MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Visual Impairment (2138); Dizziness (2194)
Date of Event	09/01/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Got saline breast implants.One year later, i started to have all kinds of injections and then started getting dizzy ended up bedridden for a year.At the age of (b)(6) my vision started to go.Every part of my body was shutting down and no dr.Could tell me why.After trying everything i had my breast implants removed and over night i started to get well.It's been a year now and i thank god i have another chance at life.They are poison and doing this to so many women.The symptoms seem so unrelated that it's the last thing you would think of even being as sick as i was.Please help take these off the market and save lives.

• Brand Name: SALINE BREAST IMPLANTS
• Common Device Name: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6756634
• Report Number: MW5071315
• Device Sequence Number: 12298803
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 07/30/2017
• 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
• Operator of Device: No Information
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Disability
• Patient Age: 30 YR
• Patient Weight: 50