BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANT STYLE 110 SILICONE BREAST IMPLANTS

    MDR report key: 2994416 · Received March 2, 2013

    Report

    Report Number
    MW5029255
    Date Received
    March 2, 2013
    Date of Event
    June 1, 2011
    Report Date
    March 2, 2013
    Product Code
    FTR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PERSISTENT LATE ONSET PERI-IMPLANT SEROMA OF LEFT BREAST - (B)(6) 2006, MASTOPEXY W/ INAMED TEXTURED SILICONE IMPLANTS - (B)(6) 2009. SYMPTOMS OF GENERAL MALAISE BEGIN INCLUDING: FATIGUE, LETHARGY, RAYNAUD'S PHENOMENON (TOES), UNEXPLAINED WEIGHT GAIN, MULTIPLE BRUISES (LEGS), NOSE AND SCALP SORES, RIGHT MAXILLARY SINUS PAIN, COGNITIVE PROBLEMS "FOGGY BRAIN", MINOR LEFT BREAST ASYMMETRY. SYMPTOMS COME AND GO AND FLUCTUATE IN INTENSITY. ON (B)(6) 2011 ABOVE SYMPTOMS MORE FREQUENT AND HIGHER INTENSITY PLUS LEFT BREAST AREOLAR SEVER ITCHINESS, SLOW TO HEAL SPONTANEOUS BREAST LESION (INNER SIDE LEFT BREAST), DIFFICULTY FALLING/STAYING ASLEEP, RIGHT EYE BLURRINESS, LEG/ARM/HAND MUSCLE WEAKNESS, SHORTNESS OF BREATH, NIGHT SWEATS, LEFT BREAST ASYMMETRY INCREASING. ON (B)(6) 2011 INCREASED ASYMMETRY, LEFT BREAST VERY LARGE. ABOVE SYMPTOMS MORE FREQUENT AND HIGHER INTENSITY PLUS RASHES ON BREAST AND CHEST INCLUDING AREAS OF RED SPIDER VEINS, 100'S OF SMALL RAISED SKIN COLORED PAPULES ON FRONT OF SHINS AND FEW ON FEET (PAPULES ONLY VISIBLE IN DIRECT SUNLIGHT), ABDOMEN IS BLOATED, BUMPY AND UNEVEN, ARM/HAND TINGLING AND NUMBNESS. BREAST ULTRASOUND/MRI, BRAIN MRI (NO LESIONS), VISION CHECK: R EYE VISION DEFICIT, UNABLE TO CORRECT DURING EXAM. ON (B)(6) 2011 LARGE AMOUNT OF PERI-IMPLANT SEROMA ASPIRATED. ALL ABOVE SYMPTOMS GRADUALLY RELIEVED PLUS WEIGHT LOSS, PAPULES ON SHINS REMAIN. ON (B)(6) 2011 PATCH OF REOCCURRING PURITIC VESICLES ON RIGHT LOWER FACE. SYMPTOMS OF GENERAL MALAISE RETURN INCLUDING, FATIGUE, LETHARGY, RAYNAUD'S PHENOMENON (TOES), UNEXPLAINED WEIGHT GAIN, ABDOMEN/ARMS/LEGS RANDOMLY LUMPY/BUMPY, MULTIPLE BRUISES (LEGS), NOSE AND SCALP SORES, COGNITIVE PROBLEMS "FOGGY BRAIN", DIFFICULTY FALLING/STAYING ASLEEP, RIGHT EYE BLURRINESS, 100'S OF SMALL RAISED SKIN COLORED PAPULES ON FRONT OF SHINS AND A FEW FEET (PAPULES ONLY VISIBLE IN DIRECT SUNLIGHT), RASHES ON BREASTS/CHEST/ARMS, MINOR LEFT BREAST ASYMMETRY. SYMPTOMS COME AND GO AND FLUCTUATE IN INTENSITY. DERMATOLOGIST DX-ACNE VULGARIS ON FACE, FLAT WARTS ON LEGS, SLEEP STUDY - NORMAL RESULTS. ON (B)(6) 2012 LEFT BREAST INCREASED ASYMMETRY, ALL ABOVE SYMPTOMS CONTINUE PLUS INCREASE IN COGNITIVE SYMPTOMS AND OCCASIONAL NIGHT SWEATS. BREAST SPECIALIST DX-REOCCURRING PERI-IMPLANT SEROMA. ON (B)(6) 2012 PARTIAL ASPIRATION OF PERI-IMPLANT FLUID. ON (B)(6) 2012 GENERAL MALAISE INCLUDING ALL ABOVE SYMPTOMS CONTINUE, WITH EXCEPTION OF LESS FREQUENT TO CESSATION OF NIGHT SWEATS. HOWEVER, DAYTIME SOAKING SWEATS WITH AN INCREASED ACTIVITY INSIDE AIR CONDITIONED HOUSE, (EXAMPLE: VACUUMING). ON (B)(6) 2012 GRADUAL DECREASE IN FEELINGS OF MALAISE INCLUDING ALL ABOVE SYMPTOMS. NO NIGHT OR DAYTIME SOAKING SWEATS. SLEEPING DIFFICULTIES SPONTANEOUSLY RESOLVED. ON (B)(6) 2012 GENERAL MALAISE PLUS ABOVE SYMPTOMS RETURN IN THE SAME WAXING AND WANING MANOR. NO NIGHT SWEATS, PLUS LEFT UPPER BACK AND SHOULDER PAIN, PAIN INTENSIFIED WHEN TAKING DEEP BREATH. LEFT BREAST ASYMMETRY INCREASING. PLASTIC SURGEON DX SUSPECTED RETURN OF PERI-IMPLANT FLUID RX: IMPLANT/SCAR CAPSULE REMOVAL. DATES OF USE: (B)(6) 2013. DIAGNOSIS OR REASON FOR USE: "BREAST RECONSTRUCTION" MASTOPEXY W/ IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90563 IMPLANT STYLE 110 SILICONE BREAST IMPLANTS SILICONE TEXTURED BREAST IMPLANT FTR 110
    90564 IMPLANT STYLE 110 SILICONE BREAST IMPLANTS SILICONE TEXTURED BREAST IMPLANT FTR 110

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention