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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE SMOOTH BREAST IMPLANTS

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MENTOR MENTOR SALINE SMOOTH BREAST IMPLANTS Back to Search Results
Event Date 02/20/2005
Event Type  Injury  
Event Description

On (b)(6) 2004 i had mentor saline implants put in by dr. (b)(6) in (b)(6). I was (b)(6) at the time. Exactly 3 months later i began having pain and swelling in my neck. I was diagnosed with acute thyroiditis. During the next 6 months to 12 months i went through hyperthyroidism and then hypothyroidism. I was diagnosed with graves disease and then eventually hashimoto's disease. I have been sick with countless sinus infections, gerd, leaky gut syndrome, loss of vision, headaches, vertigo, decreased libido, hormonal imbalance, food allergies, hair loss and breast masses at the last three mammograms. I was never explained of the possible health risks to my immune system and quality of life. I have lost the last 13 years to being sick and have an appointment tomorrow to have another mammogram and ultrasounds to begin testing for bia-alcl. Breast implant illness is a real condition and needs to be explored further and of public health concern. Not only do implants cause immune system cancer as recently released by your administration, but it begins with a snowfall effect of damage to the immune system.

 
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Brand NameMENTOR SALINE SMOOTH
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6431321
Report NumberMW5068630
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 03/22/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received03/22/2017
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: 03/22/2017 Patient Sequence Number: 1
Treatment
OTC MEDS: NA
RX MEDS: LEVOTHYROXINE
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