MAUDE Adverse Event Report: MENTOR COHESIVE MEMORYGEL IMPLANT

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.

• Brand Name: COHESIVE MEMORYGEL IMPLANT
• Type of Device: COHESIVE MEMORYGEL IMPLANT
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6559898
• MDR Text Key: 75009673
• Report Number: MW5069691
• Device Sequence Number: 1
• Product Code: FTR
• Number of Events Reported: 1
• 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 Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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