MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Visual Impairment (2138); Dizziness (2194)

Event Date 09/01/2015

Event Type  Injury  

Event 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
• Type of Device: BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6756634
• MDR Text Key: 81582128
• Report Number: MW5071315
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 30 YR
• Patient Weight: 50