MAUDE Adverse Event Report: MENTOR MENTOR SALINE BREAST IMPLANTS

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

Patient Problems Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Depression (2361)

Event Type  Injury  

Event Description

For the past approximately 10 years i have been to doctor for severe fatigue, neck/back pain, bone pain, brain fog, digestive issues, no libido, depression, etc.I've had tests done and never anything found.I've had multiple lyme tests done that were all negative.One doctor said he felt i may have fibromyalgia and another said maybe the beginning of osteo-arthritis., i've been miserable for years and just don't know how to feel better.I take vitamins and try to eat healthy.It's hard to exercise with the fatigue and pain.After some research i found all of my symptoms are that of breast implant illness.I had the mentor saline implants 14 years ago.Now i am researching how to get them properly removed.I am sick over it and sick of feeling sick.

• Brand Name: MENTOR SALINE BREAST IMPLANTS
• Type of Device: MENTOR SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 7199509
• MDR Text Key: 97673700
• Report Number: MW5074593
• Device Sequence Number: 2
• Product Code: FWM
• 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: 01/15/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• 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 Weight: 59