BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMORY GEL SILTEX ROUND MODERATE PLUS PROFILE MAMMARY PROSTHESIS

    MDR report key: 5834667 · Received July 29, 2016

    Report

    Report Number
    1645337-2016-00113
    Event Type
    Injury
    Date Received
    July 29, 2016
    Date of Event
    July 27, 2015
    Report Date
    August 17, 2016
    Manufacturer
    MENTOR WW LLC
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT WAS LATER DETERMINED NOT TO BE REPORTABLE TO THE FDA.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT WAS DIAGNOSED WITH ANAPLASTIC LARGE CELL LYMPHOMA (ALCL). THE LEFT PROSTHESIS ASSOCIATED WITH THIS COMPLAINT WILL NOT BE RETURNED TO MENTOR. SHOULD ADDITIONAL INFORMATION AND/OR THE DEVICE BECOME AVAILABLE TO PE, THIS COMPLAINT WILL BE REEVALUATED AT THAT TIME. BASED ON INFORMATION REPORTED TO FDA AND FOUND IN MEDICAL LITERATURE, A POSSIBLE ASSOCIATION HAS BEEN IDENTIFIED BETWEEN BREAST IMPLANTS AND THE RARE DEVELOPMENT OF ANAPLASTIC LARGE CELL LYMPHOMA (ALCL), A TYPE OF NON-HODGKIN'S LYMPHOMA. WOMEN WITH BREAST IMPLANTS MAY HAVE A VERY SMALL BUT INCREASED RISK OF DEVELOPING ALCL IN THE FLUID OR SCAR CAPSULE ADJACENT TO THE IMPLANT. ACCORDING TO THE FDA, THE INCIDENCE OF ALCL IN PATIENTS WITH BREAST IMPLANTS IS "A VERY SMALL FRACTION OF THE 5-10 MILLION WOMEN WHO HAVE RECEIVED BREAST IMPLANTS WORLDWIDE." AN INVESTIGATION OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES. A REVIEW OF THE NC SYSTEM AND COMPLAINT DATABASE REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH LOT 6438477. THE MAIN SYMPTOMS OF ALCL IN WOMEN WITH BREAST IMPLANTS ARE LATE ONSET, PERSISTENT SWELLING AND PAIN IN THE VICINITY OF THE IMPLANT AND PERI-IMPLANT SEROMA. IN SOME CASES, PATIENTS PRESENTED WITH CAPSULAR CONTRACTURE OR MASSES ADJACENT TO THE BREAST IMPLANT. BECAUSE OF THE SMALL NUMBER OF CASES WORLDWIDE, THERE IS NO DEFINED CONSENSUS TREATMENT REGIMEN FOR PERI-IMPLANT ALCL. MENTOR CONCURS WITH FDA'S POSITION THAT, "BECAUSE THE RISK OF ALCL APPEARS VERY SMALL, FDA BELIEVES THAT THE TOTALITY OF EVIDENCE CONTINUES TO SUPPORT A REASONABLE ASSURANCE THAT FDA-APPROVED BREAST IMPLANTS ARE SAFE AND EFFECTIVE WHEN USED AS LABELED." ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486764 MEMORY GEL SILTEX ROUND MODERATE PLUS PROFILE MAMMARY PROSTHESIS BREAST IMPLANT FTR MENTOR WW LLC 6438477

    Patients

    Seq Age Sex Outcome Treatment
    1 Other