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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
Event Date 01/01/2013
Event Type  Injury  
Event 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 NameMENTOR SMOOTH SALINE BREAST IMPLANTS
Type of DeviceMENTOR SMOOTH SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6721468
Report NumberMW5071057
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 07/14/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received07/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
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: 07/14/2017 Patient Sequence Number: 1
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