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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE BREAST IMPLANT
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MENTOR SILICONE BREAST IMPLANT Back to Search Results
Model Number 350-1640
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Fatigue (1849); Swelling (2091); Weakness (2145); Tingling (2171); Arthralgia (2355)
Event Type  Injury  
Event Description
Silicone implants causing symptoms such as weakness, as if something is sucking the life out of me, low thyroid, low wbc count, intense joint and muscle pain.I can hardly walk, my knees lock up, and i am only (b)(6), depression at times, due to weakness.Swollen hands, tingling in the hands and arms when i bend my joints.Had frozen shoulder.I feel weak more as time goes by.I have had the implants since 1998, had them removed and put new ones in from mentor back in 2004, before the fda lifted the ban on implants.Apparently mentor did not get the message about a ban on implants.Now all i want is my life back.To be able to walk and have energy again, and hopefully for the arthritis symptoms to diminish.
 
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Brand Name
SILICONE BREAST IMPLANT
Type of Device
SILICONE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6568640
MDR Text Key75368922
Report NumberMW5069787
Device Sequence Number1
Product Code FTR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/14/2017
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? No
Device Operator No Information
Device Model Number350-1640
Device Lot Number5542113
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/14/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
INSULIN; INSULIN PUMP; IODINE SUPPLEMENT; MINERALS; MULTIVITAMIN
Patient Outcome(s) Disability;
Patient Age58 YR
Patient Weight70
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