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U.S. Department of Health and Human Services

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

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MENTOR MENTOR SMOOTH ROUND HIGH PROFILE GEL BREAST IMPLANT Back to Search Results
Lot Number 5849818
Event Date 06/12/2009
Event Type  Injury  
Event 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.

 
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Brand NameMENTOR SMOOTH ROUND HIGH PROFILE GEL
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6604480
Report NumberMW5070110
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/30/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device LOT Number5849818
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/30/2017 Patient Sequence Number: 1
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