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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
Device Problems Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)
Patient Problems Breast Cancer (1759); Cyst(s) (1800); Miscarriage (1962); Toxicity (2333)
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 Name
MENTOR SMOOTH ROUND SALINE BREAST IMPLANT
Type of Device
MENTOR SMOOTH ROUND SALINE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6686726
MDR Text Key79172164
Report NumberMW5070802
Device Sequence Number1
Product Code FWM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/30/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/30/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly; Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age38 YR
Patient Weight61
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