MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) STYLE 410 COHESIVE SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number FF-410740

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Lymphoma (3263)

Event Type  Injury  

Manufacturer Narrative

A review of the device history record has been completed.No deviations or non-conformances noted.The event of lymphoma is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation due to "patient tested positive for cd30 marker alcl." further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported "patient tested positive for cd30 marker alcl." this record is for the left side.Device status is unknown.

Event Description

Patient representative reported left side "diagnosed with breast implant associated-anaplastic large cell lymphoma (¿bia-alcl¿), ¿endured pain," and "recalled biocell implants." patient representative additionally reported "suffering, disability, impairment, disfigurement, inconvenience, loss of enjoyment of life, aggravation or activation of preexisting conditions, scarring," deemed not related to the device.The device has been explanted and capsulectomy.

Manufacturer Narrative

Additional, changed, and/or corrected data: b.6., b.5., b.6., b.7., d.6b., g.1., g.2., h.6.

• Brand Name: STYLE 410 COHESIVE SILICONE GEL FILLED 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
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 8960044
• MDR Text Key: 156429382
• Report Number: 9617229-2019-13121
• Device Sequence Number: 1
• Product Code: FTR
• UDI-Device Identifier: 10888628002739
• UDI-Public: 10888628002739
• Combination Product (y/n): N
• PMA/PMN Number: P040046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2020
• Device Model Number: FF-410740
• Device Catalogue Number: FF-410740
• Device Lot Number: 2784453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female