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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Depression (2361)
Type of Reportable Event Serious Injury
Event or Problem 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 Name
MENTOR SALINE BREAST IMPLANTS
Common Device Name
MENTOR SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key7199509
Report NumberMW5074593
Device Sequence Number14885578
Product Code FWM
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2004
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 01/15/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Operator of Device No Information
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/16/2018
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
Patient Weight59
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