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U.S. Department of Health and Human Services


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Model Number 350-2350
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Chest Pain (1776); Fatigue (1849); Muscle Spasm(s) (1966); Nausea (1970); Pain (1994); Seizures (2063); Dizziness (2194); Urinary Frequency (2275); Numbness (2415); Ambulation Difficulties (2544); Confusion/ Disorientation (2553)
Event Date 08/04/2012
Event Type  Injury  
Event Description
The date above is around the time that i had my mentor saline breast implants put in.After my breast augmentation, i started to get intense neck and shoulder pain along with numbness in my hands and fingers.I went to the hospital a countless amount of times, always leaving with no answers.The only diagnosis i was able to receive was that i had anxiety.Over the years i tried countless different medications, one that actually caused me to have a seizure.I have explanted and i no longer take any psych meds.My blood pressure is no longer high, i have zero neck or shoulder pain, and almost all of my other symptoms have went away.I used to wake up every day in pain, and contemplating suicide many times because i thought i was going to have to live like that the rest of my life.Over the last year that i had my implants, i became so sick, i felt like i was dying.Chest pain, sinus problems, nausea, dizziness, chronic fatigue, muscle aches, pains, and spasms, frequent urination, dry hair, chest deformities with breast pain, hard breasts, one breast that was not ruptured, but looked deflated, skin issues, wobbly feeling when walking, loss of appetite, mental confusion, brain fog, and most likely some other symptoms that i forgot to mention.Almost 95 percent of these symptoms have went away since i have explanted.This is no coincidence, and women are getting more sick every day that passes with breast implant illness.
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Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key7178685
MDR Text Key96967665
Report NumberMW5074471
Device Sequence Number1
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 01/08/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number350-2350
Device Lot Number6570720
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Disability;
Patient Weight52