BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK MAMMARY IMPLANT

    MDR report key: 2935848 · Received January 22, 2013

    Report

    Report Number
    2024601-2013-00001
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    September 25, 2012
    Report Date
    December 28, 2012
    Manufacturer
    ALLERGAN
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SUBMITTED ON: (B)(4) 2013. DEVICE LABELING ADDRESSES THE REPORTED EVENTS AS FOLLOWS: THE (B)(4) STUDY: 7 YEAR ADVERSE EVENT RATES - FOR PRIMARY AUGMENTATION PTS, HEMATOMA RATE = (B)(4). PRIMARY RECONSTRUCTION PTS = (B)(4). (OTHER COMPLICATIONS) PRIMARY AUGMENTATION PTS, CAPSULAR CONTRACTURE RATE = (B)(4). PRIMARY RECONSTRUCTION RATES = (B)(4). THERE WERE NO REPORTED EVENTS OF LYMPHOMA/ALCL, FOR PTS IN THE (B)(4) STUDY, IN THE LABELING FOR SILICONE IMPLANTS. "AFTER BREAST IMPLANT SURGERY THE FOLLOWING MAY OCCUR AND/OR PERSIST, WITH VARYING INTENSITY AND/OR FOR A VARYING LENGTH OF TIME: HEMATOMA/SEROMA..." (ALLERGAN SILICONE LABELING). "PTS SHOULD BE ADVISED THAT CAPSULAR CONTRACTURE MAY BE MORE COMMON FOLLOWING INFECTION, HEMATOMA AND SEROMA, AND THE CHANCE OF IT HAPPENING MAY INCREASE OVER TIME." (ALLERGAN SILICONE LABELING).

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTS A CASE OF LYMPHOMA VIA INVOLUNTARY MW ((B)(4)). PT HAD PRIOR BILATERAL IMPLANTS, MCGHAN 390 ML IMPLANTS CURRENTLY KNOWN AS ALLERGAN INAMED. SHE WAS EXPERIENCING BILATERAL CAPSULAR CONTRACTURE AND ENLARGING RIGHT BREAST. SURGEON SUSPECTED SEVERE RIGHT BREAST IMPLANT RUPTURE WITH RADIOLOGICAL STUDIES. SHE ELECTED TO REMOVE BOTH IMPLANTS. NO REPLACEMENTS IMPLANTS WERE DONE. THE PATHOLOGY REPORT AND SURGICAL FINDINGS INCLUDED; RIGHT BREAST FOUND RESOLVING HEMATOMA WHICH WAS EXTRUDED, THE IMPLANT APPEARED INTACT. THE PATHOLOGY OF THE RIGHT BREAST IMPLANT CAPSULE REVEALED ALCL. THE PT IS CURRENTLY RECEIVING TREATMENT FOR LYMPHOMA. PATH REPORT ON (B)(6) 2012, LEFT BREAST IMPLANT CAPSULE; EXCISION; BENIGN; FIBROUS, PSEUDOCAPSULE AND BENIGN BREAST PARENCHYMA, CONSISTENT WITH BREAST IMPLANT CAPSULE. RIGHT BREAST IMPLANT CAPSULE, EXCISION; ALCL. DURING THE INVESTIGATION, THE SURGEON WAS ABLE TO BE LOCATED TO GATHER TO TRY AND GATHER MORE INFO REGARDING THE CASE. TO DATE, ALLERGAN HAS NOT BEEN ABLE TO GATHER ANY ADD'L INFO REGARDING THIS CASE. HOWEVER, IF MORE INFO BECOMES AVAILABLE, THIS REPORT WILL BE REVIEWED AND UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31495 UNK MAMMARY IMPLANT FWM ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention NO INFO