BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT

    MDR report key: 8278436 · Received January 25, 2019

    Report

    Report Number
    9617229-2019-00444
    Event Type
    Injury
    Date Received
    January 25, 2019
    Date of Event
    November 26, 2018
    Report Date
    January 25, 2019
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P040046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: E. RIGGIO, E. TOFFOLI AND C. TARTAGLIONE ET AL., LOCAL SAFETY OF IMMEDIATE RECONSTRUCTION DURING PRIMARY TREATMENT OF BREAST CANCER. DIRECT-TO-IMPLANT VERSUS EXPANDER-BASED SURGERY, JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY, HTTPS://DOI.ORG/10.1016/J.BJPS.2018.10.016. THE EVENTS OF CAPSULAR CONTRACTURE, NECROSIS, AND FISTULA 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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    THROUGH JOURNAL ARTICLE "LOCAL SAFETY OF IMMEDIATE RECONSTRUCTION DURING PRIMARY TREATMENT OF BREAST CANCER. DIRECT-TO-IMPLANT VERSUS EXPANDER-BASED SURGERY" FROM 'JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY PP. 1-11' THE FOLLOWING COMPLICATIONS, WHICH DID NOT NECESSITATE REVISION SURGERY, WERE REPORTED: POOR AESTHETIC RESULT, IMPLANT DISPLACEMENT, SKIN INFLAMMATION, SEROMA, RIPPLING ON THE MEDIAL QUADRANTS DUE TO TISSUE THINNING, BREAST PAIN, ALTERATION OF SCAPULAR AND HUMERAL MOVEMENT AND SKIN NECROSIS WITH FISTULA FORMATION. AND THE FOLLOWING COMPLICATIONS, WHICH DID NECESSITATE REVISION SURGERY, WERE REPORTED: POOR AESTHETIC RESULT, IMPLANT ROTATION WITH HYPERCORRECTION OF THE UPPER QUADRANTS, BAKER 2/3, AND IMPLANT MICRO-LEAKAGE DETECTED BY MRI. NO FURTHER TREATMENT INFORMATION OR AFFECTED SIDE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71380 STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention