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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH SILICONE GEL BREAST IMPLANT

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MENTOR SMOOTH SILICONE GEL BREAST IMPLANT Back to Search Results
Event Date 11/22/2011
Event Type  Injury  
Event Description

I got breast implants in (b)(6) 2011 within weeks i began feeling aches, pains, fevers, chills, racing heart, hair falling out. I've been sick ever since. No doctor can help me and i fully believe it's the breast implants making me ill. I have constant infections. Shooting and sharp pain in the breasts. I have arthritis and thyroid issues. It's never been ending and i can't get medical assistance to have them removed.

 
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Brand NameSMOOTH SILICONE GEL BREAST IMPLANT
Type of DeviceSMOOTH SILICONE GEL BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6581397
Report NumberMW5069907
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/18/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2017
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: 05/18/2017 Patient Sequence Number: 1
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