BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK GEL BREAST IMPLANT

    MDR report key: 16765972 · Received April 18, 2023

    Report

    Report Number
    9617229-2023-06761
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    January 1, 2020
    Report Date
    January 12, 2024
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FTR
    PMA / PMN Number
    P020056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED H.6: F2201. THE EVENT OF "LYMPHADENOPATHY" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. REASON FOR REOPERATION: LYMPHADENOPATHY.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE "FORGETFULNESS, CONCENTRATION PROBLEMS, DYSLEXIA, NOT BEING ABLE TO THINK CLEARLY, BEING CONSTANTLY ABSENT-MINDED, REQUENT HEADACHES, SEVERE NECK PAIN, FEELING FOGGY IN THE HEAD, BITTER METALLIC TASTE IN MOUTH, CONSTANTLY STUFFY OR RUNNY NOSE (REGARDLESS OF WEATHER OR SEASON) SICK, TIRED HEAVY BURNING EYES AND TENDERNESS OF THE EYELIDS, DIZZINESS WITH PARTIAL FLICKERING OR FLASHING IN FRONT OF THE EYES, FEELING OF PRESSURE IN THE HEAD, FLUSH IN THE FACE (SUDDENLY RED GLOWING FACE), DIGESTIVE PROBLEMS (STRONG ABDOMEN, NAUSEA, SOMETIMES DISGUST AT FOOD, GENERAL FEELING OF NAUSEA INSIDE), ASSIVE INSOMNIA, NIGHT SWEATS, IN THE MORNING AFTER GETTING UP I FEEL MORE SICK THAN HEALTHY, NO QUALITY OF LIFE ANYMORE GENERAL FEELING OF SICKNESS ALL THE TIME, DAILY TEMPERATURE FLUCTUATIONS IN THE FORM OF AN ELEVATED TEMPERATURE AND EVEN FEVER REGARDLESS OF REST OR EXERTION, PHYSICALLY AND MENTALLY ABSOLUTELY NO LONGER ABLE TO PERFORM AND WORK UNDER PRESSURE, ITCHING IN VARIOUS PARTS OF THE BODY, JOINT PAIN (ANKLE, KNEE, HIP, ELBOW, MAINLY ON THE LEFT SIDE), RECURRENT HERPES ON THE LIP SPREADING TO THE NOSE (APPROX. EVERY 2-3 MONTHS). THESE EVENTS ARE NOT DEVICE RELATED. PATIENT ALSO REPORTED EVERY NOW AND THEN ENLARGED LYMPH NODES IN ARMPIT, GROIN, NECK. PATIENT ADDITIONALLY REPORTED "ELEVATED CORTISOL LEVEL (OCTOBER 2022 - 337) CONTROL FEBRUARY 2023 - 225, CONSTANT FEELING AS IF THE BODY IS CONSTANTLY WORKING, 2022 IRON DEFICIENCY, INCREASED HAIR LOSS, SINCE 2020 MASSIVE CYCLE DISTURBANCES, INCREASED FACIAL HAIR GROWTH, MASSIVE ANXIETY ABOUT THE WHOLE SITUATION, SUDDEN RED RASH ON THE NECK". THESE EVENTS ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE "ENLARGED LYMPH NODES IN ARMPIT, GROIN, NECK", ¿RECURRENT HERPES ON THE LIP SPREADING TO THE NOSE (APPROX. EVERY 2-3 MONTHS)¿, ¿FORGETFULNESS¿, ¿CONCENTRATION PROBLEMS¿, ¿NOT BEING ABLE TO THINK CLEARLY¿, ¿BEING CONSTANTLY ABSENT-MINDED¿, ¿FEELING FOGGY IN THE HEAD¿, ¿BITTER ¿CONSTANTLY STUFFY OR RUNNY NOSE (REGARDLESS OF WEATHER OR SEASON)¿, ¿TIRED¿, FLUSH IN THE FACE (SUDDENLY RED GLOWING FACE)¿, ¿NIGHT SWEATS¿, ¿NO QUALITY OF LIFE ANYMORE¿, ¿PHYSICALLY AND MENTALLY ABSOLUTELY NO LONGER ABLE TO PERFORM AND WORK UNDER PRESSURE¿, ¿ELEVATED CORTISOL LEVEL¿, ¿CONSTANT FEELING AS IF THE BODY IS CONSTANTLY WORKING¿, ¿INCREASED HAIR LOSS¿, ¿MASSIVE CYCLE DISTURBANCES¿, ¿INCREASED FACIAL HAIR GROWTH¿, ¿DYSLEXIA¿, ¿BITTER METALLIC TASTE IN MOUTH¿, ¿SEVERE NECK PAIN¿, ¿TENDERNESS OF THE EYELIDS¿, ¿FEELING OF PRESSURE IN THE HEAD¿, ¿¿JOINT PAIN (ANKLE, KNEE, HIP, ELBOW, MAINLY ON THE LEFT SIDE)¿, ¿¿HEAVY BURNING EYES¿, ¿DIZZINESS WITH PARTIAL FLICKERING OR FLASHING IN FRONT OF THE EYES¿, ¿DIGESTIVE PROBLEMS (STRONG ABDOMEN, NAUSEA, SOMETIMES DISGUST AT FOOD, GENERAL FEELING OF NAUSEA INSIDE)¿, ¿MASSIVE INSOMNIA¿, ¿IRON DEFICIENCY¿, ''ITCHING IN VARIOUS PARTS OF THE BODY¿ AND ¿ SUDDEN RED RASH ON THE NECK¿. LATER PATIENT REPRESENTATIVE REPORTED "PATIENT SUFFERS FROM PAIN AND TENDERNESS IN BOTH BREASTS AND SUFFERED A RUPTURE, AS WELL AS CAPSULAR FIBROSIS (BAKER SEVERITY LEVEL 2) OR CAPSULAR CONTRACTURE. THERE WAS ALSO SILICONE LEAKAGE AND AN ENLARGEMENT OF THE LYMPH NODES. PATIENT HAS BEEN SUFFERING FROM SEVERE DEPRESSION AND ANXIETY." DEVICE HAS BEEN EXPLANTED.

    Description of Event or Problem · 0

    PATIENT REPORTED LEFT SIDE "FORGETFULNESS, CONCENTRATION PROBLEMS, DYSLEXIA, NOT BEING ABLE TO THINK CLEARLY, BEING CONSTANTLY ABSENT-MINDED, FREQUENT HEADACHES, SEVERE NECK PAIN, FEELING FOGGY IN THE HEAD, BITTER METALLIC TASTE IN MOUTH, CONSTANTLY STUFFY OR RUNNY NOSE (REGARDLESS OF WEATHER OR SEASON) SICK, TIRED HEAVY BURNING EYES AND TENDERNESS OF THE EYELIDS, DIZZINESS WITH PARTIAL FLICKERING OR FLASHING IN FRONT OF THE EYES, FEELING OF PRESSURE IN THE HEAD, FLUSH IN THE FACE (SUDDENLY RED GLOWING FACE), DIGESTIVE PROBLEMS (STRONG ABDOMEN, NAUSEA, SOMETIMES DISGUST AT FOOD, GENERAL FEELING OF NAUSEA INSIDE), MASSIVE INSOMNIA, NIGHT SWEATS, IN THE MORNING AFTER GETTING UP I FEEL MORE SICK THAN HEALTHY, NO QUALITY OF LIFE ANYMORE GENERAL FEELING OF SICKNESS ALL THE TIME, DAILY TEMPERATURE FLUCTUATIONS IN THE FORM OF AN ELEVATED TEMPERATURE AND EVEN FEVER REGARDLESS OF REST OR EXERTION, PHYSICALLY AND MENTALLY ABSOLUTELY NO LONGER ABLE TO PERFORM AND WORK UNDER PRESSURE, ITCHING IN VARIOUS PARTS OF THE BODY, JOINT PAIN (ANKLE, KNEE, HIP, ELBOW, MAINLY ON THE LEFT SIDE), RECURRENT HERPES ON THE LIP SPREADING TO THE NOSE (APPROX. EVERY 2-3 MONTHS). THESE EVENTS ARE NOT DEVICE RELATED. PATIENT ALSO REPORTED EVERY NOW AND THEN ENLARGED LYMPH NODES IN ARMPIT, GROIN, NECK. PATIENT ADDITIONALLY REPORTED "ELEVATED CORTISOL LEVEL ((B)(6) 2022 - (B)(4)) CONTROL (B)(6) 2023 - (B)(4), CONSTANT FEELING AS IF THE BODY IS CONSTANTLY WORKING, 2022 IRON DEFICIENCY, INCREASED HAIR LOSS, SINCE 2020 MASSIVE CYCLE DISTURBANCES, INCREASED FACIAL HAIR GROWTH, MASSIVE ANXIETY ABOUT THE WHOLE SITUATION, SUDDEN RED RASH ON THE NECK". THESE EVENTS ARE NOT DEVICE RELATED. DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1092314 UNK GEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR ALLERGAN (COSTA RICA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention