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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE BREAST IMPLANT

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MENTOR MENTOR SALINE BREAST IMPLANT Back to Search Results
Event Date 12/27/2010
Event Type  Injury  
Event Description

I got mentor saline breast implants. Within 6 months i developed autoimmune disorder; candida cystic acne, unexplained weight gain, cold sores, toe nail fungus, brain fog. Within a year i developed a hernia, then had another hernia the following year. After 4 years i developed a cyst in my right shoulder that was so large it had to be surgically removed. I also developed asthma, and allergies to foods that were never an issue before.

 
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Brand NameMENTOR SALINE BREAST IMPLANT
Type of DeviceMENTOR SALINE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6975780
Report NumberMW5072931
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 10/23/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/25/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
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: 10/25/2017 Patient Sequence Number: 1
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