BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 24945171 · Received April 21, 2026

    Report

    Report Number
    9617229-2026-07279
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E.1 POSTAL CODE: (B)(6). ARTICLE CITATION: KERSCHBAUMER C, BERGMEISTER KD, BARTELLAS G, WEBER M, STRÖBELE B, KITZWÖGERER M, SCHRÖGENDORFER KF, FLORES T. MICROBIAL CONTAMINATION¿MEDIATED INFLAMMATION IS A MAJOR CONTRIBUTOR OF BREAST IMPLANT COMPLICATIONS: PROSPECTIVE ANALYSIS OF 631 SAMPLES. JOURNAL OF CLINICAL MEDICINE. 2026; 15(6):2115. HTTPS://DOI.ORG/10.3390/JCM15062115. THE EVENTS OF MALPOSITION, CAPSULAR CONTRACTURE, BACTERIAL INFECTION, IMPAIRED HEALING 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. THE REASON FOR REOPERATION: RUPTURE, CAPSULAR CONTRACTURE, MALPOSITION, BACTERIAL INFECTION, IMPAIRED HEALING. ADDITIONAL CONTRIBUTING AUTHORS: CELINA KERSCHBAUMER 1, 2, KONSTANTIN D. BERGMEISTER 1, 2, 3, GIOVANNI BARTELLAS 1, 2, MICHAEL WEBER 1, BARBARA STRÖBELE 1, 4, MELITTA KITZWÖGERER 1, 5, KLAUS F. SCHRÖGENDORFER 1, 2, TONATIUH FLORES 1, 2, 1 KARL LANDSTEINER UNIVERSITY, DR. KARL-DORREK-STRASSE 30, 3500 KREMS, AUSTRIA; [email protected] (M.W.); [email protected] (B.S.); [email protected] (T.F.) 2 DEPARTMENT OF PLASTIC, AESTHETIC AND RECONSTRUCTIVE SURGERY, UNIVERSITY HOSPITAL ST. POELTEN¿NOE LGA, KARL LANDSTEINER UNIVERSITY, DUNANT-PLATZ 1, 3100 ST. POELTEN, AUSTRIA 3 CLINICAL LABORATORY FOR BIONIC EXTREMITY RECONSTRUCTION, DEPARTMENT OF PLASTIC, RECONSTRUCTIVE AND AESTHETIC SURGERY, MEDICAL UNIVERSITY OF VIENNA, 1090 VIENNA, AUSTRIA 4 INSTITUTE OF HYGIENE AND MICROBIOLOGY, UNIVERSITY HOSPITAL ST. POELTEN¿NOE LGA, KARL LANDSTEINER UNIVERSITY, DUNANT-PLATZ 1, 3100 ST. POELTEN, AUSTRIA 5 INSTITUTE OF CLINICAL PATHOLOGY AND MOLECULAR PATHOLOGY OF THE LOWER AUSTRIA CENTRAL REGION, UNIVERSITY HOSPITALS ST. POELTEN AND KREMS¿NOE LGA, KARL LANDSTEINER UNIVERSITY, 3100 ST. POELTEN, AUSTRIA.

    Description of Event or Problem · 0

    LITERATURE REVIEW TITLED "MICROBIAL CONTAMINATION¿MEDIATED INFLAMMATION IS A MAJOR CONTRIBUTOR OF BREAST IMPLANT COMPLICATIONS: PROSPECTIVE ANALYSIS OF 631 SAMPLES" REPORTED "RUPTURE", "CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN, PAIN", "DISLOCATION", "PERFORATION", "MECHANICAL PROBLEMS WITH EXPANDER IMPLANTS", "WOUND HEALING DISORDER", "DEFORMITY", "PERI-IMPLANT FLUID ACCUMULATION", "BACTERIAL CONTAMINATION, PERI-IMPLANT INFLAMMATION, BACTERIAL GROWTH, PRESENCE OF PERI-IMPLANT INFLAMMATION (LYMPHOCYTES, GRANULOCYTES OR MACROPHAGES IN HISTOLOGICAL SAMPLES) WAS PROVEN". THIS ARTICLE INVOLVED 97 PATIENTS. THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235423 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention