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

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.

• Brand Name: MENTOR SMOOTH ROUND SALINE BREAST IMPLANT
• Type of Device: MENTOR SMOOTH ROUND SALINE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6686726
• MDR Text Key: 79172164
• Report Number: MW5070802
• Device Sequence Number: 2
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

• Date FDA Received: 06/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 38 YR
• Patient Weight: 61