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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTORCORP.COM MENTOR SMOOTH ROUND HIGH PROFILE SALINE 450 CC

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MENTORCORP.COM MENTOR SMOOTH ROUND HIGH PROFILE SALINE 450 CC Back to Search Results
Catalog Number 350-3420
Event Date 08/22/2008
Event Type  Injury  
Event Description

In 2008, i had smooth saline implants put in, made mentor. Within in several months of having the implant put in, i started experiencing chronic fatigue. I spent months going to different doctors trying to find out why i felt so bad. During that time i was diagnosed with ibs syndrome. My eyes and mouth became very dry. I had to have plugs put into my tear ducts. In 2011, i experienced vertigo. I was unable to function. I was having breast pain in my right breast, i was fatigued. I got to where i could not swallow, i had shortness of breath, anxiety attacks, depression, memory loss and confusion. My feet and hands hurt, i could barely walk. I was told i had chronic fatigue syndrome and fibromyalgia. From (b)(6) 2008 until (b)(6) 2011, i seen around 10 or more doctors with many expensive test done. No one was able to diagnose the cause of my problems, until (b)(6) 2011, when i was told i had biotoxicity illness from my breast implants. At this point i could barely function. I was put on a detox program, to get the fungus and mold out of my body and then on (b)(6) 2011, i had the implants removed. I found out after surgery that i had a (b)(6) infection in my right breast. This had contributed to a lot of my pain and sickness. Two months after surgery i am almost 100% back to my old self. I am outraged that these companies that make breast implants are allowed to keep doing this to women. I read about women everyday that are sick from their implants and no one will help them. I was told i could not file a law suit because the time for that had past. Not only did i almost lose my life because of those toxic bombs, it also put a financial burden on my family. Somebody needs to be held accountable. Dates of use: 3 years; (b)(6) 2008 - (b)(6) 2011.

 
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Brand NameMENTOR
Type of DeviceSMOOTH ROUND HIGH PROFILE SALINE 450 CC
Manufacturer (Section D)
MENTORCORP.COM
MDR Report Key2438106
Report NumberMW5024095
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/30/2012
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received01/30/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device Catalogue Number350-3420
Device LOT Number5834632
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was Device Evaluated By Manufacturer? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 01/30/2012 Patient Sequence Number: 1
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