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U.S. Department of Health and Human Services


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Device Problems Leak/Splash (1354); Microbial Contamination of Device (2303); Defective Device (2588)
Patient Problems Chest Pain (1776); Fatigue (1849); Headache (1880); Unspecified Infection (1930); Memory Loss/Impairment (1958); Pain (1994); Rash (2033); Vertigo (2134); Dizziness (2194); Anxiety (2328); Depression (2361); Numbness (2415); Sleep Dysfunction (2517)
Event Date 11/01/1999
Event Type  Injury  
Event Description
In october, 1999, i had my plastic surgeon put in mentor saline implants, smooth over the muscle.I had several contractors of the capsule.In about 2003 or thereabouts, i went on disability with an array of problems.Initially, ra, depression, fm ,and was put on drugs that made me worse and i had 3 heat strokes.My health never got better, but i continued with other issues.Changes in thyroid, polyarthritis, rls, rashes, pain and numbness in left arm and right hand, vertigo, loss of balance, dizziness, cognitive dysfunction, fatigue, memory loss, hair loss, deep chest wall pain, nodules in lungs, sleep apnea, adrenal, severe insomnia, anxiety attacks, slow to heal, headaches, back problems, neck pain, joint issues, and more.It was not until i did some research in (b)(6) 2015 that i realized it may be leaking implants.I had surgery with dr.(b)(6), in (b)(6).On (b)(6) 2016.She found mold in my left implant, yeast and bacteria, and my implants were leaking, the valves were defective.I am going on (b)(6) and still disabled.I am getting a little better but i want some compensation for all the missed years of life due to faulty implants.I was not told of all the complications one could have with implants.I was aware of infection and surgical disruption but not that they would leak and cause harm.When i contacted the plastic surgeon, he said they did not have to be removed ever."don't fix what ain't broke" and an "elephant could sit on you and they will not leak or burst".
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Brand Name
Type of Device
Manufacturer (Section D)
MDR Report Key5633649
MDR Text Key44615043
Report NumberMW5062082
Device Sequence Number1
Product Code MRD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/02/2016
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
Device Operator No Information
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/02/2016
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention; Disability;
Patient Age62 YR
Patient Weight66