BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK TISSUE EXPANDER

    MDR report key: 6020716 · Received October 12, 2016

    Report

    Report Number
    9617229-2016-00150
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    August 9, 2016
    Report Date
    October 12, 2016
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    LCJ
    PMA / PMN Number
    K862203
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: ¿DIRECT HOSPITAL COST OF OUTCOME PATHWAYS IN IMPLANT-BASED RECONSTRUCTION WITH ACELLULAR DERMAL MATRICES,¿ ALI A. QURESHI, MD, KRISTEN BRODERICK, MD, SUSAN FUNK, MBA, NANCY REAVEN, MBA, MARISSA M. TENENBAUM, MD, AND TERENCE M. MYCKATYN, MD, FACS, FRCSC, PRS GLOBAL OPEN, 2016 PP. 1-6. THE REPORTED EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE ALLEGATION OF CONTAMINATED IMPLANTS CANNOT BE INVESTIGATED BY ANALYSIS OF THE DEVICE AS THE DEVICE IS NOT AVAILABLE FOR RETURN TO ALLERGAN. FOLLOW UP WITH THE AUTHOR RETURNED THAT NO INFORMATION WAS AVAILABLE AND FURTHER FOLLOW UP IS NOT POSSIBLE. DEVICE LABELING: THE FOLLOWING IS A LIST OF POTENTIAL ADVERSE EVENTS THAT MAY OCCUR WITH BREAST IMPLANT SURGERY. THE RISKS INCLUDE: IMPLANT DEFLATION/LEAKAGE, ADDITIONAL SURGERY, CAPSULAR CONTRACTURE, INFECTION, TOXIC SHOCK SYNDROME, NECROSIS, HEMATOMA, SEROMA, EXTRUSION, BREAST PAIN, CHANGES IN NIPPLE SENSATION, CHANGES IN BREAST SENSATION, DISSATISFACTION WITH COSMETIC RESULTS (WRINKLING, FOLDING, DISPLACEMENT, ASYMMETRY, PALPABILITY, VISIBILITY, PTOSIS, SLOSHING), CALCIFIC DEPOSITS, IRRITATION/INFLAMMATION, DELAYED WOUND HEALING, HYPERTROPHIC SCARRING, BREAST TISSUE ATROPHY/CHEST WALL DEFORMITY, DIFFICULTY/INABILITY IN BREAST FEEDING, AND INABILITY TO ADEQUATELY VISUALIZE BREAST LESIONS WITH MAMMOGRAPHY. IN ADDITION TO THESE POTENTIAL ADVERSE EVENTS, THERE HAVE BEEN CONCERNS WITH CERTAIN SYSTEMIC DISEASES. FORMATION OF A FIBROUS TISSUE CAPSULE AROUND AN IMPLANTED DEVICE IS A NORMAL PHYSIOLOGICAL RESPONSE, ALTHOUGH NOT ALL CAPSULES CONTRACT. CONTRACTURE OF THE FIBROUS CAPSULAR TISSUE SURROUNDING THE BREAST TISSUE EXPANDER MAY CAUSE A RANGE OF SYMPTOMS INCLUDING FIRMNESS, DISCOMFORT, PAIN, DISTORTION, PALPABILITY, AND/OR DISPLACEMENT. CONTRACTURE MAY MAKE EXPANSION DIFFICULT AND PAINFUL.

    Description of Event or Problem · 1

    REPORTED EVENT OF "CAPSULAR CONTRACTURE REQUIRING SURGERY NOT CONCURRENT WITH THE EXPANDER EXCHANGE" FOR THE "ONE PATIENT IN THE +ADM" GROUP FOUND WITHIN THE JOURNAL ARTICLE, "DIRECT HOSPITAL COST OF OUTCOME PATHWAYS IN IMPLANT-BASED RECONSTRUCTION WITH ACELLULAR DERMAL MATRICES," IN PRS GLOBAL OPEN, 2016 PP. 1-6. THE PATIENT WAS IMPLANTED WITH ALLERGAN TISSUE EXPANDERS AND ACELLULAR DERMAL MATRIX (ADM) ALLODERM RTM. THE AUTHORS INDICATED THAT ALL PATIENTS WERE IMPLANTED WITH "TEXTURED ALLERGAN (ALLERGAN MEDICAL, (B)(4)) 133MV DEVICES." IT IS UNKNOWN IF TREATMENT WAS PROVIDED. THE AFFECTED SIDE WAS NOT PROVIDED. AS THE STUDY WAS NOTED TO SURVEY "TWO-STAGE EXPANDER RECONSTRUCTION", IT IS ASSUMED THAT THE DEVICES WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672274 UNK TISSUE EXPANDER EXPANDER, SKIN, INFLATABLE LCJ ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention ACELLULAR DERMAL MATRIX (ADM) ALLODERM RTM