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: 2
• 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: No Information
• Device Model Number: 350-1655
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Weight: 82