MAUDE Adverse Event Report: DOW CORNING WRIGHT / MENTOR SILICONE BREAST IMPLANT

Device Problem Insufficient Information (3190)

Patient Problems Connective Tissue Disease (1786); Dyspnea (1816); Fatigue (1849); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Swollen Lymph Nodes (2093); Thyroid Problems (2102); Vertigo (2134); Weakness (2145); Burning Sensation (2146); Hot Flashes/Flushes (2153); Dizziness (2194); Viral Infection (2248); Anxiety (2328); Complaint, Ill-Defined (2331); Depression (2361); Fungal Infection (2419); Sweating (2444); Palpitations (2467); Sleep Dysfunction (2517); No Code Available (3191)

Event Date 08/18/2010

Event Type  Injury  

Event Description

This is not a one time event, but this was the beginning of many different health issues i had.I got severe spinning vertigo that lasted 6 years.Along with that were 35 other symptoms.Extreme chronic fatigue, atypical connective tissue disease, breathing problems laying down.Brain fog, memory loss, muscle pain, weakness, joint pain, dizziness.Bad gastrointestinal and digestive issues, nausea, intense night sweats and hot flashes, poor sleep and insomnia, anxiety and depression.Hypothyroid, coughing, intolerant to heat and cold, new and persistent viral infections, candida, constant yeast infections.Heart palpitation, swollen and tender lymph nodes in breast area, underarm, throat, burning sensation around breast implant and arm pit, bladder pressure pain.

• Brand Name: SILICONE BREAST IMPLANT
• Type of Device: SILICONE BREAST IMPLANT
• Manufacturer (Section D): DOW CORNING WRIGHT / MENTOR
• MDR Report Key: 6989846
• MDR Text Key: 90762578
• Report Number: MW5073034
• 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: 10/26/2017
• 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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 60 YR
• Patient Weight: 60