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

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 IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6964346
• MDR Text Key: 89952945
• Report Number: MW5072846
• Device Sequence Number: 2
• 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: No Information
• Device Model Number: 354-1308G
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Weight: 46