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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
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes Fatigue (1849); Swelling (2091); Weakness (2145); Tingling (2171); Arthralgia (2355)
Type of Reportable Event Serious Injury
Event or Problem 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
Common Device Name
SILICONE BREAST IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6568640
Report NumberMW5069787
Device Sequence Number11824724
Product Code FTR
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2004
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 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
Operator of Device No Information
Device Model Number350-1640
Device Lot Number5542113
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date05/14/2017
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
INSULIN; INSULIN PUMP; IODINE SUPPLEMENT; MINERALS; MULTIVITAMIN
Outcome Attributed to Adverse Event Disability;
Patient Age58 YR
Patient Weight70
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