BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 20465801 · Received October 16, 2024

    Report

    Report Number
    9617229-2024-22735
    Event Type
    Injury
    Date Received
    October 16, 2024
    Report Date
    October 16, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: GARY, CYRIL S., KIRLOSKAR, KUNAL M., KOH, MIN JUNG ET AL. INTRAOPERATIVE EVALUATION OF TEXTURED ANATOMICAL IMPLANT ROTATION: A PROSPECTIVE STUDY. PRS JOURNAL. 13/SEP/2023; 490-499. 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/WILL BE REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: RUPTURE; CAPSULAR CONTRACTURE, BAKER GRADES III/IV.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE, "INTRAOPERATIVE EVALUATION OF TEXTURED ANATOMICAL IMPLANT ROTATION: A PROSPECTIVE STUDY" A TOTAL OF 51 PATIENTS (80 IMPLANTS) WERE INCLUDED, IN WHICH THE FOLLOWING EVENTS WERE REPORTED "RECALL OF ALLERGAN BIOCELL TEXTURED IMPLANTS", "AESTHETIC DISSATISFACTION", "TEXTURED IMPLANT EXCHANGE", "CAPSULAR CONTRACTURE" BAKER GRADES I-IV, "DOUBLE-CAPSULE FORMATION", "MALROTATION", "ALCL CONCERN", "ANIMATION DEFORMITY", AND "CONCERN FOR RUPTURE". DUE TO INSUFFICIENT INFORMATION IT IS NOT POSSIBLE TO DETERMINE WHICH PATIENTS WERE AFFECTED BY SPECIFIC ADVERSE EVENTS. IMPLANTS WERE "EITHER REMOVED EN BLOC WITH A TOTAL CAPSULECTOMY, OR THE IMPLANT WAS REMOVED AFTER A CAPSULOTOMY WAS MADE." FIFTEEN BREAST IMPLANTS WERE REPORTED AS HAVING HAD RADIOTHERAPY TREATMENT. THIS RELATES TO THE RIGHT SIDE RECORD. THIS RECORD IS FOR THE MCGHAN BIOCELL TEXTURED IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202179 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention