BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 12660777 · Received October 19, 2021

    Report

    Report Number
    9617229-2021-52794
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    August 19, 2021
    Report Date
    October 19, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: IMPLANT RISK FAILURE IN PATIENTS UNDERGOING POSTMASTECTOMY 3-WEEK HYPOFRACTIONATED RADIOTHERAPY AFTER IMMEDIATE RECONSTRUCTION. DAMARIS PATRICIA ROJAS, MARIA CRISTINA LEONARDI, SAMUELE FRASSONI, ANNA MORRA, MARIANNA ALESSANDRA GERARDI, ELIANA LA ROCCA, FEDERICA CATTANI, ROSA LURASCHI, CRISTIANA FODOR, MATTIA ZAFFARONI, MARIO RIETJENS, FRANCESCA DE LORENZI, PAOLO VERONESI, VIVIANA ENRICA GALIMBERTI, MATTIA INTRA, VINCENZO BAGNARDI, ROBERTO ORECCHIA, SAMANTHA DICUONZO, BARBARA ALICJA JERECZEK-FOSSA. RADIOTHERAPY AND ONCOLOGY 163 (2021) 105¿113. PUBLISHED ONLINE 19AUG2021. THE EVENTS CAPSULAR CONTRACTURE, EXTRUSION, AND INFECTION 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 REMOVAL: INFECTION, EXTRUSION, CAPSULAR CONTRACTURE.

    Description of Event or Problem · 1

    CITED ARTICLE: IMPLANT RISK FAILURE IN PATIENTS UNDERGOING POSTMASTECTOMY 3-WEEK HYPOFRACTIONATED RADIOTHERAPY AFTER IMMEDIATE RECONSTRUCTION. OVER THE STUDY PERIOD, 124 CONSECUTIVE PATIENTS RECEIVED HYPOFRACTIONATED PMRT AFTER IMPLANT-BASED IBR. AIM: TO EVALUATE RECONSTRUCTION FAILURE (RF) RATE IN PATIENTS RECEIVING IMPLANT-BASED IMMEDIATE BREAST RECONSTRUCTION (IBR) AND HYPOFRACTIONATED (HF) POSTMASTECTOMY RADIATION THERAPY (PMRT). 1 IMPLANT REMOVAL BECAUSE OF INFECTION AND 1 IMPLANT REMOVAL FOR EXTRUSION. AMONG THE IRRADIATED PATIENTS, DATA ON CAPSULAR CONTRACTURE WERE AVAILABLE FOR 93 SUBJECTS, OF WHOM 42/45 (93.3%) IN THE DTI-GROUP. BAKER IV CAPSULAR CONTRACTURE WAS OBSERVED IN 6 DTI PATIENTS. THIS IS FOR AN UNKNOWN SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555859 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CT, HT, TRASTUZUMAB, RADIOTHERAPY