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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

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MENTOR SALINE BREAST IMPLANTS Back to Search Results
Event Date 09/01/2015
Event Type  Injury  
Event Description

Got saline breast implants. One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year. At the age of (b)(6) my vision started to go. Every part of my body was shutting down and no dr. Could tell me why. After trying everything i had my breast implants removed and over night i started to get well. It's been a year now and i thank god i have another chance at life. They are poison and doing this to so many women. The symptoms seem so unrelated that it's the last thing you would think of even being as sick as i was. Please help take these off the market and save lives.

 
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Brand NameSALINE BREAST IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6756634
Report NumberMW5071315
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 07/30/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received07/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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: 07/30/2017 Patient Sequence Number: 1
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