MAUDE Adverse Event Report: MENTOR SILTEX GEL-FILLED MAMMARY SALINE BREAST IMPLANTS

Model Number 354-1308G

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Asthma (1726); Chronic Obstructive Pulmonary Disease (COPD) (2237); Cancer (3262)

Event Date 01/01/2000

Event Type  Injury  

Event Description

I have been on a decline in my health since i had implants placed over the muscle in 2000. I have had thyroid cancer, parathyroid tumors, thyroidectomy with parathyroidectomies, inability to work for over one year, fibromyalgia, asthma and copd the list goes on and on. I also have become intolerant to smells and chemicals.

• Brand Name: SILTEX GEL-FILLED MAMMARY
• Type of Device: SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6964346
• MDR Text Key: 89952945
• Report Number: MW5072846
• Device Sequence Number: 1
• Product Code: FTR
• 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: 10/18/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 354-1308G
• 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: 10/20/2017 Patient Sequence Number: 1