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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SALINE BREAST IMPLANTS
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MENTOR MENTOR SALINE BREAST IMPLANTS Back to Search Results
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.
 
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Brand NameMENTOR SALINE BREAST IMPLANTS
Type of DeviceMENTOR SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key7199509
MDR Text Key97673700
Report NumberMW5074593
Device Sequence Number2
Product Code FWM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
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: 01/16/2018 Patient Sequence Number: 1
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