MAUDE Adverse Event Report: MENTOR SALINE BREAST IMPLANTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Memory Loss/Impairment (1958); Muscle Weakness (1967); Respiratory Distress (2045); Visual Impairment (2138); Tingling (2171); Anxiety (2328); Arthralgia (2355); Numbness (2415); Ambulation Difficulties (2544); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 08/01/2007

Event Type  Injury  

Event Description

I was actually sick from 2008 - 2015 from mentor saline breast implants. My symptoms started two weeks after getting them. Extreme anxiety, numbness tingling, severe joint pain, brain fog, memory loss, confusion, vision problems, major food allergies, difficulty walking, malabsorption, breathing issues, muscle atrophy, hormonal issues. I had a full hysterectomy six months after getting the implants.

• Brand Name: SALINE BREAST IMPLANTS
• Type of Device: SALINE BREAST IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6857635
• MDR Text Key: 85924185
• Report Number: MW5072099
• 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: 09/09/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• 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: 09/12/2017 Patient Sequence Number: 1