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: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MULTIVITAMIN; OTC MEDS: MAGNESIUM; PROBIOTIC; RX MEDS: FLOVENT INHALER; VITAMIN D
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 29 YR
• Patient Weight: 50