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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH SALINE BREAST IMPLANTS

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MENTOR SMOOTH SALINE BREAST IMPLANTS Back to Search Results
Event Date 05/01/2002
Event Type  Injury  
Event Description

I had mentor smooth saline breast implants placed in 1998. Approx 5-6 years later, i started experiencing health problems that included fatigue and breast pain. By 2007, my health issues had progressed with increased fatigue, emotional lability, gastrointestinal problems, and increased breast pain. In 2011, my right implant was encapsulated with severe intermittent pain. I was diagnosed with ibs in 2012 and started experiencing generalized muscle pain and increased fatigue. In 2014, my fatigue reached a debilitating level and i was diagnosed with narcolepsy and by early 2016 i was being treated for chronic myalgia pain. Other generalized symptoms included night sweats, increased emotional lability, nocturia, muscle weakness, loss of strength in my arms and hands, intermittent numbness and tingling in hands and feet, raynaud's like symptoms in my feet, calcified right breast encapsulation, and progressive joint pain in hands and wrists. All symptoms continued to worsen until surgical removal with total encapsulectomy bilaterally in (b)(6) of 2017.

 
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Brand NameSMOOTH SALINE BREAST IMPLANTS
Type of DeviceSMOOTH SALINE BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6529584
Report NumberMW5069395
Device Sequence Number1
Product CodeFWM
Report Source Voluntary
Reporter Occupation PATIENT
Report Date 04/26/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received04/26/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
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: 04/26/2017 Patient Sequence Number: 1
Treatment
ADDERALL
CELEBREX
CLONAZEPAM
FIORECET
HIGH DOSE VITAMIN D
HYDROCODONE
IBUPROFEN
TYLENOL
VITAMIN C
XYREM
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