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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR GEL SILICONE IMPLANT BREAST IMPLANT
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MENTOR GEL SILICONE IMPLANT BREAST IMPLANT Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Fatigue (1849); Fungus (1872); Memory Loss/Impairment (1958); Rash (2033); Tinnitus (2103); Urinary Retention (2119); Blurred Vision (2137); Anxiety (2328); Arthralgia (2355); Numbness (2415); Neck Pain (2433); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Weight Changes (2607)
Event Date 01/01/2013
Event Type  Injury  
Event Description
Due to having a birth defect i got mentor gel silicone breast implants in 2008. The new ones that suppose to be fda approved and safe ones. Wrong! they have slowly been poisoning my body. I have a lot of health issues because of them. Blurry vision, memory fog, fatigue, numbness in hand and feet, joint pain, urine retention, trouble concentrating, weight gain, ringing in my ears, anxiety, skin rashes, sleep problems, fungus on my rt toe that will not go away and i keep loosing my toe nail. Shoulder and neck pain, pain under my rt rib. I struggle everyday to do things and plan to explant soon.
 
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Brand NameGEL SILICONE IMPLANT
Type of DeviceBREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6238010
MDR Text Key64556005
Report NumberMW5067161
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/07/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/07/2017 Patient Sequence Number: 1
Treatment
ALLERGIES: PENICILLIN; ANXIETY; DEPRESSION; MEDICAL CONDITIONS: HIGH BLOOD PRESSURE; NUT; SHELL
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