MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH ROUND HIGH PROFILE GEL; BREAST IMPLANT

Lot Number	5849818
Health Effect - Clinical Codes	Bruise/Contusion (1754); Cellulitis (1768); Chest Pain (1776); Dry Eye(s) (1814); Fatigue (1849); Hair Loss (1877); Headache (1880); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Intraocular Pressure Increased (1937); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Thyroid Problems (2102); Tinnitus (2103); Blurred Vision (2137); Tingling (2171); Dizziness (2194); Anxiety (2328); Depression (2361); Sweating (2444); Palpitations (2467); Sleep Dysfunction (2517); Cognitive Changes (2551); Confusion/ Disorientation (2553); Weight Changes (2607)
Date of Event	06/12/2009
Type of Reportable Event	Serious Injury
Event or Problem Description
Several years after my mentor smooth silicone implants were placed in, i noticed symptoms.It behave with extreme fatigue and has increasingly gotten worse.Here are my symptoms: hormones are imbalanced (out of wack), hypothyroid.Extreme vitamin d deficiency.Extreme fatigue, loss of concentration, memory loss, along with brain fog, confusion and cognitive dysfunction.Dry eyes, blurred vision, double vision, and eye pressure.Dry hair, dry skin, dry mouth, and dry nails.Migraine headaches, depression, heart palpitations, nausea, and anxiety.Mastitis, cellulitis of the breast.Reoccurring infection like uti, bv that are persistent and often do not go away with one round of antibiotics, and bladder pain.Lowered immune system, and i get sick (strep throat, colds) and i never used to, slow clearing of colds.Extreme hair loss that has created balding (alopecia) on my scalp.Tingling hands and feet, cold hands and feet, tempt, intolerance, light sensitivity and noise sensitivity.Insomnia, feeling dizzy, or faint, almost blacking out (everything goes dark and i see stars).Loss of appetite, weight loss.Metalic taste in my mouth.Ringing in my ears daily.Muffled ears like swimmers ear.Neck, shoulder pain along with tension on where my head and spine meet.Bruise easily.Knee/joint pain.Night sweats.Vitamin deficiency and i take weekly high dosages of vitamin d (50,000) and daily vit d (8,000) and i'm barely in the normal range.Weekly b12 injections.Panic attacks, chest pain, breast pain, inflammation, depression.Loss of interest and pleasure in doing activities.

• Brand Name: MENTOR SMOOTH ROUND HIGH PROFILE GEL
• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6604480
• Report Number: MW5070110
• Device Sequence Number: 1051256
• Product Code: FTR
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 05/30/2017
• 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?: No
• Operator of Device: No Information
• Device Lot Number: 5849818
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/30/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 48