BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SOFT-TOUCH GEL

    MDR report key: 23256764 · Received October 9, 2025

    Report

    Report Number
    9617229-2025-17255
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    January 1, 2025
    Report Date
    October 9, 2025
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E.1 ADDRESS 1: (B)(6). ARTICLE CITATION: BAK EEF, GUDJONSDOTTIR LR, WELTZ TK, JØRGENSEN MG, BAK AN, FALK MW, NORLIN CB, TRAN JVQ, ORHOLT M, HEMMINGSEN MN, HÖLMICH LR, ELBERG JJ, MIELKE LV, TRILLINGSGAARD J, VESTER-GLOWINSKI PV, LARSEN A, HERLY M. BREAST IMPLANT RUPTURE IS STRONGLY ASSOCIATED WITH CAPSULAR CONTRACTURE: AN INTRAPATIENT STUDY. PLAST RECONSTR SURG. 2025 SEP 16. DOI: 10.1097/PRS.0000000000012443. EPUB AHEAD OF PRINT. PMID: 40957074. ADDITIONAL AUTHOR CONTACTS: ERIK E. F. BAK, BMSC LINDA R. GUDJONSDOTTIR, BMSC TIM K. WELTZ, MD MADS G. JØRGENSEN, MD, PHD ANNA N. BAK, BMSC MARIA W. FALK, BMSC CAROLINE B. NORLIN, BMSC JOHN V. Q. TRAN, BSC MATHIAS ØRHOLT, MD MATHILDE N. HEMMINGSEN, MD, PHD PETER V. VESTER-GLOWINSKI, MD, PHD ANDREAS LARSEN, MD, PHD COPENHAGEN UNIVERSITY HOSPITAL, DEPARTMENT OF PLASTIC SURGERY AND BURNS TREATMENT, RIGSHOSPITALET, COPENHAGEN, DENMARK. LISBET R. HÖLMICH, MD, DMSC. COPENHAGEN UNIVERSITY HOSPITAL, DEPARTMENT OF PLASTIC AND RECONSTRUCTIVE SURGERY, HERLEV AND GENTOFTE, COPENHAGEN, DENMARK UNIVERSITY OF COPENHAGEN, DEPARTMENT OF CLINICAL MEDICINE, COPENHAGEN, DENMARK. JENS J. ELBERG, MD AMALIEKLINIKKEN, COPENHAGEN, DENMARK. LOUISE V. MIELKE, MD ALERIS, COPENHAGEN, DENMARK. JESPER TRILLINGSGAARD, MD AK NYGART, COPENHAGEN, DENMARK. CORRESPONDENCE AUTHOR, ADDITIONAL CONTACT: MIKKEL HERLY, MD, PHD UNIVERSITY OF COPENHAGEN, DEPARTMENT OF IMMUNOLOGY AND MICROBIOLOGY, COPENHAGEN, DENMARK. 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 REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REOPERATION: RUPTURE, CAPSULAR CONTRACTURE BAKER GRADE UNKNOWN.

    Description of Event or Problem · 0

    LITERATURE ARTICLE TITLED "BREAST IMPLANT RUPTURE IS STRONGLY ASSOCIATED WITH CAPSULAR CONTRACTURE: AN INTRA-PATIENT STUDY" REPORTED THE EVENT OF IMPLANT RUPTURE, CAPSULAR CONTRACTURE, BAKER GRADE UNKNOWN, COSMETIC REASON AND BREAST IMPLANT ILLNESS IN A STUDY CONDUCTED IN 105 PATIENTS. THIS RECORD IS FOR UNKNOWN SIDE. DEVICE STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2512929 UNK SOFT-TOUCH GEL PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention