MAUDE Adverse Event Report: MENTOR SILICONE HIGH PROFILE MEMORY GEL IMPLANTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Headache (1880); High Blood Pressure/ Hypertension (1908); Memory Loss/Impairment (1958); Neuropathy (1983); Immunodeficiency (2156); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)

Event Date 05/01/2016

Event Type  Injury  

Event Description

I had breast implants on (b)(6) 2016.I began suffering with a poor immune system, memory loss, brain fog, fatigue, insomnia, neuropathy, high blood pressure, migraines, eye sight and hearing and had to have tubes put into my ears and could not get out of bed most days.Implants robbed me of a year of my life!.

• Brand Name: SILICONE HIGH PROFILE MEMORY GEL IMPLANTS
• Type of Device: SILICONE HIGH PROFILE MEMORY GEL IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6456467
• MDR Text Key: 71768398
• Report Number: MW5068880
• Device Sequence Number: 1
• Product Code: FTR
• 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: 03/31/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• 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): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 23 YR
• Patient Weight: 57