MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) UNK GEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number UNK GEL BREAST IMPLANT

Device Problems Material Rupture (1546); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 03/15/2019

Event Type  Injury  

Manufacturer Narrative

Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: rupture and silicone migration.

Event Description

Regulatory agency received a patient report of "rupture / leak, breast swelling, shape change, silicone in lymph nodes.".Patient reported "rupture and silicone in my lymph nodes." this record refers to left side.The device remains implanted.

Manufacturer Narrative

Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.Device evaluation: visual analysis of the photographs identified: device is seen ruptured and opening (anterior and posterior side).Device analysis performed through photographs, due to the impossibility to perform microscopic analysis it is not possible to determine the most likely failure mode.

Event Description

Patient additionally reported "diagnosed with multiple sclerosis"; this event is not device related.Device has been explanted.

• Brand Name: UNK GEL BREAST IMPLANT
• Type of Device: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 9656066
• MDR Text Key: 177408108
• Report Number: 9617229-2019-19044
• Device Sequence Number: 1
• Product Code: FTR
• Combination Product (y/n): N
• PMA/PMN Number: P020056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK GEL BREAST IMPLANT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR