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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 Type  Injury  
Event Description

I had mentor saline implants for 17 years and had a list of health problems from them. Since explanting, all of my health issues are gone. I was told by my plastic surgeon that they were safe and never warned of the dangers, including that the outer shell is made of silicone with almost 40 toxic chemicals.

 
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Brand NameSALINE BREAST IMPLANTS
Type of DeviceSALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key7212093
Report NumberMW5074726
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 01/19/2018
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received01/22/2018
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: 01/22/2018 Patient Sequence Number: 1
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