BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 17538152 · Received August 13, 2023

    Report

    Report Number
    9617229-2023-13271
    Event Type
    Injury
    Date Received
    August 13, 2023
    Date of Event
    July 15, 2023
    Report Date
    August 13, 2023
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E1 (EMAIL ADDRESS): (B)(6). CONTINUED H.6 HEALTH EFFECT CLINICAL CODE: E0307 SEROMA, CONTINUED H.6 HEALTH EFFECT IMPACT CODE: F2201 BIOPSY; F2203 IMAGING REQUIRED. ARTICLE CITATION: RACHEL L. O'CONNELL, BHUPINDER SHARMA, LIZA VAN KERCKHOVEN, AIA S. MEHDI, CHRIS MARSHALL, ANDREW WOTHERSPOON, SUNIL IYENGAR, DIMA EL-SHARKAWI, AYOMA D. ATTYGALLE, AMANDA JURGENSEN-RAUCH, DAVID CUNNINGHAM, FIONA MACNEILL, AADIL A. KHAN, MARIOS-KONSTANTINOS TASOULIS. COST AND CLINICAL BENEFIT OF IMAGING SURVEILLANCE AFTER TREATMENT FOR BREAST IMPLANT-ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA-ALCL), EUROPEAN JOURNAL OF SURGICAL ONCOLOGY, HTTPS://DOI.ORG/10.1016/J.EJSO.2021.12.463. 23DEC2021. ADDITIONAL PHYSICIANS: RACHEL L. O'CONNELL, MBBS, BSC, MD(RES), FRCS; BREAST SURGERY UNIT, THE ROYAL MARSDEN NHS FOUNDATION TRUST, LONDON UK. THE INSTITUTE OF CANCER RESEARCH, LONDON, UK. BHUPINDER SHARMA, BSC, BM, FRCR, PHD; THE INSTITUTE OF CANCER RESEARCH, LONDON, UK. DEPARTMENT OF RADIOLOGY, THE ROYAL MARSDEN NHS FOUNDATION TRUST, LONDON, UK. DIMA EL-SHARKAWI, MBBS, PHD; HEAMATO-ONCOLOGY UNIT, THE ROYAL MARSDEN NHS FOUNDATION TRUST, LONDON, UK. ANDREW WOTHERSPOON, MBBCH, FRCPATH; HEAMATO-ONCOLOGY UNIT, THE ROYAL MARSDEN NHS FOUNDATION TRUST, LONDON, UK. HISTOPATHOLOGY UNIT, THE ROYAL MARSDEN NHS FOUNDATION TRUST, LONDON, UK AYOMAD. ATTYGALLE, MBBS, FRCPATH, PHD; HEAMATO-ONCOLOGY UNIT, THE ROYAL MARSDEN NHS FOUNDATION TRUST, LONDON, UK. HISTOPATHOLOGY UNIT, THE ROYAL MARSDEN NHS FOUNDATION TRUST, LONDON, UK FIONA MACNEILL, MBBS, MD, FRCS; BREAST SURGERY UNIT, THE ROYAL MARSDEN NHS FOUNDATION TRUST, LONDON UK. AADIL A. KHAN MPH, PHD, FRCS (PLAST); THE INSTITUTE OF CANCER RESEARCH, LONDON, UK. PLASTIC SURGERY UNIT, THE ROYAL MARSDEN NHS FOUNDATION TRUST, LONDON, UK. THE EVENTS OF SEROMA, LYMPHADENOPATHY, INFECTION (UNKNOWN ONSET), AND LYMPHOMA-ALCL-SUSPECTED 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 REOPERATION: SEROMA, LYMPHADENOPATHY, INFECTION (UNKNOWN ONSET), AND LYMPHOMA-ALCL-SUSPECTED (HISTOPATHOLOGICAL MARKERS NOT PROVIDED).

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE ¿ONCOLOGICAL OUTCOMES AFTER MULTIDISCIPLINARY MANAGEMENT OF BREAST IMPLANT ASSOCIATED ANAPLASTIC LARGE CELL LYMPHOMA (BIA ALCL)", PHYSICIAN REPORTED "BETWEEN 2015 AND 2022, 18 BIA-ALCL PATIENTS WERE TREATED AT OUR INSTITUTION. TEN PATIENTS DEVELOPED BIA-ALCL AFTER COSMETIC BREAST AUGMENTATION, AND 8 AFTER BREAST RECONSTRUCTION FOLLOWING MASTECTOMY FOR CANCER. ALL PATIENTS HAD A HISTORY OF TEXTURED IMPLANT INSERTION. JOURNAL AUTHOR NOTATED THE SECOND WAS FOLLOWING IMPLANT REMOVAL WITH PARTIAL CAPSULECTOMY FOR PRESUMED IMPLANT INFECTION, WITH NEGATIVE PRE-OPERATIVE WORK-UP, INCLUDING CYTOLOGY OF SEROMA, FOR BIA-ALCL. THE PATIENT THEN UNDERWENT COMPLETION TOTAL CAPSULECTOMY AND CHEST WALL RESURFACING WITH LATISSIMUS DORSI FLAP DUE TO POOR SKIN QUALITY BECAUSE OF INDURATION AND INFLAMMATION, ALTHOUGH THE SKIN WAS NOT INVOLVED WITH THE LYMPHOMA. IN THIS PATIENT, PRE-OPERATIVE STAGING WITH A 2-DEOXY-2-[18F] FLUORO-D-GLUCOSE (FDG) POSITRON EMISSION TOMOGRAPHY/ COMPUTED TOMOGRAPHY (PET/CT) SCAN SHOWED AVID IPSILATERAL AXILLARY LYMPH NODES AND THEREFORE A TARGETED EXCISION BIOPSY OF THE RADIOLOGICALLY ABNORMAL NODES WAS UNDERTAKEN, DEMONSTRATING INVOLVEMENT WITH DISEASE UNKNOWN SIDE. HISTOPATHOLOGICAL MARKERS CONFIRMING BIA-ALCL HAVE NOT BEEN PROVIDED. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215048 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening