BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMOOTH SALINE-FILLED MAMMARY PROSTHESIS

    MDR report key: 5998011 · Received October 4, 2016

    Report

    Report Number
    1645337-2016-00133
    Event Type
    Injury
    Date Received
    October 4, 2016
    Date of Event
    September 1, 2014
    Report Date
    November 28, 2016
    Manufacturer
    MENTOR WW LLC
    Product Code
    FWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT EXPERIENCED AUTOIMMUNE SYMPTOMS "THE PATIENT EXPERIENCED DIFFICULTY FOCUSING "BRAIN FOG" AND WANTED IMPLANTS REMOVED. NO SUPPORTING DOCUMENTATION WAS PROVIDED BY A HEALTH AUTHORITY OFFICIAL. PRODUCT EVALUATION RECEIVED TWO UNLABELED DEVICES. DEVICE "A" WAS RETURNED EMPTY OF FLUID. UPON RECEIPT BY MENTOR, THE CONTRALATERAL DEVICE WEIGHED 29.3 GRAMS. BASED ON THE LABORATORY EVALUATIONS, THE DEVICES APPEARED INTACT WITH NO ANOMALIES. DUE TO THE NATURE OF THE COMPLAINTS, PE WAS PRECLUDED FROM FURTHER EVALUATING THE DEVICE. CONCERN OVER THE ASSOCIATION OF BREAST IMPLANTS TO THE DEVELOPMENT OF AUTOIMMUNE OR CONNECTIVE TISSUE DISEASES, SUCH AS LUPUS, SCLERODERMA, OR RHEUMATOID ARTHRITIS, WAS RAISED BECAUSE OF CASES REPORTED IN LITERATURE WITH SMALL NUMBERS OF WOMEN WITH IMPLANTS. SCIENTIFIC EXPERT PANELS AND LITERATURE REPORTS HAVE FOUND NO EVIDENCE OF A CONSISTENT PATTERN OF SIGNS AND SYMPTOMS ASSOCIATED WITH THESE DISEASES IN WOMEN WITH BREAST IMPLANTS. ADDITIONALLY, HAVING RHEUMATOLOGICAL SIGNS AND SYMPTOMS DOES NOT NECESSARILY MEAN A PATIENT HAS A CONNECTIVE TISSUE DISORDER OR AUTOIMMUNE DISEASE. PER THE FDA'S "UPDATE ON THE SAFETY OF SILICONE GEL-FILLED BREAST IMPLANTS" PUBLISHED IN JUNE 2011, "THERE IS NO APPARENT ASSOCIATION BETWEEN SILICONE GEL-FILLED BREAST IMPLANTS AND CONNECTIVE TISSUE DISEASE, BREAST CANCER, OR REPRODUCTIVE PROBLEMS." FURTHERMORE, (B)(6) RELEASED A FINAL REPORT STATING "A REVIEW OF SEVENTEEN EPIDEMIOLOGICAL REPORTS OF CONNECTIVE TISSUE DISEASE IN WOMEN WITH BREAST IMPLANTS WAS REMARKABLE FOR ITS CONSISTENCY IN FINDING NO ELEVATED RISKS OR ODDS RATIO FOR AN ASSOCIATION OF IMPLANTS WITH DISEASE[?]THERE IS NO EVIDENCE THAT SILICONE IMPLANTS ARE RESPONSIBLE FOR ANY MAJOR DISEASES OF THE WHOLE BODY. WOMEN ARE EXPOSED TO SILICONE CONSTANTLY IN THEIR DAILY LIVES. THERE IS NO PLAUSIBLE EVIDENCE OF A NOVEL AUTOIMMUNE.

    Description of Event or Problem · 1

    AUTOIMMUNE SYMPTOMS: DIFFICULTY FOCUSING "BRAIN FOG".

    Description of Event or Problem · 1

    AUTO IMMUNE SYMPTOMS. BRAIN FOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648580 SMOOTH SALINE-FILLED MAMMARY PROSTHESIS BREAST IMPLANT FWM MENTOR WW LLC 350-3420

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other