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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXTURED SALINE IMPLANT

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MENTOR TEXTURED SALINE IMPLANT Back to Search Results
Event Date 09/10/1994
Event Type  Injury  
Event Description

I got textured saline implants over muscle. I was told that these were lifetime devices. These implants unknowingly caused me severe neurological problems, extreme unnatural fatigue, hair loss, developed lipomas, heart palpitations, experience severe burn like pain in arms, neck, under armpit, early menopause, anxiety, loss of dreams and more. I believe the body's eventual reaction to the implants aged me prematurely.

 
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Brand NameTEXTURED SALINE IMPLANT
Type of DeviceTEXTURED SALINE IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6972010
Report NumberMW5072914
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 10/22/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/24/2017
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: 10/24/2017 Patient Sequence Number: 1
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