BEUDAMED
    FDA Adverse Event Injury Summary report: N

    120-260

    MDR report key: 787903 · Received November 7, 2006

    Report

    Report Number
    2024601-2006-00629
    Event Type
    Injury
    Date Received
    November 7, 2006
    Manufacturer
    INAMED CORPORATION SANTA BARBARA
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OF RUPTURE WAS PREVIOUSLY REPORTED ON EASR. DEVICE LABELING ADDRESSES THE POSSIBLE EVENT OF RUPTURE AS FOLLOWS: "IMPLANT DEFLATION/RUPTURE CAN OCCUR IMMEDIATELY OR PROGRESSIVELY OVER A PERIOD OF DAYS AND IS NOTICED BY LOSS OF SIZE OR SHAPE OF THE IMPLANT. SOME IMPLANTS DEFLATE IN THE FIRST FEW MONTHS AFTER BEING IMPLANTED AND SOME DEFLATE AFTER SEVERAL YEARS. CAUSES OF DEFLATION/RUPTURE INCLUDE DAMAGE BY SURGICAL INSTRUMENTS DURING SURGERY, OVERFILLING OR UNDERFILLING OF THE IMPLANT WITH SALINE SOLUTION, CAPSULAR CONTRACTURE, CLOSED CAPSULOTOMY, STRESSES SUCH AS TRAUMA OR INTENSE PHYSICAL MANIPULATION, EXCESSIVE COMPRESSION DURING MAMMOGRAPHIC IMAGING, UMBILICAL INCISION PLACEMENT, AND UNK/UNEXPLAINED REASONS. YOU SHOULD BE AWARE THAT BREAST IMPLANTS MAY WEAR OUT OVER TIME AND DEFLATE/RUPTURE. DEFLATED IMPLANTS NECESSITATE ADD'L SURGERY TO REMOVE AND POSSIBLY REPLACE THE IMPLANT." DEVICE LABELING ADDRESSES THE POSSIBLE EVENT OF CAPSULAR CONTRACTURE AS FOLLOWS: "CAPSULAR CONTRACTURE MAY BE MORE COMMON FOLLOWING INFECTION, HEMATOMA, AND SEROMA. IT IS ALSO MORE COMMON WITH SUBGLANDULAR PLACEMENT. SYMPTOMS RANGE FROM FIRMNESS AND MILD DISCOMFORT, TO PAIN, DISTORTION, PALPABILITY OF THE IMPLANT, AND/OR DISPLACEMENT OF THE IMPLANT. ADD'L SURGERY IS NEEDED IN CASES WHERE PAIN AND/OR FIRMNESS IS SEVERE. THIS SURGERY RANGES FROM REMOVAL OF THE IMPLANT CAPUSLE TISSUE TO REMOVAL AND POSSIBLE REPLACEMENT OF THE IMPLANT ITSELF. CAPUSLAR CONTRACTURE MAY HAPPEN AGAIN AFTER THESE ADD'L SURGERIES.

    Description of Event or Problem · 1

    RIGHT SIDE RUPTURE AND CAPSULAR CONTRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 120-260 GEL BREAST IMPLANT FTR INAMED CORPORATION SANTA BARBARA STYLE 120 P02-137735

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention