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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE IMPLANTS

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MENTOR SALINE IMPLANTS Back to Search Results
Model Number 359-1660
Event Date 10/31/2014
Event Type  Injury  
Event Description

In 2005, i had mentor smooth saline implants placed above the muscle. In (b)(6) 2009, i had a rupture of the left breast implant and (b)(6) 2009 had both replaced with mentor smooth saline moderate profile. Starting in (b)(6) 2014, i started having alopecia areata. I was treated by several different dermatologist with steroids im as well as into the bald patches on my head. There was a stalling hair loss for a period of time, but resumed fall out with complete hair loss by (b)(6) 2014. This included all body hair (underarms, pubic, legs) as well as any head hair. (scalp, eye brows, eye lashes, nasal hair, facial peach fuzz). I have been to a multitude of doctors, none of which have been able to treat the problem. It was bought to my attention by my new functional medicine doctor that i could be having an autoimmune response to the implants. On (b)(6) 2017, i had the mentor implants removed and no implant replacement. Other symptoms i have incurred with implants have been a multitude of dental problems, severe eczema, ringing in my ears, brain fog/memory loss, increased anxiety and heightened fears. I also tested positive for lyme disease. Adrenal fatigue.

 
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Brand NameSALINE IMPLANTS
Type of DeviceSALINE IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6940466
Report NumberMW5072707
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation
Report Date 10/09/2017
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received10/11/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number359-1660
Device Catalogue NumberSTYLE:1600
Device LOT Number5912239/RIGHT
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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