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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE IMPLANTS

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MENTOR MENTOR SALINE IMPLANTS Back to Search Results
Model Number 350-1655
Event Date 01/01/2017
Event Type  Injury  
Event Description

I got breast implants and they've made me very sick. After implants, my hormone levels plummeted (i've been to specialist who could not help me) and they were 100% healthy a month before implants. I have widespread pain, heart palpitations, extreme hair loss, rashes, insomnia, chronic fatigue, migraines, edema all over, etc. I was healthy before these implants. I will explant next week to get my life back.

 
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Brand NameMENTOR SALINE IMPLANTS
Type of DeviceMENTOR SALINE IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6968220
Report NumberMW5072871
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 10/19/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/23/2017
Is This An Adverse Event Report? Yes
Device Operator NO INFORMATION
Device MODEL Number350-1655
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: 10/23/2017 Patient Sequence Number: 1
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