MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANT

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Swollen Lymph Nodes (2093); Complaint, Ill-Defined (2331)

Event Date 01/07/2007

Event Type  Injury  

Event Description

I had mentor silicone breast implants in (b)(6) 2007.For the past several years i have had many health issues from fatigue to swollen lymph nodes that will not go away, and a lot of things in between.I have been to several doctors and specialists over the year with no help or definite answers.An e.N.T.Dr i went to questioned me about my implants and suggested, i think about having them removed.I am researching that option now.

• Brand Name: SILICONE BREAST IMPLANT
• Type of Device: SILICONE BREAST IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6875928
• MDR Text Key: 86747740
• Report Number: MW5072203
• 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: 09/17/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• 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): Disability
• Patient Age: 50 YR
• Patient Weight: 79