND RELATED WITH THE MANUFACTURING PROCESS. THE EVENT OF SEROMA - LATE 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: "COLLECTION OF FLUID IN RECONSTRUCTED BREAST".

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED RIGHT SIDE EXCHANGE DUE TO PATIENT'S CONCERN WITH THE PRODUCT. PATIENT REPRESENTATIVE REPORTED "AS PART OF A RECONSTRUCTIVE PROCEDURE, PLAINTIFF HAD A RIGHT BREAST IMPLANT PERFORMED IN 2017 WITH AN ALLERGAN BIOCELL PRODUCT, THE NATRELLE 410 HIGHLY COHESIVE ANATOMICALLY SHAPED SILICONE FILLED BREAST IMPLANT, IN BREAST. SINCE THAT TIME, PLAINTIFF HAS EXPERIENCED PAIN AND A COLLECTION OF FLUID IN RECONSTRUCTED BREAST, WHICH REQUIRED MEDICAL TREATMENT. AROUND THE TIME OF ALLERGAN USA, INC.'S 2019 RECALL OF ITS TEXTURED BREAST IMPLANTS, THE PLAINTIFF WAS EXPERIENCING PAIN, SWELLING AND FLUID COLLECTION AROUND IMPLANT, THEREFORE PATIENT CONTACTED A PHYSICIAN ABOUT CONDITION WHEREIN THE DECISION WAS MADE TO HAVE BIOCELL NATRELLE 410 DEVICE EXPLANTED. AFTER CONSULTING WITH TREATING PHYSICIANS, PLAINTIFF HAD NATRELLE 410 DEVICE EXPLANTED AND REPLACED AT OWN EXPENSE. EVEN WITH THE BREAST IMPLANT BEING REMOVED, PLAINTIFF WILL REMAIN AT RISK FOR DEVELOPING BIA-ALCL AND WILL REQUIRE REGULAR, INVASIVE, AND COSTLY MONITORING FOR THE CONDITION. PLAINTIFF HAS BEEN BE FORCED TO EXPEND SUBSTANTIAL SUMS FOR THE REMOVAL OF THE RECALLED IMPLANTS, FOR SURGICAL AND DIAGNOSTIC FEES, INCLUDING A NEW IMPLANT DEVICE, AND FOR ASSOCIATED MEDICATIONS, DIAGNOSTIC PROCEDURES AND ONGOING MEDICAL MONITORING AS A RESULT OF HER EXPOSURE TO THE RISK OF CONTRACTING BIA-ALCL. PLAINTIFF HAS EXPERIENCED PHYSICAL PAIN AND SUFFERING AND PSYCHOLOGICAL EFFECTS FROM THE STRESS, FEAR, AND UNCERTAINTY OF THIS PERCEIVED AND ACTUAL CANCER RISK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587766 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) FF-410740 2710660 10888628002739

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention