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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT

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MENTOR SALINE BREAST IMPLANT Back to Search Results
Model Number SALINE
Event Date 11/17/2016
Event Type  Injury  
Event Description

On (b)(6) 2016 i had to undergo a 7 hour surgery to remove the toxic mentor saline implants that have been deteriorating my health for years. Capsules were thick, yellowish and my chest full of yellow murk liquid. Right implant was yellow and full of particles inside. Before this surgery, i suffered from insomnia, fatigue, joint pain, back pain, brain fog, hair loss, dry skin, acne, difficulty breathing and others. After surgeon removed the implants, my health has improved by at least 90 percent. It's clear that the silicone toxins released through the shells were attacking my autoimmune system.

 
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Brand NameSALINE BREAST IMPLANT
Type of DeviceSALINE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6338997
Report NumberMW5067929
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 02/15/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received02/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberSALINE
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: 02/15/2017 Patient Sequence Number: 1
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