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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR COHESIVE MEMORYGEL IMPLANT

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MENTOR COHESIVE MEMORYGEL IMPLANT Back to Search Results
Device Problem Material Rupture (1546)
Patient Problems Dry Eye(s) (1814); Fatigue (1849); Hematoma (1884); Pneumonia (2011); Blurred Vision (2137); Dizziness (2194); Anxiety (2328); Confusion/ Disorientation (2553)
Event Date 01/01/2017
Event Type  Injury  
Event Description

I had smooth mentor memorygel breast implants placed under the muscle 2. 5 years ago. Shortly after, i began to experience a myriad of unexplained symptoms including anxiety, thyroid levels off, debilitating fatigue, dry eyes, blurred vision, brain fog, dizziness, etc. This began to get out of hand this (b)(6) and i began to research to figure out what was going on. After (b)(6) of lab work, my dad mentioned seeing a news broadcast about toxic breast implants. My last hope was to check these out via breast mri. There i saw my right implant was completely ruptured. I have had no trauma or anything to cause such a rupture, especially after having the implants for such a short period of time. They are supposed to last 10 years. I fortunately found a (b)(6) support group for women with breast implant illness, what i believed to have. There are 20,000 of us there with the same stories. I explanted the implants on (b)(6) 2017 and shortly after, developed a hematoma (in the area the silicone had to be scraped away from around my collar bone) which burst, leading to a second surgery. After that, i developed pneumonia. This has been a terrible month and year for me. My medical bills from this are near (b)(6) and it's just not right. These devices are not safe.

 
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Brand NameCOHESIVE MEMORYGEL IMPLANT
Type of DeviceCOHESIVE MEMORYGEL IMPLANT
Manufacturer (Section D)
MENTOR
MDR Report Key6559898
MDR Text Key75009673
Report NumberMW5069691
Device Sequence Number2
Product Code FTR
Combination Product (Y/N)
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 05/09/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received05/09/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
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: 05/09/2017 Patient Sequence Number: 1
Treatment
MULTIVITAMIN; OTC MEDS: MAGNESIUM; PROBIOTIC; RX MEDS: FLOVENT INHALER; VITAMIN D
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