MAUDE Adverse Event Report: MENTOR SILICONE IMPLANTS BREAST IMPLANTS

Model Number 354-2007

Event Date 01/09/2000

Event Type  Injury  

Event Description

In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted. My first symptoms in early 2000 with migraines. Then depression and daily anxiety became an issue. I have been on prescription medications for those. Around 2005, i started having raynaud's disease which always affects my nipple and toes when cold. Here are all the ongoing symptoms: migraines, anxiety, fatigue, temperature intolerance, sensitivity to smells, burning pain in breasts, inflammation in breasts, weakness, chronic back pain, whole body dryness, pigment discoloration, blurred vision, word retrieval, concentration, and rapid weight gain.

• Brand Name: SILICONE IMPLANTS
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6964414
• Report Number: MW5072854
• Device Sequence Number: 1
• Product Code: FTR
• 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: 354-2007
• Device LOT Number: 177709
• 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