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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE COHESIVE GEL BREAST IMPLANTS

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MENTOR SILICONE COHESIVE GEL BREAST IMPLANTS Back to Search Results
Model Number 350-5504BC
Event Date 05/01/2015
Event Type  Injury  
Event Description

Hair loss and dryness, skin dryness and itchiness, dry, brittle flaky nails, extreme sensitivity to cold, night sweat, depression (feeling like the world would be better without me in it), and anxiety. Difficulty swallowing/fullness in throat, decreased libido, low energy, exhausted, weak, memory loss, difficulty concentrating and brain fog. Ringing in ears, metalic taste in mouth, skin rashes - bug bites, scratches and other wounds take forever to heal. Weight gain, heavy and abnormal menstrual cycles, heart palpitations, chronic diarrhea, muscle cramping/frequent charlie horses, frequent swollen and sore lymph nodes - usually under arms sometimes neck, sensitive eyes, enlarged thyroid, allergies for the first time in my life, pain where the ribs meet the sternum.

 
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Brand NameSILICONE COHESIVE GEL BREAST IMPLANTS
Type of DeviceSILICONE COHESIVE GEL BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6776816
Report NumberMW5071454
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/07/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received08/07/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number350-5504BC
Device LOT Number6832795
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

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