MAUDE Adverse Event Report: MENTOR MENTOR SALINE IMPLANTS

Model Number	350-1655
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Fatigue (1849); Hair Loss (1877); Headache (1880); Pain (1994); Rash (2033); Complaint, Ill-Defined (2331); Palpitations (2467); Sleep Dysfunction (2517)
Date of Event	01/01/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: MENTOR SALINE IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6968220
• Report Number: MW5072871
• Device Sequence Number: 9968861
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 10/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Model Number: 350-1655
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Weight: 82