• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Model Number 5530938
Device Problem Material Integrity Problem (2978)
Patient Problems Fatigue (1849); Fever (1858); Unspecified Infection (1930); Pain (1994); Pneumonia (2011); Burning Sensation (2146); Myalgia (2238); Depression (2361)
Event Date 02/10/2015
Event Type  Injury  
Event Description
In 2004, i received a breast augmentation procedure.The implants i had put in were filled with saline.A few years went by with no incident or issue, however this was a short lived bliss.After about the fifth year of having the implants, i began having symptoms of back pain, fatigue, and a burning sensation in my chest wall.Not long after these symptoms started, soon more symptoms began to develop such as: low grade fevers that were accompanied by shooting/burning pains that consumed my entire body.After seeing my general physician for these issues, he diagnosed with fibromyalgia after many evaluations following.This came as a shock to me and all of my family.The medicines used to treat and alleviate fibromyalgia symptoms brought about side effects that were less than desirable medicines as they did not help me whatsoever and only worsened my well being.The three or so years that followed after the fibromyalgia diagnosis were a constant battle of chronic fatigue, low grade fevers, burning/shooting pains, mild depression, and flu like symptoms.In the past year, i have been mostly bed ridden and chronically ill, not able to have a normal functioning life, and dealing with the above stated symptoms that have worsened.All along these many years of dealing with symptoms unk as to why they were occurring, then being thought to have fibromyalgia, divine intervention led me to dig deeper into my existing condition, as i could not and would not accept this health deterioration as what i will face for the rest of my life.To preface this pat about my findings and what followed, i'll briefly explain how this came about.Here and there throughout these many years, i speculated that the culprit behind my health problems could possibly have been stemming from my breast implants, but after consulting the cosmetic surgeon who performed by breast augmentation, and other various physicians, i was convinced by these practitioners that my breast implants were most definitely not the cause of my health issues.Naturally, it is anyone's inclination to trust what doctors tell us, and therefore i did just that.Not being able to let go of the pressing thought that my breast implants just might be the root to all of my suffering, i began putting all of my expendable energy into rigorous research regarding breast implant illnesses.It did not take me very long to conclude that my suspicions of my breast implants were indeed the root cause of all of my many years of pain and suffering.I quickly learned about a doctor out of (b)(6) who specializes and advocates in breast implant diseases and breast implant removals.I then started a regular correspondence with this doctor and set an appointment to have my implants removed.Prior to my removal surgery, my blood laboratory results showed the presence of mycoplasma pneumonia.This alarmed me as i learned the nature of this harmful microorganism that invaded by body as a result of tainted implants and a suppressed immunity.It turns out that for years, my body was fighting a silent battle that eventually began showing its face with the onset of my initial symptoms years earlier.All of the years that went by with little to no answers or reputable treatments, the mycoplasma was wreaking havoc within my body and terribly stressing my immune system.When my breast implant removal surgery day came about, my surgeon was not surprised to see that my breast tissues surrounding the implants were badly infected and growing mold and fungus.Five infected lymph nodes were removed that were located near the breast, along with the infected tissues, and of course the implants themselves.My surgeon who performed the removal, also explained that the mycoplasma pneumonia was residing within any and all regions of by body including major internal organs.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key5221831
MDR Text Key31193114
Report NumberMW5057846
Device Sequence Number1
Product Code FWM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number5530938
Device Lot Number475 CC
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/09/2015
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age42 YR
Patient Weight70