MAUDE Adverse Event Report: MENTOR WORLDWIDE/ J AND J MEMORY GEL SILICONE; BREAST IMPLANTS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Disorder (1732); Bacterial Infection (1735); Capsular Contracture (1761); Dehydration (1807); Dry Eye(s) (1814); Ecchymosis (1818); Edema (1820); Emotional Changes (1831); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Liver Damage/Dysfunction (1954); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Respiratory Distress (2045); Skin Discoloration (2074); Swollen Lymph Nodes (2093); Thyroid Problems (2102); Tinnitus (2103); Visual Impairment (2138); Weakness (2145); Burning Sensation (2146); Tingling (2171); Twitching (2172); Dizziness (2194); Myalgia (2238); Viral Infection (2248); Urinary Frequency (2275); Anxiety (2328); Arthralgia (2355); Depression (2361); Numbness (2415); Fungal Infection (2419); Neck Pain (2433); Sweating (2444); Choking (2464); Palpitations (2467); Sleep Dysfunction (2517); Cognitive Changes (2551); Weight Changes (2607)

Event Date 09/07/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 i had woke up to a horrible pain, ended up capsular contracture grade 4 (baker), then ended up ruptured right breast tissue and implant as well as the following: fatigue or chronic fatigue, cognitive dysfunction (brain fog, difficulty concentrating, word retrieval, memory loss), muscle aches, pain, and weakness, joint pain and soreness, hair loss, dry skin, eyes, mouth, hair, weight gain or weight loss, easy bruising and slow healing of wounds, temperature intolerance, low libido, ringing in the ears, heart palpitations, photosensitivity, shortness of breath, metallic taste in the mouth, oral thrush (white tongue), night sweats, skin rashes, insomnia, estrogen/progesterone imbalance or diminishing hormones, swollen and tender lymph nodes in the breast area, underarms, throat, neck, or groin, tingling or numbness in the arms and legs, burning pain around the chest wall or breasts, cold and discolored hands and feet, foul body odor, muscle twitching, dehydration, frequent urination, chronic neck and back pain, nail changes (cracking, splitting, slow growth, etc), skin freckling, pigmentation changes (darkening or white spots), or an increase in papules (flesh colored raised bumps), edema (swelling) around eyes, premature aging, decline in vision or vision disturbances, liver and kidney dysfunction, digestive and gastrointestinal issues, food intolerances and allergies, smell or chemical sensitivities, new or persistent infections - viral, bacterial, and fungal (candida), reoccurring sinus infections, throat clearing, cough, difficult swallowing, choking feeling, chronic inflammation, feeling like you are dying, headaches, dizziness and migraines, mood swings, emotional instability, anxiety, panic attacks, suicidal thoughts, depression, hypo/hyper thyroid symptoms, hypo/hyper adrenal symptoms, symptoms or diagnosis of fibromyalgia, symptoms or diagnosis of lyme, common autoimmune disease, 33 different metals and chemicals including silicone.These are mentor memory gell 450cc breast implants still in me.

• Brand Name: MEMORY GEL SILICONE
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR WORLDWIDE/ J AND J
• MDR Report Key: 6934387
• MDR Text Key: 89012153
• Report Number: MW5072639
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/05/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 28 YR
• Patient Weight: 47