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

Medical Device Problem Codes	Metal Shedding Debris (1804); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Breast Cancer (1759); Cyst(s) (1800); Miscarriage (1962); Toxicity (2333)
Date of Event	01/25/2005
Type of Reportable Event	Serious Injury
Event or Problem 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.

• Brand Name: MENTOR SMOOTH ROUND SALINE BREAST IMPLANT
• Common Device Name: MENTOR SMOOTH ROUND SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6686726
• Report Number: MW5070802
• Device Sequence Number: 10104064
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Congenital Anomaly; Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 38 YR
• Patient Weight: 61