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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC MENTOR SALINE SMOOTH BREAST IMPLANT

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MENTOR WORLDWIDE LLC MENTOR SALINE SMOOTH BREAST IMPLANT Back to Search Results
Event Date 06/14/2001
Event Type  Injury  
Event Description

I had saline breast implants put in my body almost 11 years ago. I have been sick with inflammation and countless symptoms for the past 10 years. My illness started to get worse as of last year. I started to smell like something was rotting in my body. I had began to feel very sick. I did my own research as my md's were no help to me and found that my saline breast implants have been making me sick. I finally found a plastic surgeon that agreed with me and recommended an explant (removal) surgery. I had the surgery on (b)(6) 2012. After the surgery, my doctor showed me why i was so ill; she showed me my implants with mold fungus visible to the eye, had a very nasty smell to them. Pathology revealed that the implants had mold, fungus and (b)(6) in them. I also had a (b)(6) infection in my right breast due to the (b)(6) in the implant. My implants were made by mentor. I did a little research on mentor and found out that the company fired an employee for refusing to destroy documents containing that their implants had defective valves. My doctor also told me i had defective valves. So to sum it all up i had a slow leak of fungus, mold and (b)(6) over a very long period of time. Stop mentor from harming others!.

 
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Brand NameMENTOR
Type of DeviceSALINE SMOOTH BREAST IMPLANT
Manufacturer (Section D)
MENTOR WORLDWIDE LLC
201 mentor drive
santa barbara CA 93111
MDR Report Key2465594
Report NumberMW5024299
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 02/16/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/16/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 02/16/2012 Patient Sequence Number: 1
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