MAUDE Adverse Event Report: MENTOR SILICONE IMPLANTS; BREAST IMPLANTS

Model Number 354-2007

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fatigue (1849); Headache (1880); Inflammation (1932); Pain (1994); Skin Discoloration (2074); Blurred Vision (2137); Weakness (2145); Burning Sensation (2146); Anxiety (2328); Depression (2361); Weight Changes (2607)

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
• MDR Text Key: 89934499
• Report Number: MW5072854
• 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

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 103