MAUDE Adverse Event Report: MENTOR MENTOR SALINE IMPLANTS

Model Number 350-1655

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

Patient Problems Edema (1820); Fatigue (1849); Hair Loss (1877); Headache (1880); Pain (1994); Rash (2033); Complaint, Ill-Defined (2331); Palpitations (2467); Sleep Dysfunction (2517)

Event Date 01/01/2017

Event Type  Injury  

Event Description

I got breast implants and they've made me very sick. After implants, my hormone levels plummeted (i've been to specialist who could not help me) and they were 100% healthy a month before implants. I have widespread pain, heart palpitations, extreme hair loss, rashes, insomnia, chronic fatigue, migraines, edema all over, etc. I was healthy before these implants. I will explant next week to get my life back.

• Brand Name: MENTOR SALINE IMPLANTS
• Type of Device: MENTOR SALINE IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6968220
• MDR Text Key: 90106034
• Report Number: MW5072871
• 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: 10/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes

Device Operator

• Device Model Number: 350-1655
• 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: 10/23/2017 Patient Sequence Number: 1