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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH ROUND SALINE BREAST IMPLANT

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MENTOR MENTOR SMOOTH ROUND SALINE BREAST IMPLANT Back to Search Results
Model Number 5540606
Event Date 01/25/2005
Event Type  Injury  
Event Description

I had breast implants in 2005, mentor smooth round profile saline. In 2013 had a cyst 5cm removed from knee, 2014 - miscarriage, 2015 i had 2 miscarriage b implants. I had 3 healthy boys regular delivery. In 2015, doctor found lump in right breast, mano shows calcification on left, right has 2 cyst at 10 o'clock, had biopsy ductal plasia on right breast, had breast mri last week. I'm scheduled for lumpectomy and also explant. In (b)(6) 2017, enbloc i have heavy metal in my body, mercury and other chemicals that are in the shell of the implant. I also did genetic testing and i am now 4 times fold for celiac, cancer and 90% likely to have breast cancer.

 
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Brand NameMENTOR SMOOTH ROUND SALINE BREAST IMPLANT
Type of DeviceMENTOR SMOOTH ROUND SALINE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6686726
Report NumberMW5070802
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 06/30/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received06/30/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number5540606
Device Catalogue Number350_1655
Device LOT Number5540606
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: 06/30/2017 Patient Sequence Number: 1
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