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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

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MENTOR SALINE BREAST IMPLANTS Back to Search Results
Event Date 07/20/2008
Event Type  Injury  
Event Description

I got mentor saline breast implants and right after stated having symptoms resembling ms joint pain, confusion, numbness, brain fog, hormone issues resulting in hysterectomy at (b)(6). One year later, celiac, other food allergies, biotoxin illness, severe symptoms that were debilitating, digestive issues, leaky gut, chemical sensitivity, light and sound sensitivity. Got my implants removed after 8 years in 2015 and 75 percent of the symptoms went away. I still struggle with gut issues and joint pain. I have had years of extensive testing done. Both functional med and regular doc over (b)(6) dollars worth.

 
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Brand NameSALINE BREAST IMPLANTS
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6345452
Report NumberMW5067958
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 02/16/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received02/16/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
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: 02/16/2017 Patient Sequence Number: 1
Treatment
BERBERINE
OREGANO
OTC MEDS: MAGNESIUM CITRATE
RX MEDS: SUPPLEMENTS ONLY NO MEDICATIONS.
VITAMIN C
VITAMIN D
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