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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH ROUND HIGH PROFILE GEL

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MENTOR SMOOTH ROUND HIGH PROFILE GEL Back to Search Results
Model Number REF 350-3254BC
Event Date 05/24/2017
Event Type  Injury  
Event Description

My right mentor high profile silicone breast implant shell has completely disintegrated, implanted in 2012. Have heavy metal toxicity and silicone has been found in my lymphnodes of my left armpit and chest wall. No tear or rupture was noted over the years so doctors did not know was diagnosed with lupus in 2015 and have been on thousands of dollars worth of medication the whole time. I asked doctors if it could be my implant and they told me, "no. The fda say they are safe. " waiting for scheduled explant and lymphadenotomy when i will be hospitalized. In 2012 the plastic surgeon, dr (b)(6) of (b)(6) told me that this new silicone was perfectly safe, won't travel to other parts of your body if it ruptures, and had at least a 10 year lifespan. Only need to get an mri if you suspect a rupture or feel contracture. I'm disappointed that the fda allowed mentor to complete their own studies and so easily allowed them back on the market after only 3 years so that this implant company and plastic surgeons could make money. This is five years of my life i can't get back. Five years of being sick. Five years of medicating my body when it was trying to say please get these out of me. Please take these off the market. At least make every day doctors like rheumatologists aware that this is happening, and what can happen if they don't treat it right away. I know many, many(over (b)(6)) women suffering with this same situation.

 
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Brand NameSMOOTH ROUND HIGH PROFILE GEL
Type of DeviceSMOOTH ROUND HIGH PROFILE GEL
Manufacturer (Section D)
MENTOR
MDR Report Key6607484
Report NumberMW5070143
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/31/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberREF 350-3254BC
Device LOT Number6496948
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: 05/31/2017 Patient Sequence Number: 1
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