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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR MENTOR SMOOTH SALINE BREAST IMPLANTS
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MENTOR MENTOR SMOOTH 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); Hypersensitivity/Allergic reaction (1907); Pain (1994); Arthralgia (2355); Confusion/ Disorientation (2553)
Date of Event 01/01/2013
Type of Reportable Event Serious Injury
Event or Problem Description
What i know now to be breast implant illness began 5-6 months after i had augmentation with smooth saline implants.I was a fit, active, mother of four, very health conscious and began noticing debilitating fatigue and joint pain.As a nurse practitioner and having a physician as a husband we realized immediately that it was likely an autoimmune condition.Testing was done immediately as well as steroid treatment and then other immune modulating drugs.I became very sensitive to many foods, smells, lights, sounds even.I've suffered with pain and feeling like i'm honestly not sure that i can get through most days due to fatigue.I continue to work, but have such horrible brain fog that it worries me.I am going to schedule an explant and go through detox in hopes to feel better.I wish these side effects and possibility for this happening would have been explained to me.Not just that, but i hope women can know how severe it can be and how often it is occurring.Rx meds: none, still have implants as date hasn't been scheduled quite yet for explant.
 
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Brand Name
MENTOR SMOOTH SALINE BREAST IMPLANTS
Common Device Name
MENTOR SMOOTH SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6721468
Report NumberMW5071057
Device Sequence Number1348784
Product Code FWM
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 07/14/2017
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? No
Operator of Device No Information
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/14/2017
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
Patient Age37 YR
Patient Weight64
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