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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT BREAST IMPLANTS

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MENTOR SALINE BREAST IMPLANT BREAST IMPLANTS Back to Search Results
Model Number 1600
Event Date 05/27/2002
Event Type  Injury  
Event Description

I had a right ruptured mentor breast implant that was removed and replaced on (b)(6) 2002. Ever since that surgery, i had left scapular pain. I had lime green nipple discharge on the right side and blood coming out the left breast nipple. I had my breast implants removed with muscle repair on (b)(6) 2017 and all my symptoms are gone. I had a metal taste in my mouth, tinnitus, chronic pain, chronic fatigue, depression, brittle hair and nails with ridges, +ana test, thyroid levels off and left scapular pain so bad i wanted to overdose and die. It was the breast implant on the left side pulling my chest wall back causing my left scapular to wing out. All these things are completely gone now that these toxic bags are out. They need to be taken off the market.

 
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Brand NameSALINE BREAST IMPLANT
Type of DeviceBREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6607433
Report NumberMW5070137
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 05/31/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number1600
Device Catalogue Number350-1650
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: 05/31/2017 Patient Sequence Number: 1
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