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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
Lot Number 5535061
Event Date 09/18/2013
Event Type  Injury  
Event Description

In 2004 i had mentor breast implants. I began having various medical problems that were unexplained. Over time i suffered digestive problems, unexplained heart problems, autoimmune issues, rheumatic symptoms, memory issues, metal fog, etc. I had my implants removed (b)(6) 2013 and they were found to have defective valves with mold growing on them. Since having them removed, my symptoms immediately improved. I would like to be added to a list with the fda in the event they are ever recalled. Smooth round moderate profile.

 
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Brand NameSALINE BREAST IMPLANTS
Type of DeviceSALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key3365698
Report NumberMW5031955
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/18/2013
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received09/19/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device LOT Number5535061
OTHER Device ID Number127

Patient TREATMENT DATA
Date Received: 09/19/2013 Patient Sequence Number: 1
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