MAUDE Adverse Event Report: ALLERGAN NATRELLE 68HP

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Chest Pain (1776); Headache (1880); Unspecified Infection (1930); Memory Loss/Impairment (1958); Skin Irritation (2076); Loss of Vision (2139); Burning Sensation (2146); Myalgia (2238); Arthralgia (2355)

Event Date 03/14/2013

Event Type  Injury  

Event Description

Breast implant in (b)(6) 2012, then i started to get around (b)(6) 2013 reoccurring infections, unexplained joint and muscle pain, severe headaches, vision and memory loss, skin issues, multiple er visits, the list goes on.Recently, (b)(6) 2017, breast and nipple pain, feeling of fire, sharp chest pain.On (b)(6) 2017 breast implant removal, due to pain.There is floaties in my saline implants and the valves are brown on inside.Definitely contaminated.Allergan natrelle 68hp saline breast implant."is the product compounded: yes; did the problem stop after the person reduced the dose or stopped taking or using the product: yes." breast augmentation.

• Brand Name: NATRELLE 68HP
• Type of Device: NATRELLE 68HP
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 6669446
• MDR Text Key: 78612371
• Report Number: MW5070632
• Device Sequence Number: 1
• Product Code: FWM
• 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: 06/24/2017
• 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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 59