BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 25333451 · Received May 29, 2026

    Report

    Report Number
    9617229-2026-10027
    Event Type
    Death
    Date Received
    May 29, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 29, 2026
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: FRACOL ME, MIRANDA RN, TSAO AS, RODRIGUEZ MM, NASTOUPIL LJ, YOUNG PA, SHERROD AE, LEBLANC DM, HUNSICKER LM, BACCHI CE, GABRIEL T, MYCKATYN TM, TANAKA S, KUYKENDALL LV, RESETKOVA E, EVANS MG, JAGASIA P, MCCARTHY CM, SANTANELLI DI POMPEO F, HUNT KK, MEDEIROS LJ, HAYMAKER C, CLEMENS MW. BREAST IMPLANT-ASSOCIATED MALIGNANCIES: CURRENT RECOMMENDATIONS FOR WORKUP AND MANAGEMENT. PLAST RECONSTR SURG. 2026 MAY 1;157(5):774E-784E. DOI: 10.1097/PRS.0000000000012796. CLARIFICATION TO SECTION D: THE ONLY DEVICE INFORMATION PROVIDED WAS "TEXTURED IMPLANT" IN ALL CASES RELATED TO THE STUDY. IT IS NOT INDICATED WHETHER DEVICES ARE SALINE OR SILICONE AND THE MANUFACTURER OF THE DEVICES ARE UNKNOWN. CONTINUED E.1. FACILITY NAME: DEPARTMENT OF PLASTIC SURGERY, UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER. THE EVENT OF "LYMPHOMA-ALCL" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE 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: "BIA-ALCL". ADDITIONAL CONTRIBUTING AUTHORS & FACILITY NAMES: (CONTACT INFORMATION FOR THE PHYSICIANS BELOW WAS NOT PROVIDED) 1 MEGAN E FRACOL, ROBERTO N MIRANDA, ANNE S TSAO, MEGAN M RODRIGUEZ, LORETTA J NASTOUPIL, ERIKA RESETKOVA, KELLY K HUNT, L JEFFREY MEDEIROS, CARA HAYMAKER, MARK W CLEMENS , 2 PATRICIA A YOUNG, 3 ANDY E SHERROD, 4 DANIELLE M LEBLANC, 5 LISA M HUNSICKER, 6 CARLOS E BACCHI, THIAGO GABRIEL, 7 TERENCE M MYCKATYN, SHOICHIRO TANAKA, 8 LAUREN V KUYKENDALL, 9 MARK G EVANS, 10 PUJA JAGASIA, 11 COLLEEN M MCCARTHY, 12 FABIO SANTANELLI DI POMPEO. 1 UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER. 2 DEPARTMENT OF HEMATOLOGY AND ONCOLOGY, DAVID GEFFEN SCHOOL OF MEDICINE, UNIVERSITY OF CALIFORNIA, LOS ANGELES. 3 DEPARTMENT OF PATHOLOGY, KECK SCHOOL OF MEDICINE, UNIVERSITY OF SOUTHERN CALIFORNIA. 4 LEBLANC PLASTIC SURGERY. 5 REVALLA PLASTIC SURGERY AND MEDICAL AESTHETICS. 6 LAB BACCHI. 7 DIVISION OF PLASTIC AND RECONSTRUCTIVE SURGERY, WASHINGTON UNIVERSITY IN ST. LOUIS SCHOOL OF MEDICINE. 8 DEPARTMENT OF PLASTIC SURGERY, MORSANI COLLEGE OF MEDICINE, UNIVERSITY OF SOUTH FLORIDA. 9 CARIS LIFE SCIENCES. 10 DIVISION OF PLASTIC SURGERY, NORTHWESTERN MEMORIAL HOSPITAL. 11 DEPARTMENT OF PLASTIC AND RECONSTRUCTIVE SURGERY, MEMORIAL SLOAN KETTERING CANCER CENTER. 12 SCHOOL OF MEDICINE AND PSYCHOLOGY, SAPIENZA UNIVERSITY.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE "BREAST IMPLANT: ASSOCIATED MALIGNANCIES: CURRENT RECOMMENDATIONS FOR WORKUP AND MANAGEMENT¿, HEALTHCARE PROFESSIONAL REPORTED "BIA-ALCL", "SEROMA OR SWELLING", "INVOLVED LYMPH NODES (STAGE IIB OR IIB OR III)", "INVOLVED LYMPH NODES (STAGE IV)", "OCCASIONAL MASS", "PERI-IMPLANT FLUID COLLECTION", "FEVER", "CHILLS", "WEIGHT LOSS", "INFECTION" AND "DELAYED WOUND HEALING". THIS RECORD IS FOR AN UNKNOWN SIDE. THE DEVICE WAS EXPLANTED VIA EN-BLOC CAPSULECTOMY. TESTING OCCURRED TO CONFIRM PATHOLOGICAL MARKERS CD30+ AND ALK-, BUT SPECIFIC RESULTS WERE NOT PROVIDED. THIS RECORD INVOLVES 1 PATIENT DIAGNOSED WITH BIA-ALCL THAT DIED DUE TO THE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146023 UNK MAMMARY IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1