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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SILICONE BREAST IMPLANT SILICONE BREAST IMPLANTS

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MENTOR MENTOR SILICONE BREAST IMPLANT SILICONE BREAST IMPLANTS Back to Search Results
Event Date 12/10/2014
Event Type  Injury  
Event Description

I had mentor silicone implants in 2012. I was in a car accident in 2014. Since 2014, i have gained 50 pounds, had hair loss, hand tremors, memory loss, chronic fatigue, brain fog, slowed response time with my hands, chest, neck and back pain. I had a 3-d mammogram and everything looked fine. I was convinced that the implants had ruptured even though it didn't show up. I had them taken out. Both of the implants had holes. I am convinced that all of my problems stemmed from the holes in them. I was fine for the first two years.

 
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Brand NameMENTOR SILICONE BREAST IMPLANT
Type of DeviceSILICONE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6636341
Report NumberMW5070359
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 06/10/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received06/10/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
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: 06/10/2017 Patient Sequence Number: 1
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