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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE IMPLANTS; BREAST IMPLANTS
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MENTOR SILICONE IMPLANTS; BREAST IMPLANTS Back to Search Results
Model Number 354-2007
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fatigue (1849); Headache (1880); Inflammation (1932); Pain (1994); Skin Discoloration (2074); Blurred Vision (2137); Weakness (2145); Burning Sensation (2146); Anxiety (2328); Depression (2361); Weight Changes (2607)
Event Date 01/09/2000
Event Type  Injury  
Event Description
In 1998, i had a reconstructive surgery and mentor brand, textured, silicone implants were implanted.My first symptoms in early 2000 with migraines.Then depression and daily anxiety became an issue.I have been on prescription medications for those.Around 2005, i started having raynaud's disease which always affects my nipple and toes when cold.Here are all the ongoing symptoms: migraines, anxiety, fatigue, temperature intolerance, sensitivity to smells, burning pain in breasts, inflammation in breasts, weakness, chronic back pain, whole body dryness, pigment discoloration, blurred vision, word retrieval, concentration, and rapid weight gain.
 
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Brand Name
SILICONE IMPLANTS
Type of Device
BREAST IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6964414
MDR Text Key89934499
Report NumberMW5072854
Device Sequence Number2
Product Code FTR
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 10/18/2017
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number354-2007
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age50 YR
Patient Weight103
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