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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANT

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MENTOR SALINE BREAST IMPLANT Back to Search Results
Model Number SALINE
Device Problem Degraded (1153)
Patient Problems Dyspnea (1816); Fatigue (1849); Hair Loss (1877); Pain (1994); Arthralgia (2355); Sleep Dysfunction (2517); Confusion/ Disorientation (2553)
Event Date 11/17/2016
Event Type  Injury  
Event Description
On (b)(6) 2016 i had to undergo a 7 hour surgery to remove the toxic mentor saline implants that have been deteriorating my health for years.Capsules were thick, yellowish and my chest full of yellow murk liquid.Right implant was yellow and full of particles inside.Before this surgery, i suffered from insomnia, fatigue, joint pain, back pain, brain fog, hair loss, dry skin, acne, difficulty breathing and others.After surgeon removed the implants, my health has improved by at least 90 percent.It's clear that the silicone toxins released through the shells were attacking my autoimmune system.
 
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Brand Name
SALINE BREAST IMPLANT
Type of Device
SALINE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6338997
MDR Text Key67848536
Report NumberMW5067929
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 02/15/2017
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? Yes
Device Operator No Information
Device Model NumberSALINE
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/15/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Age38 YR
Patient Weight62
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