BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STYLE 68 SALINE FILLED BREAST IMPLANT

    MDR report key: 11616424 · Received April 5, 2021

    Report

    Report Number
    9617229-2021-00791
    Event Type
    Injury
    Date Received
    April 5, 2021
    Date of Event
    January 1, 1998
    Report Date
    June 15, 2021
    Manufacturer
    ALLERGAN (COSTA RICA)
    Product Code
    FWM
    PMA / PMN Number
    P990074
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL, CHANGED, AND/OR CORRECTED DATA: B.5, D.6B, H.6.

    Description of Event or Problem · 0

    DEVICE WAS EXPLANTED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. 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. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. REASON FOR REOPERATION: SJOGREN'S SYNDROME AS WELL AS ADDITIONAL PHYSICAL AILMENTS . ALLERGAN DID NOT SUBMIT THIS MDR WITHIN 30 DAYS OF BECOMING AWARE. RECENT STIMULATED REPORTING RELATED TO (B)(4) HAS INCREASED COMPLAINT AND MDR VOLUME. ALLERGAN IS IMPLEMENTING A PLAN TO ADDRESS THE INCREASED VOLUMES.

    Description of Event or Problem · 1

    PATIENT REPORTED VIA REGULATORY AGENCY "SWOLLEN PAINFUL LYMPH NODES ESPECIALLY AROUND THE IMPLANT SITE," "PAIN/BURNING/ITCHING AROUND IMPLANT SITE, SCAR ITCHING," "DEPRESSION, ANXIETY, PANIC ATTACKS," AND "NERVE DAMAGE AROUND IMPLANT SITE." PATIENT ADDITIONALLY REPORTED, "SJOGREN'S SYNDROME AND BREAST IMPLANT ILLNESS," "MULTIPLE SCLEROSIS, FATIGUE, FIBROMYALGIA, CONNECTIVE TISSUE DISORDERS," "LARYNGOPHARYNGEAL REFLUX, MIDDLE EAR EFFUSION, PREMATURE DENTAL CARIES AND TOOTH LOSS," "BRAIN FOG," "HYSTERECTOMY," "EARLY MENOPAUSE," "UTERINE FIBROIDS," "ENDOMETRIOSIS," "ADHESIONS," "HAIR LOSS," "DRY HAIR," "PREMATURE AGING," "INSOMNIA," "SLEEP DISTURBANCES," TINNITUS," "EXCESSIVE MUCUS IN THROAT," "THROAT CLEARING," "COUGH, THROAT/VOCAL CORD IRRITATION," "DIFFICULTY SWALLOWING/CHOKING," "GERD," "PND," "METALLIC TASTE IN MOUTH," "HYPERSOMNIA," "METALLIC SMELL," "EXTREMELY DEHYDRATED, DIFFICULTY HYDRATING, FREQUENT URINATION," "URINARY INCONTINENCE," "IBS," "STOMACH DISTENTION," "CHRONIC CONSTIPATION," "COLD/DISCOLORED LIMBS," "SHORTNESS OF BREATH," "FEEL LIKE I AM SLOWLY DYING," "SINUS SURGERY," "DEGENERATIVE DISC/JOINT/BONE DISEASE," "STENOSIS," "STUCK IN SLOW MOTION," "DEFORMED BRITTLE NAILS," "GASTRITIS, LARYNGITIS, OPTIC NEURITIS, TENDONITIS, TENOSYNOVITIS," "DRY EYES, DRY MOUTH," "COGNITIVE DYSFUNCTION," MEMORY LOSS," "SEIZURES," "OVARIAN CYSTS," "BREAST FIBROID CYSTS," "JOINT PAIN," "OSTEOARTHRITIS," "MUSCLE PAIN," "PAIN/WEAKNESS IN ARMS, HANDS, FINGERS, FEET, TOES," "MUSCLE WEAKNESS," "ECZEMA, DERMATITIS," "CHEST PAIN/HEAVINESS," "SLOW HEALING," "SLOW RECOVERY," "EASY/EXCESSIVE BRUISING," "VERTIGO," "HEADACHES, MIGRAINES, OCULAR MIGRAINE," "NAUSEA," "FREQUENT UTIS, FREQUENT YEAST INFECTIONS," "PERSISTENT BACTERIAL AND VIRAL INFECTIONS," "PALPITATIONS, RAPID HEARTBEAT, BP CHANGES," AND "BENIGN TUMOR"; THESE EVENTS ARE NOT RELATED TO THE DEVICE. DEVICE REMAINS IMPLANTED. THIS RECORD IS FOR THE RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511004 STYLE 68 SALINE FILLED BREAST IMPLANT PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM ALLERGAN (COSTA RICA) 528197

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention