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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SMOOTH GEL IMPLANTS PROSTHESIS BREAST

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MENTOR SMOOTH GEL IMPLANTS PROSTHESIS BREAST Back to Search Results
Model Number 350-7200BC
Event Date 08/15/2012
Event Type  Injury  
Event Description

Two major issues, deformity and a rare autoimmune disease seen in much older adults. Implants placed under a mentor trial in 2004, in 2005 i had revision surgery all the right implant capsulized within six months. Six months after that surgery the left capsulized; however, surgery was not safe at the time. Eventually by 2007 both implants were capsulized. Even though i was under a trial study, mentor never contacted me and i don't think the surgeon reported as per the agreement i signed. Then i got very sick in 2012 when i got a diagnosis of polymyalgia rheumatica a crippling autoimmune disease seen in senior adults. Only effects hip and shoulder joints. I was unable to walk or open windows or cupboards. Health deteriorates i lose 25 pounds and blood tests in 2015 suggest cancer. Thoroughly screened blood tests, mri, ctscan, ultrasound, endoscopy and colonoscopy. Constant fatigue, nausea, weight loss and ibs. No tumors found despite a positive test for tumor.

 
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Brand NameSMOOTH GEL IMPLANTS
Type of DevicePROSTHESIS BREAST
Manufacturer (Section D)
MENTOR
MDR Report Key6971193
Report NumberMW5072899
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 10/22/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received10/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number350-7200BC
Device LOT Number5536124
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/24/2017 Patient Sequence Number: 1
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