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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR BREAST IMPLANTS

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MENTOR BREAST IMPLANTS Back to Search Results
Event Date 01/01/2000
Event Type  Injury  
Event Description

Breast implant illness. I had mentor smooth saline with silicon shell breast implants implanted in (b)(6) 1999. I have had numerous disabilities and health issues ever since ranging from thyroid issues, chronic fatigue, cognitive dysfunction, muscle pains and weaknesses. Joint pain, hair loss, heart palpatations, foul body odor, incontinence (relating to muscle issues) rash of autoimmune responses. I'm going in this month for toxins testing. My primary care physician cannot come up with any findings related to my overall health except that the fact my body is being compromised by breast implants that were deemed safe.

 
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Brand NameBREAST IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6604639
Report NumberMW5070126
Device Sequence Number2
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 05/27/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/27/2017
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: 05/27/2017 Patient Sequence Number: 1
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