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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Nausea (1970); Weight Changes (2607); No Code Available (3191)
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 Name
SMOOTH GEL IMPLANTS
Type of Device
PROSTHESIS BREAST
Manufacturer (Section D)
MENTOR
MDR Report Key6971193
MDR Text Key90286204
Report NumberMW5072899
Device Sequence Number1
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 10/22/2017
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 Number350-7200BC
Device Lot Number5536124
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/24/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Disability;
Patient Weight57
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