MAUDE Adverse Event Report: ALLERGAN NATRELLE SALINE BREAST IMPLANT; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number UNKNOWN

Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546); Unintended Movement (3026)

Patient Problems Seroma (2069); Complaint, Ill-Defined (2331); Impaired Healing (2378)

Event Date 01/15/2020

Event Type  Injury  

Event Description

Left implant moved to armpit and it looks like its rolling up as it migrates down my ribcage.The right implant ruptured and the silicon shell is not showing on mammogram or other tests.When i got the implants i had lots of complications too.I had one that was higher and muscle was treated with botox, seromas that would not heal, etc.I am now having problems effecting the nerves in my left hand due to the constantly moving position of the implant.I am really losing some of the best days of life because of the complications of this surgery.Fda safety report id # (b)(4).

• Brand Name: NATRELLE SALINE BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): ALLERGAN
• MDR Report Key: 9733154
• MDR Text Key: 180625695
• Report Number: MW5093107
• 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: 02/15/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2021
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability